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Clinical Study on Non-Invasive Fundus Retinal Detection Technology for Early Diagnosis of Parkinson's Disease

Clinical Study on Non-Invasive Fundus Retinal Detection Technology for Early Diagnosis of Parkinson's Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118826
Enrollment
Unknown
Registered
2026-02-11
Start date
2025-11-25
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

Gold Standard:2015 International Movement Disorder Society clinical diagnostic criteria for parkinson's disease
Index test:non-invasive fundus retinal detection technology (functional optical coherence tomography angiography-retinal neurovascular coupling (fOCTA-rNVC) detection technology)

Sponsors

The second affiliated hospital of Zhejiang University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 40-80 years; 2. Parkinson's Disease Group: Patients who meet the 2015 International Movement Disorder Society clinical diagnostic criteria for Parkinson's disease, with a Hoehn and Yahr stage of 1 to 2.5 and a disease duration of =3 months; vascular: confirmed by brain MRI showing leukoaraiosis/lacunar infarction), with a disease duration of =1 year; 5. Healthy Control Group: Individuals with no parkinsonian symptoms (confirmed by neurological examination) and no use of antipsychotic/dopaminergic medications in the past 3 months; 6. All subjects have provided written informed consent and are willing to comply with the study procedures;

Exclusion criteria

Exclusion criteria: 1. Presence of severe ocular fundus diseases, such as glaucoma, cataract, retinal detachment, macular degeneration, etc; 2. Inability to tolerate the non-invasive fundus retinal detection; 3. Known allergy or investigator-suspected high risk of allergy to anti-PD drugs; 4. Presence of severe cardiovascular or cerebrovascular diseases (e.g., coronary heart disease, myocardial infarction, stroke, etc.), hepatic or renal dysfunction, cancer, or other conditions that may affect the prognosis; 5. Pregnancy or lactation; 6. Presence of active infectious diseases (e.g., tuberculosis, AIDS) or systemic inflammatory diseases (e.g., rheumatoid arthritis); 7. Presence of psychiatric disorders;

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;Area under the receiver operating characteristic curve (AUC);

Countries

China

Contacts

Public ContactFeng Gao

The second affiliated hospital of Zhejiang University school of medicine

2202012@zju.edu.cn+86 571 87784710

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026