Posterior Capsule Opacification After Implantation of Square Edge PMMA, Round Edge PMMA and Acrysof Intraocular Lenses: Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Aurolab
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- PCO
研究概览
简要总结
First object is to compare square edge PMMA with round edge PMMA IOL where the materials are same. Next objective is to compare square edge PMMA IOL with Acrysof IOL where the materials are different
详细描述
Cataract is the vision impairing disease characterized by gradual, progressive thickening of the lens. Posterior Capsular Opacification (PCO) remains the most frequent long term complication. This is initiated by the migration and proliferation of residual lens epithelial cells from the lens equator in the space between the posterior capsule and intraocular lens (IOL)
The combination of IOL material and a sharp edged design is effective in preventing PCO. Aurolab has developed 360 degree square edge IOL with polymethyl methacrylate (PMMA)
100 bilateral senile cataract patients are going to be recruited. First group of 50 patients will receive square edge PMMA in one eye and round edge PMMA in fellow eye. Another group of 50 patients will receive square edge PMMA in one eye and acrysof in fellow eye. PCO will be assessed during each follow up using EPCO software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 65 years
- •Bilateral senile cataract
- •Pupil should be at least 7mm dilated
- •Nuclear sclerosis grade I, II and III
- •Patient willing for second eye surgery within 3 months
排除标准
- •Debilitated old patients
- •Cardiac and serious illness
- •Intraoperative complications including PC rent, Zonular dialysis and Rhexis tear
- •Inherent zonular weakness
- •Glaucoma patients
- •Relative afferent papillary defect (RAPD)
- •Shallow anterior chamber
- •Pseudoexfoliation
- •Traumatic cataract
- •Uveitis and complicated cataract
- •One eyed patients
- •Corneal pathology
- •Post segment pathology including diabetic retinopathy
- •Dense Posterior subcapsular cataract (PSCC) and Posterior polar cataract (PPC)
- •High myopic and hyperopic patient
结局指标
主要结局
PCO
时间窗: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
次要结局
- Visual Acuity(1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year)