Investigation of the Regulation of Retinal and Choroidal Blood Vessels in Various AL Based on WF SS-OCTA Detection With Changes in Body Position

NCT06587776 | Not Yet Recruiting

• 1 other identifier: YH-EC-SOP-019(F)-001
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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 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?

Conditions

Myopia

Outcome Measures

Primary Outcomes (5)

• 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.

  During the procedure

• Intraocular pressure

  iCare handheld contact tonometer wIll be used to measure the intraocular pressure of the subjects

  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.

  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.

  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.

  During the procedure

Secondary Outcomes (1)

• Axial length

  Baseline, pre-procedure

Study Arms (2)

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.

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Science and Technology Department of Sichuan Province: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Chen Xiaofeng

CONTACT

13551863480; cxflucky@yeah.net

Wu Linzhi

CONTACT

18919578725; wlz666999@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share