Recruiting

Visual Retraining

Sponsor:

University of Rochester

Code:

NCT06121219

Conditions

Vision Loss Partial

Vision; Loss, Both Eyes

Hemianopia Homonymous

Hemianopia

Quadrantanopia

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Training in the Blind Field

Study Details

Brief summary:

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.

Conditions

Vision Loss Partial

Vision; Loss, Both Eyes

Hemianopia Homonymous

Hemianopia

Quadrantanopia

Study ID

NCT06121219

Start date

Sep 5, 2024

Status verified date

Jul, 2025

Completion date

Jan, 2032

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Cortically Blind Subjects

Inclusion:

  • Between 21 and 80 years of age
  • Residents of the United States or Canada
  • Unilateral stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained within the specified age range (21-75 years)
  • Reliable visual field defects in both eyes as measured by Humphrey, MAIA, Goldmann, and/or equivalent perimetry, large enough to enclose a 5-deg diameter visual stimulus.
  • Able to fixate on visual targets reliably for 1000ms
  • Must have a home computer (desktop or laptop) and reliable internet access
  • Willing, able, and competent to provide informed consent
  • Normal cognitive abilities, able to understand written and oral instructions in English, and competent and responsible adults in order to complete the visual training at home, independently, as instructed, for several months.

Exclusion:

  • Past or present eye disease interfering with visual acuity
  • BCVA worse than 20/40 in either eye
  • Damage to the dorsal Lateral Geniculate Nucleus
  • Diffuse whole brain degenerative processes
  • History of traumatic brain injury
  • Any other brain damage deemed by study staff to potentially interfere with training ability or outcome measures
  • Documented history of drug/alcohol abuse
  • Currently taking neuroactive medications which would impact training, as determined by PI
  • Presence of cognitive or seizure disorders
  • One-sided attentional neglect
  • Subjects who lack the competence or are otherwise unable to perform the visual training exercises as directed.

Control Subjects (n = 50)

Inclusion:

  • Between 21 and 80 years of age
  • Report no history of neurological disorder.
  • Competent and responsible, as determined by the Principal Investigator.

Exclusion:

  • Presence of damage to the visual system
  • Presence of an active disease process involving their nervous system.
  • Cognitive or seizure disorders
  • Best corrected visual acuity worse than 20/40 in either eye
  • Presence of vision field loss from ocular disease or disorder

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: Cortically Blind (CB) Subjects

Cortically Blind subjects will be enrolled to perform a daily home visual training task.

no intervention: Normative Comparator: Control Subjects

Healthy control subjects will be recruited to collect normative data by which to compare test results from CB subjects. No home training will be asked.

Interventions

Training in the Blind Field

A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. Subjects will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion, the presence of motion, or the orientation of a visual stimulus (either a small cloud of dots or bars) located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least 3 and up to 12 months at a time.

Primary outcome measure

  • Change in Mean Direction Discrimination Threshold [ Time Frame: Baseline to 4-6 months ]
  • Change in Mean Direction Discrimination Threshold [ Time Frame: Baseline to 8-12 months ]
  • Change in Mean Direction Integration Threshold [ Time Frame: Baseline to 4-6 months ]
  • Change in Mean Direction Integration Threshold [ Time Frame: Baseline to 8-12 months ]
  • Change in Mean Contrast Sensitivity for Direction [ Time Frame: Baseline to 4-6 months ]
  • Change in Mean Contrast Sensitivity for Direction [ Time Frame: Baseline to 8-12 months ]
  • Change in Mean Contrast Sensitivity for Static Orientation [ Time Frame: Baseline to 4-6 months ]
  • Change in Mean Contrast Sensitivity for Static Orientation [ Time Frame: Baseline to 8-12 months ]

Central Contacts and Locations

Central contacts

Evan Burr

585-275-5234Evan_Burr@urmc.rochester.edu

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Evan Burr, BA

585-275-5423Evan_Burr@URMC.Rochester.edu

Principal Investigator:

Krystel R Huxlin, PhD

More Information

Sponsor

University of Rochester

Last update posted

Jul 16, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Rochester on 2025-07-16.