Phase 4 N=87 Randomized Treatment

Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery

Cataract · Cystoid Macular Edema After Phacoemulsification

Bottom Line

View on ClinicalTrials.gov: NCT06785090 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2025

Primary outcome: Primary: Change in Macular Thickness From Baseline to 6 Weeks Postoperatively After Cataract Surgery — 252.6; 253.1 Microns

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Bromfenac (Drug); Moxifloxacin 0.5% ophthalmic solution (Drug); Dexamethasone phosphate 0.1% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Inas Abd
Primary completion: Jan 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Macular Thickness From Baseline to 6 Weeks Postoperatively After Cataract Surgery	252.6; 253.1	—
SECONDARY Incidence of Adverse Events Related to Bromfenac	5	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.
Patients lost to follow-up.
Patients with an allergy to one of the postoperative medications.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06785090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.