non-invasive fundus retinal detect… for Parkinson's (NCT07244640)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 3 years and 1 month.
- 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.
- 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.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.