Comparative Efficacy of Saccadic and Biofeedback Training in Homonymous Hemianopia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of stroke

Presence of hemianopia with central vision involvement

Stroke occurred at least 6-months before enrollment

Disqualifiers

Presence of hemianopia with macular sparing

Diagnosis of hemispatial neglect

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biofeedback Fixation Training

    Behavioral

    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 Training

    Behavioral

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Biofeedback Fixation ArmExperimental treatment 1 intervention
Group B: Saccadic Reading ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
Pre-training and at 6-weeks.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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