Controlling Dry Eye Disease after Femtosecond Laser Cataract Surgery by use of Topical Lubricants: A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- OSDI SCORE13
研究概览
简要总结
The patients who meet the inclusion criteria will be administered written Informed Consent, after which he/she undergoes pre-op history, examination, IOL workup and the inflammatory markers in tears are done. After which they are randomly divided into 2 groups- 20 in treatment and 20 in control group. Topical lubricants is given to the treatment group and placebo drops (0.9% saline) is given to the control group patients 3 day prior to the surgery along with standard pre-operative medications. After which all the patients undergo femtosecond laser cataract surgery. Post-operative history, examination and dry eye evaluation done at day 1, 1st week and 1st month and 3rd month. Tear inflammatory markers will be evaluated at 1 month post op. Along with the standard post-operative medications, the treatment group would receive topical lubricants and the control group would receive placebo drops. Patients who develop dry eye symptoms/signs during the study period will be additionally treated with HPMC 0.5 % QID and response noted. Treatment code will be broken at end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •patients who are posted for femtosecond laser cataract surgery.
排除标准
- •1 pre-operative dry eyes 2 contact lens wear 3 disorders of lid and nasolacrimal gland 4 history of smoking 5 ocular allergy 6 systemic disease like sjogrens, diabetes mellitus.
结局指标
主要结局
OSDI SCORE13
时间窗: 1st week, 3 months
次要结局
- NIBUT10 SECONDS(OCULAR SURFACE STAINING 5 CORNEAL SPOTS AND 14 CONJUNCTIVAL SPOTS)
