Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques

Study Overview
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Brief Summary
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To compare anatomic and functional results, and to evaluate postoperatively the healing process in 2 different techniques for the closure of the macular holes (MH)

Detailed Description
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Patients with macular holes classified in stages 3 and 4 will be randomized into 2 groups. . In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed. The 20% sulfur hexafluoride (SF6) gas will be used as a tamponade agent in all surgeries, and patients will be instructed to avoid the prone position for 5 days. OCT images will be performed in the first 5 postoperative days and months 1, 3 and 6. The primary outcome is anatomic closure of the MH closure in the month 6. The second outcomes are: mean best corrected visual acuity (BCVA) at month 6, mean change in the BCVA at month 6; integrity of the perifoveal external limiting membrane and ellipsoid zone on Optical Coherence Tomography (OCT); MH closure rate over time in days; functional improvement of microperimetry Statistical analysis will be performed with Student t-test and the p-value of ≤ 0.05 is considered significant.

Official Title
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Randomized Clinical Trials to Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques

Conditions
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Macular Holes

Intervention / Treatment
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* Procedure: Conventional ILM Peeling
* Procedure: Inverted ILM Peeling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > Stage 3 and 4 macular holes with visual acuity between 20/30 and 20/800 according to the ETDRS chart. Exclusion Criteria: Macular holes secondary to ocular trauma, myopia or retinal detachment Any previous treatment for the macular hole Evidence on examination of any diabetic retinopathy History or presence of wet or dry age macular degeneration (AMD) Presence of epiretinal membrane or prior uveitis Any ocular surgery within 3 months before baseline Intra or periocular infection

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
Interventional Model Description: In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: Conventional ILM peeling<br>peeling with complete removal of the internal limiting membrane (ILM) | Procedure: Conventional ILM Peeling<br>* peeling with complete removal of the internal limiting membrane (ILM)<br>|
| Active Comparator: GroupB: Inverted ILM Peeling<br>the inverted ILM peeling technique, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange | Procedure: Inverted ILM Peeling<br>* the inverted ILM peeling technique - the technique of Inverted flap described by Michalewska, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Anatomic closure | Rate of anatomic macular hole closure in the OCT at month 6 | Month 6 post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA mean | mean best corrected visual acuity (BCVA) at month 6 | Month 6 post operative | 
| BCVA change | change in the BCVA at month 6 | Screening and Month 6 post operative | 
| Integrity Membrane measured in microns (μm) by OCT | In the month 6, the area of discontinuity of the perifoveal external limiting membrane and ellipsoid zone in the OCT images will be measured in microns (μm) and correlated between groups | Month 6 post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular holes