Actively Recruiting
Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery
Led by Nemocnice Kolín · Updated on 2025-09-17
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying which of three eye drop medications—bromfenac 0.09%, nepafenac 0.3%, and diclofenac 0.1%—is more effective in preventing and treating cystoid macular oedema following cataract surgery. The study aims to find out which drug better prevents this condition and to compare the medical problems participants might have when using different drugs. Participants will be randomly assigned to use one of these drugs before and after their cataract surgery. Participants will use eye drops in their operated eye for up to 26 days, starting four days before surgery and continuing for 21 days after. The bromfenac group applies drops twice daily, the nepafenac group once daily, and the diclofenac group four times daily. This dosing schedule is followed throughout the treatment period to assess and compare the drugs' effects. During the study, participants will visit the clinic for exams on the first day, one week, three weeks, and six weeks after surgery. Assessments include retina examination using optical coherence tomography (OCT), vision tests, and questionnaires about their quality of life. Researchers will track the presence of macular oedema over six weeks and monitor changes in vision-related quality of life. The total participation lasts about six weeks after surgery with regular follow-up visits.
CONDITIONS
Brief Title
Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older who require cataract surgery without other surgical procedures during the operation
- Agree not to have any other eye surgeries in either eye from 15 days before dosing until study completion
- Best corrected visual acuity of 20/200 or better in either eye
- Able to self-administer eye drops or have a caregiver to assist with dosing
You will not qualify if you...
- Known allergy to bromfenac, nepafenac, diclofenac, or any components of the study medications or related procedural drops
- Intraocular inflammation in the study eye at screening
- Blood disorders, unstable peptic ulcer disease, inflammatory bowel disease, or uncontrolled systemic diseases
- Use of ocular or systemic NSAIDs, gentamicin, or cyclosporine within 7 days before dosing except stable aspirin use
- Diagnosis of any type of diabetes
- Vitreoretinal interface pathology or history of pars plana vitrectomy in the study eye
- Certain types of glaucoma (secondary, closed angle, severe open angle)
- Use of ocular prostaglandins within 30 days prior to dosing
- Active corneal disease in the study eye that is non-stable or more than mild
- Any extraocular or intraocular inflammation in the study eye except mild blepharitis
- Use of steroids (topical, ocular, inhaled, systemic) within 14 days before screening
- History of alcohol or drug abuse within six months before screening
- Pregnant or nursing/lactating women
- Participation in another investigational drug or device study within 30 days before randomization
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 26 days
Participants instill eye drops in the operative eye starting 4 days before cataract surgery, continuing on the day of surgery and for 21 days after surgery to prevent cystoid macular oedema.
Daily self-administration of eye drops for up to 26 days
Duration - Up to 6 weeks from enrollment
Participants are monitored for treatment effects and quality of life changes after completing the eye drop regimen.
Visits as scheduled to assess outcomes until 6 weeks post enrollment
Trial Site Locations
Total: 1 location
1
Oblastní nemocnice Kolín a.s.
Kolín, Czechia, 28002
Actively Recruiting
Research Team
T
Tomas Vanek
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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