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

Phase 4RecruitingNCT05072262

Oslo University Hospital300 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)Descemet Membrane Endothelial Keratoplasty (DMEK)

Interventions

Nepafenac OphthalmicDRUG

Topical nepafenac (Nevanac) 3 mg/ml

Dexamethasone OphthalmicDRUG

Topical dexamethasone 1 mg/ml (Spersadex)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Department of Ophthalmology, Oslo University Hospital

Oslo, Norway

RECRUITING

Outcomes

Primary Outcomes

Central macular thickness after 4 weeks

Measure central macular thickness (in um) on optical coherence tomography (OCT)

Time frame: 4 weeks after surgery

Cystoid macular edema (CME) after 4 weeks

Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)

Time frame: 4 weeks after surgery

Secondary Outcomes

Intraocular inflammation

Measured by laser flare meter

Time frame: Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery

Intraocular pressure

Measured by tonometry

Time frame: Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery

Visual outcome

Measure uncorrected and corrected distance visual acuity using visual acuity chart

Time frame: Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery

Corneal endothelial status

Measure corneal endothelial cell density using microscopy instrument

Time frame: 1 week, 4 weeks, 2 months and 2 years after surgery

Patient reported outcome measure (PROM)

COMToL questionnaire for ocular medication

Time frame: 1 week, 4 weeks and 2 months after surgery

Central macular thickness (CMT)

Measure CMT (in um) on optical coherence tomography (OCT)

Central Contacts

Olav Kristianslund, MD PhD

CONTACT

+4722118545 olakri@ous-hf.no

Data from ClinicalTrials.gov

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