NCT04882189Unknown不适用
A Prospective Randomized Controlled Masked Study of Endothelial Cell Condition After Cataract Surgery Performed Using Manual Capsulorhexis or the ZEPTO Precision Capsulotomy System
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Endothelial Cell Density Loss
研究概览
简要总结
This study will use images of the subjects' corneal endothelium obtained using non-invasive specular microscopy to obtain corneal endothelial cell density, the coefficient of variation in endothelial cell size, and the percentage of hexagonal endothelial cells following routine cataract surgery performed using the standard method of manual capsulorhexis compared to cataract surgery performed using Zepto Precision Capsulotomy System.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the treatment of symptomatic age-related lens cataract, and then electing to undergo the study,
- •Subjects must be willing and able to return for scheduled treatment and follow-up examinations at 1 and 3 months.
排除标准
- •Pre-existing corneal endothelium pathology
- •Presence of guttae
- •Narrow angle glaucoma or advanced glaucoma
- •Psuedoexfoliation
- •Zonular abnormalities
- •Corneal endothelial cell density less than 1800 cells/mm2
- •Anterior chamber depth less than 2.5mm or greater than 3.75mm
- •Cataract grade LOCS II > 3
- •Posterior polar cataract
- •Planned implantation of IOL > 25D
- •Prior ocular surgery in the study eye
- •History of medications with potential corneal endothelial cell toxicity
- •Any condition that in the surgeon's judgement should exclude the subject from study enrollment.
- •Current participation in another drug or device clinical study, or participation in such a clinical study within the prior six months and during the duration of the current study
结局指标
主要结局
Endothelial Cell Density Loss
时间窗: 3 months
Post Cataract Surgery
次要结局
- % of hexagonal cells(1 and 3 months)
- Endothelial Cell Density Loss(1 month)
- Coefficient of Variation in Endothelial Cell Size(1 and 3 months)
研究者
研究点 (2)
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