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

NCT ID: NCT07244640

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-12-31

Brief Summary

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

Parkinson's Disease (PD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Parkinson's Syndromes

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.

non-invasive fundus retinal detection

Intervention Type: DIAGNOSTIC_TEST

functional optical coherence tomography angiography-retinal neurovascular coupling (fOCTA-rNVC) detection technology

Essential Tremor

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.

non-invasive fundus retinal detection

Intervention Type: DIAGNOSTIC_TEST

functional optical coherence tomography angiography-retinal neurovascular coupling (fOCTA-rNVC) detection technology

Healthy Control

Individuals with no parkinsonian symptoms (confirmed by neurological examination) and no use of antipsychotic/dopaminergic medications in the past 3 months.

non-invasive fundus retinal detection

Intervention Type: DIAGNOSTIC_TEST

functional optical coherence tomography angiography-retinal neurovascular coupling (fOCTA-rNVC) detection technology

Parkinson's Disease

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.

non-invasive fundus retinal detection

Intervention Type: DIAGNOSTIC_TEST

functional optical coherence tomography angiography-retinal neurovascular coupling (fOCTA-rNVC) detection technology

Interventions

non-invasive fundus retinal detection

functional optical coherence tomography angiography-retinal neurovascular coupling (fOCTA-rNVC) detection technology

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

College of Optical Science and Engineering, Zhejiang University

UNKNOWN

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Gao, MD, PhD

Role: CONTACT

2202012@zju.edu.cn

13588451471

Facility Contacts

Feng Gao, MD, PhD

Role: primary

2202012@zju.edu.cn

13588451471

Other Identifiers

20251675

Identifier Type: -

Identifier Source: org_study_id