Clinical trial NCT03287102: Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap (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
Overall status: UNKNOWN
Phase: NA
Conditions: Macula Hole
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Number of dimples on optical coherence tomography
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Retinal sensitivity on microperimetry testing (decibel)
timeFrame: 3 months after surgery
measure: Macular hole closure rate on optical coherence tomography
timeFrame: 3 months after surgery
measure: Visual acuity (Logarithm of the Minimum Angle of Resolution)
timeFrame: 3 months after surgery
measure: Ellipsoide zone defect on optical coherence tomography
timeFrame: 3 months after surgery
measure: External limiting membrane defect on optical coherence tomography
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Brabois Hospital
Study officials:
affiliation: Brabois Hospital, Nancy, France
name: Jean-Baptiste CONART
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.