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

University of Molise28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Macular Holes

Interventions

Cover GroupPROCEDURE

"Cover" when the ILM flap is everted over the MH gap in a single layer

Fill GroupPROCEDURE

"Fill" when the ILM is folded into multiple layers within the MH

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Molise

Campobasso, Italy

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: five months

Secondary Outcomes

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.

Time frame: five months

Central Contacts

Ciro Costagliola, MD

CONTACT

+390874404448 ciro.costagliola@unimol.it

Data from ClinicalTrials.gov

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