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Vision Restoration Training in Glaucoma (gVRT)

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
vision restoration training
Discrimination Training
Sponsored by
University of Magdeburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring vision, restoration, visual field

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Visual filed defect caused by glaucoma
  • Presence of a reproducible and stable visual field defect inside 30° eccentricity in at least one eye in 2 consecutive ophthalmologic visits during the last 12 months before recruitment
  • Well controlled intraocular pressure (IOP), and (iv) age between 25 and 80 years

Exclusion Criteria:

  • History of any medical condition precluding scheduled study visits or completion of the study (e.g. unstable cardiovascular disease)
  • History of any chronic degenerative or chronic inflammatory disease that could affect the visual field (e.g. multiple sclerosis, tumor
  • History of trauma or any non-glaucoma ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration, macular detachment, vascular occlusion
  • Severe cognitive or motor impairments
  • Insufficient fixation ability
  • Photosensitivity
  • Intraocular surgery or laser treatment performed within the previous 12 months before recruitment; OR
  • Scheduled intraocular surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    vision restoration training

    Discrimination training

    Arm Description

    Vision restoration training (VRT): visual stimuli repetitively presented to stimulate areas of residual vision. The training consists of luminance increment stimuli similar to perimetry and the task isa simple detection task (pressing a key whenever a target stimulus was detected).

    Discrimination training. Here, the stimulus is a line segment (bar) which is always presented within the central ±5° visual field in one of four possible random orientations: horizontal, vertical, oblique to the right or oblique to the left. If the patient has visual field defects in this central area, 80% of the stimuli are presented in the intact part of the training region. The task is to identify the orientation of the line segment and press, as fast as possible, one of 4 assigned buttons on the keyboard.

    Outcomes

    Primary Outcome Measures

    Detection accuracy change in percent over baseline of the visual field
    visual stimulus detection in residual and absolutely defect field of vision will be assessed using computer-based high resolution perimetry (HRP)

    Secondary Outcome Measures

    change in visual stimulus perimetric detection rate
    improvement of visual field in near-threshold perimetry measured by static perimetry (average threshold in db, average excentricity in degrees of visual angle
    improvement of reaction time
    change in average reaction time in ms, measured by HRP

    Full Information

    First Posted
    February 21, 2013
    Last Updated
    July 7, 2019
    Sponsor
    University of Magdeburg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01799707
    Brief Title
    Vision Restoration Training in Glaucoma
    Acronym
    gVRT
    Official Title
    Vision Restoration Training in Glaucoma - A Double-blind, Randomized, Placebo-controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Magdeburg

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Importance: Visual field loss after retinal damage in glaucoma is considered irreversible and methods are needed to achieve vision restoration. Behavioral vision restoration training (VRT), shown to improve visual fields in hemianopia and optic nerve damage, might comprise such a method. Objective: To determine if behaviorally activating areas of residual visual (ARV) using VRT by daily one hour training for 3 months improves detection performance in perimetry compared to a vision discrimination task in the intact visual field sector.
    Detailed Description
    Design: Prospective, randomized, double-blind, placebo controlled trial. Setting: Ambulatory care and home training Participants: Volunteer sample of glaucoma patients (25-80 yrs old) with stable visual fields and well controlled intraocular pressure (IOP). Intervention: Computer-based home training with VRT (n=15) or placebo discrimination training (n=15). Main Outcome Measures: The primary endpoint is change in detection performance in High Resolution Perimetry (HRP). Secondary endpoints are 30° white/white and 30° blue/yellow near-threshold perimetry. Further measures are eye movements, vision-related quality of life (vQoL) as assessed with (NEI-VFQ) and health-related quality of life (hQoL) using SF-36 Health Survey-Short Form. Investigators hypothesize that VRT will improve visual performance in glaucoma

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma
    Keywords
    vision, restoration, visual field

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    vision restoration training
    Arm Type
    Active Comparator
    Arm Description
    Vision restoration training (VRT): visual stimuli repetitively presented to stimulate areas of residual vision. The training consists of luminance increment stimuli similar to perimetry and the task isa simple detection task (pressing a key whenever a target stimulus was detected).
    Arm Title
    Discrimination training
    Arm Type
    Placebo Comparator
    Arm Description
    Discrimination training. Here, the stimulus is a line segment (bar) which is always presented within the central ±5° visual field in one of four possible random orientations: horizontal, vertical, oblique to the right or oblique to the left. If the patient has visual field defects in this central area, 80% of the stimuli are presented in the intact part of the training region. The task is to identify the orientation of the line segment and press, as fast as possible, one of 4 assigned buttons on the keyboard.
    Intervention Type
    Behavioral
    Intervention Name(s)
    vision restoration training
    Other Intervention Name(s)
    gVRT
    Intervention Description
    visual stimuli repetitively presented to stimulate areas of residual vision. The training consists of luminance increment stimuli similar to perimetry and the task isa simple detection task (pressing a key whenever a target stimulus was detected).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Discrimination Training
    Intervention Description
    the stimulus is a line segment (bar) which is always presented within the central ±5° visual field in one of four possible random orientations: horizontal, vertical, oblique to the right or oblique to the left. If the patient has visual field defects in this central area, 80% of the stimuli are presented in the intact part of the training region. The task is to identify the orientation of the line segment and press, as fast as possible, one of 4 assigned buttons on the keyboard.
    Primary Outcome Measure Information:
    Title
    Detection accuracy change in percent over baseline of the visual field
    Description
    visual stimulus detection in residual and absolutely defect field of vision will be assessed using computer-based high resolution perimetry (HRP)
    Time Frame
    between baseline and 3 months of training
    Secondary Outcome Measure Information:
    Title
    change in visual stimulus perimetric detection rate
    Description
    improvement of visual field in near-threshold perimetry measured by static perimetry (average threshold in db, average excentricity in degrees of visual angle
    Time Frame
    between baseline and 3 months of training
    Title
    improvement of reaction time
    Description
    change in average reaction time in ms, measured by HRP
    Time Frame
    between baseline and 3 months of training
    Other Pre-specified Outcome Measures:
    Title
    Eye movement control
    Description
    visual stimulus detection in residual and absolutely defect field of vision will be assessed using computer-based high resolution perimetry (HRP)
    Time Frame
    between baseline and 3 months of training

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Visual filed defect caused by glaucoma Presence of a reproducible and stable visual field defect inside 30° eccentricity in at least one eye in 2 consecutive ophthalmologic visits during the last 12 months before recruitment Well controlled intraocular pressure (IOP), and (iv) age between 25 and 80 years Exclusion Criteria: History of any medical condition precluding scheduled study visits or completion of the study (e.g. unstable cardiovascular disease) History of any chronic degenerative or chronic inflammatory disease that could affect the visual field (e.g. multiple sclerosis, tumor History of trauma or any non-glaucoma ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration, macular detachment, vascular occlusion Severe cognitive or motor impairments Insufficient fixation ability Photosensitivity Intraocular surgery or laser treatment performed within the previous 12 months before recruitment; OR Scheduled intraocular surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bernhard A Sabel, PhD
    Organizational Affiliation
    University of Magdeburg
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24504128
    Citation
    Sabel BA, Gudlin J. Vision restoration training for glaucoma: a randomized clinical trial. JAMA Ophthalmol. 2014 Apr 1;132(4):381-9. doi: 10.1001/jamaophthalmol.2013.7963.
    Results Reference
    derived

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    Vision Restoration Training in Glaucoma

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