Which eye drop—bromfenac, nepafenac, or diclofenac—works best after cataract surgery?
Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery
This trial will try three different anti-inflammatory eye drops (bromfenac 0.09%, nepafenac 0.3%, and diclofenac 0.1%) to see which best prevents or treats cystoid macular edema in adults having cataract surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nemocnice Kolín Academic / other |
| Locations | 1 site (Kolín) |
| Trial ID | NCT07178639 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for cataract surgery are randomly assigned to one of three topical NSAID regimens given before and after the operation. Participants return for follow-up visits on day 1, week 1, week 3, and week 6 when investigators measure retinal thickness with OCT, record best-corrected visual acuity, and collect quality-of-life questionnaires. The study compares the incidence and severity of cystoid macular edema and records adverse events for each drug. Outcomes will determine relative efficacy and tolerability of the three commonly used ophthalmic NSAIDs in this surgical setting.
Who should consider this trial
Good fit: Adults (18+) who need cataract surgery, have best-corrected visual acuity of 20/200 or better in either eye, and can self-administer drops or have a caregiver to do so are appropriate candidates.
Not a fit: People with known hypersensitivity to bromfenac, nepafenac, or diclofenac, active intraocular inflammation, blood dyscrasia, or who require additional ocular surgery are unlikely to benefit from participation.
Why it matters
Potential benefit: If one drug is superior, patients could experience lower rates of postoperative cystoid macular edema and faster visual recovery after cataract surgery.
How similar studies have performed: Previous studies show topical NSAIDs can reduce postoperative macular edema, but direct head-to-head comparisons between these specific concentrations are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * Have any extraocular/intraocular inflammation in the study eye at screening visit (blepharitis allowed if mild only, and no concurrent conjunctivitis or lid erythema/edema) or ongoing, unresolved uveitis. * Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening. * Have a history of abuse of alcohol/drugs within six months prior to the screening visit. * Are pregnant or nursing/lactating. * Have participated in any other study of an investigational drug or device within 30 days prior to randomization.
Where this trial is running
Kolín
- Oblastní nemocnice Kolín a.s. — Kolín, Czechia (Recruiting)
Study contacts
- Study coordinator: Tomas Vanek
- Email: tomas.vanek@nemocnicekolin.cz
- Phone: +420728872150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.