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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01431-50 | Registry Identifier | ID/RCB |
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Principal investigator left the institution
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Macular hole is an infrequent retinal pathology (2 to 4/1000) which most often affects people aged over 60, and twice common in women than men.
The vast majority of cases are idiopathic. Without treatment, the macular hole evolves through a series of stages until the extension of the diameter (up to 500 microns and higher values). With a fully developed macular hole, patients complain of metamorphopsia and decreased visual acuity.
This pathology has clearly benefited from advances in microsurgery and better understanding of its pathophysiology. Macular hole treatment has evolved to include small-gauge pars plana vitrectomy with or without internal limiting membrane (ILM) peeling and placement of intraocular gas tamponade.
The postoperative closure rate is close to 80%, but strongly depends on the initial characteristics of the hole, its diameter remaining the main prognostic factor. Thus for macular holes <400 microns, the closure rate is close to 92% dropping to 56% for macular holes above 400 microns. In case of surgical failure, one or more reoperations can be proposed, but with a lower closure rate.
The quest for a surgical technique presenting a greater success rate is a common goal to all retinologists.
Here the investigators propose a new surgical technique, derived from the FLAP method, and consisting of an inner limiting membrane transposition.
The objective of this study is to evaluate the feasibility of a new surgical technique for the treatment of macular holes already operated but without macular hole closure, allowing these patients a new therapeutic alternative. The success of this technique will be confirmed by detecting postoperatively the presence of the transposed internal limiting membrane into the foveal region.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ILMT | Experimental | internal limiting membrane autologous transplantation (ILMT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| internal limiting membrane transplantation (ILMT) | Procedure | internal limiting membrane autologous transplantation (ILMT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of the internal limiting membrane transposed into foveal region | 8 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The size and appearance of the macular hole will be assessed by optical coherence tomography (OCT) | 8 weeks after surgery | |
| Visual acuity will be assessed by clinical examination | 8 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick LENOBLE, MD | Groupe Hospitalier de la Region de Mulhouse et Sud Alsace | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHRMSA | Mulhouse | 68100 | France |
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| The patient's visual comfort will be assessed using the NEI-VFQ-25 Quality of Life questionary | 8 weeks after surgery |