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High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps

Primary Purpose

High Myopia, Macular Holes, Retinal Detachment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inverted and free ILM insertion
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Myopia

Eligibility Criteria

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

Inclusion Criteria:

  • Macular hole with retinal detachment in high myopia

Exclusion Criteria:

  • History of trauma, peripheral retinal breaks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Inverted and free ILM insertion

    Arm Description

    Both inverted and free ILM flaps were inserted into the macular hole

    Outcomes

    Primary Outcome Measures

    Closure of macular hole
    Closure of macular hole demonstrated by optical coherence tomography

    Secondary Outcome Measures

    Retinal reattachment
    Retinal reattachment observed by fundoscopy

    Full Information

    First Posted
    May 23, 2017
    Last Updated
    May 31, 2017
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03174639
    Brief Title
    High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps
    Official Title
    High Myopia Macular Hole and Retinal Detachment Accepted Internal Limiting Membrane Flip Packing and Free Flap Was the Internal Limiting Membrane (ILM Flap Was Double)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 11, 2016 (Actual)
    Primary Completion Date
    June 30, 2016 (Actual)
    Study Completion Date
    June 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed.
    Detailed Description
    From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed. Patients with a history of trauma or concurrent peripheral breaks were excluded. The anatomical and function outcomes, including the status of the macular hole and retina were assessed.The study was approved by the ethnic committee and research board.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Myopia, Macular Holes, Retinal Detachment

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Inverted and free ILM insertion
    Arm Type
    Experimental
    Arm Description
    Both inverted and free ILM flaps were inserted into the macular hole
    Intervention Type
    Procedure
    Intervention Name(s)
    Inverted and free ILM insertion
    Intervention Description
    ILM was peeled and the ILM flap was inverted and inserted into the macular hole, followed by insertion of free ILM flap.
    Primary Outcome Measure Information:
    Title
    Closure of macular hole
    Description
    Closure of macular hole demonstrated by optical coherence tomography
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Retinal reattachment
    Description
    Retinal reattachment observed by fundoscopy
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Macular hole with retinal detachment in high myopia Exclusion Criteria: History of trauma, peripheral retinal breaks

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28845304
    Citation
    Chen SN, Yang CM. Double Internal Limiting Membrane Insertion for Macular Hole-Associated Retinal Detachment. J Ophthalmol. 2017;2017:3236516. doi: 10.1155/2017/3236516. Epub 2017 Jul 30.
    Results Reference
    derived

    Learn more about this trial

    High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps

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