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.
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.
- Conditions
- Myopia, High-Grade, Myopia; Refractive Error
- 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 group | Role | What they receive |
|---|---|---|
| myopia, low and middle grade | Not described | |
| myopia, high grade | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
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
Axis of the eye
Measure the axial length of the subject's eye using the IOL-Master 500
Measured: Baseline
Best corrected vision cutiy
Assess the best corrected vision by subjective refraction
Measured: Baseline
Intraocular pressure
Measure intraocular pressure in both eyes using a non-contact tonometer.
Measured: Baseline
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.
- First posted4 Jul 2025
- Study start25 Jun 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, High-GradeStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Application Evaluation of a Precise and Accurate Measurement Method for Retinal Hemodynamics Based on Adaptive Optics Scanning Laser Ophthalmoscopy (AOSLO)
- ClinicalTrials.gov ID
- NCT07051317
- Acronym / sponsor ID
- 2024KYPJ100
- Conditions
- Myopia, High-Grade, Myopia; Refractive Error
- Keywords
- Myopia, High-Grade, Adaptive optics, Retinal hemodynamics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myopia, low and middle grade | – | – |
| myopia, high grade | – | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The people From Guangzhou, Guangdong Province, China
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood flow velocity in the central arteries and veins of the retina
Time frame: 7 days after the enrollment
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.
The structure of central retinal arteries and veins
Time frame: 7 days after the enrollment
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.
Retinal and choroidal capillary morphological parameters
Time frame: 7 days after the enrollment
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.
5 secondary outcomes
The examination for anterior segment of eyes
Time frame: Baseline
Axis of the eye
Time frame: Baseline
Best corrected vision cutiy
Time frame: Baseline
Intraocular pressure
Time frame: Baseline
Fundus color photography
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
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.