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

Macula Hole Clinical Trial

— MARTIAL  

Official title:

Dissociated Optic Nerve Fiber Layer Appearance and Retinal Sensitivity After Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap Technique

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03287102
• Other study ID #: 2017-A02061-52
• Status: Not yet recruiting
• Phase: N/A
• First received: September 15, 2017
• Last updated: January 29, 2018
• Start date: February 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: September 2017
• Source: Central Hospital, Nancy, France
• Contact: Jean-Baptiste CONART
• Phone: +33383155203
• Email: jbconart[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Macula Hole
• Retinal Perforations

Intervention

Procedure:
• Macular hole surgery
Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade

Locations

Country	Name	City	State
France	Brabois Hospital	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of dimples on optical coherence tomography	Incidence of DONFL appearance	3 months after surgery
Secondary	Retinal sensitivity on microperimetry testing (decibel)		3 months after surgery
Secondary	Macular hole closure rate on optical coherence tomography		3 months after surgery
Secondary	Visual acuity (Logarithm of the Minimum Angle of Resolution)		3 months after surgery
Secondary	Ellipsoide zone defect on optical coherence tomography		3 months after surgery
Secondary	External limiting membrane defect on optical coherence tomography		3 months after surgery