Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap (MARTIAL)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-02-01

Brief Summary

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Since 1991, idiopathic macular holes (MH) can benefit from an effective treatment initially involving pars plana vitrectomy, stripping of epiretinal membranes and intraocular gas tamponade followed by facedown positioning. The initial 58% success rate has further increased to 85-100% with internal limiting membrane (ILM) peeling. However, complete ILM removal has been shown to lead to anatomic changes causing the retina to have the appearance of a dissociated optic nerve fiber layer (DONFL). Moreover, it has been associated with decreased retinal sensitivity that may cause visual discomfort despite good visual acuity. Nawrocki et al. recently suggested to reduce the area of peeled ILM (temporal inverted ILM flap technique) in order to minimize iatrogenic trauma while maintaining satisfactory surgical outcomes. The aim of this study is to compare the incidence of DONFL appearance and retinal sensitivity after macular hole surgery in eyes that underwent temporal inverted ILM flap technique and eyes that had complete ILM peeling

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Detailed Description

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Conditions

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Macula Hole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Temporal inverted ILM peeling group

The internal limiting membrane is peeled from the temporal side of the fovea only

Group Type OTHER

Macular hole surgery

Intervention Type PROCEDURE

Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade

Complete ILM peeling group

The internal limiting membrane is completely removed around the fovea

Group Type OTHER

Macular hole surgery

Intervention Type PROCEDURE

Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade

Interventions

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