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Evaluation of a New Surgical Technique for Macular Hole Which Was Not Closed After a Previous Surgery (ILMT)

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ClinicalTrials.gov Identifier: NCT02946372
Recruitment Status : Completed
First Posted : October 27, 2016
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Retinal Perforations Procedure: internal limiting membrane transplantation (ILMT) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transposition of Internal Limiting Membrane in the Treatment of Macular Holes. A Descriptive Pilot Study
Study Start Date : November 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: ILMT
internal limiting membrane autologous transplantation (ILMT)
Procedure: internal limiting membrane transplantation (ILMT)
internal limiting membrane autologous transplantation (ILMT)




Primary Outcome Measures :
  1. Presence of the internal limiting membrane transposed into foveal region [ Time Frame: 8 weeks after surgery ]

Secondary Outcome Measures :
  1. The size and appearance of the macular hole will be assessed by optical coherence tomography (OCT) [ Time Frame: 8 weeks after surgery ]
  2. Visual acuity will be assessed by clinical examination [ Time Frame: 8 weeks after surgery ]
  3. The patient's visual comfort will be assessed using the NEI-VFQ-25 Quality of Life questionary [ Time Frame: 8 weeks after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient aged over 18,
  2. Patient who already received at least a macular hole surgery,
  3. Period of at least 4 months since last macular hole surgery,
  4. Patient who underwent peeling of the internal limiting membrane,
  5. Presents in OCT an open criteria macular hole,
  6. The presence of a cataract in the preoperative clinical examination is not against indication. Its removal can be integrated to the surgery,
  7. Patient who signed the consent form

Exclusion Criteria:

  1. Patient with against-indication or surgical anesthetic,
  2. Macular Hole "flat open" or closed,
  3. No progressive macular pathology other than the presence of a macular hole (retinal detachment, Macular degeneration related to age) Idiopathic and secondary macular holes are eligible if they have already been operated with the prior internal limiting membrane coat.
  4. Patient unaffiliated or not the beneficiary of a social security system, or equivalent health insurance,
  5. Pregnant or breastfeeding women,
  6. Absence of patient consent,
  7. Patient in exclusion period involved in another study,
  8. Patient on administrative or judicial supervision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946372


Locations
France
GHRMSA
Mulhouse, France, 68100
Sponsors and Collaborators
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Investigators
Principal Investigator: Patrick LENOBLE, MD Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Responsible Party: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
ClinicalTrials.gov Identifier: NCT02946372     History of Changes
Other Study ID Numbers: GHR n°872
2016-A01431-50 ( Registry Identifier: ID/RCB )
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace:
retina surgery
macula
macular hole
internal limiting membrane (ILM)
vitrectomy
autologous transplantation

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases