The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
181
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.
Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ PanOptix Presbyopia Correcting IOL
Peking University People's Hospital
Beijing, China
Beijing Tongren Hospital Capital Medical University
Beijing, China
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guandong, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
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)
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)
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)
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.
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Hangzhou, China
Ophthalmic Hospital Affiliated to Shandong University of Traditional Chinese Medicine
Shandong, China
Eye & ENT Hospital of Fudan University
Shanghai, China
Shanxi Eye Hospital
Shanxi, China
West China Hospital of Sichuan University
Sichuan, China
Tianjin Medical University Eye Hospital
Tianjin, China
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
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)
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)
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)
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)
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)
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)
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)
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)
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)