MyopiaNCT06587776
Investigation of the Regulation of Retinal and Choroidal Blood Vessels in Various AL Based on WF SS-OCTA Detection With Changes in Body Position
An observational study of Myopia, run by Science and Technology Department of Sichuan Province.
Trial summary
This prospective observational study aims to understand the effects of different subaxial body positions on choroidal and retinal blood vessel density. The main questions it aims to answer are as follows:1) How do retinal and choroidal blood vessels adjust and repair after changes in body position?2) Is the change of… Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Myopia
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 to 40 years
- All sexes
- Child, Adult
Study population: Healthy people in Chengdu City will be recruited through advertisement, and those who meet the inclusion and exclusion criteria will enter the study.
Who may be able to join
- Corrected visual acuity ≥1.0 (international standard visual acuity chart);
- Age 10-40 years old;
- In good health;
- Give informed consent and volunteer for the study. The process of obtaining informed consent complies with GCP regulations.
Who cannot join
- Can not cooperate with the completion of relevant inspection and data collection;
- Pregnant and lactating women;
- Patients with amblyopia, glaucoma, retinitis pigmentosa, senile macular degeneration, retinal artery obstruction, retinal vein obstruction, diabetic retinopathy and other eye diseases that may affect the blood circulation and vascular diameter of the retina and vein, or those who have undergone intraocular surgery;
- Patients with cardiovascular and cerebrovascular diseases, endocrine diseases, autoimmune diseases;
- Long history of smoking and drinking;
- History of ocular trauma;
- The mentally ill;
- Those who have taken drugs that affect blood circulation in the past 3 months;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of the Regulation of Retinal and Choroidal Blood Vessels in Various Ocular Axes Lengths Based on Ultra-widefield Swept-source Optical Coherence Tomography Angiography Detection With Changes in Body Position
This prospective observational study aims to understand the effects of different subaxial body positions on choroidal and retinal blood vessel density. The main questions it aims to answer are as follows:1) How do retinal and choroidal blood vessels adjust and repair after changes in body position?2) Is the change of body position related to the factors that cause myopia？ 3) Are there any differences in the regulation ability of fundus blood vessels in people with different ocular axes under the condition of changes in body position?
Read the detailed description
This project will use the wide field swept-source optical coherence tomography angiography, combined with data analysis and mining methods, to explore the self-adjustment and change mode and mechanism of retinal and choroidal blood vessels in the case of posture changes in an all-round and multi-angle way. There would be three kinds of postural changes, one is 15° head-up position, one is supine position, and the other is 15° head-down position. Relevant ophthalmological measurements would be performed before and after the postural changes. The objective is to discover the three-dimensional change mode of retinal and choroid blood vessels in different postures and compare the differences among people with different lengths of ocular axes, and to elucidate the relationship between the mode and ability of retinal and choroidal blood vessels to adjust and repair changes after changes in body position and myopia, to provide more ideas and objective basis for the occurrence and development of myopia, and lay a foundation for further research. It is of great significance to innovate the pathogenesis of myopia, deepen the theoretical understanding, and guide the prevention and control of myopia.
- Conditions
- Myopia
- Medical subject headings
- Myopia
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 |
|---|---|---|
| Normal axial length grooup | At the screening stage, the axial length of the subjects was measured by IOL master 700. If the other conditions were met, the subjects would be included in this group If the axial length is between 23mm and 24mm. | |
| Long axial group | At the screening stage, the axial length of the subjects was measured by IOL master 700. If the other conditions were met, the subjects would be included in this group if the axial length is greater than 24mm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal blood flow density
Two modes of SS-OCTA will be used for scanning, one is the wide-angle range of 24mm*20mm grid for quantitative analysis of choroidal and retinal vascular density. The other is a scanning range of 12mm*12mm mode, and the choroidal thickness, choroidal vascular volume ratio, and the area and perimeter of the macular avascular zone will be analysed.
Measured: During the procedure
Intraocular pressure
iCare handheld contact tonometer wIll be used to measure the intraocular pressure of the subjects
Measured: During the procedure
Choroidal blood flow density
Two modes of SS-OCTA will be used for scanning, one is the wide-angle range of 24mm*20mm grid for quantitative analysis of choroidal and retinal vascular density. The other is a scanning range of 12mm*12mm mode, and the choroidal thickness, choroidal vascular volume ratio, and the area and perimeter of the macular avascular zone will be analysed.
Measured: During the procedure
Choroidal thickness
Two modes of SS-OCTA will be used for scanning, one is the wide-angle range of 24mm*20mm grid for quantitative analysis of choroidal and retinal vascular density. The other is a scanning range of 12mm*12mm mode, and the choroidal thickness, choroidal vascular volume ratio, and the area and perimeter of the macular avascular zone will be analysed.
Measured: During the procedure
Foveal avascular zone area
Two modes of SS-OCTA will be used for scanning, one is the wide-angle range of 24mm*20mm grid for quantitative analysis of choroidal and retinal vascular density. The other is a scanning range of 12mm*12mm mode, and the choroidal thickness, choroidal vascular volume ratio, and the area and perimeter of the macular avascular zone will be analysed.
