Clinical trial NCT06785090
Conditions: Cataract Cystoid Macular Edema After Phacoemulsification
Keywords: cataract phacoemulsification cystoid macular edema
Sponsor: Inas Abd
Start date: 2023-05-01; Completion date: 2024-01-31
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Detailed description:
The goal of this clinical trial is to investigate the effectiveness of bromfenac ophthalmic solution in preventing cystoid macular edema (CME) and reducing macular thickness in patients who have undergone cataract surgery using phacoemulsification. Cataract surgery, while generally safe, can sometimes lead to complications such as CME, a condition that causes swelling in the macula and may impair vision. Bromfenac, a non-steroidal anti-inflammatory drug (NSAID), is commonly used after cataract surgery to reduce inflammation and prevent such complications.

The main questions this study aims to answer are:

Can bromfenac ophthalmic solution effectively lower the risk of CME after cataract surgery? Does bromfenac help maintain or reduce macular thickness more effectively compared to standard postoperative care? Are there any significant side effects or risks associated with bromfenac use in this context? investigators will compare the outcomes of patients treated with bromfenac ophthalmic solution to those who receive standard postoperative treatment without bromfenac. This will help determine whether bromfenac provides superior protection against CME and better management of macular thickness.

Participant Involvement:

Participants will:

Use bromfenac ophthalmic solution as prescribed, Undergo detailed eye examinations, including macular thickness measurements, before surgery and during follow-up visits.

Be monitored for any side effects or adverse reactions to bromfenac during the study period.

Attend scheduled follow-up visits for assessments, which may include optical coherence tomography (OCT) imaging and visual acuity tests.

This study is focused on improving the understanding of bromfenac's role in postoperative eye care and helping optimize treatment protocols for cataract surgery patients to ensure better outcomes and prevent vision-related complications.

Arms: arm 1: 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 arm 2: : 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
Interventions: intervention 1: Bromfenac intervention 2: Moxifloxacin 0.5% ophthalmic solution intervention 3: Dexamethasone phosphate 0.1%
Intervention descriptions: intervention 1: 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. intervention 2: antibiotic, standard postoperative care regimen intervention 3: steroid, standard postoperative care regimen

Protocol documents:
Prot_SAP_000.pdf: 
Study Protocol 
 
Title: Effects of Topical Bromfenac Solution on Macular 
Thickness in Cataract Patients Undergoing Phacoemulsification 
Surgery 
Clinical 
Trial 
Registration 
Number: 
NCT06785090 
Document Date: March 28, 2025. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
1. Background and Rationale 
Cystoid macular edema (CME) is a common postoperative complication following cataract 
surgery. Bromfenac, a topical nonsteroidal anti-inflammatory drug (NSAID), is hypothesized to 
reduce macular thickness and prevent CME. This study investigates the efficacy and safety of 
bromfenac in patients undergoing phacoemulsification. 
2. Study Objectives 
• 
Primary Objective: To assess the effect of bromfenac 0.09% ophthalmic solution on 
macular thickness after phacoemulsification. 
• 
Secondary Objective: To evaluate potential adverse effects, including corneal erosion. 
3. Study Design 
• 
Study Type: Randomized controlled trial 
• 
Allocation: Randomized 
• 
Intervention Model: Parallel assignment 
• 
Masking: Single-blinded (Investigator) 
4. Eligibility Criteria 
Inclusion Criteria: 
1. All patients 18 years of age and older. 
2. Patients diagnosed with cataracts. 
Exclusion Criteria 
1- Patients less than 18 years of age. 
2- Patients with glaucoma, ocular hypertension, pseudo-exfoliation syndrome, or any optic nerve 
disease. 
3- Patients with ocular diseases that might influence macular thickness, such as age-related 
macular degeneration, epiretinal membrane, history of uveitis, intraoperative complications, 
and traumatic cases. 
4- Patients have undergone previous ocular surgery in the same eye, such as vitrectomy, 
intravitreal injection, retinal laser therapy, or corneal surgery 
5- Patients who developed severe adverse effects from other drugs or had complications 
intraoperatively or postoperatively unrelated to bromfenac. 
6- Patients take antiglaucoma medications. 


7- Patients lost to follow-up.  
8- Patients with an allergy to one of the postoperative medications. 
5. Intervention and Follow-up 
• Group one- consisted of forty-five patients who received 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. 
• Group two- consisted of forty-two patients who received only Moxifloxacin 0.5% every 
6hrs and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6hrs without the 
administration of bromfenac 0.09% ophthalmic drops. 
6. Outcome Measures 
• 
Primary Outcome: Change in central macular thickness (CMT) measured by Optical 
Coherence Tomography (OCT)  
• 
Secondary Outcomes: adverse effects  
7. Statistical Methods 
• 
Sample size calculation based on a power of 80% and significance level of 0.05. 
• 
Independent t-test for intergroup comparisons. 
• 
Paired t-test for intragroup pre- and post-treatment comparisons. 
 
Statistical Analysis Plan (SAP) 
1. Introduction 
This SAP outlines the statistical methodologies for analyzing data collected in the clinical trial 
titled "Effects of Topical Bromfenac Solution on Macular Thickness in Cataract Patients 
Undergoing Phacoemulsification Surgery." 
2. Study Population 
• 
Intent-to-Treat (ITT) Population: All randomized patients. 
• 
Per-Protocol (PP) Population: Patients who adhered to treatment and completed follow-
up assessments. 
3. Statistical Methods 
• 
Descriptive Analysis: Means and standard deviations (SD) for continuous variables. 
• 
Inferential Analysis: 


o Primary Outcome: Two-sample t-test for between-group comparisons of CMT 
change. 
o Secondary Outcomes: 
▪ 
Incidence of CME: Chi-square test. 
▪ 
Adverse effects: Fisher's exact test. 
4. Handling of Missing Data 
• 
Missing data <5%: Complete case analysis. 
• 
Missing data >5%: Multiple imputation methods. 
5. Software Used 
All analyses will be performed using SPSS.