Hemianopia, HomonymousNCT06638619
Comparative Efficacy of Saccadic and Biofeedback Training in Homonymous Hemianopia
A study testing Biofeedback Fixation Training and Saccadic Reading Training in people with Hemianopia, Homonymous, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This pilot study aims to understand how eye movements change in people with vision loss from stroke after completing one of two types of training. The study will look at how eye movements and reading performance change after training. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hemianopia, Homonymous
- What is being tested?
- Biofeedback Fixation Training and Saccadic Reading Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2027to Dec 2027
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stroke
- Presence of hemianopia with central vision involvement
- Stroke occurred at least 6-months before enrollment
Who cannot join
- Presence of hemianopia with macular sparing
- Diagnosis of hemispatial neglect
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Saccadic and Biofeedback Training in Homonymous Hemianopia: A Comprehensive Eye Movement Pilot Study
This pilot study aims to understand how eye movements change in people with vision loss from stroke after completing one of two types of training. The study will look at how eye movements and reading performance change after training. Researchers will compare the results of two groups: one group will complete five clinical training sessions using an eye-tracking machine for 30 minutes each, while the other group will do at-home reading exercises for 20 minutes a day, 5 days a week, for 6 weeks. The goal is to see if there is a difference in performance between the two types of training.
- Conditions
- Hemianopia, Homonymous
- Being tested
- Biofeedback Fixation Training, Saccadic Reading Training
- Keywords
- stroke, vision, hemianopia
- Medical subject headings
- Hemianopsia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback Fixation TrainingBehavioural
This training type involves the use of microperimetry. Microperimetry is a visual field test that incorporates perimetry and retinal imaging and is a standard ophthalmic clinical technology. It allows for direct observation of the fundus, but uses an eye-tracking system to compensate for involuntary eye movements. A program designed to train patients to direct and hold their gaze at an eccentric location programmed by the controller will be used. When the participant directs their gaze towards the pre-programmed location, a sound of increasing frequency is emitted to let them know they are approaching the correct location. The sound stabilizes into a solid tone when the patient is gazing directly at the trained location (biofeedback) and they are asked to attempt to hold their gaze at this location for as long as possible.
Saccadic Reading TrainingBehavioural
Participants will be assigned to participate in an at-home reading program. The reading exercises consist of worksheets with letter and number combinations of increasing complexity and font sizes. They are intended to increase accuracy in identifying letters and numbers. Worksheets will initially be dispensed with larger font type and spacing and be graded at weekly intervals towards regular, newspaper-size print and spacing over the course of training.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback Fixation Arm | Experimental | Biofeedback training is a mind-body therapy that helps people learn to control their involuntary bodily functions, such as eye movements. The goal is to improve eye movement control to improve gaze stability. Receives: Behavioral: Biofeedback Fixation Training |
| Saccadic Reading Arm | Active comparator | Saccadic reading training helps people to learn to control their involuntary eye movements. The goal is to improve eye movement control to improve saccadic and fixational behaviors during reading activities. Receives: Behavioral: Saccadic Reading Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oculomotor Metrics
Participants will be asked to read aloud a series of sentences presented on a display. Eye movements will be recorded in real-time using an Eye-Link 1000 infrared eye-tracking camera, as the patient is reading what is on the display. The primary outcome measure will be the first saccade landing location.
Measured: Pre-training and at 6-weeks.
Secondary outcomes (1)
Pepper Visual Skills Reading Test (VSRST)
A clinical reading assessment used in low vision settings to assess for common patterns of reading errors (misidentifications, skipped letters or words, skipped lines). The participant reads aloud lines of text (random letters and words of increasing complexity and decreasing line spacing.
Measured: Pre-training and at 6-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study startJun 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemianopia, HomonymousStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Eugene Vice, University of Alabama at Birmingham
- Investigators
- Jason Vice, Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638619
- Sponsor's protocol ID
- IRB-300013228
- Other IDs
- 000
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Saccadic and Biofeedback Training in Homonymous Hemianopia: A Comprehensive Eye Movement Pilot Study
- ClinicalTrials.gov ID
- NCT06638619
- Acronym / sponsor ID
- IRB-300013228
- Conditions
- Hemianopia, Homonymous
- Keywords
- stroke, vision, hemianopia
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: funding
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jun 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Oct 2024 (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 pilot study aims to understand how eye movements change in people with vision loss from stroke after completing one of two types of training. The study will look at how eye movements and reading performance change after training. Researchers will compare the results of two groups: one group will complete five clinical training sessions using an eye-tracking machine for 30 minutes each, while the other group will do at-home reading exercises for 20 minutes a day, 5 days a week, for 6 weeks. The goal is to see if there is a difference in performance between the two types of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback Fixation Arm | Experimental | Behavioral: Biofeedback Fixation TrainingBiofeedback training is a mind-body therapy that helps people learn to control their involuntary bodily functions, such as eye movements. The goal is to improve eye movement control to improve gaze stability. |
| Saccadic Reading Arm | Active comparator | Behavioral: Saccadic Reading TrainingSaccadic reading training helps people to learn to control their involuntary eye movements. The goal is to improve eye movement control to improve saccadic and fixational behaviors during reading activities. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of stroke
- Presence of hemianopia with central vision involvement
- Stroke occurred at least 6-months before enrollment
Key exclusion criteria (2 listed)
- Presence of hemianopia with macular sparing
- Diagnosis of hemispatial neglect
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 |
|---|---|---|
| Biofeedback Fixation TrainingThis training type involves the use of microperimetry. Microperimetry is a visual field test that incorporates perimetry and retinal imaging and is a standard ophthalmic clinical technology. It allows for direct observation of the fundus, but uses an eye-tracking system to compensate for involuntary eye movements. A program designed to train patients to direct and hold their gaze at an eccentric location programmed by the controller will be used. When the participant directs their gaze towards the pre-programmed location, a sound of increasing frequency is emitted to let them know they are approaching the correct location. The sound stabilizes into a solid tone when the patient is gazing directly at the trained location (biofeedback) and they are asked to attempt to hold their gaze at this location for as long as possible. | Behavioural | Biofeedback Fixation Arm |
| Saccadic Reading TrainingParticipants will be assigned to participate in an at-home reading program. The reading exercises consist of worksheets with letter and number combinations of increasing complexity and font sizes. They are intended to increase accuracy in identifying letters and numbers. Worksheets will initially be dispensed with larger font type and spacing and be graded at weekly intervals towards regular, newspaper-size print and spacing over the course of training. | Behavioural | Saccadic Reading Arm |
Primary outcome
Oculomotor Metrics
Time frame: Pre-training and at 6-weeks.
Participants will be asked to read aloud a series of sentences presented on a display. Eye movements will be recorded in real-time using an Eye-Link 1000 infrared eye-tracking camera, as the patient is reading what is on the display. The primary outcome measure will be the first saccade landing location.
1 secondary outcome
Pepper Visual Skills Reading Test (VSRST)
Time frame: Pre-training and at 6-weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Statistical Learning as a Novel Intervention for Cortical Blindness
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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.
Jason Vice, Ph.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback Fixation Training and Saccadic Reading Training in people with Hemianopia, Homonymous, run by University of Alabama at Birmingham 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 3 inclusion and 2 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: paused, as of the sponsor's last update on 25 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?
Results are not available in the source record.
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?
Oculomotor Metrics (time frame: Pre-training and at 6-weeks.). 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 Sep 2026.