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Ensaio clínico

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

NCT: NCT07529041 · ENROLLING_BY_INVITATION

ID NCTNCT07529041
EstadoENROLLING_BY_INVITATION
Data de início2025-08-27
Conclusão2026-05-15

Resumo breve

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.

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