Trial Outcomes & Findings for Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery (NCT NCT06785090)

Last Updated: 2025-05-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

87 participants

Primary outcome timeframe

6 weeks postoperatively

Results posted on

2025-05-06

Participant Flow

Participants were recruited from the outpatient clinic at Jenna Ophthalmic Center. Eligible patients were adults aged 40-75 years with cataracts undergoing phacoemulsification surgery. Recruitment was done through clinic referrals and patient consultations. Patients were informed about the study and consent was obtained before enrollment.

All participants underwent a pre-operative assessment, including eye exams, intraocular pressure measurements, visual acuity testing and a medical history review to screen for comorbidities. Eligible patients were randomized into two groups: Bromfenac treatment and control group.

Participant milestones

Participant milestones
Measure	Bromfenac Group This group received Bromfenac 0.09% ophthalmic solution, applied twice daily for 6 weeks following phacoemulsification surgery. The treatment was aimed at preventing cystoid macular edema (CME) and reducing macular thickness post-operatively. Participants were monitored for efficacy and any adverse events during the follow-up period.	Control Group This group received Moxifloxacin 0.5% ophthalmic drops every 6 hours and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6 hours post-operatively, without administering Bromfenac 0.09% ophthalmic drops.
Overall Study STARTED	45	42
Overall Study COMPLETED	45	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bromfenac Group n=45 Participants This group received Bromfenac 0.09% ophthalmic solution, applied twice daily for 6 weeks following phacoemulsification surgery. The treatment was aimed at preventing cystoid macular edema (CME) and reducing macular thickness post-operatively. Participants were monitored for efficacy and any adverse events during the follow-up period.	Control Group n=42 Participants This group received Moxifloxacin 0.5% ophthalmic drops every 6 hours and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6 hours post-operatively, without administering Bromfenac 0.09% ophthalmic drops.	Total n=87 Participants Total of all reporting groups
Sex: Female, Male Female	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants	18 Participants n=7 Participants	44 Participants n=5 Participants
Preoperative Macular Thickness	252.6 Microns STANDARD_DEVIATION 15.4 • n=5 Participants	253.1 Microns STANDARD_DEVIATION 14.8 • n=7 Participants	252.8 Microns STANDARD_DEVIATION 15.1 • n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	45 Participants n=5 Participants	42 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	42 Participants n=7 Participants	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks postoperatively

Population: All participants were included in the analysis, with no exclusions due to missing data, dropouts, or protocol violations

Outcome measures

Outcome measures
Measure	Bromfenac Group n=45 Participants Participants who received bromfenac ophthalmic solution post-cataract surgery.	Control Group n=42 Participants This group received Moxifloxacin 0.5% ophthalmic drops every 6 hours and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6 hours post-operatively, without administering Bromfenac 0.09% ophthalmic drops.
Change in Macular Thickness From Baseline to 6 Weeks Postoperatively After Cataract Surgery	252.6 Microns Standard Deviation 15.4	253.1 Microns Standard Deviation 14.8

SECONDARY outcome

Timeframe: 6 weeks postoperatively

This outcome evaluates the safety of bromfenac ophthalmic solution by assessing the incidence of adverse events related to its use after cataract surgery. Adverse events include corneal erosion, irritation, and any other complications recorded during follow-up visits up to 6 weeks postoperatively

Outcome measures

Outcome measures
Measure	Bromfenac Group n=45 Participants Participants who received bromfenac ophthalmic solution post-cataract surgery.	Control Group This group received Moxifloxacin 0.5% ophthalmic drops every 6 hours and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6 hours post-operatively, without administering Bromfenac 0.09% ophthalmic drops.
Incidence of Adverse Events Related to Bromfenac	5 Participants	—

Adverse Events

Bromfenac Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bromfenac Group n=45 participants at risk 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 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. Moxifloxacin 0.5% ophthalmic solution: antibiotic, standard postoperative care regimen Dexamethasone phosphate 0.1%: steroid, standard postoperative care regimen	Control Group n=42 participants at risk : 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 Moxifloxacin 0.5% ophthalmic solution: antibiotic, standard postoperative care regimen Dexamethasone phosphate 0.1%: steroid, standard postoperative care regimen
Eye disorders Punctate Epithelial Erosion (PEE)	11.1% 5/45 • Adverse event data were collected over a 6-week postoperative period following cataract surgery. Adverse events were defined as ocular complications during the 6-week postoperative period, including punctate epithelial erosion, ocular irritation, corneal edema, and intraocular pressure changes. Serious adverse events included significant visual impairment, infection, retinal detachment, or the need for surgery. Adverse events were assessed at follow-ups (1 day, 1 week, 6 weeks) through clinical exams, patient symptoms, and intraocular pressure measurements.	0.00% 0/42 • Adverse event data were collected over a 6-week postoperative period following cataract surgery. Adverse events were defined as ocular complications during the 6-week postoperative period, including punctate epithelial erosion, ocular irritation, corneal edema, and intraocular pressure changes. Serious adverse events included significant visual impairment, infection, retinal detachment, or the need for surgery. Adverse events were assessed at follow-ups (1 day, 1 week, 6 weeks) through clinical exams, patient symptoms, and intraocular pressure measurements.

Additional Information

Enas Sabeeh

College of Medicine, University of Baghdad

Phone: 09647704294077

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place