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Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy

Primary Purpose

Myopic Traction Maculopathy, Pars Plana Vitrectomy, Internal Limiting Membrane Peeling

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pars Plana Vitrectomy with Internal Limiting Membrane peel
Sponsored by
Tanta University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopic Traction Maculopathy

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Highly myopic patients, having a refractive errors (spherical equivalent) of more than - 8 Diopter, or an axial length more than 26.5 mm.
  • Best Corrected Visual Acuity less than 0.1
  • Spectral Domain Optical Coherence Tomography showed; staphylomatous changes, with either: Macular retinoschisis, foveal retinal detachment, full thickness macular hole (with or without macualr hole retinal detachment), or lamellar macular hole, with epiretinal membrane

At least 6 months follow-up

Exclusion Criteria:

  • Eyes with diffuse chorioretinal macular atrophy
  • Concomitant presence of a choroidal neovascular membrane
  • Young patients less than 21 years old.
  • History of trauma
  • Dense media opacity (corneal/ lenticular)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Improvement of best corrected visual acuity

    Secondary Outcome Measures

    Full Information

    First Posted
    February 12, 2020
    Last Updated
    February 19, 2020
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04278079
    Brief Title
    Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy
    Official Title
    Evaluation of Pars Plana Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    December 2019 (Actual)
    Study Completion Date
    February 2020 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    Investigate the effectiveness and safety of pars plans vitrectomy, with internal limiting membrane peeling for cases of myopic traction maculopathy
    Detailed Description
    Performing pars plana vitrectomy for highly myopic patients with decreased visual acuity is the standard of care for patients with myopic traction. A variety of findings are seen by Optical Coherence Tomography. Epiretinal membranes, retinoschisis, lamellar macular holes, and full thickness macular holes are seen. Undergoing vitrectomy, with or without tamponade, in our center, is retrospectively evaluated. Visual acuity change, as well as improvement of the retinal structure by OCT will be examined.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopic Traction Maculopathy, Pars Plana Vitrectomy, Internal Limiting Membrane Peeling

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Pars Plana Vitrectomy with Internal Limiting Membrane peel
    Intervention Description
    Pars plana vitrectomy with staining and peeling of internal limiting membrane
    Primary Outcome Measure Information:
    Title
    Improvement of best corrected visual acuity
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Highly myopic patients, having a refractive errors (spherical equivalent) of more than - 8 Diopter, or an axial length more than 26.5 mm. Best Corrected Visual Acuity less than 0.1 Spectral Domain Optical Coherence Tomography showed; staphylomatous changes, with either: Macular retinoschisis, foveal retinal detachment, full thickness macular hole (with or without macualr hole retinal detachment), or lamellar macular hole, with epiretinal membrane At least 6 months follow-up Exclusion Criteria: Eyes with diffuse chorioretinal macular atrophy Concomitant presence of a choroidal neovascular membrane Young patients less than 21 years old. History of trauma Dense media opacity (corneal/ lenticular)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy

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