Principal investigator left the institution
ILMT
Transposition of Internal Limiting Membrane in the Treatment of Macular Holes. A Descriptive Pilot Study
Sponsor study identifier
Secondary identifiers
REGISTRY · ID/RCB
interventional
16
1 country
1
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2017
Actual (reported)Study Completion
June 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2016
Actual (reported)October 27, 2016
Actual (reported)November 2016
Date type not reportedThis date has not been verified as actual or estimated.
February 2017
Actual (reported)June 2017
Actual (reported)Presence of the internal limiting membrane transposed into foveal region
8 weeks after surgery
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
The patient's visual comfort will be assessed using the NEI-VFQ-25 Quality of Life questionary
8 weeks after surgery
internal limiting membrane autologous transplantation (ILMT)
internal limiting membrane autologous transplantation (ILMT)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
GHRMSA
Mulhouse, 68100, France
Patrick LENOBLE, MD
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
16 participants (actual enrollment reported by the registry).
First Submitted
October 25, 2016
First Posted
October 27, 2016
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2017
Actual (reported)Study Completion
June 2017
Actual (reported)Last Updated
November 20, 2025
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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