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

Primary Purpose

Macula Hole

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Macular hole surgery
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macula Hole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Brabois Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Temporal inverted ILM peeling group

Complete ILM peeling group

Arm Description

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

The internal limiting membrane is completely removed around the fovea

Outcomes

Primary Outcome Measures

Number of dimples on optical coherence tomography
Incidence of DONFL appearance

Secondary Outcome Measures

Retinal sensitivity on microperimetry testing (decibel)
Macular hole closure rate on optical coherence tomography
Visual acuity (Logarithm of the Minimum Angle of Resolution)
Ellipsoide zone defect on optical coherence tomography
External limiting membrane defect on optical coherence tomography

Full Information

First Posted
September 15, 2017
Last Updated
January 29, 2018
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03287102
Brief Title
Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap (MARTIAL)
Acronym
MARTIAL
Official Title
Dissociated Optic Nerve Fiber Layer Appearance and Retinal Sensitivity After Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap Technique
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Anticipated)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macula Hole

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Temporal inverted ILM peeling group
Arm Type
Other
Arm Description
The internal limiting membrane is peeled from the temporal side of the fovea only
Arm Title
Complete ILM peeling group
Arm Type
Other
Arm Description
The internal limiting membrane is completely removed around the fovea
Intervention Type
Procedure
Intervention Name(s)
Macular hole surgery
Intervention Description
Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade
Primary Outcome Measure Information:
Title
Number of dimples on optical coherence tomography
Description
Incidence of DONFL appearance
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Retinal sensitivity on microperimetry testing (decibel)
Time Frame
3 months after surgery
Title
Macular hole closure rate on optical coherence tomography
Time Frame
3 months after surgery
Title
Visual acuity (Logarithm of the Minimum Angle of Resolution)
Time Frame
3 months after surgery
Title
Ellipsoide zone defect on optical coherence tomography
Time Frame
3 months after surgery
Title
External limiting membrane defect on optical coherence tomography
Time Frame
3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Baptiste CONART
Phone
+33383155203
Email
jbconart@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste CONART
Organizational Affiliation
Brabois Hospital, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brabois Hospital
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste CONART
Phone
+33383155203
Email
jbconart@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25946691
Citation
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.
Results Reference
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PubMed Identifier
24263468
Citation
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.
Results Reference
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PubMed Identifier
23077227
Citation
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.
Results Reference
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PubMed Identifier
20541263
Citation
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.
Results Reference
background
PubMed Identifier
11733271
Citation
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. doi: 10.1016/s0161-6420(01)00856-9.
Results Reference
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Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap (MARTIAL)

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