Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003408-15 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (dexamethasone only) | Active Comparator | Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery |
|
| Study group (NSAIDs and dexamethasone) | Experimental | Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepafenac Ophthalmic | Drug | Topical nepafenac (Nevanac) 3 mg/ml |
| |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olav Kristianslund, MD PhD | Contact | +4722118545 | olakri@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Olav Kristianslund, MD PhD | Department of Ophthalmology, Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Oslo University Hospital | Recruiting | Oslo | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dexamethasone Ophthalmic |
| Drug |
Topical dexamethasone 1 mg/ml (Spersadex) |
|
| 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 |