Clinical trial NCT01799707: Vision Restoration Training in Glaucoma
Official title: Vision Restoration Training in Glaucoma - A Double-blind, Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Keywords: vision
restoration
visual field
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Detection accuracy change in percent over baseline of the visual field
timeFrame: between baseline and 3 months of training
Secondary outcomes:
measure: change in visual stimulus perimetric detection rate
timeFrame: between baseline and 3 months of training
measure: improvement of reaction time
timeFrame: between baseline and 3 months of training
Other outcomes:
measure: Eye movement control
timeFrame: between baseline and 3 months of training
Locations:
Study officials:
affiliation: University of Magdeburg
name: Bernhard A Sabel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.