Vision Restoration Training in Glaucoma (gVRT)

University of Magdeburg

Status and phase: Completed; Phase 2

Conditions: Glaucoma

Treatments: Behavioral: vision restoration training; Behavioral: Discrimination Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01799707

VRT 03-2003

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

vision restoration training

Active Comparator group

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).

Treatment:

Behavioral: vision restoration training

Discrimination training

Placebo Comparator group

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.

Treatment:

Behavioral: Discrimination Training