Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis

Study Overview
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Brief Summary
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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.

Detailed Description
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Interventional study in large macular holes (diameter > 550 μm) using an amniotic membrane with and without internal limiting membrane peeling.

Official Title
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Comparison of Macular Hole Closure Rate in Patients With Poor Prognosis Clinical Features Treated With Amniotic Membrane Graft With and Without Limitorrhexis

Conditions
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Macular Holes

Intervention / Treatment
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* Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not myopic patients (<6 Dioptre or <26 mm) Large macular hole >550 μm > 6 months symptoms Signing informed consent Exclusion Criteria: Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc) Using systemic drugs that are toxic for the optic nerve or retina (chloroquine, hydroxychloroquine, tamoxifen, ethambutol, etc) Patients with ocular surgery

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 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: Sequential Assignment
Interventional Model Description: Large MHs (diameter > 550 μm)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amniotic membrane without internal limiting membrane peeling<br>The surgery performed will be phacoemulsification + vitrectomy using an amniotic membrane to plug the macular hole using air as tamponade. | Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling<br>* Pars plana vitrectomy with/without internal limiting membrane peeling, amniotic membrane, and air tamponade<br>|
| Active Comparator: Amniotic membrane with internal limiting membrane peeling<br>The surgery performed will be phacoemulsification + vitrectomy + internal limiting membrane peeling using an amniotic membrane to plug the macular hole using air as tamponade. | Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling<br>* Pars plana vitrectomy with/without internal limiting membrane peeling, amniotic membrane, and air tamponade<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of macular hole clousure measured with OCT | Closure of the macular hole by optical coherence tomography | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 6 months |