Trial Outcomes & Findings for Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population (NCT NCT04755231)
NCT ID: NCT04755231
Last Updated: 2023-10-10
Results Overview
Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
181 participants
Primary outcome timeframe
Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Results posted on
2023-10-10
Participant Flow
Participants were recruited from 9 investigative sites located in China.
Of the 181 who signed an informed consent document, 37 participants were discontinued prior to implantation: 27 participants were screen failures, and 10 participants withdrew. This reporting group includes all participants with attempted implantation (144).
Unit of analysis: eyes
Participant milestones
| Measure |
PanOptix IOL
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|
|
Overall Study
STARTED
|
144 288
|
|
Overall Study
Attempted Implantation, First Eye
|
144 144
|
|
Overall Study
Attempted Implantation Second Eye
|
142 142
|
|
Overall Study
Successful Implantation, First Eye
|
144 144
|
|
Overall Study
Successful Implantation Second Eye
|
142 142
|
|
Overall Study
COMPLETED
|
134 268
|
|
Overall Study
NOT COMPLETED
|
10 20
|
Reasons for withdrawal
| Measure |
PanOptix IOL
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population
Baseline characteristics by cohort
| Measure |
PanOptix IOL
n=144 Participants
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 9.19 • n=99 Participants
|
|
Age, Customized
Less than 65 years
|
72 Participants
n=99 Participants
|
|
Age, Customized
65 years and older
|
72 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Chinese/Asian
|
144 Participants
n=99 Participants
|
|
Region of Enrollment
China
|
144 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)Population: Full Analysis Set with data at visit
Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=135 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
n=135 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
n=270 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular
|
100 percentage of eyes
|
98.5 percentage of eyes
|
99.3 percentage of eyes
|
PRIMARY outcome
Timeframe: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)Population: Full Analysis Set with data at visit
VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=270 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular
|
100 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)Population: Full Analysis Set with data at visit
Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=135 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
n=135 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
n=270 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular
|
-0.02 logMAR
Standard Deviation 0.102
|
-0.02 logMAR
Standard Deviation 0.119
|
-0.02 logMAR
Standard Deviation 0.110
|
PRIMARY outcome
Timeframe: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)Population: Full Analysis Set with data at visit
VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=270 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular
|
-0.08 logMAR
Standard Deviation 0.102
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)Population: Full Analysis Set with data at visit
VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=135 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
n=135 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
n=270 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular
|
0.073 logMAR
Standard Deviation 0.1110
|
0.072 logMAR
Standard Deviation 0.1329
|
0.073 logMAR
Standard Deviation 0.1222
|
PRIMARY outcome
Timeframe: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)Population: Full Analysis Set with data at visit
VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=270 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular
|
0.018 logMAR
Standard Deviation 0.0875
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)Population: Full Analysis Set with data at visit
VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=135 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
n=135 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
n=270 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular
|
0.082 logMAR
Standard Deviation 0.1074
|
0.078 logMAR
Standard Deviation 0.1175
|
0.080 logMAR
Standard Deviation 0.1124
|
PRIMARY outcome
Timeframe: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)Population: Full Analysis Set with data at visit
VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=270 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular
|
0.025 logMAR
Standard Deviation 0.0865
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)Population: Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=144 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
n=142 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
n=286 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Number of Ocular Treatment Emergent Adverse Events
|
37 adverse events
|
33 adverse events
|
70 adverse events
|
PRIMARY outcome
Timeframe: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)Population: Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=144 Participants
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Number of Non-Ocular Treatment Emergent Adverse Events
|
28 adverse events
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)Population: Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
A secondary surgical intervention (SSI) was defined as a surgical procedure occurring after primary implantation of the IOL. Posterior capsulotomies were excluded from the definition of secondary surgical interventions. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=144 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
n=142 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
n=286 eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Number of Secondary Surgical Interventions
|
0 secondary surgical interventions
|
