Non-invasive retinal imaging for early diagnosis of Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.