Clinical trial NCT05072262: DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Descemet Membrane Endothelial Keratoplasty (DMEK)
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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)

Primary outcomes:
measure: Central macular thickness after 4 weeks
timeFrame: 4 weeks after surgery
measure: Cystoid macular edema (CME) after 4 weeks
timeFrame: 4 weeks after surgery
Secondary outcomes:
measure: Intraocular inflammation
timeFrame: Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery
measure: Intraocular pressure
timeFrame: Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery
measure: Visual outcome
timeFrame: Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery
measure: Corneal endothelial status
timeFrame: 1 week, 4 weeks, 2 months and 2 years after surgery
measure: Patient reported outcome measure (PROM)
timeFrame: 1 week, 4 weeks and 2 months after surgery
measure: Central macular thickness (CMT)
timeFrame: Preoperatively, and 1 week, 2 months, and 2 years after surgery
measure: Cystoid macular edema (CME)
timeFrame: Preoperatively, and 1 week, 2 months, and 2 years after surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Ophthalmology, Oslo University Hospital
Study officials:
affiliation: Department of Ophthalmology, Oslo University Hospital
name: Olav Kristianslund, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: