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Myopia, High-GradeNCT07051317

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

An observational study of Myopia, High-Grade and Myopia; Refractive Error, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Myopia, High-Grade, Myopia; Refractive Error
How many people
120 participants
Where
No sites listed yet
Study dates
25 Jun 2025to 31 Aug 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: The people From Guangzhou, Guangdong Province, China

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

Official title: Establishment and Application Evaluation of a Precise and Accurate Measurement Method for Retinal Hemodynamics Based on Adaptive Optics Scanning Laser Ophthalmoscopy (AOSLO)

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.

Read the detailed description

The retina is the initial site where the eye receives external light and forms vision, and it is also the site where various blinding eye diseases occur. Retinal diseases such as diabetic retinopathy (DR), high myopia-related retinal disease, and age-related macular degeneration (AMD) impose a significant visual burden worldwide. The retinal vascular system is involved in the nutrient supply and waste transport of retinal cells, and the integrity of its structure and function is the foundation for maintaining retinal function. Therefore, assessing changes in retinal blood flow can help understand the mechanisms underlying disease progression, thereby promoting early diagnosis and precise treatment of retinal diseases.

Retinal vessels are the only circulatory system in the human body that can be directly observed, allowing for direct visualization and assessment of changes in hemodynamic characteristics such as retinal vascular blood flow velocity. Traditional fluorescein fundus angiography (FFA) involves intravenous injection of fluorescein to indirectly assess retinal perfusion velocity by observing the distribution of fluorescein in the retinal vascular system over time. However, FFA is an invasive procedure and is not suitable for evaluating early hemodynamic changes.

With the development of ophthalmic imaging technology, new fundus imaging techniques can provide more objective, convenient, and non-invasive tools for measuring blood flow velocity. Currently, mainstream hemodynamic evaluation devices, such as laser Doppler, retinal function imaging (RFI), and laser speckle technology, can quantify parameters such as blood flow velocity, blood flow volume, and vascular resistance by extracting spatiotemporal imaging signals of red blood cell movement or analyzing the optical effects caused by movement. However, these devices are limited in clinical application due to issues such as low resolution, low measurement accuracy, and poor reproducibility.

Adaptive optics (AO) is a technology that corrects aberrations and improves the imaging resolution of optical systems. By combining high-definition fundus scanning with a scanning laser ophthalmoscope (SLO), it is possible to achieve cellular-level resolution imaging and quantitative analysis of retinal vascular structures. By using AO-SLO to collect high spatio-temporal resolution image sequences of retinal vessels, it is possible to establish a novel method for evaluating retinal hemodynamics, enabling precise and stable measurements of blood flow velocity and blood flow volume.

Myopia is a highly prevalent eye disease worldwide, with an estimated prevalence exceeding 50% by 2050. Compared to moderate and low myopia, high myopia significantly increases the incidence of macular degeneration and glaucoma. The exact mechanisms underlying the pathological changes in high myopia remain controversial, but increasing evidence suggests that blood flow alterations may be a key pathological mechanism in high myopia-related retinal diseases. Due to the lack of objective evaluation methods, the patterns of hemodynamic changes in high myopia remain unclear. In summary, there is currently a lack of objective, precise hemodynamic quantification assessment tools in ophthalmic clinical practice. Developing a novel retinal hemodynamic imaging assessment model based on AO-SLO, establishing precise hemodynamic measurement methods, and achieving real-time, non-invasive, high-resolution imaging and quantitative analysis of retinal blood flow in living human eyes will provide important imaging evidence for the early diagnosis of retinal diseases such as high myopia-related retinal lesions.

This project will Innovate the AO-SLO blood flow imaging scanning module and acquisition mode, develop algorithms for extracting spatio-temporal signal features from blood flow images, and achieve quantitative analysis of retinal hemodynamics based on AO-SLO; construct an in vitro retinal hemodynamic measurement simulation eye, conduct multi-dimensional AO-SLO hemodynamic measurements, and establish an intelligent model for precise calibration of retinal hemodynamic parameters; 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.

This study will analyze the following indicators: retinal blood flow velocity, flow velocity standard deviation, flow rate, vessel diameter, lumen diameter, wall thickness, wall-to-lumen ratio, vascular density, diameter, and tortuosity measurements in participants with high myopia and non-high myopia one week after enrollment. Quantitative data will be described using mean ± standard deviation (M±SD), and differences between the two groups will be analyzed, along with correlation analysis.

Keywords
Myopia, High-Grade, Adaptive optics, Retinal hemodynamics
Medical subject headings
Myopia, Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07051317
Study groupRoleWhat they receive
myopia, low and middle gradeNot described
myopia, high gradeNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 days after the enrollment

  2. 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.

    Measured: 7 days after the enrollment

  3. 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.

    Measured: 7 days after the enrollment

Secondary outcomes (5)
  1. The examination for anterior segment of eyes

    Use a slit lamp microscope to examine the cornea, conjunctiva, anterior chamber, lens, and other anterior structures of the anterior segment of the eye

    Measured: Baseline

  2. Axis of the eye

    Measure the axial length of the subject's eye using the IOL-Master 500

    Measured: Baseline

  3. Best corrected vision cutiy

    Assess the best corrected vision by subjective refraction

    Measured: Baseline

  4. Intraocular pressure

    Measure intraocular pressure in both eyes using a non-contact tonometer.

    Measured: Baseline

  5. Fundus color photography

    Using non-mydriatic fundus photography to obtain images of the posterior pole of the retina

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2025
  2. Study start25 Jun 2025 (estimated)
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07051317
Sponsor's protocol ID
2024KYPJ100
Status last verified
Feb 2025
First submitted
18 Jun 2025
Last updated
4 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Myopia, High-Grade and Myopia; Refractive Error, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood flow velocity in the central arteries and veins of the retina (time frame: 7 days after the enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.

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