An interventional study of internal limiting membrane transplantation (ILMT) in Retinal Perforations, sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Not applicable, Interventional, and Treatment
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.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's enrollment of 16 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Groupe Hospitalier de la Region de Mulhouse et Sud Alsace is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
internal limiting membrane autologous transplantation (ILMT)
Procedure: internal limiting membrane transplantation (ILMT)
internal limiting membrane autologous transplantation (ILMT)
Presence of the internal limiting membrane transposed into foveal region
Time frame: 8 weeks after surgery
The size and appearance of the macular hole will be assessed by optical coherence tomography (OCT)
Time frame: 8 weeks after surgery
Visual acuity will be assessed by clinical examination
Time frame: 8 weeks after surgery
The patient's visual comfort will be assessed using the NEI-VFQ-25 Quality of Life questionary
Time frame: 8 weeks after surgery
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier de la Region de Mulhouse et Sud Alsace