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临床试验/CTRI/2020/09/028005
CTRI/2020/09/028005尚未招募不适用

Controlling Dry Eye Disease after Femtosecond Laser Cataract Surgery by use of Topical Lubricants: A Double Blind Randomized Controlled Trial

Dr Rajendra Prasad Centre of Ophthalmic Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月30日最近更新:

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)

研究者

发起方
Dr Rajendra Prasad Centre of Ophthalmic Sciences
申办方类型
Government medical college

研究点 (1)

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