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

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record status
This record was last updated April 14, 2026 (before its estimated April 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov