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Nd:YAG Laser Hyaloidotomy for Premacular Hemorrhage in Diabetic Eyes

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nd:YAG laser Hyaloidotomy
Sponsored by
Tanta University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy

Eligibility Criteria

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

Inclusion Criteria:

  • Eyes with premacular subhyaloid hemorrhage of more than 3 disc diameters, involving the fovea.
  • Eyes with proliferative diabetic retinopathy

Exclusion Criteria:

  • Dense media opacity (corneal/cataract)
  • Patients with bleeding tendency or on anti-coagulant drugs

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Visual acuity improvement
    Testing VA after YAG laser

    Secondary Outcome Measures

    Full Information

    First Posted
    February 23, 2020
    Last Updated
    February 23, 2020
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04285151
    Brief Title
    Nd:YAG Laser Hyaloidotomy for Premacular Hemorrhage in Diabetic Eyes
    Official Title
    Evaluation of Nd:YAG Laser Hyaloidotomy for Management of Premacular Subhyaloid Hemorrhage in Eyes With Proliferative Diabetic Retinopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    January 2020 (Actual)
    Study Completion Date
    January 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
    Premacular Subhyaloid hemorrhage is a sudden profound loss of vision in eyes with proliferative diabetic retinopathy (PDR). Pars plana vitrectomy is the treatment of choice for premacular hemorrhage in eyes with proliferative changes. Nd:YAG laser hyaloidotomy has been used to evacuate the premacular hemorrhage

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Proliferative Diabetic Retinopathy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Nd:YAG laser Hyaloidotomy
    Intervention Description
    Using the YAG laser for opening the posterior hyaloid in eyes with premacular hemorrhage, and evacuating the entrapped hemorrhage
    Primary Outcome Measure Information:
    Title
    Visual acuity improvement
    Description
    Testing VA after YAG laser
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Eyes with premacular subhyaloid hemorrhage of more than 3 disc diameters, involving the fovea. Eyes with proliferative diabetic retinopathy Exclusion Criteria: Dense media opacity (corneal/cataract) Patients with bleeding tendency or on anti-coagulant drugs

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Nd:YAG Laser Hyaloidotomy for Premacular Hemorrhage in Diabetic Eyes

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