Trial Outcomes & Findings for A Clinical Investigation of the ClarVista HARMONI™ Modular Intraocular Lens Implant Following Cataract Surgery (NCT NCT02521766)
NCT ID: NCT02521766
Last Updated: 2020-05-14
Results Overview
Visual acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS)-Fast method under well-lit conditions at a distance of 4 meters (m) with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
217 participants
Primary outcome timeframe
Month 1 postoperative, Month 3 postoperative
Results posted on
2020-05-14
Participant Flow
Subjects were recruited from 3 investigational sites located in the Philippines (2) and New Zealand (1).
Of the 217 enrolled, 101 subjects did exit the study prior to implantation, and 2 subjects failed implantation of Harmoni Modular Intraocular Lens (HMIOL). This reporting group includes all subjects with successful HMIOL implantation (114) by subgroup (Cohort 1 and Cohort 2).
Participant milestones
| Measure |
Cohort 1
HMIOL implantation with no optic exchange
|
Cohort 2
HMIOL implantation with optic exchange
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
65
|
|
Overall Study
Per Protocol
|
47
|
65
|
|
Overall Study
COMPLETED
|
44
|
62
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Investigation of the ClarVista HARMONI™ Modular Intraocular Lens Implant Following Cataract Surgery
Baseline characteristics by cohort
| Measure |
Cohort 1
n=47 Participants
HMIOL implantation with no optic exchange
|
Cohort 2
n=65 Participants
HMIOL implantation with optic exchange
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 6.9 • n=99 Participants
|
65.4 years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
66.0 years
STANDARD_DEVIATION 6.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
28 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
19 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 1 postoperative, Month 3 postoperativePopulation: Per Protocol Population, with available data at the visit
Visual acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS)-Fast method under well-lit conditions at a distance of 4 meters (m) with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=112 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort
Month 1 postoperative
|
99.1 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort
Month 3 postoperative
|
100.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperativePopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=47 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1
Month 1 postoperative
|
100.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1
Month 3 postoperative
|
100.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1
Month 6 postoperative
|
100.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1
Month 12 postoperative
|
100.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchangePopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned
Outcome measures
| Measure |
All HMIOL Cohort
n=65 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2
Month 1 postoperative
|
98.5 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2
Month 3 postoperative
|
100 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2
Week 1 post-optic exchange
|
100 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2
Month 3 post-optic exchange
|
100 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2
Month 6 post-optic exchange
|
100 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2
Month 12 post-optic exchange
|
96.8 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2
Month 1 post-optic exchange
|
100 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 postoperative, Month 3 postoperative, Month 12 postoperativePopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=111 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye
Month 1 postoperative
|
100.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye
Month 3 postoperative
|
100.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye
Month 12 postoperative
|
100.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 1 postoperative, Month 1 postoperative, Month 3 postoperativePopulation: Per Protocol Population, with available data at the visit
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=112 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort
Week 1 postoperative: Within ± 0.5 D of Target
|
33.9 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort
Week 1 postoperative: Within ± 1.0 D of Target
|
70.6 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort
Month 1 postoperative: Within ± 0.5 D of Target
|
26.8 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort
Month 1 postoperative: Within ± 1.0 D of Target
|
61.6 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort
Month 3 postoperative: Within ± 0.5 D of Target
|
19.6 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort
Month 3 postoperative: Within ± 1.0 D of Target
|
52.7 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperativePopulation: Per Protocol Population, with available data at the visit
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=47 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1
Week 1 postoperative: Within ± 0.5 D of Target
|
31.1 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1
Week 1 postoperative: Within ± 1.0 D of Target
|
57.8 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1
Month 1 postoperative: Within ± 0.5 D of Target
|
23.4 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1
Month 1 postoperative: Within ± 1.0 D of Target
|
48.9 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1
Month 3 postoperative: Within ± 0.5 D of Target
|
19.1 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1
Month 3 postoperative: Within ± 1.0 D of Target
|
