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

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.

NCT Number	NCT07529041
Lead Sponsor	University Medical Center Goettingen Collaborators: Else Kröner Fresenius Foundation
Conditions	Retinal Dystrophies, Geographic Atrophy, Blindness
Enrollment	22 participants
Start Date	2025-08-27
Primary Completion	2026-04-15 (estimated)
Study Completion	2026-05-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-14