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Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage

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University of Rochester

Status

Completed

Conditions

Hemianopia
Hemianopia Homonymous
Vision Loss Partial
Quadrantanopia
Stroke, Ischemic

Treatments

Other: Training in the Sighted Field
Other: Training in the Blind Field

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05098236
STUDY00000075
R01EY027314 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This project is intended to collect data using standard clinical tests and psychophysics to quantify the effect of visual cortical damage on the structure of the residual visual system, visual perception, spatial awareness, and brain function. The investigators will also assess the effect of intensive visual retraining on the residual visual system, processing of visual information and the use of such information in real-world situations following damage. This research is intended to improve our understanding of the consequences of permanent visual system damage in humans, of methods that can be used to reverse visual loss, and of brain mechanisms by which visual recovery is achieved.

Enrollment

280 patients

Sex

All

Ages

17 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Cortically Blind Subject Inclusion Criteria:

  • Subjects between the ages of 17 and 75, who have sustained damage to primary visual cortex at age 17 or later, and are rendered blind over a portion of their visual field.
  • Subjects must have some intact visual cortical areas (other than primary visual cortex) in the damaged brain hemisphere. This assessment will be made from MRI or CT scans of the subject's head, which will be obtained via standard release from their neurologist.
  • Subjects who demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field.
  • Subjects who are competent and responsible, as determined by the Principal Investigator.
  • Subjects who will receive retinal electrophysiology (mfERG) testing must have a report from their ophthalmologist stating that they are able to receive dilating drops

Cortically Blind Subject Exclusion Criteria:

  • Subjects who do not possess damage of primary visual cortex or its immediate afferents
  • Subjects who are suffering from an active disease process involving their nervous system.
  • Subjects who are unable to fixate visual targets precisely with their eyes
  • Subjects who have unreliable vision fields from prior testing indicated by greater than 20% fixation losses, false positives or false negatives
  • Best corrected visual acuity worse than 20/40 in either eye
  • Impaired foveal sensitivity as indicated by visual field tests
  • Presence of vision loss from ocular disease or disorder
  • Presence of bilateral visual acuity loss from any source
  • Subjects who are suffering from one-sided attentional neglect
  • Subjects who have impaired auditory thresholds that would influence test results and training efficacy (all our testing and training involves sound as a cue for trial/stimulus onset or as feedback)
  • Persons who lack the competence or are otherwise unable to perform the visual training exercises as directed.

Control Subject Inclusion Criteria:

  • Subjects must be between the ages of 17 and 75 years of age
  • Subjects must report no history of neurological disorder.
  • Subjects who are competent and responsible, as determined by the Principal Investigator.

Control Subject Exclusion criteria:

  • Subjects who possess damage to the visual system
  • Subjects who are suffering from an active disease process involving their nervous system.
  • Subjects who are unable to fixate visual targets precisely with their eyes
  • Best corrected visual acuity worse than 20/40 in either eye
  • Presence of vision loss from ocular disease or disorder
  • Presence of bilateral visual acuity loss from any source
  • Subjects who are suffering from one-sided attentional neglect
  • Subjects who have impaired auditory thresholds that would influence test results and training efficacy (all our testing and training involves sound as a cue for trial/stimulus onset or as feedback)
  • Persons who lack the competence or are otherwise unable to perform the visual testing/training exercises as directed.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

280 participants in 2 patient groups, including a placebo group

Cortically Blind Subjects
Experimental group
Treatment:
Other: Training in the Blind Field
Control
Placebo Comparator group
Treatment:
Other: Training in the Sighted Field

Trial contacts and locations

1

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Central trial contact

Christine Callan

Data sourced from clinicaltrials.gov

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