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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Macular hole surgery | Vitrectomy, 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.