Real-time Acoustic Biofeedback for Enhancing Fixation Stability: A Proof-of-concept Study to Improve Ophthalmic Imaging Diagnostic Quality

Condition(s) studied

Investigational drug(s) / intervention(s)

A device providing acoustic real-time biofeedback: We use a camera and an eye tracking software, linked with our spatial-audio mapping tool. Participants receive real-time audio feedback on the location of their gaze. Negative feedback sounds are encoded to convey distance and direction of the deviation from the center. When the patients fixate on the target area, they receive a positive feedback sound.

Study summary

The goal of this Proof of Concept Feasibility Study is to improve the fixation stability in patients with fixation loss due to blindness or central vision loss using a patented acoustic real-time feedback device. The main questions it aims to answer are:

1. Fixation guidance - can real-time acoustic biofeedback improve the fixation in healthy patients as well as patients with fixation loss?
2. Optimization of fixation guidance - testing of different stimuli to optimize an acoustic training protocol.
3. Optimization of imaging acquisition - testing improvement of both imaging quality and acquisition time using the acoustic feedback tool.

For the proof-of-concept-study, patients are asked to fixate on a target point in a darkened room and keep up the fixation. We record patients eye movements with near-infrared-lighting and a camera. Fixation is tested in three conditions - visual target only, auditory feedback only, and visual target followed by auditory feedback. In between each set of trials, patients are asked to rate their subjective exhaustion on a Likert scale. At the end of each recording session, patients are handed a questionnaire for feedback on our proof-of-concept study and device settings.

An ethics-approved extension phase is planned to further optimize device parameters and assess performance in a clinical setting.

Eligibility

Primary outcome measure(s)

• Fixation stability - change from baseline fixation stability recorded without acoustic fixation device compared to fixation stability recorded with acoustic fixation device — Day 1
  In Phase A, we analyse the fixation stability as the distance from the target center (Median \[IQR\]), duration of fixation and time to achieve stable fixation (latency). We also use posthoc video analysis to generate the BCEA as a measure of fixation stability in each condition and each angle (0 and 15 degrees).

Trial sites (1)

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