ClinicalTrials.gg
Active, not recruitingNCT04798924Updated Dec 3, 2025

Visual Rehabilitation After Occipital Stroke

An interventional study of Subacute Training in the intact field and Subacute Training in the blind field in Stroke, Ischemic, Quadrantanopia and Vision Loss Partial, sponsored by University of Rochester. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by University of Rochester · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
01

Study summary

This research aims to examine changes in plastic potential of the visual system with time from stroke affecting primary visual cortex. We will measure structural and mechanistic aspects of progressive degeneration along the early visual pathways, correlating them with changes in visual performance, and in responsiveness to visual restoration training. This project will advance both scientific knowledge, as well as technical capability and clinical practices for restoring vision and quality of life for people suffering from cortical blindness.

02

Conditions studied

  • Stroke, Ischemic
  • Quadrantanopia
  • Vision Loss Partial
  • Visual Field Defect, Peripheral
  • Peripheral Visual Field Defect of Both Eyes
  • Peripheral Visual Field Defect
  • Hemianopsia
  • Hemianopia
  • Homonymous Hemianopia
  • Homonymous Hemianopsia
  • Visual Fields Hemianopsia
  • Occipital Lobe Infarct
  • Quadrantanopsia
  • Stroke Hemorrhagic

Keywords

  • Occipital stroke
  • vision loss
  • Homonymous quadrantanopia
  • Homonymous quadrantanopsia
  • stroke
  • Vision loss after stroke
  • Vision recovery
  • Vision restoration
  • Partial vision loss
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 60 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Residents of US and Canada
  • MRI and/or CT scans showing evidence of one-sided / unilateral stroke or stroke-like damage to the primary visual cortex or its immediate afferent white matter sustained less than 6-months prior to enrollment
  • Reliable visual field defects in both eyes as measured by Humphrey, Macular Integrity Assessment (MAIA), Goldmann, and/or equivalent perimetry. This deficit must be large enough to enclose a 5-deg diameter visual stimulus.
  • Ability to fixate on visual targets reliably for 1000ms (as demonstrated by visual fields, and verified in study participation)
  • Willing and safely able to undergo magnetic resonance imaging (MRI) scanning
  • Willing, able, and competent to provide
  • Fluent in written and spoken English
  • Cognitively able, responsible, and willing to complete daily visual training independently at home for several months.

Exclusion criteria

Exclusion Criteria:

  • Past or present ocular disease interfering with vision
  • Best corrected visual acuity worse than 20/40 in either eye
  • Presence of damage to the dorsal Lateral Geniculate Nucleus, as shown on MRI/CT scans
  • Diffuse, whole brain degenerative processes
  • Brain damage deemed by study staff to potentially interfere with training ability or outcome measures
  • History of traumatic brain injury
  • Documented history of drug/alcohol abuse
  • Currently use of neuroactive medications which would impact training, as determined by PI
  • Cognitive or seizure disorders
  • One-sided attentional neglect
  • Inability to perform the visual training exercises as directed
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Training in the blind field

    Training in the blind field using specialized software

    Device: Subacute Training in the blind field · Device: Chronic Training in the blind field

  • Experimental
    Training in the intact field

    Training in the intact field using specialized software

    Device: Subacute Training in the intact field · Device: Chronic Training in the blind field

Interventions

  • DeviceSubacute Training in the intact field

    A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. They 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 of a small cloud of dots located at a predetermined location in the intact 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 one and up to 6 months.

  • DeviceSubacute 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. They 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 of a small cloud of dots 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 one and up to 6 months.

  • DeviceChronic Training in the blind field

    After the initial training period of one to six months, the same computer software will continue to be used for all subjects. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots 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 6 months.

06

What researchers measure

Primary outcomes

  1. Direction Discrimination Threshold

    For each subject, we will measure the ability to detect differences in the motion direction of visual stimuli relative to horizontal, measured in degrees of visual angle. These assessments will be based on what can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline to 6-months post-stroke, then 6- to 12-months post stroke, and baseline to 12-months.\*\* \*\*NOTE: Our protocol allows for a +1 month variance for all timepoints.

    Time frame: baseline, 6 months, 12 months

Secondary outcomes

  1. Direction Integration Threshold

    This will measure the ability of subjects to integrate across a range of motion directions measured in degrees of visual angle. These assessments will be based on what range of motion directions can be reliably integrated at a 72-75% correct level of performance. These measures of change will be evaluated baseline to 6-months post-stroke, then 6- to 12-months post stroke, and baseline to 12-months. \*\*NOTE: Our protocol allows for a +1 month variance for all timepoints.

    Time frame: baseline, 6 months, 12 months

  2. Contrast Sensitivity for Direction

    Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for direction discrimination. For each subject, we will measure the ability to correctly detect the motion direction of visual stimuli that are also varying in contrast against a grey background. We will measure the luminance contrast that can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline to 6-months post-stroke, then 6- to 12-months post stroke, and baseline to 12-months. \*\*NOTE: Our protocol allows for a +1 month variance for all timepoints.

    Time frame: baseline, 6 months, 12 months

  3. contrast sensitivity for static orientation

    Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for static orientation discrimination. For each subject, we will measure the ability to correctly detect the orientation of non-moving visual stimuli that vary in contrast against a grey background. We will measure the luminance that can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline to 6-months post-stroke, then 6- to 12-months post stroke, and baseline to 12-months. \*\*NOTE: Our protocol allows for a +1 month variance for all timepoints.

    Time frame: baseline, 6 months, 12 months

  4. Ganglion cell complex thickness laterality

    Change in thickness of the ganglion cell complex will be measured by retinal optical coherence tomography (OCT) scans from baseline to 6- and 12- months post stroke.\*\* We will perform OCT imaging of the foveal region of the retina (6mm ETDRS) in both eyes of each patient. Images will be automatically segmented. Estimated thickness of the ganglion cell complex will be extracted and aligned with estimates of the blind field's visual sensitivity obtained from fundus-controlled MAIA perimetry. We will then compute a laterality index LI as follows: LIGCCT=(Tc-Ti)/(Tc+Ti) where Tc=thickness in the control lateral OCT quadrant, Ti=thickness in the impaired lateral OCT quadrant. \*\*NOTE: Our protocol allows for a +1 month variance for all timepoints.

    Time frame: baseline, 6 months, 12 months

  5. Ganglion cell complex volume laterality

    Change in volume of the ganglion cell complex will be measured by retinal optical coherence tomography (OCT) scans from baseline to 6- and 12- months post stroke.\*\* We will perform OCT imaging of the foveal region of the retina (6mm ETDRS) in both eyes of each patient. Images will be automatically segmented. Estimated volume of the ganglion cell complex will be extracted and aligned with estimates of the blind field's visual sensitivity obtained from fundus-controlled MAIA perimetry. We will then compute a laterality index as follows: LIGCCT=(Tc-Ti)/(Tc+Ti) where Tc=thickness in the control lateral OCT quadrant, Ti=thickness in the impaired lateral OCT quadrant. \*\*NOTE: Our protocol allows for a +1 month variance for all timepoints.

    Time frame: baseline, 6 months, 12 months

  6. Optic Tract (OT) laterality

    OT volume analysis will be performed from high resolution structural T1 MRI images of the brain. Mirrored masks of equal size will be hand-drawn over the OTs in each brain slice of a given subject, starting three slices posterior to the optic chiasm and continuing posteriorly until the OTs are no longer distinct from surrounding structures. The volume of each optic tract will be calculated from these masks by first establishing the maximum voxel intensity (range from 0 to 255) across the two OTs, then counting the number of voxels in each OT mask with brightness values between 5 and 85% of this maximum. We will then compute an OT laterality Index (LI85) to represent the relative difference in estimated volume between the two OTs of each participant, where LI85=(OTc-OTi)/(OTc+OTi), where OTc=number of voxels with brightness 5-85% of maximum in the contralesional OT and OTi = number of voxels with brightness 5-85% of maximum in the ipsilesional OT.

    Time frame: baseline, 6 months, 12 months

Other outcomes

  1. MAIA Visual Field Perimetry

    We will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system. These changes will be measured and compared between baseline, 6-months post stroke, and 12 months post stroke.\*\* \*\*NOTE: Our protocol allows for a +1 month variance for all timepoints.

    Time frame: baseline, 6 months, 12 months

  2. Humphrey 10-2 and 24-2 perimetry

    We will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system. These changes will be measured and compared between baseline, 6-months post stroke, and 12 months post stroke.\*\* \*\*NOTE: Our protocol allows for a +1 month variance for all timepoints.

    Time frame: baseline, 6 months, 12 months

  3. Goldmann perimetry

    We 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 we will compare are: 1. I2e 1asb, 0.25 mm\^2 2. I4e 10asb, 0.25 mm\^2 3. V4e 1000asb, 64 mm\^2 These changes will be measured and compared between baseline, 6-months post stroke, and 12 months post stroke.\*\* \*\*NOTE: Our protocol allows for a +1 month variance for all timepoints.

    Time frame: baseline, 6 months, 12 months

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04798924
Responsible party
Krystel Huxlin (James V. Aquavella Professor of Ophthalmology, Associate Chair for Research, Dept. Ophthalmology, University of Rochester) — Principal investigator
First posted
Mar 15, 2021
Start date
Jul 19, 2021
Primary completion
Sep 26, 2025
Completion
Jan 2028 (estimated)
Last update
Dec 3, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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