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

NCT07529041 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-04-14

No results posted yet for this 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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • EKFZ Else Kroener Fresenius Center for Optogenetic Therapies

    collaborator UNKNOWN

  • University Medical Center Goettingen

    lead OTHER

Principal Investigators

  • Dorothea S Laurence, MD · University Medical Center Goettingen

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-27
Primary Completion
2026-04-15
Completion
2026-05-15

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07529041 on ClinicalTrials.gov