Retinal imaging detects early Parkinson
- Trial ID
- NCT07244640
- Official Title
- Clinical Study on Non-Invasive Fundus Retinal Detection Technology for Early Diagnosis of Parkinson's Disease
- Goal
- Retinal imaging detects early Parkinson
- Status
- RECRUITING
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study Type
- OBSERVATIONAL
- Enrollment
- 200 participants
- Conditions
- Parkinson's Disease (PD)
- Interventions
- non-invasive fundus retinal detection
Summary For Families
They want to find eye-based signs that could help detect Parkinson's disease earlier by comparing retinal images from people with early PD, atypical parkinsonism, essential tremor, and healthy volunteers. The approach uses non-invasive fundus retinal imaging to take detailed photos of the back of the eye, looking for changes in retinal nerve layers or blood vessel patterns that might correlate with Parkinson's, so no injections or surgery are involved. The study is enrolling people aged 40 to 80, including Parkinson's patients diagnosed within five years at Hoehn and Yahr stage 1 to 2.5, people with atypical or secondary parkinsonism within five years, people with essential tremor, and healthy controls. People with severe eye disease, major heart/liver/kidney problems, active infections or systemic inflammatory diseases, pregnancy, inability to tolerate the imaging, or significant psychiatric disorders are excluded.
Locations
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying non-invasive fundus retinal detection. They want to find eye-based signs that could help detect Parkinson's disease earlier by comparing retinal images from people with early PD, atypical parkinsonism, essential tremor, and healthy volunteers. The approach uses non-invasive fundus retinal imaging to take detailed photos of the back of the eye, looking for changes in retinal nerve layers or blood vessel patterns that might correlate with Parkinson's, so no injections or surgery are involved. The study is enrolling people aged 40 to 80, including Parkinson's patients diagnosed within five years at Hoehn and Yahr stage 1 to 2.5, people with atypical or secondary parkinsonism within five years, people with essential tremor, and healthy controls. People with severe eye disease, major heart/liver/kidney problems, active infections or systemic inflammatory diseases, pregnancy, inability to tolerate the imaging, or significant psychiatric disorders are excluded.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 3 years and 1 month.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.