Effects of Cataract Extraction Surgery and Limbal Relaxing Incision on Corneal Sensation and Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 32
- 主要终点
- The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured
研究概览
简要总结
This is a multicenter evaluation of the effects of the cataract extraction and limbal relaxing incisions (LRI) on corneal sensation and dry eye signs and symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled to undergo clear corneal cataract extraction with planned limbal relaxing incision for correction of a corneal astigmatism
排除标准
- •Uncontrolled systemic disease
- •Have undergone refractive surgery or any surgery involving a limbal or corneal incision
- •Use of topical cyclosporine (Restasis) within three months of baseline/randomization visit
- •Temporary or permanent occlusion of the lacrimal puncta
结局指标
主要结局
The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured
时间窗: Month 3
The percentage of subjects at month 3 with corneal sensitivity \< 50 mm at any of the locations measured. Corneal sensitivity is evaluated by using a nylon filament to measure the capability of the cornea (clear front portion of the eye) to respond to touch. The longest filament length at which a minimum of the 3 out of 5 stimulus applications produce a positive response from the subject was the corneal touch threshold (sensitivity). Measurements were taken at 5 different locations in each cornea.
次要结局
- Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3(Baseline, Month 3)
- Change From Baseline in Corneal Staining at Month 3(Baseline, Month 3)
- Change From Baseline in Conjunctival Staining at Month 3(Baseline, Month 3)
- Change From Baseline in Tear Break-Up Time at Month 3(Baseline, Month 3)
- Change From Baseline in Schirmer's Test at Month 3(Baseline, Month 3)