An interventional study of A device providing acoustic real-time biofeedback in Retinal Dystrophies, Geographic Atrophy and Blindness, sponsored by University Medical Center Goettingen. Enrolling by invitation at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by University Medical Center Goettingen · Not applicable, Interventional, and Other
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:
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.
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:
Primary endpoints: Fixation stability (in BCEA and distance from target center), fixation duration, time to fixate. We test fixation in two angles: neutral position (0°) and at 15° eccentricity. We compare three conditions: visual target only, combined visual and auditory feedback, and auditory feedback only.
Secondary endpoints: adaptation and training effects over time, exhaustion measured in a Likert scale. We measure changes of pupil diameter in response to acoustic and visual stimuli. We also compare efficacy between healthy subjects and subjects with fixation loss and compare efficacy between the three conditions.
For the proof-of-concept part of our study, patients are asked to fixate on a target point in a darkened room and keep up fixation for 10 seconds. We record patients eye movements with near-infrared-lighting and a camera. There are three blocks for each condition (visual, auditory, combined), each block consists of 10 trials per eye and per angle. 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, we ask patients for their subjective feedback on which condition was easiest to keep up fixation, whether auditory stimuli were sufficient and open-ended questions on potential improvements of the setup.
An ethics-approved extension phase is planned to further optimize device parameters and assess performance in a clinical setting. We validate the findings of our proof-of-concept study and optimize the device settings by adding the acoustic fixation device to our imaging devices. We will compare the results to answer the question whether the acoustic fixation device will lead to an improved imaging quality and acquisition time.
60 studies on the registry are indexed under Retinal Dystrophies; 20 are open to participants now.
This study's planned enrollment of 22 is above the median of 18 across 34 interventional studies indexed under Retinal Dystrophies.
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Healthy participants:
Patients:
Exclusion Criteria:
Blind participants receive auditory feedback via our acoustic fixation device in three conditions to assess effects on fixation.
Device: A device providing acoustic real-time biofeedback
Healthy participants receive the same auditory feedback via our acoustic fixation device in three conditions to assess effects on fixation.
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.
Also known as: eyeFAST - eye Fixation by Acoustic Stabilization & Tracking
Fixation stability - change from baseline fixation stability recorded without acoustic fixation device compared to fixation stability recorded with acoustic fixation device
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).
Time frame: Day 1
Change in time to achieve fixation over repeated trials
Time required to achieve fixation was assessed across repeated trials to evaluate potential training or adaptation effects. We calculate the time to achieve fixation in seconds across 10 trials per eye per condition per angle. We compare the time to fixate in milliseconds of the first half of trials to the second half of trials.
Time frame: Day 1
Subjective exhaustion rating (Likert scale, 1-10)
We test the subjective exhaustion of each participant after each recording session. We provide a scale from 1-10 (1 being extremely exhausted, 10 being not exhausted at all) for participants to provide subjecte exhaustion feedback.
Time frame: Day 1
Difference in fixation stability (BCEA, time to fixate in ms) between blind and healthy participants across feedback conditions
We compare the efficacy of auditory feedback on fixation stabilty between the healthy and the patient subject group. We also compare the efficacy of the three modalities (combined, auditory and visual) in between groups and within each arm to assess the effect of auditory feedback.
Time frame: Day 1
Correlation between pupil diameter change (mm) and fixation stability (BCEA)
Further, we measure the pupil reaction as changes in pupil diameter (mm) over time (seconds) across different feedback conditions (visual, auditory, combined) and correlate those changes with the achieved fixation stability parameter (BCEA).
Time frame: Day 1
Comparison of fixation stability with clinical and imaging parameters
We further analyse the correlation between achieved fixation stability and clinical parameters (such as visual acuity, age of disease onset, year of diagnosis, clinical and genetic diagnosis) and imaging parameters (presence of EZ in OCT-Scans, thickness of retinal layers, perfusion density, vascular density of deep, intermediate and superficial retinal vascular plexuses in OCTA), fundus autofluorescence, visual field parameters and ophthalmological examination results.
Time frame: Day 1
Plan to share: No
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Started Aug 2025 (actual). Primary completion is estimated for Apr 2026, 7 months after the start.
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University Medical Center Goettingen