search
Back to results

Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

Primary Purpose

Epiretinal Membrane, Macular Holes

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sharkskin
Grieshaber
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiretinal Membrane

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Macular pathology

Exclusion Criteria:

  • No prior vitreoretinal surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Sharkskin Arm

    Grieshaber Arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    Surgical time

    Secondary Outcome Measures

    Ease of peeling - surgeon
    Use of standardized questionnaire to the surgeon.
    Ease of peeling - masked grader
    Use of standardized questionnaire to the masked grader.

    Full Information

    First Posted
    June 29, 2020
    Last Updated
    July 2, 2020
    Sponsor
    Wills Eye
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04459949
    Brief Title
    Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling
    Official Title
    Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 6, 2020 (Anticipated)
    Primary Completion Date
    December 1, 2020 (Anticipated)
    Study Completion Date
    June 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wills Eye

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the performance and anatomic outcomes of the Sharkskin internal limiting membrane (ILM) forceps and the Grieshaber ILM forceps in macular surgery. Peeling of the ILM is a difficult aspect of vitreoretinal surgery and often daunting task from a vitreoretinal fellow's perspective. The hypothesis is that the newer Sharkskin forceps have a larger platform and micro-abrasions along the forcep surface to increase grasping ability and potentially limit trauma to the retina surface compared to the Grieshaber forceps. This project may also serve as an education tool for fellows learning the basics of ILM peeling.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epiretinal Membrane, Macular Holes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sharkskin Arm
    Arm Type
    Active Comparator
    Arm Title
    Grieshaber Arm
    Arm Type
    Placebo Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Sharkskin
    Intervention Description
    Use of Sharkskin ILM forceps
    Intervention Type
    Device
    Intervention Name(s)
    Grieshaber
    Intervention Description
    Use of Grieshaber ILM forceps
    Primary Outcome Measure Information:
    Title
    Surgical time
    Time Frame
    During surgery
    Secondary Outcome Measure Information:
    Title
    Ease of peeling - surgeon
    Description
    Use of standardized questionnaire to the surgeon.
    Time Frame
    During surgery
    Title
    Ease of peeling - masked grader
    Description
    Use of standardized questionnaire to the masked grader.
    Time Frame
    Through study completion, up to one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Macular pathology Exclusion Criteria: No prior vitreoretinal surgery

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

    We'll reach out to this number within 24 hrs