Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison

Study Overview
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Brief Summary
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To report closure rate, Best Corrected Visual Acuity (BCVA), Retinal Sensitivity (RS) and Fixation Stability (FS) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure.

Detailed Description
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Patients will be randomized (1:1) to receive a vitrectomy with either Cover or Fill ILM flap technique. Cover when the ILM flap is everted over the MH gap in a single layer, Fill when the ILM is folded into multiple layers within the MH. All patients will undergo BCVA, RS and FS assessment at baseline, 1-month and 3-months after surgery. Purpose of the study is to report retinal differential sensitivity and fixation stability as well as anatomic and visual outcomes of patients operated on for idiopathic MH and randomly assigned to Fill or Cover Groups.

Official Title
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Comparing Retinal Sensitivity and Fixation Stability of Inverted ILM-flap Techniques Variants for Macular Hole Surgery

Conditions
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Macular Holes

Intervention / Treatment
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* Procedure: Cover Group
* Procedure: Fill Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with idiopatic macular holes Exclusion Criteria: Patients with MH duration greater than 6 months myopia exceeding 6 diopters history of trauma previous ocular surgery except uncomplicated cataract extraction with in-the-bag IOL implantation any ocular illness including glaucoma, uveitis, optic nerve pathology

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cover Group (CG)<br>All patients will undergo a 25G standard 3-port PPV with posterior vitreous detachment induction (if not already present), ILM staining with 0,25 g/l of brilliant blue-G and creation of a 360°ILM flap around the MH rim. Phakic patients will undergo combined phacoemulsification with IOL implant in-the-bag. In the Cover Group the ILM flap will be folded as a single layer to bridge tissue dehiscence during air-fluid exchange. All eyes will recive a mixture of 20% sulfur hexafluoride tamponade and will be instructed to position face down for 4 hours a day during the first 3 days post-operative | Procedure: Cover Group<br>* Cover when the ILM flap is everted over the MH gap in a single layer<br>|
| Other: Fill Group (FG)<br>All patients will undergo a 25G standard 3-port PPV with posterior vitreous detachment induction (if not already present), ILM staining with 0,25 g/l of brilliant blue-G and creation of a 360°ILM flap around the MH rim. Phakic patients will undergo combined phacoemulsification with IOL implant in-the-bag. In the Fill Group, multiple layers of ILM will be deliberately folded within the loss of tissue before air-fluid exchange. All eyes will receive a mixture of 20% sulfur hexafluoride tamponade and will be instructed to position face down for 4 hours a day during the first 3 days post-operative | Procedure: Fill Group<br>* Fill when the ILM is folded into multiple layers within the MH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual outcome linked to Cover and Fill procedures | To report : - Best Corrected Visual Acuity (BCVA expressed in logMAR) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure. | five months | 
| Anatomical outcome linked to Cover and Fill procedures | To report: - closure rate (μm) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure | five months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular sensitivity linked to Cover and Fill procedures | To report: Retinal Sensitivity (RS expressed in dB) Fixation Stability (FS expressed as: 0 = stable, 1 = relatively (stable,2 = unstable) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure. | five months |