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

Launched by OSLO UNIVERSITY HOSPITAL · Oct 5, 2021

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ClinConnect Summary

The DMEC trial is a research study looking at how different medications affect inflammation and a condition called cystoid macular edema (swelling in the eye) after two types of eye surgeries known as DSAEK and DMEK, which are procedures to replace damaged corneal tissue. The study is comparing the effects of using only steroid eye drops versus using both steroid and anti-inflammatory eye drops (called NSAIDs) after surgery. The goal is to see if adding the NSAIDs helps improve recovery and reduce swelling better than using steroids alone.

To participate in this study, you must be at least 18 years old and scheduled for either DSAEK or DMEK surgery. You should be able to follow instructions during check-ups and give informed consent, meaning you understand and agree to be part of the study. However, certain people cannot join, including those who are pregnant, have specific allergies to medications, or have other serious eye conditions. If you choose to participate, you can expect regular follow-ups to monitor your progress and how well the medications are working. This trial is currently recruiting participants, so if you're interested, it’s a great opportunity to contribute to important research in eye health.

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Eligibility 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)