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

University of Oslo (UIO)

Status and phase: Enrolling; Phase 4

Conditions: Descemet Membrane Endothelial Keratoplasty (DMEK); Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Treatments: Drug: Dexamethasone Ophthalmic; Drug: Nepafenac Ophthalmic

Study type: Interventional

Funder types: Other

Identifiers

NCT05072262

2020-003408-15 (EudraCT Number)

131128

Details and patient eligibility

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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Control (dexamethasone only)

Active Comparator group

Description:

Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery

Treatment:

Drug: Dexamethasone Ophthalmic

Study group (NSAIDs and dexamethasone)

Experimental group

Description:

Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery.

Treatment:

Drug: Dexamethasone Ophthalmic

Drug: Nepafenac Ophthalmic