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

Primary Purpose

Retinal Perforations

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
internal limiting membrane transplantation (ILMT)
Sponsored by
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Perforations focused on measuring retina surgery, macula, macular hole, internal limiting membrane (ILM), vitrectomy, autologous transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GHRMSA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ILMT

Arm Description

internal limiting membrane autologous transplantation (ILMT)

Outcomes

Primary Outcome Measures

Presence of the internal limiting membrane transposed into foveal region

Secondary Outcome Measures

The size and appearance of the macular hole will be assessed by optical coherence tomography (OCT)
Visual acuity will be assessed by clinical examination
The patient's visual comfort will be assessed using the NEI-VFQ-25 Quality of Life questionary

Full Information

First Posted
October 25, 2016
Last Updated
August 1, 2017
Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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1. Study Identification

Unique Protocol Identification Number
NCT02946372
Brief Title
Evaluation of a New Surgical Technique for Macular Hole Which Was Not Closed After a Previous Surgery
Acronym
ILMT
Official Title
Transposition of Internal Limiting Membrane in the Treatment of Macular Holes. A Descriptive Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Perforations
Keywords
retina surgery, macula, macular hole, internal limiting membrane (ILM), vitrectomy, autologous transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ILMT
Arm Type
Experimental
Arm Description
internal limiting membrane autologous transplantation (ILMT)
Intervention Type
Procedure
Intervention Name(s)
internal limiting membrane transplantation (ILMT)
Intervention Description
internal limiting membrane autologous transplantation (ILMT)
Primary Outcome Measure Information:
Title
Presence of the internal limiting membrane transposed into foveal region
Time Frame
8 weeks after surgery
Secondary Outcome Measure Information:
Title
The size and appearance of the macular hole will be assessed by optical coherence tomography (OCT)
Time Frame
8 weeks after surgery
Title
Visual acuity will be assessed by clinical examination
Time Frame
8 weeks after surgery
Title
The patient's visual comfort will be assessed using the NEI-VFQ-25 Quality of Life questionary
Time Frame
8 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient aged over 18, Patient who already received at least a macular hole surgery, Period of at least 4 months since last macular hole surgery, Patient who underwent peeling of the internal limiting membrane, Presents in OCT an open criteria macular hole, The presence of a cataract in the preoperative clinical examination is not against indication. Its removal can be integrated to the surgery, Patient who signed the consent form Exclusion Criteria: Patient with against-indication or surgical anesthetic, Macular Hole "flat open" or closed, 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. Patient unaffiliated or not the beneficiary of a social security system, or equivalent health insurance, Pregnant or breastfeeding women, Absence of patient consent, Patient in exclusion period involved in another study, Patient on administrative or judicial supervision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick LENOBLE, MD
Organizational Affiliation
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Official's Role
Principal Investigator
Facility Information:
Facility Name
GHRMSA
City
Mulhouse
ZIP/Postal Code
68100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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