Actively Recruiting

Age: 40Years - 80Years
All Genders
Healthy Volunteers
NCT07244640

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

Age: 40Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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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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