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

Study Overview
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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

Official Title
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Dissociated Optic Nerve Fiber Layer Appearance and Retinal Sensitivity After Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap Technique

Conditions
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Macula Hole

Intervention / Treatment
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* Procedure: Macular hole surgery


Participation Criteria
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Eligibility Criteria
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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)

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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Accepts Healthy Volunteers

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Temporal inverted ILM peeling group<br>The internal limiting membrane is peeled from the temporal side of the fovea only | Procedure: Macular hole surgery<br>* Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade<br>|
| Other: Complete ILM peeling group<br>The internal limiting membrane is completely removed around the fovea | Procedure: Macular hole surgery<br>* Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of dimples on optical coherence tomography | Incidence of DONFL appearance | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal sensitivity on microperimetry testing (decibel) |  | 3 months after surgery | 
| Macular hole closure rate on optical coherence tomography |  | 3 months after surgery | 
| Visual acuity (Logarithm of the Minimum Angle of Resolution) |  | 3 months after surgery | 
| Ellipsoide zone defect on optical coherence tomography |  | 3 months after surgery | 
| External limiting membrane defect on optical coherence tomography |  | 3 months after surgery |