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Not yet recruiting NCT06587776

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

Observational Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: 10 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Primary outcome measures

  • Retinal blood flow density [Time frame: During the procedure]
  • Intraocular pressure [Time frame: During the procedure]
  • Choroidal blood flow density [Time frame: During the procedure]
  • Choroidal thickness [Time frame: During the procedure]
  • Foveal avascular zone area [Time frame: During the procedure]
Secondary outcome measures (1)
  • Axial length [Time frame: Baseline, pre-procedure]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06587776 · YH-EC-SOP-019(F)-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