Aphakia, Presbyopia
Conditions
Keywords
Cataract, Intraocular Lens
Brief summary
The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.
Detailed description
In this clinical study, subjects will be implanted with the PanOptix IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 14 months. This study will be conducted in China.
Interventions
DEVICEAcrySof IQ PanOptix Presbyopia Correcting IOL
UV and blue-light filtering foldable multifocal IOL with a +2.17 diopter (D) addition power of intermediate visual acuity and a +3.25 D addition power of near visual acuity. This device is approved in China.
PROCEDURECataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ PanOptix Presbyopia Correcting IOL
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Able to comprehend and sign an informed consent form; * Able to complete all study visits required in the protocol; * Chinese; diagnosed with cataracts in both eyes; * Planned bilateral cataract removal by routine phacoemulsification; * Pre-operative regular corneal astigmatism of less than 1.0 diopter (D); * Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal to 0.3 LogMAR in each eye; * Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better in both eyes based on the investigator expert medical opinion. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve; * Clinically significant corneal diseases; * Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion; * Previous intraocular or corneal surgery; * Pregnancy or lactation during study or planning to be pregnant/lactating; * Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject; * Other planned ocular surgical procedures; * Patients who desire monovision correction. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | 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. |
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | 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. |
| Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | 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. |
| Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | 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. |
| Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | 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. |
| Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | 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. |
| Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | 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. |
| Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | 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. |
| Number of Ocular Treatment Emergent Adverse Events | Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) | 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. |
| Number of Non-Ocular Treatment Emergent Adverse Events | Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) | 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. |
| Number of Secondary Surgical Interventions | Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) | 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. |
| Number of Participants Reporting a Severe Visual Disturbance (QUVID) | 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) | 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. |
| Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | 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) | 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. |
Countries
China
Participant flow
Recruitment details
Participants were recruited from 9 investigative sites located in China.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| PanOptix IOL AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery | 144 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | PanOptix IOL |
|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 9.19 |
| Age, Customized 65 years and older | 72 Participants |
| Age, Customized Less than 65 years | 72 Participants |
| Race/Ethnicity, Customized Chinese/Asian | 144 Participants |
| Region of Enrollment China | 144 Participants |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 144 | 0 / 144 | 0 / 142 | 0 / 144 |
| other Total, other adverse events | 2 / 144 | 15 / 144 | 11 / 142 | 0 / 144 |
| serious Total, serious adverse events | 0 / 144 | 2 / 144 | 3 / 142 | 6 / 144 |
Outcome results
Primary
Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Population: Full Analysis Set with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PanOptix IOL - First Eye | Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular | -0.08 logMAR | Standard Deviation 0.102 |
Primary
Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Population: Full Analysis Set with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PanOptix IOL - First Eye | Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular | -0.02 logMAR | Standard Deviation 0.102 |
| PanOptix IOL - Second Eye | Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular | -0.02 logMAR | Standard Deviation 0.119 |
| PanOptix IOL - All Eyes | Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular | -0.02 logMAR | Standard Deviation 0.11 |
Primary
Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Population: Full Analysis Set with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PanOptix IOL - First Eye | Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular | 0.018 logMAR | Standard Deviation 0.0875 |
Primary
Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Population: Full Analysis Set with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PanOptix IOL - First Eye | Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular | 0.073 logMAR | Standard Deviation 0.111 |
| PanOptix IOL - Second Eye | Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular | 0.072 logMAR | Standard Deviation 0.1329 |
| PanOptix IOL - All Eyes | Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular | 0.073 logMAR | Standard Deviation 0.1222 |
Primary
Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Population: Full Analysis Set with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PanOptix IOL - First Eye | Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular | 0.025 logMAR | Standard Deviation 0.0865 |
Primary
Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Population: Full Analysis Set with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PanOptix IOL - First Eye | Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular | 0.082 logMAR | Standard Deviation 0.1074 |
| PanOptix IOL - Second Eye | Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular | 0.078 logMAR | Standard Deviation 0.1175 |
| PanOptix IOL - All Eyes | Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular | 0.080 logMAR | Standard Deviation 0.1124 |
Primary
Number of Non-Ocular Treatment Emergent Adverse Events
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PanOptix IOL - First Eye | Number of Non-Ocular Treatment Emergent Adverse Events | 28 adverse events |
Primary
Number of Ocular Treatment Emergent Adverse Events
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PanOptix IOL - First Eye | Number of Ocular Treatment Emergent Adverse Events | 37 adverse events |
| PanOptix IOL - Second Eye | Number of Ocular Treatment Emergent Adverse Events | 33 adverse events |
| PanOptix IOL - All Eyes | Number of Ocular Treatment Emergent Adverse Events | 70 adverse events |
Primary
Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PanOptix IOL - First Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Double Vision | 0 participants |
| PanOptix IOL - First Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Glare | 4 participants |
| PanOptix IOL - First Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Dark Area | 0 participants |
| PanOptix IOL - First Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Hazy Vision | 0 participants |
| PanOptix IOL - First Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Halos | 3 participants |
| PanOptix IOL - First Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Blurred Vision | 1 participants |
| PanOptix IOL - First Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Starbursts | 2 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Blurred Vision | 1 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Double Vision | 0 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Dark Area | 0 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Starbursts | 2 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Halos | 2 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Glare | 2 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | Hazy Vision | 0 participants |
Primary
Number of Participants Reporting a Severe Visual Disturbance (QUVID)
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PanOptix IOL - First Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Halos | 9 participants |
| PanOptix IOL - First Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Glare | 6 participants |
| PanOptix IOL - First Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Hazy Vision | 3 participants |
| PanOptix IOL - First Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Blurred Vision | 3 participants |
| PanOptix IOL - First Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Double Vision | 0 participants |
| PanOptix IOL - First Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Dark Area | 0 participants |
| PanOptix IOL - First Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Starbursts | 13 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Halos | 6 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Double Vision | 0 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Glare | 3 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Starbursts | 21 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Hazy Vision | 1 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Dark Area | 0 participants |
| PanOptix IOL - Second Eye | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | Blurred Vision | 2 participants |
Primary
Number of Secondary Surgical Interventions
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PanOptix IOL - First Eye | Number of Secondary Surgical Interventions | 0 secondary surgical interventions |
| PanOptix IOL - Second Eye | Number of Secondary Surgical Interventions | 0 secondary surgical interventions |
| PanOptix IOL - All Eyes | Number of Secondary Surgical Interventions | 0 secondary surgical interventions |
Primary
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Population: Full Analysis Set with data at visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PanOptix IOL - First Eye | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular | 100 percentage of participants |
Primary
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Population: Full Analysis Set with data at visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PanOptix IOL - First Eye | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular | 100 percentage of eyes |
| PanOptix IOL - Second Eye | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular | 98.5 percentage of eyes |
| PanOptix IOL - All Eyes | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular | 99.3 percentage of eyes |