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NCT07886450

Oculomotor-Pupillary AI Biomarkers in Parkinson's

Sponsor: The Hong Kong Polytechnic University

View on ClinicalTrials.gov

Summary

The goal of this prospective observational study is to investigate whether oculomotor-pupillary abnormalities detected using a novel edge-AI eye-tracking device can serve as objective and quantitative biomarkers for the early screening and clinical evaluation of Parkinson's disease (PD). The study will include individuals with early-to-moderate PD and healthy controls. The main question it aims to answer is: Can oculomotor-pupillary abnormalities detected by a novel edge-AI eye-tracking device serve as objective and quantitative biomarkers for the early screening of Parkinson's disease? Researchers will compare oculomotor-pupillary parameters between participants with PD and healthy controls and evaluate the ability of these parameters to distinguish PD from healthy controls. Participants with PD will also be followed for 12 months to assess longitudinal changes in eye-tracking measures and their associations with clinical changes. Participants will: 1. Complete standardized eye-tracking tasks to assess oculomotor and pupillary function using the study eye-tracking device. 2. Undergo clinical assessments of motor function, cognitive function, and non-motor symptoms. 3. For participants with PD, attend follow-up assessments over 12 months to evaluate changes in eye-tracking and clinical measures. The study will also evaluate the feasibility and clinical application of the independently developed edge-AI eye-tracking system and develop and validate lightweight real-time models for PD classification and prediction of disease progression.

Official title: Applied Database Study of Oculomotor-Pupillary Biomarkers Using Edge AI for Clinical Evaluation and Prediction in Parkinson's Disease

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

OBSERVATIONAL

Enrollment

128

Start Date

2026-11-01

Completion Date

2027-12-31

Last Updated

2026-10-21

Healthy Volunteers

Yes

Interventions

DEVICE

Edge-AI Eye-Tracking Assessment

Participants will undergo standardized oculomotor and pupillary assessments using the study-developed edge-AI eye-tracking device. The assessment includes standardized visual tasks designed to evaluate fixation, saccadic eye movements, smooth pursuit, and pupillary responses. Eye movement and pupil data will be recorded and analyzed to identify oculomotor-pupillary biomarkers associated with Parkinson's disease. The device is used for research assessment only and does not alter participants' routine clinical treatment.

Locations (2)

First affiliated hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong