Study of the effects of two eyedrops, Nepafenac and Flurbiprofen in reducing pain and inflammation in patients who are undergoing cataract surgery.

Phase 4

Recruiting

• Conditions: Uncomplicated cataract patients undergoing phacoemulsification/small incision cataract surgery fulfilling the inclusion/exclusion criteria will be enrolled in the study.

• Registration Number: CTRI/2017/01/007737
• Lead Sponsor: Dr Saiyadali Allisabanavar

Brief Summary

This study is a randomized, double blind, parallel group trail comparing the safety and efficacy of topical Flurbiprofen 0.03% eye drops thrice daily  and topical Nepafenac 0.1%,  eye drops thrice daily for one week in 80 patients with uncomplicated cataract undergoing phacoemulsification/small incision cataract surgery fulfilling the inclusion/exclusion criteria that will be conducted in one center in India. The primary outcome measures will be Measuring percentage reduction in pain  and is  assessed by Visual analogue scale  and  Anterior Chamber Cells and flare after by Sun Working Group Grading  Scheme for  one week. The secondary outcomes will be Conjunctival redness by conjunctival hyperemia score and  lid edema by Lid edema scoring after one week.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-27
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1.Patients willing to give written informed consent.
• 2.Patients undergoing uncomplicated cataract surgery.

Exclusion Criteria

• 1.Surgeries other than phacoemulsification/small incisional cataract surgery.
• 2.Known sensitivity to any of the ingredients in the study medications.
• 3.Patients with preexisting ocular pathology, inflammation, tumor and glaucoma.
• 4.History of previous intraocular surgery, uveitis and iritis or intraocular inflammation in the study eye.
• 5.Use of steroids and Non steroidal inflammatory drugs by systemic route within the 14 days of surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Measuring percentage reduction in pain and is assessed by Visual analogue scale and Anterior Chamber Cells and flare by The Sun Working Group Grading Scheme .	one week

Secondary Outcome Measures

Name	Time	Method
Conjunctival redness by conjunctival hyperemia score and lid edema by Lid edema scoring	one week

Trial Locations

Locations (1)

Minto hospital; 🇮🇳 Bangalore, KARNATAKA, India

Minto hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Saiyadali Allisabanavar

Principal investigator

9739458704

saiyadali06bims@gmail.com