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Surgical Management of Optic Disc Pit Maculaopathy

Sponsor
Minia University (Other)
Overall Status
Completed
CT.gov ID
NCT03185936
Collaborator
(none)
9
Enrollment
1
Arm
73
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: pars plana vitrectomy with internal limiting membrane (ILM) peeling
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pars Plana Vitrectomy With Internal Limiting Membrane Peeling in Optic Disc Pit Maculopathy
Actual Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Optic disc pit maculopathy

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

Procedure: pars plana vitrectomy with internal limiting membrane (ILM) peeling
pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.
Other Names:
  • Endolaser photocoagulation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. anatomical improvement [6 months]

      Retinal reattachment

    Secondary Outcome Measures

    1. Functional improvement [6 months]

      Visual acuity letters gain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Minia University

    Investigators

    • Principal Investigator: Mahmud Genaidy, MD, Assistant professor of ophthalmology, ophthalmology department, Minia university, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahmoud Genaidy, Assistant professor of ophthalmology, Minia University
    ClinicalTrials.gov Identifier:
    NCT03185936
    Other Study ID Numbers:
    • ODP-M
    First Posted:
    Jun 14, 2017
    Last Update Posted:
    Jun 14, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mahmoud Genaidy, Assistant professor of ophthalmology, Minia University
    optic disc pit
    retinal detachment
    maculopathy
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Jun 14, 2017