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

Central Hospital, Nancy, France

Status: Unknown

Conditions: Macula Hole

Treatments: Procedure: Macular hole surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03287102

2017-A02061-52

Details and patient eligibility

About

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

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients older than 18 years old

Exclusion criteria

• Underage patients
• History of intraocular surgery (except for cataract surgery)
• Macular hole secondary to trauma, diabetic retinopathy, uveitis or associated with retinal detachment
• Concurrent macular disease (diabetic maculopathy, age-related macular degeneration)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Temporal inverted ILM peeling group

Other group

Description:

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

Treatment:

Procedure: Macular hole surgery

Complete ILM peeling group

Other group

Description:

The internal limiting membrane is completely removed around the fovea

Treatment:

Procedure: Macular hole surgery