44.7 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1
Month 6 postoperative: Within ± 0.5 D of Target
|
14.9 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1
Month 6 postoperative: Within ± 1.0 D of Target
|
44.7 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1
Month 12 postoperative: Within ± 0.5 D of Target
|
20.9 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1
Month 12 postoperative: Within ± 1.0 D of Target
|
37.2 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchangePopulation: Per Protocol Population, with available data at the visit
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=65 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Month 12 post-exchange: Within ± 1.0 D of Target
|
95.2 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Week 1 postoperative: Within ± 0.5 D of Target
|
35.9 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Week 1 postoperative: Within ± 1.0 D of Target
|
79.7 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Month 1 postoperative: Within ± 0.5 D of Target
|
29.2 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Month 1 postoperative: Within ± 1.0 D of Target
|
70.8 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Month 3 postoperative: Within ± 0.5 D of Target
|
20.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Month 3 postoperative: Within ± 1.0 D of Target
|
58.5 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Week 1 post-exchange: Within ± 0.5 D of Target
|
76.9 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Week 1 post-exchange: Within ± 1.0 D of Target
|
98.5 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Month 1 post-exchange: Within ± 0.5 D of Target
|
82.8 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Month 1 post-exchange: Within ± 1.0 D of Target
|
100.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Month 3 post-exchange: Within ± 0.5 D of Target
|
81.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Month 3 post-exchange: Within ± 1.0 D of Target
|
98.4 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Month 6 post-exchange: Within ± 0.5 D of Target
|
84.1 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Month 6 post-exchange: Within ± 1.0 D of Target
|
100.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
Month 12 post-exchange: Within ± 0.5 D of Target
|
77.4 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 1 postoperative, Month 3 postoperative, Month 12 postoperativePopulation: Per Protocol Population, with available data at the visit
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=111 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye
Month 1 postoperative: Within ± 0.5 D of Target
|
78.5 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye
Month 1 postoperative: Within ± 1.0 D of Target
|
98.1 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye
Month 3 postoperative: Within ± 0.5 D of Target
|
81.1 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye
Month 3 postoperative: Within ± 1.0 D of Target
|
99.1 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye
Month 12 postoperative: Within ± 0.5 D of Target
|
72.2 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye
Month 12 postoperative: Within ± 1.0 D of Target
|
97.2 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -90 to Day -1 preoperative, Month 1 postoperative, Month 3 postoperativePopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=112 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort
Month 1 postoperative
|
84.6 letters
Standard Deviation 4.5
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort
Month 3 postoperative
|
85.4 letters
Standard Deviation 3.8
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort
Day -90 to Day -1 preoperative
|
75.2 letters
Standard Deviation 14.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperativePopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=47 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 1
Day -90 to -1 preoperative
|
79.9 letters
Standard Deviation 9.4
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 1
Month 1 postoperative
|
85.8 letters
Standard Deviation 3.6
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 1
Month 3 postoperative
|
86.7 letters
Standard Deviation 3.5
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 1
Month 6 postoperative
|
86.2 letters
Standard Deviation 3.9
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 1
Month 12 postoperative
|
86.2 letters
Standard Deviation 4.5
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchangePopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange.This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=65 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 2
Week 1 post-optic exchange
|
84.5 letters
Standard Deviation 4.4
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 2
Month 1 post-optic exchange
|
85.1 letters
Standard Deviation 4.0
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 2
Month 3 post-optic exchange
|
85.2 letters
Standard Deviation 4.0
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 2
Day -90 to -1 preoperative
|
71.8 letters
Standard Deviation 16.1
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 2
Month 1 postoperative
|
83.7 letters
Standard Deviation 4.9
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 2
Month 3 postoperative
|
84.4 letters
Standard Deviation 3.8
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 2
Month 6 post-optic exchange
|
85.6 letters
Standard Deviation 3.5
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Cohort 2
Month 12 post-optic exchange
|
83.5 letters
Standard Deviation 9.9
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 12 postoperativePopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was rrecorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=114 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Mean BCDVA (Letters Read) by Study Visit - Fellow Eye
Month 1 postoperative
|
86.3 letters
Standard Deviation 4.0
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Fellow Eye
Month 3 postoperative
|
86.9 letters
Standard Deviation 3.4
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Fellow Eye
Month 12 postoperative
|
86.9 letters
Standard Deviation 3.5
|
—
|
—
|
—
|
—
|
—
|
|
Mean BCDVA (Letters Read) by Study Visit - Fellow Eye
Day -90 to -1 preoperative
|
74.5 letters
Standard Deviation 17.9
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperativePopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=112 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort
Day 1 postoperative
|
71.5 letters
Standard Deviation 11.0
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort
Week 1 postoperative
|
70.4 letters
Standard Deviation 10.1
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort
Month 1 postoperative
|
70.6 letters
Standard Deviation 10.2
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort
Month 3 postoperative
|
73.4 letters
Standard Deviation 9.3
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperativePopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=47 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1
Week 1 postoperative
|
73.7 letters
Standard Deviation 9.2
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1
Month 1 postoperative
|
75.4 letters
Standard Deviation 8.3
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1
Month 3 postoperative
|
77.1 letters
Standard Deviation 8.2
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1
Month 6 postoperative
|
78.1 letters
Standard Deviation 7.3
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1
Month 12 postoperative
|
77.9 letters
Standard Deviation 6.9
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1
Day 1 postoperative
|
74.8 letters
Standard Deviation 10.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchPopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=65 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2
Month 1 postoperative
|
67.2 letters
Standard Deviation 10.2
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2
Month 3 postoperative
|
70.7 letters
Standard Deviation 9.2
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2
Day 1 post-optic exchange
|
76.8 letters
Standard Deviation 13.4
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2
Week 1 post-optic exchange
|
79.8 letters
Standard Deviation 6.0
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2
Month 1 post-optic exchange
|
80.7 letters
Standard Deviation 6.4
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2
Month 3 post-optic exchange
|
81.1 letters
Standard Deviation 5.5
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2
Month 6 post-optic exchange
|
81.2 letters
Standard Deviation 5.4
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2
Month 12 post-optic exchange
|
78.2 letters
Standard Deviation 13.4
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2
Day 1 postoperative
|
69.1 letters
Standard Deviation 10.9
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2
Week 1 postoperative
|
68.1 letters
Standard Deviation 10.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperativePopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=114 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye
Month 1 postoperative
|
81.3 letters
Standard Deviation 5.8
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye
Month 3 postoperative
|
82.4 letters
Standard Deviation 5.4
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye
Day 1 postoperative
|
80.6 letters
Standard Deviation 8.0
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye
Week 1 postoperative
|
81.3 letters
Standard Deviation 6.4
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye
Month 6 postoperative
|
83.0 letters
Standard Deviation 5.0
|
—
|
—
|
—
|
—
|
—
|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye
Month 12 postoperative
|
82.1 letters
Standard Deviation 5.5
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchangePopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye, Cohort 2 only. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=65 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
n=65 eyes
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
n=64 eyes
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
n=63 eyes
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
n=63 eyes
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
n=63 eyes
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2
20/20 Snellen or Better
|
41.5 percentage of eyes
|
47.7 percentage of eyes
|
53.1 percentage of eyes
|
49.2 percentage of eyes
|
55.6 percentage of eyes
|
50.0 percentage of eyes
|
|
Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2
20/25 Snellen or Better
|
67.7 percentage of eyes
|
69.2 percentage of eyes
|
70.3 percentage of eyes
|
81.0 percentage of eyes
|
79.4 percentage of eyes
|
74.2 percentage of eyes
|
|
Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2
20/32 Snellen or Better
|
80.0 percentage of eyes
|
87.7 percentage of eyes
|
92.2 percentage of eyes
|
93.7 percentage of eyes
|
93.7 percentage of eyes
|
83.9 percentage of eyes
|
|
Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2
20/40 Snellen or Better
|
87.7 percentage of eyes
|
93.8 percentage of eyes
|
96.9 percentage of eyes
|
96.8 percentage of eyes
|
98.4 percentage of eyes
|
95.2 percentage of eyes
|
|
Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2
Worse than 20/40 Snellen
|
12.3 percentage of eyes
|
6.2 percentage of eyes
|
3.1 percentage of eyes
