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| Name | Class |
|---|---|
| Ukrainian Vitreoretinal Society | OTHER |
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The goal of this clinical trial is to evaluate the visual and anatomical outcomes of large (410-1000 μm) full-thickness macular holes repair surgery using perfluoropropane (15% C3F8), sulfur hexafluoride (20% SF6) gas tamponade.
The project is a randomized clinical trial with a follow up time of 6 months comparing the effects of surgical treatment of large (410-1000 μm) idiopathic macular holes. Patients are randomized to vitrectomy surgery with internal limiting membrane peeling using perfluoropropane (15% C3F8), sulfur hexafluoride (20% SF6) gas tamponad. Intra- and postoperative complications are registered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perfluoropropane (15% C3F8) gas tamponade | Other | Macular hole surgery with ILM-peeling and 15% C3F8 gas tamponade |
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| Hexafluoride (20% SF6) gas tamponade | Other | Macular hole surgery with ILM-peeling and hexafluoride (20% SF6) gas tamponade |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pars plana vitrectomy | Procedure | All operations are performed in a similar fashion using the vitrectomy system with 23-gauge and 25-gauge vitrectomy probes. Surgical approach and technique include the use of tissue-staining dyes, choice of endotamponade, and postoperative face-down positioning regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Closure of macular holes | Closure of macular hole evaluated on optical coherence tomography | 6 months |
| Type of macular hole closure | U-, V-, W-types of macular hole closure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best-corrected visual acuity | Visual acuity measured at last follow-up | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Filatov Institute of Eye Diseases and Tissue Therapy | Odesa | 65061 | Ukraine |
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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