Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07178639

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

30 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female at least 18 years old who require cataract surgery only
  • Agree not to have any other eye surgeries within 15 days before or during the study
  • Best corrected vision of 20/200 or better in either eye
  • Able to self-administer eye drops or have a caregiver to help
Not Eligible

You will not qualify if you...

  • Allergy to bromfenac, nepafenac, diclofenac, or any ingredient in the study medications
  • Eye inflammation in the study eye at screening
  • Known blood or bone marrow problems, unstable ulcers, inflammatory bowel disease, or unstable major diseases
  • Use of NSAIDs, gentamicin, or cyclosporine eye drops within 7 days before or during the study (except stable low-dose aspirin)
  • Diabetes of any type
  • Problems with the retina or vitreoretinal interface in the study eye
  • History of certain eye surgeries like pars plana vitrectomy in the study eye
  • Certain types of glaucoma
  • Use of ocular prostaglandins within 30 days before or during the study
  • Active corneal problems in the study eye that are unstable or severe
  • Any eye inflammation except mild eyelid inflammation without conjunctivitis
  • Use of steroids within 14 days before screening
  • History of alcohol or drug abuse within 6 months before screening
  • Pregnant or nursing
  • Participation in another drug or device study within 30 days before randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Oblastní nemocnice Kolín a.s.

Kolín, Czechia, 28002

Actively Recruiting

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Research Team

T

Tomas Vanek

CONTACT

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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