Measured: During the procedure
Secondary outcomes (1)
Axial length
IOL Master700 will be used for the acquisition of axial length data.
Measured: Baseline, pre-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Science and Technology Department of Sichuan Province
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587776
- Sponsor's protocol ID
- YH-EC-SOP-019(F)-001
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Regulation of Retinal and Choroidal Blood Vessels in Various Ocular Axes Lengths Based on Ultra-widefield Swept-source Optical Coherence Tomography Angiography Detection With Changes in Body Position
- ClinicalTrials.gov ID
- NCT06587776
- Acronym / sponsor ID
- YH-EC-SOP-019(F)-001
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Science and Technology Department of Sichuan ProvinceUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
This prospective observational study aims to understand the effects of different subaxial body positions on choroidal and retinal blood vessel density. The main questions it aims to answer are as follows:1) How do retinal and choroidal blood vessels adjust and repair after changes in body position?2) Is the change of body position related to the factors that cause myopia？ 3) Are there any differences in the regulation ability of fundus blood vessels in people with different ocular axes under the condition of changes in body position?
Detailed description
This project will use the wide field swept-source optical coherence tomography angiography, combined with data analysis and mining methods, to explore the self-adjustment and change mode and mechanism of retinal and choroidal blood vessels in the case of posture changes in an all-round and multi-angle way. There would be three kinds of postural changes, one is 15° head-up position, one is supine position, and the other is 15° head-down position. Relevant ophthalmological measurements would be performed before and after the postural changes. The objective is to discover the three-dimensional change mode of retinal and choroid blood vessels in different postures and compare the differences among people with different lengths of ocular axes, and to elucidate the relationship between the mode and ability of retinal and choroidal blood vessels to adjust and repair changes after changes in body position and myopia, to provide more ideas and objective basis for the occurrence and development of myopia, and lay a foundation for further research. It is of great significance to innovate the pathogenesis of myopia, deepen the theoretical understanding, and guide the prevention and control of myopia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal axial length grooup | – | –At the screening stage, the axial length of the subjects was measured by IOL master 700. If the other conditions were met, the subjects would be included in this group If the axial length is between 23mm and 24mm. |
| Long axial group | – | –At the screening stage, the axial length of the subjects was measured by IOL master 700. If the other conditions were met, the subjects would be included in this group if the axial length is greater than 24mm. |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Healthy people in Chengdu City will be recruited through advertisement, and those who meet the inclusion and exclusion criteria will enter the study.
Key inclusion criteria (4 listed)
- Corrected visual acuity ≥1.0 (international standard visual acuity chart);
- Age 10-40 years old;
- In good health;
- Give informed consent and volunteer for the study. The process of obtaining informed consent complies with GCP regulations.
Key exclusion criteria (8 listed)
- Can not cooperate with the completion of relevant inspection and data collection;
- Pregnant and lactating women;
- Patients with amblyopia, glaucoma, retinitis pigmentosa, senile macular degeneration, retinal artery obstruction, retinal vein obstruction, diabetic retinopathy and other eye diseases that may affect the blood circulation and vascular diameter of the retina and vein, or those who have undergone intraocular surgery;
- Patients with cardiovascular and cerebrovascular diseases, endocrine diseases, autoimmune diseases;
- Long history of smoking and drinking;
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
Retinal blood flow density
Time frame: During the procedure
Two modes of SS-OCTA will be used for scanning, one is the wide-angle range of 24mm*20mm grid for quantitative analysis of choroidal and retinal vascular density. The other is a scanning range of 12mm*12mm mode, and the choroidal thickness, choroidal vascular volume ratio, and the area and perimeter of the macular avascular zone will be analysed.
Intraocular pressure
Time frame: During the procedure
iCare handheld contact tonometer wIll be used to measure the intraocular pressure of the subjects
Choroidal blood flow density
Time frame: During the procedure
Two modes of SS-OCTA will be used for scanning, one is the wide-angle range of 24mm*20mm grid for quantitative analysis of choroidal and retinal vascular density. The other is a scanning range of 12mm*12mm mode, and the choroidal thickness, choroidal vascular volume ratio, and the area and perimeter of the macular avascular zone will be analysed.
Choroidal thickness
Time frame: During the procedure
Two modes of SS-OCTA will be used for scanning, one is the wide-angle range of 24mm*20mm grid for quantitative analysis of choroidal and retinal vascular density. The other is a scanning range of 12mm*12mm mode, and the choroidal thickness, choroidal vascular volume ratio, and the area and perimeter of the macular avascular zone will be analysed.
Foveal avascular zone area
Time frame: During the procedure
Two modes of SS-OCTA will be used for scanning, one is the wide-angle range of 24mm*20mm grid for quantitative analysis of choroidal and retinal vascular density. The other is a scanning range of 12mm*12mm mode, and the choroidal thickness, choroidal vascular volume ratio, and the area and perimeter of the macular avascular zone will be analysed.
1 secondary outcome
Axial length
Time frame: Baseline, pre-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Science and Technology Department of Sichuan Province.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Xiaofeng (13551863480, cxflucky@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal blood flow density (time frame: During the procedure). The study lists 5 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 19 Sep 2024.