An Open-label, Prospective, Randomized, Multi-Center, Clinical Trial Designed to Evaluate the Clinical Outcomes with Digital Workflow Solution Versus Conventional Workflow Solution Refractive Outcomes Among Patients Undergoing Cataract Surgery with Toric Intraocular Lens
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- One-month postoperative refraction
研究概览
简要总结
An Open-label, Prospective, Randomized, Multi-Center, Clinical Trial Designed to Evaluate the Clinical Outcomes with Digital Workflow Solution Versus Conventional Workflow Solution Refractive Outcomes Among Patients Undergoing Cataract Surgery with Toric Intraocular Lens, Sponsor name-Center for Application Research in India (CARIn) Carl Zeiss India (Bangalore) Pvt Ltd Bangalore, India. Sample size is 80 subjects of which 40 subjects will receive Digital Workflow Solution and rest 40 subjects will receive Conventional Workflow Solution, Where the primary end point is Primary endpoints: One-month postoperative manifest refraction. Secondary Endpoints: Uncorrected and best-corrected visual acuity by log MAR visual acuity: 1 month, IOL axis alignment: immediate postop; 1-day postop, and 1 month postop.
The Exploratory Endpoints: Time to manually mark IOL axis prior to surgery by the surgeon, before drops used (patient prep time, # drops, time for axis marking at slit lamp, patient transport to OR), Total surgery time for cataract extraction and Toric IOL implantation, Time for IOL alignment during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with regular corneal astigmatism greater than 0.75D willing to undergo cataract extraction.
- •Patient willing to undergo cataract surgery with implantation of an Toric intraocular lenses.
- •Patient giving full and free consent for involvement in the study.
- •Patient willing to come for follow up study visits and measurements.
排除标准
- •Any ocular pathology or degeneration that could have impact on vision and/or a contradiction to Toric IOL implantation.
- •Any surgical complication felt to in any way impact upon the quality of visual outcome.
- •Any other comorbid conditions or risk factors that may affect the surgical procedure.
结局指标
主要结局
One-month postoperative refraction
时间窗: 1 week and 1 month
次要结局
- Uncorrected & best corrected visual acuity by log MAR visual acuity 1 month. IOL axis alignment, immediate postop, 1 day postop & 1 month postop.(1 week & 1 month.)
研究者
Dr Merle Fernandes
LV Prasad Eye Institute