Descemet Membrane Endothelial Keratoplasty (DMEK), Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Conditions
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).
Interventions
Topical nepafenac (Nevanac) 3 mg/ml
Topical dexamethasone 1 mg/ml (Spersadex)
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central macular thickness after 4 weeks | 4 weeks after surgery | Measure central macular thickness (in um) on optical coherence tomography (OCT) |
| Cystoid macular edema (CME) after 4 weeks | 4 weeks after surgery | Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual outcome | Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery | Measure uncorrected and corrected distance visual acuity using visual acuity chart |
| Corneal endothelial status | 1 week, 4 weeks, 2 months and 2 years after surgery | Measure corneal endothelial cell density using microscopy instrument |
| Intraocular inflammation | Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery | Measured by laser flare meter |
| Central macular thickness (CMT) | Preoperatively, and 1 week, 2 months, and 2 years after surgery | Measure CMT (in um) on optical coherence tomography (OCT) |
| Cystoid macular edema (CME) | Preoperatively, and 1 week, 2 months, and 2 years after surgery | Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT) |
| Patient reported outcome measure (PROM) | 1 week, 4 weeks and 2 months after surgery | COMToL questionnaire for ocular medication |
| Intraocular pressure | Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery | Measured by tonometry |
Countries
Norway
Contacts
Primary ContactOlav Kristianslund, MD PhD
Outcome results
None listed