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

Not Applicable

• Conditions: Macula Hole
• Interventions: Procedure: Macular hole surgery

• Registration Number: NCT03287102
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-19
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-30
• Study Start: 2018-02-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Temporal inverted ILM peeling group	Macular hole surgery	The internal limiting membrane is peeled from the temporal side of the fovea only
Complete ILM peeling group	Macular hole surgery	The internal limiting membrane is completely removed around the fovea

Primary Outcome Measures

Name	Time	Method
Number of dimples on optical coherence tomography	3 months after surgery	Incidence of DONFL appearance

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Brabois Hospital; 🇫🇷 Vandœuvre-lès-Nancy, France