RecruitingPhase 4NCT05072262

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

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 (DMEC)


Sponsor

Oslo University Hospital

Enrollment

300 participants

Start Date

Nov 25, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether a topical eye drop medication called nepafenac (an anti-inflammatory NSAID) can prevent cystoid macular edema (CME) — a type of swelling in the center of the retina — after corneal transplant surgery (DSAEK or DMEK). CME can impair vision after what is otherwise a successful transplant. You may be eligible if: - You are 18 years or older - You are scheduled to undergo DSAEK or DMEK corneal transplant surgery - You are able to cooperate during eye examinations - You are willing and able to participate and provide informed consent You may NOT be eligible if: - You have a known contraindication to any study medication (e.g., allergy, pregnancy, breastfeeding) - You already have macular edema before surgery - This is a repeat (re-transplantation) procedure - You have an implanted glaucoma shunt or valve in the eye - You do not have a lens in your eye (aphakic) - Your expected vision after surgery is very poor (below 0.1 Snellen) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNepafenac Ophthalmic

Topical nepafenac (Nevanac) 3 mg/ml

DRUGDexamethasone Ophthalmic

Topical dexamethasone 1 mg/ml (Spersadex)


Locations(1)

Department of Ophthalmology, Oslo University Hospital

Oslo, Norway

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NCT05072262


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