0 secondary surgical interventions
|
0 secondary surgical interventions
|
PRIMARY outcome
Timeframe: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)Population: Safety Analysis Set with data at visit
The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Severe Was Your Worst Experience" and responded on a 5-point scale, where 0-4 scale, where 0=none, 1=a little, 2=mild, 3=moderate, and 4=severe. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=135 Participants
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
n=135 Participants
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Number of Participants Reporting a Severe Visual Disturbance (QUVID)
Starbursts
|
13 participants
|
21 participants
|
—
|
|
Number of Participants Reporting a Severe Visual Disturbance (QUVID)
Halos
|
9 participants
|
6 participants
|
—
|
|
Number of Participants Reporting a Severe Visual Disturbance (QUVID)
Glare
|
6 participants
|
3 participants
|
—
|
|
Number of Participants Reporting a Severe Visual Disturbance (QUVID)
Hazy Vision
|
3 participants
|
1 participants
|
—
|
|
Number of Participants Reporting a Severe Visual Disturbance (QUVID)
Blurred Vision
|
3 participants
|
2 participants
|
—
|
|
Number of Participants Reporting a Severe Visual Disturbance (QUVID)
Double Vision
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting a Severe Visual Disturbance (QUVID)
Dark Area
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)Population: Safety Analysis Set with data at visit
The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Much Were You Bothered With" and responded on a 5-point scale, where 0=not bothered at all, 1=bothered a little, 2=bothered somewhat, 3=bothered quite a bit, and 4=bothered very much (most bothersome). No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
PanOptix IOL - First Eye
n=135 Participants
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - Second Eye
n=135 Participants
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
PanOptix IOL - All Eyes
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
|
|---|---|---|---|
|
Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
Starbursts
|
2 participants
|
2 participants
|
—
|
|
Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
Halos
|
3 participants
|
2 participants
|
—
|
|
Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
Glare
|
4 participants
|
2 participants
|
—
|
|
Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
Hazy Vision
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
Blurred Vision
|
1 participants
|
1 participants
|
—
|
|
Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
Double Vision
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
Dark Area
|
0 participants
|
0 participants
|
—
|
Adverse Events
Pretreatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PanOptix IOL Ocular - First Eye
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
PanOptix IOL Ocular - Second Eye
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
PanOptix IOL Systemic
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pretreatment
n=144 participants at risk
Events reported in this group occurred prior to attempted implantation with the test article and may include ocular events in the second eye prior to implantation, as well as overall systemic events.
|
PanOptix IOL Ocular - First Eye
n=144 participants at risk
Events reported in this group occurred after attempted implantation with the test article and include ocular events in the first implanted eye
|
PanOptix IOL Ocular - Second Eye
n=142 participants at risk
Events reported in this group occurred after attempted implantation with the test article and include ocular events in the second implanted eye
|
PanOptix IOL Systemic
n=144 participants at risk
Events reported in this group occurred after attempted implantation with the test article
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/142 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.69%
1/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/142 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.69%
1/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
1.4%
2/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
2.1%
3/142 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/142 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.69%
1/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/142 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.69%
1/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/142 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.69%
1/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/142 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.69%
1/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
Other adverse events
| Measure |
Pretreatment
n=144 participants at risk
Events reported in this group occurred prior to attempted implantation with the test article and may include ocular events in the second eye prior to implantation, as well as overall systemic events.
|
PanOptix IOL Ocular - First Eye
n=144 participants at risk
Events reported in this group occurred after attempted implantation with the test article and include ocular events in the first implanted eye
|
PanOptix IOL Ocular - Second Eye
n=142 participants at risk
Events reported in this group occurred after attempted implantation with the test article and include ocular events in the second implanted eye
|
PanOptix IOL Systemic
n=144 participants at risk
Events reported in this group occurred after attempted implantation with the test article
|
|---|---|---|---|---|
|
Eye disorders
Dry eye
|
1.4%
2/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
10.4%
15/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
7.7%
11/142 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
0.00%
0/144 • Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
|
Additional Information
Director, Clinical Projects, 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