Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery

Inas Abd

Status and phase: Completed; Phase 4

Conditions: Cataract; Cystoid Macular Edema After Phacoemulsification

Treatments: Drug: Dexamethasone phosphate 0.1%; Drug: Bromfenac; Drug: Moxifloxacin 0.5% ophthalmic solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06785090

ES-Bromphaco-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

Bromfenac Group

Experimental group

Description:

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

Treatment:

Drug: Moxifloxacin 0.5% ophthalmic solution

Drug: Bromfenac

Drug: Dexamethasone phosphate 0.1%

Control Group

Active Comparator group

Description:

: 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

Treatment:

Drug: Moxifloxacin 0.5% ophthalmic solution

Drug: Dexamethasone phosphate 0.1%