2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
NCT Number: NCT07244640
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.
Interested in participating?
Request Info40 year–80 year
All sexes
Observational
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
functional optical coherence tomography angiography-retinal neurovascular coupling (fOCTA-rNVC) detection technology
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.
Time frame: At enrollment
The AUC will be computed to evaluate the overall discriminatory power of continuous retinal parameters.
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.
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.
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Clinical Study on Non-Invasive Fundus Retinal Detection Technology for Early Diagnosis of Parkinson's Disease
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.
Published trials that share one or more normalized conditions with this study.
NCT07734181
Basal Ganglia Diseases, Brain Diseases
Arlesheim, Basel-Landschaft, Switzerland
View Trial DetailsNCT07730073
Basal Ganglia Diseases, Brain Diseases
Kâğıthane, Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07630545
Basal Ganglia Diseases, Brain Diseases
Adelaide, Australia
View Trial DetailsNCT07284784
Basal Ganglia Diseases, Brain Diseases
Birmingham, Alabama, United States
View Trial Details