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Foveal Sparing of the ILM

Primary Purpose

Retinal Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Complete Macular Peeling
Macular Peeling with Foveal Sparing
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Sensitivity

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • provision of written informed consent
  • age > 60 years
  • presence of idiopathic macular pucker or macular hole documented by OCT

Exclusion Criteria:

  • any prior intraocular surgery
  • pathologic myopia (> 7 diopters)
  • age related macular degeneration
  • glaucoma and diabetic retinopathy or any other retinal vascular disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Complete Peeling

    Foveal Sparing

    Arm Description

    Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with complete macular peeling of the internal limiting membrane.

    Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with partial peeling the internal limiting membrane (foveal sparing).

    Outcomes

    Primary Outcome Measures

    Retinal Sensitivity (dB)
    Microperimetry was done to assess macular sensitivity
    Visual Acuity (LogMAR)
    ETDRS charts were used to assess best corrected visual acuity
    Central Retinal Thickness (microns)
    Optical Coherence Tomography will be used to assess central retinal thickness

    Secondary Outcome Measures

    Full Information

    First Posted
    March 28, 2018
    Last Updated
    March 28, 2018
    Sponsor
    Università degli Studi di Brescia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03488576
    Brief Title
    Foveal Sparing of the ILM
    Official Title
    Macular Peeling With Foveal Sparing of the Internal Limiting Membrane: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2014 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    June 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Università degli Studi di Brescia

    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
    To compare the retinal sensitivity of complete internal limiting membrane (ILM) peeling versus foveal sparing ILM peeling during vitrectomy for epiretinal membrane or macular hole.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinal Sensitivity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This was a prospective study including ninety-one eyes of 190 phakic patients scheduled to undergo vitrectomy for idiopathic macular pucker or macular hole, from July 2014 to December 2016. Patients were randomized in a 1:1 ratio to complete peeling of the ILM (CP group) or foveal sparing (FS group).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    190 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Complete Peeling
    Arm Type
    Active Comparator
    Arm Description
    Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with complete macular peeling of the internal limiting membrane.
    Arm Title
    Foveal Sparing
    Arm Type
    Experimental
    Arm Description
    Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with partial peeling the internal limiting membrane (foveal sparing).
    Intervention Type
    Procedure
    Intervention Name(s)
    Complete Macular Peeling
    Intervention Description
    A complete peeling of the internal limiting membrane was performed
    Intervention Type
    Procedure
    Intervention Name(s)
    Macular Peeling with Foveal Sparing
    Intervention Description
    A partial peeling of the internal limiting membrane was performed, sparing the fovea.
    Primary Outcome Measure Information:
    Title
    Retinal Sensitivity (dB)
    Description
    Microperimetry was done to assess macular sensitivity
    Time Frame
    12-month
    Title
    Visual Acuity (LogMAR)
    Description
    ETDRS charts were used to assess best corrected visual acuity
    Time Frame
    12-month
    Title
    Central Retinal Thickness (microns)
    Description
    Optical Coherence Tomography will be used to assess central retinal thickness
    Time Frame
    12-month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: provision of written informed consent age > 60 years presence of idiopathic macular pucker or macular hole documented by OCT Exclusion Criteria: any prior intraocular surgery pathologic myopia (> 7 diopters) age related macular degeneration glaucoma and diabetic retinopathy or any other retinal vascular disease

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Foveal Sparing of the ILM

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