Trial Outcomes & Findings for Clinical Investigation of a New Intraocular Lens (NCT NCT02203721)
NCT ID: NCT02203721
Last Updated: 2017-01-11
Results Overview
FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
324 participants
Primary outcome timeframe
At 6 months
Results posted on
2017-01-11
Participant Flow
Beginning August 27, 2014, a total of 324 subjects were enrolled (consented) in the study and 299 of these subjects were implanted with a study lens in at least one operative eye between September 16, 2014, and February 10, 2015, across 15 U.S. clinical sites.
A total of 23 subjects were consented but were not assigned to a group due to failure to meet inclusion/exclusion criteria, withdrawn consent, non-ocular health, or lost-to-follow-up.
Participant milestones
| Measure |
TECNIS Intraocular Lens, Model ZXR00
Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
|
TECNIS Intraocular Lens, Model ZCB00
Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
151
|
|
Overall Study
COMPLETED
|
147
|
148
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
TECNIS Intraocular Lens, Model ZXR00
Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
|
TECNIS Intraocular Lens, Model ZCB00
Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Illness
|
0
|
1
|
Baseline Characteristics
Clinical Investigation of a New Intraocular Lens
Baseline characteristics by cohort
| Measure |
TECNIS Intraocular Lens, Model ZXR00
n=148 Participants
Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
|
TECNIS Intraocular Lens, Model ZCB00
n=151 Participants
Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
|
Total
n=299 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
63 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Age, Continuous
|
68.0 Years
STANDARD_DEVIATION 7.5 • n=99 Participants
|
67.9 Years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
67.9 Years
STANDARD_DEVIATION 7.7 • n=206 Participants
|
|
Gender
Female
|
91 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Gender
Male
|
57 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
148 participants
n=99 Participants
|
151 participants
n=107 Participants
|
299 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Intent to Treat Population
FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
Outcome measures
| Measure |
TECNIS Intraocular Lens, Model ZXR00
n=147 Participants
Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
|
TECNIS Intraocular Lens, Model ZCB00
n=148 Participants
Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
|
|---|---|---|
|
Distance Corrected Intermediate Visual Acuity
|
0.105 LogMAR
Standard Error 0.009
|
0.343 LogMAR
Standard Error 0.013
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent to Treat population
Uncorrected Intermediate Visual Acuity at 6 months.
Outcome measures
| Measure |
TECNIS Intraocular Lens, Model ZXR00
n=147 Participants
Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
|
TECNIS Intraocular Lens, Model ZCB00
n=148 Participants
Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
|
|---|---|---|
|
Uncorrected Intermediate Visual Acuity
|
0.087 LogMAR
Standard Error 0.009
|
0.258 LogMAR
Standard Error 0.014
|
Adverse Events
TECNIS Intraocular Lens, Model ZXR00
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
TECNIS Intraocular Lens, Model ZCB00
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TECNIS Intraocular Lens, Model ZXR00
n=148 participants at risk
Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
|
TECNIS Intraocular Lens, Model ZCB00
n=151 participants at risk
Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
|
|---|---|---|
|
Eye disorders
Cystoid Macular Edema
|
1.4%
2/148 • Number of events 2 • 6 months
|
3.3%
5/151 • Number of events 5 • 6 months
|
|
Eye disorders
Pupillary Capture
|
0.68%
1/148 • Number of events 1 • 6 months
|
0.00%
0/151 • 6 months
|
|
Eye disorders
Endophthalmitis
|
0.68%
1/148 • Number of events 1 • 6 months
|
0.00%
0/151 • 6 months
|
|
Eye disorders
Hypopyon
|
0.68%
1/148 • Number of events 1 • 6 months
|
0.00%
0/151 • 6 months
|
|
Eye disorders
Epiretinal Membrane Peel
|
0.00%
0/148 • 6 months
|
0.66%
1/151 • Number of events 1 • 6 months
|
|
Eye disorders
Anterior Ischemic Optic Neuropathy
|
0.00%
0/148 • 6 months
|
0.66%
1/151 • Number of events 1 • 6 months
|
|
Eye disorders
Lens Fragment
|
0.00%
0/148 • 6 months
|
1.3%
2/151 • Number of events 2 • 6 months
|
|
Eye disorders
Anterior Basement Membrane Distrophy
|
0.00%
0/148 • 6 months
|
0.66%
1/151 • Number of events 1 • 6 months
|
|
Eye disorders
Inflammation
|
0.00%
0/148 • 6 months
|
0.66%
1/151 • Number of events 1 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Kendra Hileman, Ph.D., Director of Clinical Research and Development
Abbott Medical Optics
Phone: 714-247-8613
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
- Publication restrictions are in place
Restriction type: OTHER