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NCT Number: NCT07244640

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Feng Gao, MD, PhD

CONTACT

[email protected]

13588451471

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

non-invasive fundus retinal detection

Diagnostic Test

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

Primary outcomes

  1. Sensitivity and specificity of non-invasive fundus retinal detection technology for early parkinson's disease diagnosis

    Time frame: At enrollment

    Sensitivity and specificity will be calculated by comparing the results of non-invasive fundus retinal detection against the clinical diagnostic criteria. Values with 95% confidence intervals will be reported.

  2. Area under the ROC curve (AUC) of retinal parameters for discriminating early parkinson's disease

    Time frame: At enrollment

    The AUC will be computed to evaluate the overall discriminatory power of continuous retinal parameters.

Secondary outcomes

  1. Differential diagnostic accuracy of non-invasive fundus retinal detection technology

    Time frame: At enrollment

    To evaluate the ability of non-invasive fundus retinal detection technology in differentiating among patients with early parkinson's disease, parkinson's syndromes, and essential tremor. Accuracy will be calculated based on the proportion of patients correctly classified into their clinical diagnostic groups (as defined by the international MDS criteria) using retinal parameters.

  2. Comparison of diagnostic accuracy between non-invasive fundus retinal detection technology and DAT-PET in early parkinson's disease

    Time frame: At enrollment

    To evaluate and compare the capability of non-invasive fundus retinal detection technology and dopamine transporter positron emission tomography (DAT-PET) in diagnosing early parkinson's disease, against the clinical diagnostic criteria. Metrics including sensitivity, specificity, AUC, and agreement (e.g., Kappa) will be assessed and compared between the two methods.

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Gao, MD, PhD

CONTACT

[email protected]

13588451471

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • College of Optical Science and Engineering, Zhejiang University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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