Inverted Flap Versus Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes

Study Overview
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Brief Summary
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Primary outcome: difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique Secondary outcomes: difference of visual change after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique; difference in closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique

Official Title
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Vitrectomy and Inverted Flap or Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes

Conditions
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Full Thickness Macular Hole

Intervention / Treatment
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* Procedure: inverted flap
* Procedure: peeling internal limiting membrane (ILM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years old idiopathic full thickness macular hole ≤ 350 micron of diameter phakic or pseudophakic absence of systemic adverse conditions Exclusion Criteria: concomitant retinal and other ocular disease previous ocular surgery except cataract surgery axial length >26mm

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: inverted flap<br> | Procedure: inverted flap<br>* full thickness macular hole surgery<br>|
| Active Comparator: peeling internal limiting membrane (ILM)<br> | Procedure: peeling internal limiting membrane (ILM)<br>* full thickness macular hole surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microperimetry retinal sensitivity | Difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity (BCVA) | Difference of best corrected visual acuity (BCVA) after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique | 3 months | 
| Closure rate | Closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Full thickness macular hole, Vitrectomy, Inverted flap, Internal limiting membrane peeling