Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population
- Conditions
- PresbyopiaAphakia
- Interventions
- Device: AcrySof IQ PanOptix Presbyopia Correcting IOLProcedure: Cataract surgery
- Registration Number
- NCT04755231
- Lead Sponsor
- Alcon Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
- 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
- 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 exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PanOptix IOL AcrySof IQ PanOptix Presbyopia Correcting IOL AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery PanOptix IOL Cataract surgery AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
- Primary Outcome Measures
Name Time Method 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 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.
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.
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.
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.
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.
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.
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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Shanxi Eye Hospital
🇨🇳Shanxi, China
Peking University People's Hospital
🇨🇳Peking, China
West China Hospital of Sichuan University
🇨🇳Sichuan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Ophthalmic Hospital Affiliated to Shandong University of Traditional Chinese Medicine
🇨🇳Shandong, China
Zhongshan Ophthalmic Center, Sun Yat-Sen University
🇨🇳Guandong, China
Eye & ENT Hospital of Fudan University
🇨🇳Shanghai, China
Tianjin Medical University Eye Hospital
🇨🇳Tianjin, China
Beijing Tongren Hospital Capital Medical University
🇨🇳Beijing, China