Vision Loss PartialNCT05098236
Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage
A study testing Training in the Blind Field and Training in the Sighted Field in people with Vision Loss Partial and Hemianopia, run by University of Rochester at 1 site in United States.
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 17 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision Loss Partial, Hemianopia, Hemianopia Homonymous
- What is being tested?
- Training in the Blind Field and Training in the Sighted Field
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2003to 4 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
Flaum Eye Institute, University of Rochester Medical Center
Rochester, New York, 14642
About this study
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, Training in the Sighted Field
- Medical subject headings
- Hemianopsia, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in the Blind FieldOther
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.
Training in the Sighted FieldOther
This training will take place in lab at the University of Rochester Medical Center. Subject will perform one daily training session, 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 visual field. The computer program will automatically create a record of patient performance during each training session. Subjects will train daily (about 30-40 minutes total), 5 to 7 days per week for at 7 - 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Cortically Blind Subjects | Experimental | Not described Receives: Other: Training in the Blind Field |
| Control | Placebo comparator | Not described Receives: Other: Training in the Sighted Field |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. 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 and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Measured: Baseline, 4-months, 12-months
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. 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 and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Measured: Baseline to 4-months, 12-months
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. 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 and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Measured: Baseline, 4-months, 12-months
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. 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 and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Measured: Baseline, 4-months, 12-months
Secondary outcomes (3)
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-months, then baseline to 12-months from start of training.
Measured: Baseline, 4-months, 12-months
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-months, then baseline to 12-months from start of training.
Measured: Baseline, 4-months, 12-months
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-months, then baseline to 12-months from start of training.
Measured: Baseline, 4-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start26 Sep 2003
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision Loss PartialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Krystel Huxlin, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098236
- Sponsor's protocol ID
- STUDY00000075
- Other IDs
- R01EY027314
- Status last verified
- Aug 2026
- First submitted
- 13 Oct 2021
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage
- ClinicalTrials.gov ID
- NCT05098236
- Acronym / sponsor ID
- STUDY00000075
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 26 Sep 2003 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cortically Blind Subjects | Experimental | Other: Training in the Blind Field |
| Control | Placebo comparator | Other: Training in the Sighted Field |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in the Blind FieldA 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. | Other | Cortically Blind Subjects |
| Training in the Sighted FieldThis training will take place in lab at the University of Rochester Medical Center. Subject will perform one daily training session, 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 visual field. The computer program will automatically create a record of patient performance during each training session. Subjects will train daily (about 30-40 minutes total), 5 to 7 days per week for at 7 - 14 days. | Other | Control |
Primary outcome
Direction Discrimination Threshold
Time frame: Baseline, 4-months, 12-months
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. 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 and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Direction Integration Threshold
Time frame: Baseline to 4-months, 12-months
This will measure the change in 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 and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Contrast Sensitivity for Direction
Time frame: Baseline, 4-months, 12-months
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. 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 and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
Contrast Sensitivity for Static Orientation
Time frame: Baseline, 4-months, 12-months
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. 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 and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.
3 secondary outcomes
Humphrey 10-2 and 24-2 perimetry
Time frame: Baseline, 4-months, 12-months
Goldmann perimetry
Time frame: Baseline, 4-months, 12-months
MAIA Visual Field Perimetry
Time frame: Baseline, 4-months, 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Vision Loss Partial
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Recruiting
Effect of Visual Retraining After Stroke
Vision Loss Partial, Vision; Loss, Both Eyes
RecruitingObservational study
Mechanisms of Visual Restoration After Occipital Stroke
Cortical Blindness, Stroke Ischemic
Recruiting
Vision Loss Impact on Navigation in Virtual Reality
Stroke, Ischemic, Quadrantanopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in the Blind Field and Training in the Sighted Field in people with Vision Loss Partial and Hemianopia, 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?
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: finished, as of the sponsor's last update on 25 Aug 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direction Discrimination Threshold (time frame: Baseline, 4-months, 12-months). The study lists 4 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 25 Aug 2026.