Real-World Study of AcrySof™ IQ Vivity Extended Vision Intraocular Lenses (IOLs)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye
研究概览
简要总结
The primary objective of this clinical study is to assess the clinical performance of the AcrySof IQ Vivity Extended Vision IOL in a Chinese population.
详细描述
In this clinical study, subjects will be implanted with the AcrySof IQ Vivity Extended Vision 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 13 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 understand and sign an approved informed consent;
- •Willing and able to attend all scheduled study visits as required per protocol;
- •Diagnosed with cataracts in both eyes;
- •Pre-operative regular corneal astigmatism less than 1.0 diopter (D);
- •Planned bilateral cataract removal by phacoemulsification.
- •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 surgery history;
- •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 can only undergo cataract surgery in one eye.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Vivity IOL
AcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
干预措施: AcrySof IQ Vivity Extended Vision IOL (Device)
Vivity IOL
AcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
干预措施: Cataract surgery (Procedure)
结局指标
主要结局
Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye
时间窗: Month 6 post second eye implantation
Near visual acuity will be assessed at 40 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye. .
Incidence of severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire)
时间窗: Up to Month 12 post second eye implantation
Subjects will be surveyed using the QUVID questionnaire.
Incidence of ocular adverse events
时间窗: Up to Month 12 post second eye implantation
Ocular adverse events will be reported.
Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye
时间窗: Month 6 post second eye implantation
Intermediate visual acuity will be assessed at 66 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye.
Incidence of secondary surgical interventions (SSIs)
时间窗: Up to Month 12 post second eye implantation
Secondary surgical interventions will be reported.
次要结局
- Percentage of Eyes Achieving 0.2 logMAR or better Best Corrected Distance Visual Acuity (BCDVA) - First Eye(Month 6 post second eye implantation)