Actively Recruiting
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
Eligibility Criteria
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.
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
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Trial Site Locations
Total: 1 location
1
Department of Ophthalmology, Oslo University Hospital
Oslo, Norway
Actively Recruiting
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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