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Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity

Primary Purpose

Macular Holes

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Large extent of ILM Peeling
Small extent of ILM Peeling
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Holes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clear diagnosis of macular hole;
  • The minimum diameter of the macular hole is >400 μm;
  • Without serious systemic disease that make patients can not be operated;

Exclusion Criteria:

  • suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, PVR, etc.;
  • opacitas in the refractive medium can not perform Angio-OCT and visual acuity examination;
  • eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis;
  • traumatic macular hole, secondary macular hole, high myopia macular hole, etc.;
  • having a history of vitrectomy surgery;
  • glaucoma in stage of preclinical, severe stenosis or closure;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Large extent of ILM Peeling

    Small extent of ILM Peeling

    Arm Description

    Extent of ILM peeling is 4DD and the ILM flap is inserted

    Extent of ILM peeling is 2DD and the ILM flap is inserted

    Outcomes

    Primary Outcome Measures

    Condition of postoperative healing of macular holes
    postoperative photograph of macular retina scanned by Angiography Optical Coherence Tomography(AngioOCT)
    Mean change from baseline in best-corrected visual acuity (BCVA)
    Assessed using the ETDRS protocol
    change from baseline in foveal avascular zone (FAZ) areas and diameter
    Assessed on AngioOCT
    change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels
    Assessed on AngioOCT

    Secondary Outcome Measures

    Full Information

    First Posted
    January 13, 2019
    Last Updated
    January 13, 2019
    Sponsor
    Wenzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03805763
    Brief Title
    Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity
    Official Title
    Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2019 (Anticipated)
    Primary Completion Date
    November 1, 2019 (Anticipated)
    Study Completion Date
    January 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Macular Holes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Large extent of ILM Peeling
    Arm Type
    Experimental
    Arm Description
    Extent of ILM peeling is 4DD and the ILM flap is inserted
    Arm Title
    Small extent of ILM Peeling
    Arm Type
    Experimental
    Arm Description
    Extent of ILM peeling is 2DD and the ILM flap is inserted
    Intervention Type
    Procedure
    Intervention Name(s)
    Large extent of ILM Peeling
    Intervention Description
    The extent of ILM peeling is 4DD
    Intervention Type
    Procedure
    Intervention Name(s)
    Small extent of ILM Peeling
    Intervention Description
    The extent of ILM peeling is 2DD
    Primary Outcome Measure Information:
    Title
    Condition of postoperative healing of macular holes
    Description
    postoperative photograph of macular retina scanned by Angiography Optical Coherence Tomography(AngioOCT)
    Time Frame
    1 year
    Title
    Mean change from baseline in best-corrected visual acuity (BCVA)
    Description
    Assessed using the ETDRS protocol
    Time Frame
    1 year
    Title
    change from baseline in foveal avascular zone (FAZ) areas and diameter
    Description
    Assessed on AngioOCT
    Time Frame
    1 year
    Title
    change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels
    Description
    Assessed on AngioOCT
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clear diagnosis of macular hole; The minimum diameter of the macular hole is >400 μm; Without serious systemic disease that make patients can not be operated; Exclusion Criteria: suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, PVR, etc.; opacitas in the refractive medium can not perform Angio-OCT and visual acuity examination; eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis; traumatic macular hole, secondary macular hole, high myopia macular hole, etc.; having a history of vitrectomy surgery; glaucoma in stage of preclinical, severe stenosis or closure;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zongduan Zhang, M.D,PhD
    Phone
    +86 13587604949
    Email
    zzduan@yeah.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qintuo Pan, M.D
    Phone
    -86 13958851073
    Email
    panqintuo@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zongduan Zhang, M.D,PhD
    Organizational Affiliation
    The Eye Hospital of Wenzhou Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity

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