|
3.2 percentage of eyes
|
1.6 percentage of eyes
|
4.8 percentage of eyes
|
PRIMARY outcome
Timeframe: Month 3 postoperativePopulation: Per Protocol Population, with available data at the visit
VA was assessed using the ETDRS-Fast method under mesopic (dimly lit) conditions at a distance of 4 m with the correction obtained from manifest refraction testing. Testing was performed with and without glare. Chart luminance was set to 3 cd/m2. mBCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye, All HMIOL Cohort only. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
All HMIOL Cohort
n=112 eyes
HMIOL implantation with or without optic exchange
|
Cohort 2 Week 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 1 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 3 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 6 Post-optic Exchange
HMIOL implantation with optic exchange
|
Cohort 2 Month 12 Post-optic Exchange
HMIOL implantation with optic exchange
|
|---|---|---|---|---|---|---|
|
Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort
With glare
|
81.0 letters
Standard Deviation 4.9
|
—
|
—
|
—
|
—
|
—
|
|
Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort
Without glare
|
81.1 letters
Standard Deviation 5.6
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1 (Ocular)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2 Pre-exchange (Ocular)
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 Post-exchange (Ocular)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Fellow Eye (Ocular)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Systemic (Non-ocular)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (Ocular)
n=51 participants at risk
HMIOL implantation with no optic exchange
Events reported in this group occurred in the study eye from time of consent to study exit (up to 15 months)
|
Cohort 2 Pre-exchange (Ocular)
n=65 participants at risk
HMIOL implantation pre-optic exchange
Events reported in this group occurred in the study eye from time of consent to time of optic exchange (up to 6 months)
|
Cohort 2 Post-exchange (Ocular)
n=65 participants at risk
HMIOL implantation post-optic exchange
Events reported in this group occurred in the study eye from time of optic exchange to time of study exit (up to 12 months)
|
Fellow Eye (Ocular)
n=114 participants at risk
IOL per standard of care
Events reported in this group occurred in the fellow eye from time of consent to study exit (up to 15 months if study eye was enrolled in Cohort 1, up to 18 months if study eye was enrolled in Cohort 2)
|
Systemic (Non-ocular)
n=114 participants at risk
Events reported in this group occurred from time of consent to study exit (up to 15 months if subject was enrolled in Cohort 1, up to 18 months if subject was enrolled in Cohort 2)
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/51 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.88%
1/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/51 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.88%
1/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/51 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.88%
1/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
|
Eye disorders
Posterior Capsule Rupture
|
2.0%
1/51 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.00%
0/51 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.88%
1/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/51 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.88%
1/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/51 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.88%
1/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
|
Surgical and medical procedures
Eye operation
|
0.00%
0/51 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
1.5%
1/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
|
Surgical and medical procedures
Intraocular lens implant
|
2.0%
1/51 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/51 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
1.5%
1/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
Other adverse events
| Measure |
Cohort 1 (Ocular)
n=51 participants at risk
HMIOL implantation with no optic exchange
Events reported in this group occurred in the study eye from time of consent to study exit (up to 15 months)
|
Cohort 2 Pre-exchange (Ocular)
n=65 participants at risk
HMIOL implantation pre-optic exchange
Events reported in this group occurred in the study eye from time of consent to time of optic exchange (up to 6 months)
|
Cohort 2 Post-exchange (Ocular)
n=65 participants at risk
HMIOL implantation post-optic exchange
Events reported in this group occurred in the study eye from time of optic exchange to time of study exit (up to 12 months)
|
Fellow Eye (Ocular)
n=114 participants at risk
IOL per standard of care
Events reported in this group occurred in the fellow eye from time of consent to study exit (up to 15 months if study eye was enrolled in Cohort 1, up to 18 months if study eye was enrolled in Cohort 2)
|
Systemic (Non-ocular)
n=114 participants at risk
Events reported in this group occurred from time of consent to study exit (up to 15 months if subject was enrolled in Cohort 1, up to 18 months if subject was enrolled in Cohort 2)
|
|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
3.9%
2/51 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
1.5%
1/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
9.2%
6/65 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
4.4%
5/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
0.00%
0/114 • Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
|
Additional Information
Sr. Clinical Trial Lead, CDMA Surgical
Alcon Research, LLC
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER