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

Study Overview
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Brief Summary
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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).

Official Title
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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)

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

Intervention / Treatment
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* Drug: Nepafenac Ophthalmic
* Drug: Dexamethasone Ophthalmic


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control (dexamethasone only)<br>Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery | Drug: Dexamethasone Ophthalmic<br>* Topical dexamethasone 1 mg/ml (Spersadex)<br>|
| Experimental: Study group (NSAIDs and dexamethasone)<br>Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery. | Drug: Nepafenac Ophthalmic<br>* Topical nepafenac (Nevanac) 3 mg/ml<br>Drug: Dexamethasone Ophthalmic<br>* Topical dexamethasone 1 mg/ml (Spersadex)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central macular thickness after 4 weeks | Measure central macular thickness (in um) on optical coherence tomography (OCT) | 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) | 4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular inflammation | Measured by laser flare meter | Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery | 
| Intraocular pressure | Measured by tonometry | 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 | Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery | 
| Corneal endothelial status | Measure corneal endothelial cell density using microscopy instrument | 1 week, 4 weeks, 2 months and 2 years after surgery | 
| Patient reported outcome measure (PROM) | COMToL questionnaire for ocular medication | 1 week, 4 weeks and 2 months after surgery | 
| Central macular thickness (CMT) | Measure CMT (in um) on optical coherence tomography (OCT) | Preoperatively, and 1 week, 2 months, and 2 years after surgery | 
| Cystoid macular edema (CME) | Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT) | Preoperatively, and 1 week, 2 months, and 2 years after surgery |