DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Control (dexamethasone only) Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery |
Drug: Dexamethasone Ophthalmic
Topical dexamethasone 1 mg/ml (Spersadex)
|
Experimental: Study group (NSAIDs and dexamethasone) Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery. |
Drug: Nepafenac Ophthalmic
Topical nepafenac (Nevanac) 3 mg/ml
Drug: Dexamethasone Ophthalmic
Topical dexamethasone 1 mg/ml (Spersadex)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Intraocular inflammation [Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery]
Measured by laser flare meter
- Intraocular pressure [Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery]
Measured by tonometry
- 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
- Patient reported outcome measure (PROM) [1 week, 4 weeks and 2 months after surgery]
COMToL questionnaire for ocular medication
- 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)
Eligibility Criteria
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.
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Scheduled for DSAEK or DMEK
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Ability to cooperate fairly well during the examinations
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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:
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Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)
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Pregnancy or possible pregnancy during the study period
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Preoperative macular edema and/or ongoing treatment for macular edema
-
Re-transplantation
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In-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve)
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Aphakic eyes (eyes without a biological or artificial intraocular lens)
-
Loss of central vision (expected visual acuity potential after surgery below 0.1 Snellen)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Oslo University Hospital
Investigators
- Principal Investigator: Olav Kristianslund, MD PhD, Department of Ophthalmology, Oslo University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 131128
- 2020-003408-15