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Patients with idiopathic macular holes (MHs) postoperative closure rates for large MHs (diameter > 550 μm) are disappointing and often require a second intervention, different techniques have been described with very variable success rates in different published studies, an efficient technique with good functional outcome has not been found.
Interventional study in large macular holes (diameter > 550 μm) using an amniotic membrane with and without internal limiting membrane peeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amniotic membrane without internal limiting membrane peeling | Experimental | The surgery performed will be phacoemulsification + vitrectomy using an amniotic membrane to plug the macular hole using air as tamponade. |
|
| Amniotic membrane with internal limiting membrane peeling | Active Comparator | The surgery performed will be phacoemulsification + vitrectomy + internal limiting membrane peeling using an amniotic membrane to plug the macular hole using air as tamponade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macular hole closure with amniotic membrane with/without internal limiting membrane peeling | Procedure | Pars plana vitrectomy with/without internal limiting membrane peeling, amniotic membrane, and air tamponade |
| Measure | Description | Time Frame |
|---|---|---|
| % of macular hole clousure measured with OCT | Closure of the macular hole by optical coherence tomography | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best-corrected visual acuity measured with Snellen Chart | Improvement of 2 lines in best-corrected visual acuity | 6 months |
| Superficial and deep retinal capillary plexus density with OCT-A | Presence of capillary plexus in macular hole area |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zita Chao Loyo, MD | Contact | +52 33994182 | investigacionretinaconval@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Rios Esquer, MD | Instituto de Oftalmologia Conde de Valenciana | Principal Investigator |
| Ishtar A Astorga Carballo, MD | Instituto de Oftalmologia Conde de Valenciana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Oftalmologia Conde de Valenciana | Recruiting | Mexico City | 06800 | Mexico |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 22, 2024 | |
| Reset | Jul 18, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 22, 2024 | Jul 18, 2024 |
| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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Large MHs (diameter > 550 μm)
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We never let the patient know the performed surgery
| 6 months |
| Jose L Rodriguez Loaiza, MD | Instituto de Oftalmologia Conde de Valenciana | Principal Investigator |
| Zita Chao Loyo, MD | Instituto de Oftalmologia Conde de Valenciana | Principal Investigator |
| Felipe Esparza Correa, MD | Instituto de Oftalmologia Conde de Valenciana | Principal Investigator |