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Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes

Primary Purpose

Macular Hole Retinal Detachment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitrectomy
Sponsored by
Kyorin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Hole Retinal Detachment focused on measuring vitrectomy, macular hole retinal detachment, high myopia

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal or inverted for macular hole retinal detachment and had followed for more than 6 months.

Exclusion Criteria:

  • The patients with follow-up less than 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Inverted ILM flap group

    ILM peeling group

    Arm Description

    Eyes underwent vitrectomy with inverted internal limiting membrane technique

    Eyes underwent vitrectomy with internal limiting membrane peeling

    Outcomes

    Primary Outcome Measures

    Visual acuity before and after surgery

    Secondary Outcome Measures

    Optical coherence tomography

    Full Information

    First Posted
    September 7, 2016
    Last Updated
    January 9, 2017
    Sponsor
    Kyorin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02896972
    Brief Title
    Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
    Official Title
    Efficacy of Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kyorin University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for macular hole retinal detachment (MHRD) in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography (OCT)
    Detailed Description
    Macular hole retinal detachment (MHRD) threatens a certain number of highly myopic patients for irreversible visual dysfunction, and mostly requires immediate surgical intervention. The aim of they study is to evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for MHRD in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Macular Hole Retinal Detachment
    Keywords
    vitrectomy, macular hole retinal detachment, high myopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Inverted ILM flap group
    Arm Type
    Active Comparator
    Arm Description
    Eyes underwent vitrectomy with inverted internal limiting membrane technique
    Arm Title
    ILM peeling group
    Arm Type
    Active Comparator
    Arm Description
    Eyes underwent vitrectomy with internal limiting membrane peeling
    Intervention Type
    Procedure
    Intervention Name(s)
    Vitrectomy
    Intervention Description
    Vitrectomy with inverted ILM technique or ILM peeling
    Primary Outcome Measure Information:
    Title
    Visual acuity before and after surgery
    Time Frame
    Changes from baseline to 1, 3, 6 months
    Secondary Outcome Measure Information:
    Title
    Optical coherence tomography
    Time Frame
    Changes from baseline up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal or inverted for macular hole retinal detachment and had followed for more than 6 months. Exclusion Criteria: The patients with follow-up less than 6 months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Makoto Inoue, MD
    Organizational Affiliation
    Kyorin Eye Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes

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