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Vision Restoration Training in Glaucoma (gVRT)

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ClinicalTrials.gov Identifier: NCT01799707
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Bernhard A. Sabel, University of Magdeburg

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.


Condition or disease Intervention/treatment Phase
Glaucoma Behavioral: vision restoration training Behavioral: Discrimination Training Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vision Restoration Training in Glaucoma - A Double-blind, Randomized, Placebo-controlled Clinical Trial
Study Start Date : July 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: vision restoration training
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).
Behavioral: vision restoration training
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).
Other Name: gVRT

Placebo Comparator: Discrimination training
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.
Behavioral: Discrimination Training
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 Measures :
  1. Detection accuracy change in percent over baseline of the visual field [ Time Frame: between baseline and 3 months of training ]
    visual stimulus detection in residual and absolutely defect field of vision will be assessed using computer-based high resolution perimetry (HRP)


Secondary Outcome Measures :
  1. change in visual stimulus perimetric detection rate [ Time Frame: between baseline and 3 months of training ]
    improvement of visual field in near-threshold perimetry measured by static perimetry (average threshold in db, average excentricity in degrees of visual angle

  2. improvement of reaction time [ Time Frame: between baseline and 3 months of training ]
    change in average reaction time in ms, measured by HRP


Other Outcome Measures:
  1. Eye movement control [ Time Frame: between baseline and 3 months of training ]
    visual stimulus detection in residual and absolutely defect field of vision will be assessed using computer-based high resolution perimetry (HRP)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799707


Sponsors and Collaborators
University of Magdeburg
Investigators
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Principal Investigator: Bernhard A Sabel, PhD University of Magdeburg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bernhard A. Sabel, Director, Principle Investigator and Study Director, University of Magdeburg
ClinicalTrials.gov Identifier: NCT01799707    
Other Study ID Numbers: VRT 03-2003
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Keywords provided by Bernhard A. Sabel, University of Magdeburg:
vision
restoration
visual field
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases