Clinical trial to study the effect Of Eye drop Nepafenac, a non steroidal antiinflammatory drug in Prevention of macular edema post Cataract Surgery In Diabetic Patients

Phase 1

Completed

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2021/02/031147
• Lead Sponsor: AFMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 168

Inclusion Criteria

Diabetic patients with no clinical evidence of diabetic retinopathy who have senile immature cataract scheduled to undergo cataract extraction and posterior chamber Intra-ocular lens implantation.

Exclusion Criteria

1)Anterior segment pathology (corneal opacities, pseudo-exfoliation syndrome, dense cataract interfering with OCT imaging)

2)Posterior segment pathology, e.g. DR, previous retinal photocoagulation therapy, DME, age-related macular degeneration, retinal vascular diseases or history of uveitis, intra-operative complications including: posterior capsular rupture, vitreous loss or IOL not implanted in the capsular bag.

3)Postoperative complications: e.g. increased IOP, leaking incision, inflammation or corneal edema;

4)Patients using concomitant medication such as topical or systemic NSAIDs, steroids which may interfere with the assessment of the study outcome measures, topical prostaglandin analogues;

5)Hypersensitivity to the NSAIDs;

6)History of any intraocular surgery and ocular trauma to the same eye.

7)Patient refusal to participate in study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Central macular thickness by SD-OCT (Cirrus HD-OCT, Carl Zeiss) pre and post operatively at 01 week and 04week.Timepoint: Pre-operatively <br/ ><br>post-operatively at 01 week <br/ ><br>post-operatively at 04 weeks

Secondary Outcome Measures

Name	Time	Method
â?¢Best Corrected Visual Acuity (BCVA) by Snellen chart <br/ ><br>â?¢Intraocular pressure (IOP) <br/ ><br>â?¢Progression or development of cystoid macular edema by SD-OCTTimepoint: all parameters will be measured at; <br/ ><br>Pre-operatively <br/ ><br>post-operatively at 01 week <br/ ><br>post-operatively at 04 weeks