Vision Restoration Training in Glaucoma

NCT01799707 | Completed Phase 2

• 1 other identifier: VRT 03-2003
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma

Keywords

vision; restoration; visual field

Outcome Measures

Primary Outcomes (1)

• Detection accuracy change in percent over baseline of the visual field

  visual stimulus detection in residual and absolutely defect field of vision will be assessed using computer-based high resolution perimetry (HRP)

  between baseline and 3 months of training

Secondary Outcomes (2)

• change in visual stimulus perimetric detection rate

  between baseline and 3 months of training

• improvement of reaction time

  between baseline and 3 months of training

Other Outcomes (1)

• Eye movement control

  between baseline and 3 months of training

Study Arms (2)

vision restoration training

ACTIVE COMPARATOR

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).

Behavioral: vision restoration training

Discrimination training

PLACEBO COMPARATOR

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.

Behavioral: Discrimination Training

Interventions

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).

Also known as: gVRT

vision restoration training

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.

Discrimination training

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Magdeburg: lead

Related Publications (1)

• 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.

  PMID: 24504128 DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Bernhard A Sabel, PhD

  University of Magdeburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principle Investigator and Study Director

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: February 27, 2013
• Study Start: July 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: March 1, 2013
• Last Updated: July 9, 2019

Record last verified: 2019-07