Factors Influencing Physiological Hyperopia in Children

Recruiting

• Conditions: Myopia Progression
• Interventions: Other: This study was observational with no intervention.

• Registration Number: NCT06498947
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

The trend of myopia in children and its low age is a major social and public health problem in China. More seriously, retinopathy associated with high myopia has become the number one cause of irreversible blinding eye disease in adults in some parts of China. Physiological hyperopia has a protective effect on preventing the onset of myopia, and is one of the strongest predictors of myopia on its own, which is significant in curbing myopia from occurring at a younger age and preventing the development of high myopia before adulthood. However, it is not yet known how the physiological hyperopia changes in childhood, the stage at which the critical inflection point occurs, which key factors lead to the rapid fading of the physiological hyperopia and progression to myopia, and the strength of its effect. In the early stage of the study, the research group established a prospective cohort of preschoolers based on natural population sampling, which included a total of 2109 preschoolers aged 3-6 years from 22 kindergartens in a district in Beijing, and completed a 2-year follow-up, obtaining exploratory results on the changing pattern of physiological hyperopia and key influencing factors in younger children. The group will add new samples to the existing whole cohort sampling cohort and adopt the design scheme of prospective nested case-control study to determine the changing trend of fading trajectory of physiological hyperopia in school-age children, key inflection points and key risk factors, so as to provide new techniques for the prevention and control of childhood myopia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-06-01
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-01-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1006

Inclusion Criteria

1. Children aged 6-9 years old, male or female;
2. Good cooperation in examination;
3. Parents cooperate and sign the informed consent form;

Exclusion Criteria

1. Children with a history of drug allergy;
2. Pediatric patients with heart disease, cranial trauma or epilepsy, Down syndrome, or glaucoma will be excluded from the cohort.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	This study was observational with no intervention.	Group B is defined as whose physiological hyperopia exceeds 95% confidence interval for children of same age (Near Myopia).
Group A	This study was observational with no intervention.	Group A is defined as those whose physiological hyperopia (sphere+1/2 cylinder) of at least - 0.5 diopters(D) in either eye.
Group C	This study was observational with no intervention.	Group C is defined as whose physiological hyperopia exceeds 90% confidence interval for children of same age.

Primary Outcome Measures

Name	Time	Method
myopia	1 year	Myopia in this study was defined as an equivalent spherical lens degree ( SER ) error (sphere+1/2 cylinder) of at least - 0.5 diopters(D) in either eye.

Secondary Outcome Measures

Name	Time	Method
Myopia Prevalence	3 year	Myopia is defined as a spherical equivalent refractive (SER) (sphere + 1/2 cylinder) of at least -0.5 diopter (D) in either eye.
The change in anterior chamber depth	3 year	Calculate the change in anterior chamber depth by subtracting each year's measurement from the previous year's measurement.
The change in the ratio of axial length to corneal curvature	3 year	Calculate the change in the ratio of axial length to corneal curvature by subtracting each year's measurement from the previous year's measurement.
The change in ocular axis length	3 year	The change in ocular axis length was calculated by subtracting each year's measurement from the previous year's measurement.
The change in corneal curvature	3 year	Calculate the change in corneal curvature by subtracting each year's measurement from the previous year's measurement.

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China