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Vision Restoration Training in Glaucoma

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01799707
Acronym
gVRT
Enrollment
30
Registered
2013-02-27
Start date
2004-07-31
Completion date
2013-03-31
Last updated
2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

vision, restoration, visual field

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

Interventions

BEHAVIORALvision 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).

BEHAVIORALDiscrimination 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.

Sponsors

University of Magdeburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Detection accuracy change in percent over baseline of the visual fieldbetween baseline and 3 months of trainingvisual stimulus detection in residual and absolutely defect field of vision will be assessed using computer-based high resolution perimetry (HRP)

Secondary

MeasureTime frameDescription
change in visual stimulus perimetric detection ratebetween baseline and 3 months of trainingimprovement 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 timebetween baseline and 3 months of trainingchange in average reaction time in ms, measured by HRP

Other

MeasureTime frameDescription
Eye movement controlbetween baseline and 3 months of trainingvisual stimulus detection in residual and absolutely defect field of vision will be assessed using computer-based high resolution perimetry (HRP)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026