DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nepafenac Ophthalmic, Dexamethasone Ophthalmic.
- Who it may be relevant to
- Registry conditions: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), Descemet Membrane Endothelial Keratoplasty (DMEK). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
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).
Interventions
- Drug Nepafenac Ophthalmic
Topical nepafenac (Nevanac) 3 mg/ml - Drug Dexamethasone Ophthalmic
Topical dexamethasone 1 mg/ml (Spersadex)
Primary outcome measures
- Central macular thickness after 4 weeks [Time frame: 4 weeks after surgery]
- Cystoid macular edema (CME) after 4 weeks [Time frame: 4 weeks after surgery]
Secondary outcome measures (7)
- Intraocular inflammation [Time frame: Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery]
- Intraocular pressure [Time frame: Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery]
- Visual outcome [Time frame: Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery]
- Corneal endothelial status [Time frame: 1 week, 4 weeks, 2 months and 2 years after surgery]
- Patient reported outcome measure (PROM) [Time frame: 1 week, 4 weeks and 2 months after surgery]
- Central macular thickness (CMT) [Time frame: Preoperatively, and 1 week, 2 months, and 2 years after surgery]
- Cystoid macular edema (CME) [Time frame: Preoperatively, and 1 week, 2 months, and 2 years after surgery]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Department of Ophthalmology, Oslo University Hospital — Oslo
Identifiers
NCT: NCT05072262 · 131128 · 2020-003408-15