Clinical Trials Directory

Trials / Unknown

UnknownNCT03287102

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
130 (estimated)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREMacular hole surgeryVitrectomy, temporal inverted or complete ILM peeling and gas tamponade

Timeline

Start date
2018-02-01
Primary completion
2020-02-01
Completion
2020-02-01
First posted
2017-09-19
Last updated
2018-01-30

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03287102. Inclusion in this directory is not an endorsement.