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Vision Loss PartialurochesterNCT06121219

Effect of Visual Retraining After Stroke

A study testing Training in the Blind Field in people with Vision Loss Partial and Vision; Loss, Both Eyes, run by University of Rochester at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 80 yearsHealthy volunteers can take part
What is being tested?
Training in the Blind Field
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
5 Sep 2024to Jan 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 17Show fewer
  • 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)
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • University of Rochester Medical Center

    Rochester, New York, 14642

    Evan Burr, BA, 585-275-5423, Evan_Burr@URMC.Rochester.edu

    Krystel R Huxlin, PhD

    Recruiting

Other trials in United States

About this study

Official title: Effect of Visual Retraining on Visual Loss Following Cortical Damage

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.

Being tested
Training in the Blind Field
Medical subject headings
Blindness, Hemianopsia, Ischemic Stroke, Blindness, Cortical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training in the Blind FieldDevice

    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.

Study groups in NCT06121219
Study groupRoleWhat they receive
Experimental: Cortically Blind (CB) SubjectsExperimentalCortically Blind subjects will be enrolled to perform a daily home visual training task.
Receives: Device: Training in the Blind Field
Normative Comparator: Control SubjectsNo interventionHealthy control subjects will be recruited to collect normative data by which to compare test results from CB subjects. No home training will be asked.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mean Direction Discrimination Threshold

    For each subject, the investigators will measure the change in ability to detect differences in the motion direction of visual stimuli relative to horizontal, measured in degrees of visual angle with respect to the stimulus. These assessments will be based on what can be reliably detected at a 72-75% correct level of performance on our 2AFC task, with task difficulty adjusted on a 3:1 staircase. The degrees of visual angle for the stimulus vary from 90 degrees (fully vertical) to 0.1 degrees (virtually overlapping the horizontal axis).

    These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training

    Measured: Baseline to 4-6 months

  2. Change in Mean Direction Discrimination Threshold

    For each subject, the investigators will measure the change in ability to detect differences in the motion direction of visual stimuli relative to horizontal, measured in degrees of visual angle with respect to the stimulus. These assessments will be based on what can be reliably detected at a 72-75% correct level of performance on our 2AFC task, with task difficulty adjusted on a 3:1 staircase. The degrees of visual angle for the stimulus vary from 90 degrees (fully vertical) to 0.1 degrees (virtually overlapping the horizontal axis).

    These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training

    Measured: Baseline to 8-12 months

  3. Change in Mean Direction Integration Threshold

    This will measure the change in ability of subjects to integrate across a range of motion directions measured in degrees of visual angle, with respect to the stimulus. These assessments will be based on what range of motion directions can be reliably integrated at a 72-75% correct level of performance on our 2AFC task, with task difficulty adjusted on a 3:1 staircase. The degrees of visual angle for the stimulus vary from 90 degrees (fully vertical) to 0.1 degrees (virtually overlapping the horizontal axis) .

    These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

    Measured: Baseline to 4-6 months

  4. Change in Mean Direction Integration Threshold

    This will measure the change in ability of subjects to integrate across a range of motion directions measured in degrees of visual angle, with respect to the stimulus. These assessments will be based on what range of motion directions can be reliably integrated at a 72-75% correct level of performance on our 2AFC task, with task difficulty adjusted on a 3:1 staircase. The degrees of visual angle for the stimulus vary from 90 degrees (fully vertical) to 0.1 degrees (virtually overlapping the horizontal axis) .

    These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

    Measured: Baseline to 8-12 months

  5. Change in Mean Contrast Sensitivity for Direction

    Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for direction discrimination. This is a change metric as transfer must be compared from pre- to post- each course of training.

    For each subject, the investigators will measure the ability to correctly detect the motion direction of visual stimuli that are also varying in contrast against a grey background. The investigators will measure the luminance contrast, measured in percentage of contrast with respect to the stimulus, that can be reliably detected at a 72-75% correct level of performance. Contrast will vary between 100% (maximum contrast of black on grey) and 0.1% (minimum contrast visible of grey-on-grey) based on subject performance and a 3:1 staircase.

