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| Name | Class |
|---|---|
| Ibinsina Modern Eye and Retina Center | OTHER |
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In this study, the investigators will make the only upper flap either from the internal limiting membrane or from the epiretinal membrane to cover the full thickness macular hole.
After the investigators completed the clinical trial NCT05269563, which was a double flap technique; that consists of two flaps from the internal limiting membrane and the epiretinal membrane. The inferior flap was implanted inside the hole, but the upper flap was utilized to cover the hole. The results were encouraging. Therefore, in this study, the investigators will make the only upper flap to cover the full thickness macular hole, to compare both visual and anatomical outcomes with the double flapped technique (NCT05269563) results. Therefore the double flap will be our control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single superior flap technique to secure macular hole closure. | Experimental | The patients are divided into two groups: For the first group, the flap will be carried out under the effect of perfluorocarbon. For the second group, the flap stabilized with methylcellulose. |
|
| Double flap technique to secure macular hole closure. | Active Comparator | This arm is NCT05269563, we utilize the results as a comparator to the superior single flap technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical intervention | Other | Pars-plana vitrectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical outcome | OCT | The fourth weeks post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome | Best corrected visual acuity | The fourth week post-operatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omer Othman Abdullah | Erbil | 44001 | Iraq |
Both the best corrected visual acuity and the OCT.
Expected to be available around the end of November 2022
via your permisson
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| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D019773 | Epiretinal Membrane |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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