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Effects of Different Area of Internal Limiting Membrane Peeling (ILM) Peeling on Anatomical Outcomes in Macular Hole Surgery

Primary Purpose

Macular Hole

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ILM peeling surgery
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Hole

Eligibility Criteria

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

Inclusion Criteria:

  • patients with IMH
  • patients signed the informed consent form (ICF)
  • patients with course of IMH less than 3 years

Exclusion Criteria:

  • patients with hyper myopia
  • patients with traumatic macular hole
  • accompanied or secondary of other fundus disease
  • open or reopen after receiving MH surgery
  • patients with retinal detachment
  • received vitrectomy due to other diseases
  • glaucoma cannot be controled by medication
  • patients with other retinal or choroidal disease that may affect VA
  • poor patients compliance
  • poor condition that cannot undertake the surgery
  • dioptric media opacities which make it difficult to exam fundus or measure on OCT

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    4PD diameter of ILM peeling in surgery

    2PD diameter of ILM peeling in surgery

    Arm Description

    patients in this group was given 4papillary diameter (PD) diameter of internal limiting membrane (ILM) peeling in surgery

    patients in this group was given 2PD diameter of ILM peeling in surgery

    Outcomes

    Primary Outcome Measures

    Anatomical closure grades in OCT

    Secondary Outcome Measures

    Change of anatomical closure grades in OCT
    Change from baseline in BCVA (best corrected visual acuity)

    Full Information

    First Posted
    October 10, 2016
    Last Updated
    October 11, 2016
    Sponsor
    Peking University People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02930369
    Brief Title
    Effects of Different Area of Internal Limiting Membrane Peeling (ILM) Peeling on Anatomical Outcomes in Macular Hole Surgery
    Official Title
    A Randomized, Comparative, Prospective Study of Anatomical Outcomes With Different Internal Limiting Membrane Peeling Area in Surgery for Idiopathic Macular Hole
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University People's Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the effects of two different internal limiting membrane (ILM) peeling area on anatomical closure outcomes after macular hole surgery measured by optical coherence tomography (OCT).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    128 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    4PD diameter of ILM peeling in surgery
    Arm Type
    Active Comparator
    Arm Description
    patients in this group was given 4papillary diameter (PD) diameter of internal limiting membrane (ILM) peeling in surgery
    Arm Title
    2PD diameter of ILM peeling in surgery
    Arm Type
    Experimental
    Arm Description
    patients in this group was given 2PD diameter of ILM peeling in surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    ILM peeling surgery
    Intervention Description
    4PD or 2PD diameter of ILM peeling in surgery was given to patients with idiopathic macular hole (IMH)
    Primary Outcome Measure Information:
    Title
    Anatomical closure grades in OCT
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Change of anatomical closure grades in OCT
    Time Frame
    3 months, 6 months, 1 year
    Title
    Change from baseline in BCVA (best corrected visual acuity)
    Time Frame
    3 months, 6 months, 1 year

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with IMH patients signed the informed consent form (ICF) patients with course of IMH less than 3 years Exclusion Criteria: patients with hyper myopia patients with traumatic macular hole accompanied or secondary of other fundus disease open or reopen after receiving MH surgery patients with retinal detachment received vitrectomy due to other diseases glaucoma cannot be controled by medication patients with other retinal or choroidal disease that may affect VA poor patients compliance poor condition that cannot undertake the surgery dioptric media opacities which make it difficult to exam fundus or measure on OCT
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mingwei Zhao, M.D
    Organizational Affiliation
    Peking University People's Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Different Area of Internal Limiting Membrane Peeling (ILM) Peeling on Anatomical Outcomes in Macular Hole Surgery

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