    These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

    Measured: Baseline to 4-6 months

  6. Change in Mean Contrast Sensitivity for Direction

    Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for direction discrimination. This is a change metric as transfer must be compared from pre- to post- each course of training.

    For each subject, the investigators will measure the ability to correctly detect the motion direction of visual stimuli that are also varying in contrast against a grey background. The investigators will measure the luminance contrast, measured in percentage of contrast with respect to the stimulus, that can be reliably detected at a 72-75% correct level of performance. Contrast will vary between 100% (maximum contrast of black on grey) and 0.1% (minimum contrast visible of grey-on-grey) based on subject performance and a 3:1 staircase.

    These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

    Measured: Baseline to 8-12 months

  7. Change in Mean Contrast Sensitivity for Static Orientation

    Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for static orientation discrimination. This is a change metric as transfer must be compared from pre- to post- each course of training.

    For each subject, the investigators will measure the ability to correctly detect the orientation of non-moving visual stimuli that vary in contrast against a grey background. The investigators will measure the luminance contrast, measured in percentage of contrast with respect to the stimulus, that can be reliably detected at a 72-75% correct level of performance. Contrast will vary between 100% (maximum contrast of black on grey) and 0.1% (minimum contrast visible of grey-on-grey) based on subject performance and a 3:1 staircase.

    These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

    Measured: Baseline to 4-6 months

  8. Change in Mean Contrast Sensitivity for Static Orientation

    Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for static orientation discrimination. This is a change metric as transfer must be compared from pre- to post- each course of training.

    For each subject, the investigators will measure the ability to correctly detect the orientation of non-moving visual stimuli that vary in contrast against a grey background. The investigators will measure the luminance contrast, measured in percentage of contrast with respect to the stimulus, that can be reliably detected at a 72-75% correct level of performance. Contrast will vary between 100% (maximum contrast of black on grey) and 0.1% (minimum contrast visible of grey-on-grey) based on subject performance and a 3:1 staircase.

    These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

    Measured: Baseline to 8-12 months

Secondary outcomes (6)
  1. Humphrey 10-2 and 24-2 perimetry

    The investigators will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system.

    These measures will be evaluated at baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

    Measured: Baseline to 4-6 months

  2. Humphrey 10-2 and 24-2 perimetry

    The investigators will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system.

    These measures will be evaluated at baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

    Measured: Baseline to 8-12 months

  3. Goldmann perimetry

    The investigators will measure the change in area of vision (degrees squared) as encompassed by each isopter, measured by one of 3 different light stimuli.

    The 3 isopters which will be compared are:

    I2e 1asb, 0.25 mm^2 I4e 10asb, 0.25 mm^2 V4e 1000asb, 64 mm^2

    These measures will be evaluated at baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

    Measured: Baseline to 4-6 months

  4. Goldmann perimetry

    The investigators will measure the change in area of vision (degrees squared) as encompassed by each isopter, measured by one of 3 different light stimuli.

    The 3 isopters which will be compared are:

    I2e 1asb, 0.25 mm^2 I4e 10asb, 0.25 mm^2 V4e 1000asb, 64 mm^2

    These measures will be evaluated at baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

    Measured: Baseline to 8-12 months

  5. MAIA Visual Field Perimetry

    The investigators will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system.

    These measures will be evaluated at baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

    Measured: Baseline to 4-6 months

  6. MAIA Visual Field Perimetry

    The investigators will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system.

    These measures will be evaluated at baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

    Measured: Baseline to 8-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start5 Sep 2024
  3. Primary completionJan 2030 (estimated)
  4. Study completionJan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06121219
Sponsor's protocol ID
STUDY00008697
Acronym
urochester
Status last verified
Sep 2026
First submitted
31 Oct 2023
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Training in the Blind Field in people with Vision Loss Partial and Vision; Loss, Both Eyes, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Evan Burr (585-275-5234, Evan_Burr@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Direction Discrimination Threshold (time frame: Baseline to 4-6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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