Post-Market Clinical Study of the AcrySof® IQ PanOptix® Presbyopia Correcting Intraocular Lens in a Chinese Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 15
- 主要终点
- Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular
研究概览
简要总结
The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点