Clinical trial NCT06785090: Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery
Official title: Effects of Topical Bromfenac Solution on Macular Thickness in Cataract Patients Undergoing Phacoemulsification Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Cystoid Macular Edema After Phacoemulsification
Keywords: cataract
phacoemulsification
cystoid macular edema
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Macular Thickness From Baseline to 6 Weeks Postoperatively After Cataract Surgery
timeFrame: 6 weeks postoperatively
Secondary outcomes:
measure: Incidence of Adverse Events Related to Bromfenac
timeFrame: 6 weeks postoperatively
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Medicine, University of Baghdad
state: Baghdad Governorate
Study officials:
affiliation: Ibn Al Haitham eye teaching hospital.
name: Zaid R Hussein, consultant ophthalmologist
role: STUDY_DIRECTOR
References: