Non-invasive retinal imaging for early diagnosis of Parkinson's disease
Clinical Study on Non-Invasive Fundus Retinal Detection Technology for Early Diagnosis of Parkinson's Disease
This project will test whether a quick, non-invasive eye (fundus) scan can spot early Parkinson's disease in people aged 40–80, including those with early PD, atypical parkinsonism, essential tremor, and healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07244640 on ClinicalTrials.gov |
What this trial studies
This observational study will use non-invasive fundus retinal imaging to look for retinal signs that might indicate early Parkinson's disease. Researchers will enroll cohorts of early PD patients, people with atypical parkinsonian syndromes, essential tremor patients, and healthy controls to compare imaging findings across groups. For participants who also receive DAT-PET, the study will directly compare the diagnostic performance of retinal imaging against DAT-PET, measuring sensitivity and specificity. The team will analyze whether retinal imaging can reliably distinguish early PD from other movement disorders and from healthy aging.
Who should consider this trial
Good fit: Ideal candidates are adults 40–80 years old including people with early-stage Parkinson's disease (≤5 years duration, Hoehn and Yahr 1–2.5), patients with atypical parkinsonism, individuals with essential tremor, and healthy volunteers.
Not a fit: People younger than 40 or older than 80, those with advanced Parkinson's disease, or individuals with significant ocular disease or other conditions that affect the retina may not benefit from this approach.
Why it matters
Potential benefit: If successful, this could provide a faster, cheaper, and non-invasive way to detect Parkinson's disease earlier than current standard methods.
How similar studies have performed: Preliminary studies have reported retinal changes in Parkinson's disease, but using retinal imaging as a diagnostic tool remains experimental and has not yet matched established methods like DAT-PET.
Eligibility criteria
Show full inclusion / exclusion 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 ≤5 years; 3. Parkinson's Syndromes Group: Patients who meet the International Movement Disorder Society diagnostic criteria for atypical parkinson's syndromes (including progressive supranuclear palsy, dementia with Lewy bodies, and corticobasal degeneration), multiple system atrophy (P subtype), or secondary parkinson's syndrome (drug-induced: having taken antipsychotic medications for ≥3 months; vascular: confirmed by brain MRI showing leukoaraiosis/lacunar infarction), with a disease duration of ≤5 years; 4. Essential Tremor Group: Patients who meet the 2018 International Movement Disorder Society clinical diagnostic criteria for essential tremor, with no parkinsonian symptoms, and 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: * 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.
Where this trial is running
Hangzhou, Zhejiang
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Feng Gao, MD, PhD
- Email: 2202012@zju.edu.cn
- Phone: 13588451471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.