Fundus lesions
Conditions
Interventions
Trial Group I (age >= 3 years):Investigational device (MyBright-PEFA-D50-400K) paired with control device (BM-40W Ultra) for crossover evaluation
Trial Group II (age < 3 years):Investigational device (MyBright-PEFA-D50-400K) used alone for evaluation
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients who require posterior segment tomography and posterior segment blood flow imaging for clinical purposes, such as suspected macular lesions, optic nerve lesions, or choroidal neovascularization; 2. The subject or their legal representative voluntarily agrees to participate in this clinical trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals who have undergone photodynamic therapy within the last 48 hours. 2. High-risk groups with heightened sensitivity to the hazards of optical radiation. 3. Individuals unable to undergo fundus imaging due to severe anterior segment diseases. 4. Individuals with a history of significant ocular trauma or surgery that may affect examination results. 5. Individuals suffering from severe systemic diseases (e.g., serious heart, liver, or kidney conditions) that make them unable to tolerate posterior segment optical coherence tomography or posterior segment blood flow imaging examinations. 6. Individuals currently participating in other medical device clinical trials. 7. Other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Image quality consistency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Image quality excellence rate;Repeatability;Ease of Use Score; | — |
Countries
China
Contacts
Public ContactZhong Jie
Sichuan Provincial People's Hospital
Outcome results
None listed