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Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery | Clinical Trials | Clareo Health

RECRUITINGNA

Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery

NCT07178639•Nemocnice Kolín

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn which of the drugs bromfenac 0.09%, nepafenac 0.3% and diclofenac 0.1% has better efficacy in treatment and prevention of cystoid macular oedema after cataract surgery. The main questions it aims to answer are: Which of the drugs has better efficacy in macular oedema prevention? What medical problems do participants have when taking different drugs? Researchers will compare drugs to each other. Participants will: Take on of the drugs (randomized) as their treatment in preoperative and postoperative period. Visit the clinic after the surgery on the first day, first week, in three weeks and in six weeks. Undergo retina examination with OCT (optical coherence tomography), best vision, and fill in forms considering their quality of life.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Are male or female at least 18 years of age who require cataract surgery and no other surgical procedures during the cataract surgery.
•Agree not to have any other ocular surgical procedures in the study or fellow (non study) eye within 15 days prior to the initiation of dosing with the test article or throughout the duration of the study.
•Have a Best Corrected Visual Acuity of 20/200 or better in either eye.
•Are able to self administer test article (or have a caregiver available to instill all doses of test article).

Exclusion Criteria

•Have known hypersensitivity to bromfenac, nepafenac, diclofenac or any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
•Have intraocular inflammation (i.e., cells or flare in the anterior chamber as measured on slit lamp examination) in study eye at screening visit.
•Have a known blood dyscrasia or bone marrow suppression, a diagnosis of uncontrolled/unstable peptic ulcer disease, inflammatory bowel disease, or ulcerative colitis, or any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease.
•Have used ocular, topical, or systemic NSAIDs or ocular, topical, or systemic gentamicin, or cyclosporine ophthalmic emulsion within 7 days prior to initiation of dosing with the test article or throughout the duration of study,with exception of allowing patients on a stable dose of aspirin 81 mg daily or less.
•Have diabetes of any type.
•Have any pathology of vitreoretinal interface (recognised on opcital coherence tomography).
•Have any history of pars plana vitrectomy in the study eye.
•Have glaucoma of the following types: any secondary, closed angle, severe open angle.
•Have used ocular prostaglandins within 30 days prior to initiation of dosing with test article or throughout the duration of study.
•Have active corneal pathology noted in the study eye at screening visit. Active corneal pathology is defined as corneal pathology that is non stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment. Superficial punctate keratitis in study eye.
+5 more criteria

Locations (1)

Oblastní nemocnice Kolín a.s.

Kolín, Czechia

Key Dates

Start Date

August 1, 2025

Primary Completion Date

February 28, 2026

Completion Date

February 28, 2026

Last Updated

September 17, 2025

Enrollment

150

ESTIMATED participants

Conditions

Macular OedemaCataract SurgeryNSAID (Non-Steroidal Anti-Inflammatory Drug)

Interventions

Bromfenac 0.09 % Ophthalmic Solution

DRUG

Nepafenac 0.3% Oph Susp

DRUG

diclofenac 0.1% ophthalmic susp.

DRUG

Contacts

Tomas Vanek

CONTACT

+420728872150 tomas.vanek@nemocnicekolin.cz

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery

Inclusion Criteria

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