Dissociated Optic Nerve Fiber Layer Appearance and Retinal Sensitivity After Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap Technique
| Registry | NCT03287102, acronym MARTIAL |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 130 (Estimated) |
| Sponsor | Central Hospital, Nancy, France (Other) |
| Conditions | Macula Hole |
| Interventions | Macular hole surgery (Procedure) |
| Dates | start 2018-02-01 (estimated), primary completion 2020-02-01 (estimated), completion 2020-02-01 (estimated), first posted 2017-09-19, last updated 2018-01-30 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Macula Hole All trials of Macular hole surgery
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Temporal inverted ILM peeling group | Other | Procedure: Macular hole surgery | The internal limiting membrane is peeled from the temporal side of the fovea only |
| Complete ILM peeling group | Other | Procedure: Macular hole surgery | The internal limiting membrane is completely removed around the fovea |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Brabois Hospital | Vandœuvre-lès-Nancy | France |