Effects of Topical Bromfenac Solution on Macular Thickness in Cataract Patients Undergoing Phacoemulsification Surgery
Phase: PHASE4
Conditions: Cataract, Cystoid Macular Edema After Phacoemulsification
Sponsor: Inas Abd

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.