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

Effect Of Topical Nepafenac 0.1% In Prevention Of Macular Edema Post Cataract Surgery In Diabetic Patients At A Tertiary Care Centre In Western India: A Randomized Controlled Trial - NEPATACT

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031147

Enrollment

Registered

2021-02-09

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: topical Nepafenac 0.1% one drop three times a day

breakfast, lunch and before bed time. Patients will begin medications two days pre-operatively and will continue for one month post-operatively. Postoperative follow up will be done for 1 month : non

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
â?¢Central macular thickness by SD-OCT (Cirrus HD-OCT, Carl Zeiss) pre and post operatively at 01 week and 04week.Timepoint: Pre-operatively post-operatively at 01 week post-operatively at 04 weeks	—

Secondary

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

Countries

India

Contacts

Public ContactMAJ Dr ERAM RIYAZ

armed forces medical college

eram1408@rediffmail.com7051583500

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026