MedTrace Logo

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

NCT07696104 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

  • Pseudophakic Cystoid Macular Edema

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.

Sponsors & Collaborators

  • Pomeranian Medical University Szczecin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2024-05-22
Completion
2024-05-22

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07696104 on ClinicalTrials.gov