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
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