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Internal Limiting Membrane Peeling on Retinal Displacement

Primary Purpose

Internal Limiting Membrane Peeling

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
idiopathic macular hole (MH) surgery
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Internal Limiting Membrane Peeling focused on measuring Retinal displacement, Idiopathic macular hole, Internal limiting membrane peeling

Eligibility Criteria

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

Inclusion Criteria:

Eyes with idiopathic macular hole

Exclusion Criteria:

Eyes having re-do macular hole surgery, with high myopia, with proliferative vitreoretinopathy or with a retinal detachment combined with the MH, with other macular diseases, such as age-related macular degeneration.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    N-T group

    T-N group

    Arm Description

    ILM was peeled off from nasal retina to temporal retina.

    ILM was peeled off from temporal retina to nasal retina

    Outcomes

    Primary Outcome Measures

    T-OD
    measurement of temporal vessel to optic disc

    Secondary Outcome Measures

    Full Information

    First Posted
    November 30, 2020
    Last Updated
    November 30, 2020
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04655781
    Brief Title
    Internal Limiting Membrane Peeling on Retinal Displacement
    Official Title
    Displacement of the Retina After Idiopathic Macular Hole Surgery With Different Internal Limiting Membrane Peeling Patterns
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    January 31, 2018 (Actual)
    Study Completion Date
    January 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    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
    The purpose of this study is to investigate displacement of the retina after idiopathic macular hole surgery with different internal limiting membrane peeling patterns.
    Detailed Description
    After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. All patients with idiopathic MH will be randomly allocated into two groups, N-T group or T-N group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Internal Limiting Membrane Peeling
    Keywords
    Retinal displacement, Idiopathic macular hole, Internal limiting membrane peeling

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    N-T group
    Arm Type
    Experimental
    Arm Description
    ILM was peeled off from nasal retina to temporal retina.
    Arm Title
    T-N group
    Arm Type
    Experimental
    Arm Description
    ILM was peeled off from temporal retina to nasal retina
    Intervention Type
    Procedure
    Intervention Name(s)
    idiopathic macular hole (MH) surgery
    Intervention Description
    Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns
    Primary Outcome Measure Information:
    Title
    T-OD
    Description
    measurement of temporal vessel to optic disc
    Time Frame
    preoperation to postoperative 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Eyes with idiopathic macular hole Exclusion Criteria: Eyes having re-do macular hole surgery, with high myopia, with proliferative vitreoretinopathy or with a retinal detachment combined with the MH, with other macular diseases, such as age-related macular degeneration.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Internal Limiting Membrane Peeling on Retinal Displacement

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