NCT07886450Not yet recruiting
Oculomotor-Pupillary AI Biomarkers in Parkinson's
Applied Database Study of Oculomotor-Pupillary Biomarkers Using Edge AI for Clinical Evaluation and Prediction in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 128 (estimated)
- First submitted
- 1 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The Hong Kong Polytechnic University
- Diseases
- Parkinson disease
- NCT number
- NCT07886450
What you commit to
- Study type: Observational
- Planned participants: 128
- From 1 Nov 2026 to the primary completion date, 31 Dec 2027
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Combined with eye diseases that affect eye movement or vision, such as severe cataracts, glaucoma, macular degeneration, oculomotor paralysis, etc.
- Other neurological disorders, such as progressive supranuclear palsy, multiple system atrophy, Huntington's disease, cerebellar disorders, etc.
- Severe mental diseases, such as major depressive disorder or schizophrenia.
Other
- Habitual visual acuity less than 20/63 (LogMAR 0.5) in either eye.
- Illiteracy or severe cognitive dysfunction.
- Unable to cooperate in completing the eye-tracking test.
Who the study is looking for
- PD Group:
- Age ≥ 45 years old.
- Diagnosed with Parkinson's disease (PD) by a neurologist.
- Hoehn-Yahr (H\&Y) is staged as stage 1-3 (early-to-moderate PD).
- Newly diagnosed or drug-naive patients will be given priority, or patients who are already on medication but can stop taking it for at least 12 hours before testing ("Off" status).
- Participants who need to take medication must be accompanied by a caregiver, bring their own medication, and take it immediately after the assessment.
- Informed consent and voluntary participation in this study.
- HC Group:
- Age ≥ 45 years old.
- No history of neurological or mental illness or prodromal symptoms.
- No family history of PD or prodromal symptoms of PD.
- Not taking any medications that may affect eye movement or nervous system function.
- Informed consent and voluntary participation in this study.
Age in the registry: 45 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First affiliated hospital of Henan University of Chinese Medicine Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Hong Kong Polytechnic University Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.