Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery

NCT06785090 | Completed Phase 4 Results FDA Drug

• 1 other identifier: ES-Bromphaco-2024
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cataract; phacoemulsification; cystoid macular edema

Outcome Measures

Primary Outcomes (1)

• Change in Macular Thickness From Baseline to 6 Weeks Postoperatively After Cataract Surgery

  This outcome measures the change in macular thickness in participants treated with bromfenac ophthalmic solution compared to the control group. Macular thickness was assessed using Optical Coherence Tomography (OCT) at two time points: preoperatively (baseline) and 6 weeks postoperatively. The change was calculated as: Macular Thickness at 6 Weeks Postoperative - Baseline Macular Thickness. A negative value indicates a decrease (thinning), while a positive value indicates an increase (thickening) in macular thickness.

  6 weeks postoperatively

Secondary Outcomes (1)

• Incidence of Adverse Events Related to Bromfenac

  6 weeks postoperatively

Study Arms (2)

Bromfenac Group

EXPERIMENTAL

Participants in this group will receive bromfenac 0.09% ophthalmic solution as part of their postoperative care regimen following cataract surgery. • Interventions: 0.09% bromfenac ophthalmic solution twice daily in addition to Moxifloxacin 0.5% ophthalmic drops every 6hrs and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6hrs for six weeks

Drug: Bromfenac; Drug: Moxifloxacin 0.5% ophthalmic solution; Drug: Dexamethasone phosphate 0.1%

Control Group

ACTIVE COMPARATOR

: Participants in this group will receive the standard postoperative care regimen without bromfenac. • Interventions: Moxifloxacin 0.5% every 6hrs and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6hrs for six weeks

Drug: Moxifloxacin 0.5% ophthalmic solution; Drug: Dexamethasone phosphate 0.1%

Interventions

Bromfenac DRUG

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.

Bromfenac Group

Moxifloxacin 0.5% ophthalmic solution DRUG

antibiotic, standard postoperative care regimen

Bromfenac Group; Control Group

Dexamethasone phosphate 0.1% DRUG

steroid, standard postoperative care regimen

Bromfenac Group; Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients 18 years of age and older.
• Patients diagnosed with cataracts.

You may not qualify if:

• Patients less than 18 years of age.
• Patients with glaucoma, ocular hypertension, pseudo-exfoliation syndrome, or any optic nerve disease.
• Patients with ocular diseases that might influence macular thickness, such as:
• Age-related macular degeneration
• Epiretinal membrane
• History of uveitis
• Intraoperative complications
• Traumatic cases
• Patients who have undergone previous ocular surgery in the same eye, such as:
• Vitrectomy
• Intravitreal injection
• Retinal laser therapy
• Corneal surgery
• Patients who developed severe adverse effects from other drugs or had complications intraoperatively or postoperatively unrelated to bromfenac.
• Patients taking antiglaucoma medications.

Sponsors & Collaborators

• Inas Abd: lead

Study Sites (1)

College of Medicine, University of Baghdad

Baghdad, Baghdad Governorate, 10001, Iraq

Location

Related Links

• This link provides access to the de-identified raw data from the clinical trial investigating the effects of bromfenac on macular thickness in cataract patients following phacoemulsification surgery.

MeSH Terms

Conditions

Cataract; Macular Edema

Interventions

bromfenac; Moxifloxacin; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Limitations and Caveats

This study had a small sample size (45 in Bromfenac group, 42 in control), limiting statistical power. The short follow-up period of 6 weeks may not capture long-term effects. Results were based on a single-center study in Iraq, reducing generalizability. Adverse events were reported subjectively, which may have led to underreporting. Further studies with a larger sample size, extended follow-up, and diverse populations are needed.

Results Point of Contact

• Title: Enas Sabeeh
• Organization: College of Medicine, University of Baghdad

inas.abd2206m@comed.uobaghdad.edu.iq

09647704294077

Study Officials

• Zaid R Hussein, consultant ophthalmologist

  Ibn Al Haitham eye teaching hospital.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: May 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-04

Locations

IR (1)