Controlling the dry eye symptoms caused by Femtosecond Cataract surgery with the help of topical lubricants

Not yet recruiting

• Conditions: Age-related nuclear cataract,

• Registration Number: CTRI/2020/09/028005
• Lead Sponsor: Dr Rajendra Prasad Centre of Ophthalmic Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-09-18
• Study Start: 2020-09-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

patients who are posted for femtosecond laser cataract surgery.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OSDI SCORE13	1st week, 3 months

Secondary Outcome Measures

Name	Time	Method
NIBUT10 SECONDS	OCULAR SURFACE STAINING 5 CORNEAL SPOTS AND 14 CONJUNCTIVAL SPOTS

Trial Locations

Locations (1)

Dr RP centre for ophthalmic sciences, new delhi; 🇮🇳 South, DELHI, India

Dr RP centre for ophthalmic sciences, new delhi

🇮🇳South, DELHI, India

Dr Radhika Tandon

Principal investigator

011-26593145

radhika_tan@yahoo.com