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Partial Posterior Hyaloidectomy in Macular Surgery

Primary Purpose

Retinal Break, Retinal Detachment

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Partial posterior hyaloidectomy (a modified procedure of vitrectomy)
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Retinal Break focused on measuring prevention, retinal break, vitrectomy, partial posterior hyaloidectomy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cases of idiopathic ERM or idiopathic MH without evidence of PVD preoperatively

Exclusion Criteria:

  • history of previous intraocular surgery

Sites / Locations

    Outcomes

    Primary Outcome Measures

    incidence of intraoperative and postoperative retinal break related to surgery
    The eyes that completed a follow-up of at least 3 months were included in the result analysis. The incidence of retinal breaks related to the surgery was measured.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 17, 2011
    Last Updated
    October 18, 2011
    Sponsor
    Samsung Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01454466
    Brief Title
    Partial Posterior Hyaloidectomy in Macular Surgery
    Official Title
    Partial Posterior Hyaloidectomy in Macular Surgery : A Modified Procedure of Vitrectomy to Prevent Retinal Break Related to Induction of a Posterior Vitreous Detachment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Samsung Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the effect of partial posterior hyaloidectomy on preventing iatrogenic retinal breaks related to induction of a posterior vitreous detachment
    Detailed Description
    The induction of a posterior vitreous detachment (IPVD) during vitrectomy have been suggested as one of the etiologies of iatrogenic retinal break related to vitrectomy.The iatrogenic retinal breaks related to IPVD usually develop near or anterior to the equatorial region. Thus, the investigators hypothesized that this complication could be prevented by restricting the extent of IPVD, and planned a modified procedure of vitrectomy in which the extent of IPVD and removal of vitreous cortex was restricted to about slightly beyond the margin of temporal major vascular arcade. The investigators have termed this procedure, partial posterior hyaloidectomy. Unlike RRD or proliferative diabetic retinopathy, lesions are localized within the major vascular arcade in macular disorders so that macular disorders could be an eligible indication for this procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinal Break, Retinal Detachment
    Keywords
    prevention, retinal break, vitrectomy, partial posterior hyaloidectomy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Partial posterior hyaloidectomy (a modified procedure of vitrectomy)
    Intervention Description
    The core vitrectomy entails more extensive removal of vitreous gel, in contrast to the conventional core vitrectomy. IPVD was conducted by engaging the attached posterior cortical vitreous with a 23-gauge needle with angulated tip in the area adjacent to the optic disc followed by gently moving the tip to approximately 3 disc diameters away from the margin of the optic disc. After then, slightly elevating the tip in a posteroanterior direction with slowly proceeding it to the extent that we planned. With IPVD, the surgeon was able to visualize a floating Weiss ring in all of the cases. Active suction to initiate IPVD was not used in any of the cases. In the temporal direction, the extension of a PVD was restricted to approximately 2 disc diameters distance beyond the margin of temporal major vascular arcade
    Primary Outcome Measure Information:
    Title
    incidence of intraoperative and postoperative retinal break related to surgery
    Description
    The eyes that completed a follow-up of at least 3 months were included in the result analysis. The incidence of retinal breaks related to the surgery was measured.
    Time Frame
    postoperative 3 to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cases of idiopathic ERM or idiopathic MH without evidence of PVD preoperatively Exclusion Criteria: history of previous intraocular surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Se Woong Kang, M.D.
    Organizational Affiliation
    Samsung Medical Center
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Jae Hui Kim, M.D.
    Organizational Affiliation
    Samsung Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Partial Posterior Hyaloidectomy in Macular Surgery

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