Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05072262

DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)

Led by Oslo University Hospital · Updated on 2022-12-01

300

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The DMEC trial is a randomized clinical two-arm trial comparing inflammation and cystoid macular edema for the medication regimens postoperative topical NSAIDs and steroids to only postoperative topical steroids in patients undergoing corneal endothelial transplantations (DSAEK or DMEK).

CONDITIONS

Official Title

DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit.
  • Scheduled for DSAEK or DMEK
  • Ability to cooperate fairly well during the examinations
  • Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol.
Not Eligible

You will not qualify if you...

  • Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)
  • Pregnancy or possible pregnancy during the study period
  • Preoperative macular edema and/or ongoing treatment for macular edema
  • Re-transplantation
  • In-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve)
  • Aphakic eyes (eyes without a biological or artificial intraocular lens)
  • Loss of central vision (expected visual acuity potential after surgery below 0.1 Snellen)

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

Department of Ophthalmology, Oslo University Hospital

Oslo, Norway

Actively Recruiting

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Research Team

O

Olav Kristianslund, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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