NCT01799707

Vision Restoration Training in Glaucoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Magdeburg · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Glaucoma

Interventions

Type	Name	Description
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).
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.

Timeline

• Start date: 2004-07-01
• Primary completion: 2007-08-01
• Completion: 2013-03-01
• First posted: 2013-02-27
• Last updated: 2019-07-09