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

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03287102
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Macula Hole	Procedure: Macular hole surgery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dissociated Optic Nerve Fiber Layer Appearance and Retinal Sensitivity After Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap Technique
• Anticipated Study Start Date: Feb 1, 2018
• Anticipated Primary Completion Date: Feb 1, 2020
• Anticipated Study Completion Date: Feb 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of dimples on optical coherence tomography [3 months after surgery]

   Incidence of DONFL appearance

Secondary Outcome Measures

1. Retinal sensitivity on microperimetry testing (decibel) [3 months after surgery]

2. Macular hole closure rate on optical coherence tomography [3 months after surgery]

3. Visual acuity (Logarithm of the Minimum Angle of Resolution) [3 months after surgery]

4. Ellipsoide zone defect on optical coherence tomography [3 months after surgery]

5. External limiting membrane defect on optical coherence tomography [3 months after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brabois Hospital	Vandœuvre-lès-Nancy		France	54500

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

• Principal Investigator: Jean-Baptiste CONART, Brabois Hospital, Nancy, France

Study Documents (Full-Text)

None provided.

More Information

Publications

• Michalewska Z, Michalewski J, Adelman RA, Nawrocki J. Inverted internal limiting membrane flap technique for large macular holes. Ophthalmology. 2010 Oct;117(10):2018-25. doi: 10.1016/j.ophtha.2010.02.011. Epub 2010 Jun 11.
• Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Adelman RA, Nawrocki J. TEMPORAL INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE VERSUS CLASSIC INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE: A Comparative Study. Retina. 2015 Sep;35(9):1844-50. doi: 10.1097/IAE.0000000000000555.
• Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Nawrocki J. Inverted internal limiting membrane flap technique for surgical repair of myopic macular holes. Retina. 2014 Apr;34(4):664-9. doi: 10.1097/IAE.0000000000000042.
• Tadayoni R, Paques M, Massin P, Mouki-Benani S, Mikol J, Gaudric A. Dissociated optic nerve fiber layer appearance of the fundus after idiopathic epiretinal membrane removal. Ophthalmology. 2001 Dec;108(12):2279-83.
• Tadayoni R, Svorenova I, Erginay A, Gaudric A, Massin P. Decreased retinal sensitivity after internal limiting membrane peeling for macular hole surgery. Br J Ophthalmol. 2012 Dec;96(12):1513-6. doi: 10.1136/bjophthalmol-2012-302035. Epub 2012 Oct 17.

• Responsible Party: Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT03287102
• Other Study ID Numbers: 2017-A02061-52
• First Posted: Sep 19, 2017
• Last Update Posted: Jan 30, 2018
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Retinal Perforations

Study Results

No Results Posted as of Jan 30, 2018