PARKINSON DISEASE (Disorder)NCT07886450
Oculomotor-Pupillary AI Biomarkers in Parkinson's
An observational study of PARKINSON DISEASE (Disorder), run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Edge-AI Eye-Tracking Assessment
- Type of treatment
- Medical device
- How many people
- 128 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2026to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adults aged 45 years or older, including participants with early-to-moderate Parkinson's disease and age-comparable healthy controls. Participants with Parkinson's disease will be recruited from clinical populations and will undergo baseline eye-tracking and clinical assessments followed by longitudinal assessments over 12 months. Healthy controls without Parkinson's disease or other major neurological disorders will undergo baseline assessments for comparison with the Parkinson's disease group. All participants must be able to complete the required eye-tracking tasks and clinical assessments.
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- Habitual visual acuity less than 20/63 (LogMAR 0.5) in either eye.
- 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.
- Illiteracy or severe cognitive dysfunction.
- Severe mental diseases, such as major depressive disorder or schizophrenia.
- Unable to cooperate in completing the eye-tracking test.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
China1 site
First affiliated hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450000
Yanxian CHEN, +852 27666111, yan-xian.chen@polyu.edu.hk
Hong Kong1 site
Hong Kong Polytechnic University
Hong Kong, Hong Kong
Yanxian CHEN, +852 27666111, yan-xian.chen@polyu.edu.hk
About this study
Official title: Applied Database Study of Oculomotor-Pupillary Biomarkers Using Edge AI for Clinical Evaluation and Prediction in Parkinson's Disease
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?
Read more
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:
- Complete standardized eye-tracking tasks to assess oculomotor and pupillary function using the study eye-tracking device.
- Undergo clinical assessments of motor function, cognitive function, and non-motor symptoms.
- 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.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Edge-AI Eye-Tracking Assessment
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edge-AI Eye-Tracking AssessmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease Group | Not described Receives: Device: Edge-AI Eye-Tracking Assessment | |
| Healthy Control Group | Not described Receives: Device: Edge-AI Eye-Tracking Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in mean prosaccade gain between early-to-moderate PD patients and healthy controls.
Prosaccade gain is defined as the ratio of the primary saccade amplitude to the target displacement amplitude, measured using a head-mounted infrared eye-tracking device. The mean gain across valid trials will be calculated for each participant. Mean prosaccade gain will be compared between patients with early-to-moderate PD and healthy controls.
Measured: Baseline
Differences in antisaccade directional error rate between early-to-moderate PD patients and healthy controls.
Antisaccade directional error rate is defined as the percentage of valid antisaccade trials in which the initial saccade is incorrectly directed toward the visual target rather than in the opposite direction, measured using a head-mounted infrared eye-tracking device. The error rate will be calculated for each participant as the number of directional error trials divided by the total number of valid antisaccade trials, multiplied by 100. Antisaccade directional error rate will be compared between patients with early-to-moderate PD and healthy controls.
Measured: Baseline
Differences in mean prosaccade peak velocity between early-to-moderate PD patients and healthy controls.
Prosaccade peak velocity is defined as the maximum angular eye velocity during the primary prosaccade, measured in degrees per second (°/s) using a head-mounted infrared eye-tracking device. The mean peak velocity across valid trials will be calculated for each participant. Mean prosaccade peak velocity will be compared between patients with early-to-moderate PD and healthy controls.
Measured: Baseline
Secondary outcomes (3)
Correlation Between Changes in Prosaccade Gain and MDS-UPDRS Part III Scores Over 12 Months
The correlation between changes in mean prosaccade gain and changes in motor symptom severity will be assessed in patients with PD over 12 months. Mean prosaccade gain will be measured using a head-mounted infrared eye-tracking device, while motor symptom severity will be assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). Changes in both measures will be calculated from baseline to 12 months, and their association will be quantified using a correlation coefficient (r).
Measured: Baseline to 12 months
Correlation Between Changes in Antisaccade Directional Error Rate and MoCA Scores Over 12 Months
The correlation between changes in antisaccade directional error rate and changes in cognitive function will be assessed in patients with PD over 12 months. Antisaccade directional error rate is defined as the percentage of valid antisaccade trials in which the initial saccade is incorrectly directed toward the visual target, measured using a head-mounted infrared eye-tracking device. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). Changes in both measures from baseline to 12 months will be calculated, and their association will be quantified using a correlation coefficient (r).
