Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cataract Cystoid Macular Edema After Phacoemulsification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bromfenac Group

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

Group Type EXPERIMENTAL

Bromfenac

Intervention Type 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.

Moxifloxacin 0.5% ophthalmic solution

Intervention Type DRUG

antibiotic, standard postoperative care regimen

Dexamethasone phosphate 0.1%

Intervention Type DRUG

steroid, standard postoperative care regimen

Control Group

: 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

Group Type ACTIVE_COMPARATOR

Moxifloxacin 0.5% ophthalmic solution

Intervention Type DRUG

antibiotic, standard postoperative care regimen

Dexamethasone phosphate 0.1%

Intervention Type DRUG

steroid, standard postoperative care regimen

Interventions

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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.

Intervention Type DRUG

Moxifloxacin 0.5% ophthalmic solution

antibiotic, standard postoperative care regimen

Intervention Type DRUG

Dexamethasone phosphate 0.1%

steroid, standard postoperative care regimen

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Inas Abd

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zaid R Hussein, consultant ophthalmologist

Role: STUDY_DIRECTOR

Ibn Al Haitham eye teaching hospital.

Locations

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College of Medicine, University of Baghdad

Baghdad, Baghdad Governorate, Iraq

Site Status

Countries

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Iraq

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Study Documents

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Document Type: Individual Participant Data Set

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.

View Document