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Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery

NCT06785090 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2025-05-06

Study results available
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Summary

The goal of this clinical trial is to learn if bromfenac ophthalmic solution can prevent cystoid macular edema (CME) and reduce macular thickness in patients undergoing phacoemulsification surgery for cataract removal. The main questions it aims to answer are:

Does bromfenac reduce the incidence of CME after cataract surgery? Does bromfenac effectively control macular thickness postoperatively compared to standard care? investigators will compare the effects of bromfenac ophthalmic solution to a control group receiving standard postoperative treatment to see if bromfenac provides additional benefits.

Participants will:

Use bromfenac ophthalmic solution as prescribed postoperatively. Attend follow-up visits for macular thickness measurements and assessments of eye health.

Undergo routine postoperative evaluations to monitor for adverse effects.

Conditions

  • Cataract
  • Cystoid Macular Edema After Phacoemulsification

Interventions

DRUG

Bromfenac

Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) formulated as a 0.09% ophthalmic solution. It is administered to reduce inflammation and prevent cystoid macular edema (CME) following cataract surgery.

DRUG

Moxifloxacin 0.5% ophthalmic solution

antibiotic, standard postoperative care regimen

DRUG

Dexamethasone phosphate 0.1%

steroid, standard postoperative care regimen

Sponsors & Collaborators

  • Inas Abd

    lead OTHER

Principal Investigators

  • Zaid R Hussein, consultant ophthalmologist · Ibn Al Haitham eye teaching hospital.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-01-31
Completion
2024-01-31
FDA Drug
Yes

Countries

  • Iraq

Study Locations

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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 NCT06785090 on ClinicalTrials.gov