Actively Recruiting
Non-Invasive Fundus Retinal Detection Technology for Early Diagnosis of Parkinson's Disease
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-11-24
200
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
C
College of Optical Science and Engineering, Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of this observational study is to investigate whether non-invasive fundus retinal detection technology can be used for the early diagnosis of parkinson's disease (PD). It aims to answer the following primary questions: the sensitivity and specificity of non-invasive fundus retinal detection technology in the early diagnosis of PD; and whether this technology offers advantages over dopamine transporter positron emission tomography (DAT-PET), a conventional screening method for PD. The researchers will analyze the diagnostic performance of this technology for early-stage PD patients among cohorts including early parkinson's disease, parkinson's syndromes, essential tremor patients, and healthy individuals. Furthermore, in PD patients who concurrently undergo DAT-PET imaging, the study will compare the diagnostic value of non-invasive retinal imaging against that of DAT-PET.
CONDITIONS
Official Title
Non-Invasive Fundus Retinal Detection Technology for Early Diagnosis of Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 80 years
- Parkinson's disease patients meeting 2015 clinical criteria with Hoehn and Yahr stage 1 to 2.5 and disease duration of 5 years or less
- Patients with parkinsonian syndromes meeting diagnostic criteria including progressive supranuclear palsy, dementia with Lewy bodies, corticobasal degeneration, multiple system atrophy (P subtype), or secondary parkinsonism with disease duration of 5 years or less
- Essential tremor patients diagnosed by 2018 criteria without parkinsonian symptoms and disease duration of at least 1 year
- Healthy individuals with no parkinsonian symptoms confirmed by neurological exam and no antipsychotic or dopaminergic medication use in the past 3 months
- All participants must provide written informed consent and agree to follow study procedures
You will not qualify if you...
- Severe eye diseases such as glaucoma, cataract, retinal detachment, or macular degeneration
- Inability to tolerate the non-invasive fundus retinal detection
- Known allergy or high risk of allergy to anti-Parkinson's disease drugs
- Severe cardiovascular or cerebrovascular diseases, liver or kidney dysfunction, cancer, or other conditions affecting prognosis
- Pregnancy or breastfeeding
- Active infectious diseases such as tuberculosis or AIDS, or systemic inflammatory diseases like rheumatoid arthritis
- Presence of psychiatric disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
F
Feng Gao, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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