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

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Dexamethasone; Nepafenac

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)