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COMPLETED
NCT07696104
PHASE4

Efficacy of Nonsteroidal Anti-Inflammatory Drugs for the Prevention of Cystoid Macular Edema Following Cataract Phacoemulsification

Sponsor: Pomeranian Medical University Szczecin

View on ClinicalTrials.gov

Summary

This randomized clinical study evaluated the effectiveness of different postoperative nonsteroidal anti-inflammatory drug (NSAID) regimens in patients undergoing uncomplicated phacoemulsification cataract surgery. Eighty-eight eligible participants were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure: bromfenac 0.09% twice daily for 2 weeks, bromfenac 0.09% twice daily for 4 weeks, diclofenac 0.1% four times daily for 4 weeks, or nepafenac 0.1% three times daily for 4 weeks. All patients received the same standard perioperative care and adjunctive dexamethasone treatment. The primary outcome was central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT) at 6 and 12 weeks after surgery. Secondary outcomes included best-corrected distance visual acuity, refraction, and intraocular pressure.

Key Details

Gender

All

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2020-10-14

Completion Date

2024-05-22

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

DRUG

Bromfenac 0.09 % Ophthalmic Solution

Bromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery.

DRUG

Bromfenac 0.09 % Ophthalmic Solution

Bromfenac 0.09% ophthalmic solution administered twice daily for 4 weeks after cataract surgery.

DRUG

Nepafenac 0.1% eyedrops

Nepafenac 0.1% ophthalmic solution administered three times daily for 4 weeks after cataract surgery.

DRUG

diclofenac 0.1% ophthalmic susp.

Diclofenac 0.1% ophthalmic solution administered four times daily for 4 weeks after cataract surgery.

Locations (1)

University Clinical Hospital No. 2, Pomeranian Medical University in Szczecin

Szczecin, Poland