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

NCT07244640 RECRUITING

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.

Details

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Status	RECRUITING
Enrolment	200
Start date	2025-11
Completion	2028-12

Conditions

• Parkinson's Disease (PD)

Interventions

• non-invasive fundus retinal detection

Primary outcomes

• Sensitivity and specificity of non-invasive fundus retinal detection technology for early parkinson's disease diagnosis — 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.
• Area under the ROC curve (AUC) of retinal parameters for discriminating early parkinson's disease — At enrollment
  The AUC will be computed to evaluate the overall discriminatory power of continuous retinal parameters.

Countries

China