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Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spectral domain Optical Coherence Tomography
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring Glaucoma, Optical Coherence Tomography, Primary Open Angle Glaucoma, Visual Field

Eligibility Criteria

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

Inclusion Criteria:

  • Best-corrected visual acuity of 20/40 or better
  • No media opacities
  • Spherical equivalent refractive errors in a range of -6 to +6 diopters
  • Cylinder correction within 3.0 diopters.

Exclusion Criteria:

  • Age < 18 years old
  • Visual Acuity < 20/40
  • Nuclear sclerosis > +2
  • Corneal diseases
  • Contact lens use
  • History of posterior segment intraocular surgery
  • Systemic or ocular diseases that can cause visual field loss.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Open-angle glaucoma

    Healthy Controls

    Arm Description

    Participants with primary open-angle glaucoma and an abnormal visual field defect in one eye. Spectral domain Optical Coherence Tomography will be obtained from the effected eye and fellow eye of each glaucoma patient.

    Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control.

    Outcomes

    Primary Outcome Measures

    Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements
    Using Spectral Domain optical coherence tomography (SD-OCT), horizontal macular thickness of the lamina cribrosa (boundaries of the retinal layers) is measured in the eyes of each participant in microohms.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 17, 2015
    Last Updated
    February 27, 2019
    Sponsor
    Wills Eye
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02622191
    Brief Title
    Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye
    Official Title
    Segmental Analysis of Retinal Layers and Measurement of Lamina Cribrosa Thickness in Patients With Asymmetric Primary Open-Angle Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (Actual)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study aims to further understand glaucoma pathogenesis and progression by utilizing enhanced depth imaging optical coherence tomography to visualize and measure lamina cribrosa in vivo and segmentation technology to accurately delineate and measure boundaries of the retinal layers. Investigators will elaborate further on key concepts of lamina cribrosa thickness and trans-synaptic degeneration.
    Detailed Description
    Two important areas of the eye that need investigation in order to further understanding of glaucoma. First is the retina (part of the eye that converts images from the eye's optical system into electrical impulses sent along the optic nerve to the brain). Newer technology, Spectral Domain Optical Coherence Tomography (SD-OCT), allows us to look at different layers of the retina and carefully measure thickness of each layer. Second area is lamina cribrosa (a portion of the white part of the eye which has nerve fibers passing through it connecting the eye to the brain). If lamina cribrosa is thin, it is possible it may bend easily and disrupt nerve fibers. SD-OCT allows measurement of lamina cribrosa thickness. Findings will help monitor changes that occur in the eye as a result of glaucoma. Individuals with primary open-angle glaucoma and unilateral visual field defects were chosen as the main patient population (in addition to normal controls). By approximating each participants baseline anatomy using the fellow, "internal control" eye, investigators will be able to better determine if any changes occur in the macula or the lamina cribrosa as a result of glaucoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma
    Keywords
    Glaucoma, Optical Coherence Tomography, Primary Open Angle Glaucoma, Visual Field

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Open-angle glaucoma
    Arm Type
    Experimental
    Arm Description
    Participants with primary open-angle glaucoma and an abnormal visual field defect in one eye. Spectral domain Optical Coherence Tomography will be obtained from the effected eye and fellow eye of each glaucoma patient.
    Arm Title
    Healthy Controls
    Arm Type
    Experimental
    Arm Description
    Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control.
    Intervention Type
    Device
    Intervention Name(s)
    Spectral domain Optical Coherence Tomography
    Other Intervention Name(s)
    SD-OCT
    Intervention Description
    Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea were acquired using Spectralis Heidelberg Retinal Angiography (HRA)+OCT (Heidelberg Engineering GmbH, Heidelberg, Germany).
    Primary Outcome Measure Information:
    Title
    Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements
    Description
    Using Spectral Domain optical coherence tomography (SD-OCT), horizontal macular thickness of the lamina cribrosa (boundaries of the retinal layers) is measured in the eyes of each participant in microohms.
    Time Frame
    1 examination, approximately one hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Best-corrected visual acuity of 20/40 or better No media opacities Spherical equivalent refractive errors in a range of -6 to +6 diopters Cylinder correction within 3.0 diopters. Exclusion Criteria: Age < 18 years old Visual Acuity < 20/40 Nuclear sclerosis > +2 Corneal diseases Contact lens use History of posterior segment intraocular surgery Systemic or ocular diseases that can cause visual field loss.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    L J Katz, MD
    Organizational Affiliation
    Wills Eye Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26550975
    Citation
    Zangalli CS, Ahmed OM, Waisbourd M, H Ali M, Cvintal V, Affel E, Gupta L, Katz LJ, C Sergott R. Segmental Analysis of Macular Layers in Patients With Unilateral Primary Open-Angle Glaucoma. J Glaucoma. 2016 Apr;25(4):e401-7. doi: 10.1097/IJG.0000000000000336.
    Results Reference
    result

    Learn more about this trial

    Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye

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