Vision Restoration Training in Glaucoma

NCT ID: NCT01799707

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2013-03-31

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

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

vision restoration training

Intervention Type: 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).

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.

Group Type: PLACEBO_COMPARATOR

Discrimination Training

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

gVRT

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Magdeburg

OTHER

Sponsor Role: lead

Responsible Party

Bernhard A. Sabel

Director, Principle Investigator and Study Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernhard A Sabel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Magdeburg

References

Sabel BA, Gudlin J. Vision restoration training for glaucoma: a randomized clinical trial. JAMA Ophthalmol. 2014 Apr 1;132(4):381-9. doi: 10.1001/jamaophthalmol.2013.7963.

Reference Type: DERIVED

PMID: 24504128 (View on PubMed)

Other Identifiers

VRT 03-2003

Identifier Type: -

Identifier Source: org_study_id