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OpenTrials
Completed

NCT Number: NCT01799707

Vision Restoration Training in Glaucoma

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.

Completed

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vision restoration training

Behavioral

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 names: gVRT

Discrimination Training

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Registry information

Official study title

Vision Restoration Training in Glaucoma - A Double-blind, Randomized, Placebo-controlled Clinical Trial

Acronym: gVRT

Important dates

Study start
2004
Primary completion
2007
Study completion
2013
First posted
Feb 27, 2013
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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