AOSLO-Based Precise Measurement of Retinal Hemodynamics: Development and Application Assessment

NCT07051317 | Not Yet Recruiting DMC

• 1 other identifier: 2024KYPJ100
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Changes in retinal hemodynamics play a key role in the development of various eye diseases. Currently, mainstream hemodynamic evaluation techniques have low resolution and poor measurement accuracy, limiting their widespread application. Adaptive optical laser scanning ophthalmoscopy (AO-SLO) can capture retinal vascular images at the cellular level, offering the potential for high-precision retinal hemodynamic evaluation. This project will: ① innovate the AO-SLO blood flow imaging scanning module and acquisition mode, develop algorithms for extracting spatiotemporal signal features from blood flow images, and achieve quantitative analysis of retinal hemodynamics based on AO-SLO; ② construct an in vitro retinal hemodynamic measurement simulation eye, conduct multidimensional AO-SLO hemodynamic measurements, and establish an intelligent model for precise calibration of retinal hemodynamic parameters; ③ conduct AO-SLO-based retinal hemodynamic studies in high myopia, integrating multi-modal ophthalmic imaging to investigate the patterns of changes in retinal vascular structure and blood flow function in high myopia. Ultimately, a new precision measurement imaging technology platform for retinal hemodynamics will be established.

Conditions

Myopia, High-Grade; Myopia; Refractive Error

Keywords

Myopia, High-Grade; Adaptive optics; Retinal hemodynamics

Outcome Measures

Primary Outcomes (3)

• Blood flow velocity in the central arteries and veins of the retina

  Measure the blood flow velocity and flow velocity standard deviation of the central arteries and veins of the retina of the subject using an adaptive optical laser scanning ophthalmoscope.

  7 days after the enrollment

• The structure of central retinal arteries and veins

  Measure the diameter of the central arteries and veins of the retina, the thickness of the vessel walls, and the wall-to-lumen ratio of the subjects using an adaptive optics laser scanning ophthalmoscope.

  7 days after the enrollment

• Retinal and choroidal capillary morphological parameters

  Use OCTA to obtain images of superficial and deep capillaries and choroidal capillaries within a 3×3 mm area of the posterior pole of the retina, and use a proprietary algorithm to extract morphological parameters.

  7 days after the enrollment

Secondary Outcomes (5)

• The examination for anterior segment of eyes

  Baseline

• Axis of the eye

  Baseline

• Best corrected vision cutiy

  Baseline

• Intraocular pressure

  Baseline

• Fundus color photography

  Baseline

Study Arms (2)

myopia, low and middle grade

myopia, high grade

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The people From Guangzhou, Guangdong Province, China

You may qualify if:

• Participants must understand the clinical study and voluntarily participate, and sign an informed consent form;
• Age 18-30 years old, no gender restrictions;
• Equivalent spherical power≤0D cylindrical power -2.0D to +2.0D, best-corrected visual acuity ≥ 1.0

You may not qualify if:

• Participants with significant refractive media opacity-related conditions (severe cataracts, vitreous diseases, corneal diseases, etc.) at screening, or unable to complete or cooperate with routine ophthalmic examinations;
• History of or concurrent conditions such as ptosis, nystagmus, diabetic retinopathy, various macular degeneration, retinal vascular diseases, optic nerve inflammatory diseases, primary angle-closure glaucoma, various secondary glaucoma, amblyopia, or severe strabismus
• History of previous eye surgery
• Patients with severe hypertension, diabetes, or other systemic diseases that cause secondary changes in the retina
• Patients with posterior scleral staphyloma, lacquer cracks, choroidal neovascularization, or Fuchs' spots
• Pregnant women, breastfeeding women, monocular individuals, and individuals with disabilities.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 4, 2025
• Study Start: June 25, 2025
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR