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Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal

Primary Purpose

Epiretinal Membrane

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pars plana vitrectomy and removal of epiretinal membrane
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epiretinal Membrane focused on measuring epiretinal membrane, visual acuity, metamorphopsia, thickness of retinal layers, spectral domain optical coherence tomography

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who were diagnosed with idiopathic epiretinal membrane and were scheduled for epiretinal membrane removal

Exclusion Criteria:

  • evidence of ocular inflammation, diabetic retinopathy, hypertensive retinopathy, and retinal vasculitis, media opacity that would influence visual acuity or preclude acquisition of clear spectral domain optical coherence tomography images,
  • presence of cataract judged to affect visual function, -6.0 diopters or more of spherical equivalent, prominent staphyloma, history of intraocular surgery other than uncomplicated cataract surgery, history of retinal detachment, other ocular diseases that may influence the macular microstructure or visual function, immeasurable fovea location on the spectral domain optical coherence tomography image due to severe retinal contraction, and indistinct intraretinal structure on spectral domain optical coherence tomography images.
  • patients who underwent combined epiretinal membrane removal and cataract extraction, less than six months follow-up after epiretinal membrane removal, who had occurrence or progression of cataract after the surgery judged to affect visual function, or who experienced recurrence of epiretinal membrane during the follow-up period

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Postoperative changes in visual acuity
    Changes in visual acuity (Early treatment diabetic retinopathy study score)was evaluated preoperatively and at 2-month and 6-month postoperative follow-up visits.
    Postoperative changes in metamorphopsia
    Changes in metamorphopsia score (M-score) was measured using M-chart and evaluated preoperatively and at 2-month and 6-month postoperative follow-up visits.
    Postoperative parafoveal thickness of each retinal layer
    Changes in parafoveal thickness of each retinal layer was evaluated based on spectral domain optical coherence tomography images

    Secondary Outcome Measures

    Full Information

    First Posted
    October 21, 2011
    Last Updated
    November 15, 2011
    Sponsor
    Samsung Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01474655
    Brief Title
    Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal
    Official Title
    Assessment of Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the changes in visual acuity, metamorphopsia, and thickness of retinal layers after epiretinal membrane removal and to investigate factors associated with visual function.
    Detailed Description
    Eyes with idiopathic Epiretinal Membrane Removal (ERM) scheduled to underwent ERM removal were included. Changes in visual acuity, metamorphopsia score (M-score) using M-chart, and parafoveal thickness of each retinal layer were evaluated preoperatively and at 2-month and 6-month postoperative follow-up visits. Factors associated with visual acuity and M-score were investigated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epiretinal Membrane
    Keywords
    epiretinal membrane, visual acuity, metamorphopsia, thickness of retinal layers, spectral domain optical coherence tomography

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Pars plana vitrectomy and removal of epiretinal membrane
    Intervention Description
    A three-port standard pars plana vitrectomy was performed by a single surgeon using a 23-gauge vitrectomy system, either Associate®(Dutch Ophthalmic Research Center. Inc., Zuidland, The Netherlands) or Accurus®(Alcon Laboratories Inc., Fort Worth, USA), with one step scleral tunnel incision. Visualization of the fundus was achieved using a wide-angle viewing system. After core vitrectomy, induction of a posterior vitreous detachment was conducted using a 23-gauge angulated dissecting needle in cases without presence of a posterior vitreous detachment. The epiretinal membrane and internal limiting membrane was removed in all eyes. In most cases, internal limiting membrane was removed without the assistance of staining dye. Indocyanine green dye was used to facilitate the removal of internal limiting membrane in some of the cases.
    Primary Outcome Measure Information:
    Title
    Postoperative changes in visual acuity
    Description
    Changes in visual acuity (Early treatment diabetic retinopathy study score)was evaluated preoperatively and at 2-month and 6-month postoperative follow-up visits.
    Time Frame
    preop, 2-month postop, 6-months postop
    Title
    Postoperative changes in metamorphopsia
    Description
    Changes in metamorphopsia score (M-score) was measured using M-chart and evaluated preoperatively and at 2-month and 6-month postoperative follow-up visits.
    Time Frame
    preop, 2 months postop, 6 months postop
    Title
    Postoperative parafoveal thickness of each retinal layer
    Description
    Changes in parafoveal thickness of each retinal layer was evaluated based on spectral domain optical coherence tomography images
    Time Frame
    preop, 2 months postop, 6 months postop

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who were diagnosed with idiopathic epiretinal membrane and were scheduled for epiretinal membrane removal Exclusion Criteria: evidence of ocular inflammation, diabetic retinopathy, hypertensive retinopathy, and retinal vasculitis, media opacity that would influence visual acuity or preclude acquisition of clear spectral domain optical coherence tomography images, presence of cataract judged to affect visual function, -6.0 diopters or more of spherical equivalent, prominent staphyloma, history of intraocular surgery other than uncomplicated cataract surgery, history of retinal detachment, other ocular diseases that may influence the macular microstructure or visual function, immeasurable fovea location on the spectral domain optical coherence tomography image due to severe retinal contraction, and indistinct intraretinal structure on spectral domain optical coherence tomography images. patients who underwent combined epiretinal membrane removal and cataract extraction, less than six months follow-up after epiretinal membrane removal, who had occurrence or progression of cataract after the surgery judged to affect visual function, or who experienced recurrence of epiretinal membrane during the follow-up period
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Se Woong Kang, M.D.
    Organizational Affiliation
    Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22875136
    Citation
    Kim JH, Kang SW, Kong MG, Ha HS. Assessment of retinal layers and visual rehabilitation after epiretinal membrane removal. Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1055-64. doi: 10.1007/s00417-012-2120-7. Epub 2012 Aug 9.
    Results Reference
    derived

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    Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal

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