Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap (MARTIAL)
MARTIAL
Dissociated Optic Nerve Fiber Layer Appearance and Retinal Sensitivity After Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap Technique
1 other identifier
interventional
130
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedJanuary 30, 2018
September 1, 2017
2 years
September 15, 2017
January 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of dimples on optical coherence tomography
Incidence of DONFL appearance
3 months after surgery
Secondary Outcomes (5)
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
Study Arms (2)
Temporal inverted ILM peeling group
OTHERThe internal limiting membrane is peeled from the temporal side of the fovea only
Complete ILM peeling group
OTHERThe internal limiting membrane is completely removed around the fovea
Interventions
Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade
Eligibility Criteria
You may qualify if:
- Patients older than 18 years old
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brabois Hospital
Vandœuvre-lès-Nancy, 54500, France
Related Publications (5)
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.
PMID: 25946691BACKGROUNDMichalewska 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.
PMID: 24263468BACKGROUNDTadayoni 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.
PMID: 23077227BACKGROUNDMichalewska 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.
PMID: 20541263BACKGROUNDTadayoni 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.
PMID: 11733271BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Baptiste CONART
Brabois Hospital, Nancy, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2017
First Posted
September 19, 2017
Study Start
February 1, 2018
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
January 30, 2018
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share