Comparative Efficacy of Saccadic and Biofeedback Training in Homonymous Hemianopia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemianopia, Homonymous
• Intervention / Treatment: Behavioral: Biofeedback Fixation Training; Behavioral: Saccadic Reading Training

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason Vice, Ph.D.; Phone Number: 205-996-1374; Email: jasonvice@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of stroke
• Presence of hemianopia with central vision involvement
• Stroke occurred at least 6-months before enrollment

Exclusion Criteria:

• Presence of hemianopia with macular sparing
• Diagnosis of hemispatial neglect

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biofeedback Fixation Arm; 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.	Behavioral: Biofeedback Fixation Training; 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.
Active Comparator: Saccadic Reading Arm; 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.	Behavioral: Saccadic Reading Training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-training and at 6-weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-training and at 6-weeks.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Jason Vice, Ph.D., University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: stroke; vision; hemianopia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Blindness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Hemianopsia
• Other Study ID Numbers: IRB-300013228; 000 (Other Identifier: CTGTY)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No