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Surgical Management of Optic Disc Pit Maculaopathy

Primary Purpose

Optic Disc Structural Anomaly, Maculopathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pars plana vitrectomy with internal limiting membrane (ILM) peeling
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Disc Structural Anomaly focused on measuring optic disc pit, retinal detachment, maculopathy

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients included in this study are those with ODP associated with macular detachment

Exclusion Criteria:

  • Exclusion criteria included patients unfit for general anesthesia, those with insufficient clear media to perform the surgery with ILM peeling and those with other ocular diseases that can affect central macular thickness (CMT) and the best corrected visual acuity (BCVA).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Optic disc pit maculopathy

    Arm Description

    pars plana vitrectomy with internal limiting membrane (ILM) peeling, endolaser

    Outcomes

    Primary Outcome Measures

    anatomical improvement
    Retinal reattachment

    Secondary Outcome Measures

    Functional improvement
    Visual acuity letters gain

    Full Information

    First Posted
    June 9, 2017
    Last Updated
    June 9, 2017
    Sponsor
    Minia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03185936
    Brief Title
    Surgical Management of Optic Disc Pit Maculaopathy
    Official Title
    Pars Plana Vitrectomy With Internal Limiting Membrane Peeling in Optic Disc Pit Maculopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2011 (Actual)
    Primary Completion Date
    April 1, 2016 (Actual)
    Study Completion Date
    April 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Minia 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
    To evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.
    Detailed Description
    As it is well known, optic disc pit (ODP) is a rare congenital disease which is usually associated with maculopathy (ODP-M) in the form of intraretinal and subretinal fluid accumulation at the macular area leading to visual impairment. With no definite treatment and absence of guidelines for its management, the invistigators considered their prospective, interventional case series to evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Optic Disc Structural Anomaly, Maculopathy
    Keywords
    optic disc pit, retinal detachment, maculopathy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Optic disc pit maculopathy
    Arm Type
    Experimental
    Arm Description
    pars plana vitrectomy with internal limiting membrane (ILM) peeling, endolaser
    Intervention Type
    Procedure
    Intervention Name(s)
    pars plana vitrectomy with internal limiting membrane (ILM) peeling
    Other Intervention Name(s)
    Endolaser photocoagulation
    Intervention Description
    pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.
    Primary Outcome Measure Information:
    Title
    anatomical improvement
    Description
    Retinal reattachment
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Functional improvement
    Description
    Visual acuity letters gain
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients included in this study are those with ODP associated with macular detachment Exclusion Criteria: Exclusion criteria included patients unfit for general anesthesia, those with insufficient clear media to perform the surgery with ILM peeling and those with other ocular diseases that can affect central macular thickness (CMT) and the best corrected visual acuity (BCVA).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mahmud Genaidy, MD
    Organizational Affiliation
    Assistant professor of ophthalmology, ophthalmology department, Minia university, Egypt
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Can not be shared

    Learn more about this trial

    Surgical Management of Optic Disc Pit Maculaopathy

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