Measured: Baseline to 12 months
Area Under the Receiver Operating Characteristic Curve (AUC) for PD Classification
The diagnostic performance of an edge-AI model based on oculomotor-pupillary features measured using a head-mounted infrared eye-tracking device will be evaluated for distinguishing patients with PD from healthy controls. Model performance will be assessed using AUC, with values ranging from 0 to 1, where higher values indicate better discriminative performance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886450
- Sponsor's protocol ID
- HSEARS20251219006
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applied Database Study of Oculomotor-Pupillary Biomarkers Using Edge AI for Clinical Evaluation and Prediction in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07886450
- Acronym / sponsor ID
- HSEARS20251219006
- Conditions
- PARKINSON DISEASE (Disorder)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Complete standardized eye-tracking tasks to assess oculomotor and pupillary function using the study eye-tracking device.
- Undergo clinical assessments of motor function, cognitive function, and non-motor symptoms.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease Group | – | Device: Edge-AI Eye-Tracking Assessment |
| Healthy Control Group | – | Device: Edge-AI Eye-Tracking Assessment |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults aged 45 years or older, including participants with early-to-moderate Parkinson's disease and age-comparable healthy controls. Participants with Parkinson's disease will be recruited from clinical populations and will undergo baseline eye-tracking and clinical assessments followed by longitudinal assessments over 12 months. Healthy controls without Parkinson's disease or other major neurological disorders will undergo baseline assessments for comparison with the Parkinson's disease group. All participants must be able to complete the required eye-tracking tasks and clinical assessments.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (6 listed)
- Habitual visual acuity less than 20/63 (LogMAR 0.5) in either eye.
- 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.
- Illiteracy or severe cognitive dysfunction.
- Severe mental diseases, such as major depressive disorder or schizophrenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edge-AI Eye-Tracking AssessmentParticipants 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. | Device | Healthy Control Group, Parkinson's Disease Group |
Primary outcome
Differences in mean prosaccade gain between early-to-moderate PD patients and healthy controls.
Time frame: Baseline
Prosaccade gain is defined as the ratio of the primary saccade amplitude to the target displacement amplitude, measured using a head-mounted infrared eye-tracking device. The mean gain across valid trials will be calculated for each participant. Mean prosaccade gain will be compared between patients with early-to-moderate PD and healthy controls.
Differences in antisaccade directional error rate between early-to-moderate PD patients and healthy controls.
Time frame: Baseline
Antisaccade directional error rate is defined as the percentage of valid antisaccade trials in which the initial saccade is incorrectly directed toward the visual target rather than in the opposite direction, measured using a head-mounted infrared eye-tracking device. The error rate will be calculated for each participant as the number of directional error trials divided by the total number of valid antisaccade trials, multiplied by 100. Antisaccade directional error rate will be compared between patients with early-to-moderate PD and healthy controls.
Differences in mean prosaccade peak velocity between early-to-moderate PD patients and healthy controls.
Time frame: Baseline
Prosaccade peak velocity is defined as the maximum angular eye velocity during the primary prosaccade, measured in degrees per second (°/s) using a head-mounted infrared eye-tracking device. The mean peak velocity across valid trials will be calculated for each participant. Mean prosaccade peak velocity will be compared between patients with early-to-moderate PD and healthy controls.
3 secondary outcomes
Correlation Between Changes in Prosaccade Gain and MDS-UPDRS Part III Scores Over 12 Months
Time frame: Baseline to 12 months
Correlation Between Changes in Antisaccade Directional Error Rate and MoCA Scores Over 12 Months
Time frame: Baseline to 12 months
Area Under the Receiver Operating Characteristic Curve (AUC) for PD Classification
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
First affiliated hospital of Henan University of Chinese Medicine
Zhengzhou, China
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PARKINSON DISEASE (Disorder), run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in mean prosaccade gain between early-to-moderate PD patients and healthy controls. (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.