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Factors Influencing Physiological Hyperopia in Children

Factors Influencing Physiological Hyperopia in Children: A Prospective Nested Case-control Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06498947
Enrollment
1006
Registered
2024-07-12
Start date
2024-06-01
Completion date
2026-12-31
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia Progression

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.

Interventions

OTHERThis study was observational with no intervention.

This study was observational with no intervention.

Sponsors

Beijing Tongren Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
myopia1 yearMyopia 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

MeasureTime frameDescription
Myopia Prevalence3 yearMyopia 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 ocular axis length3 yearThe change in ocular axis length was calculated by subtracting each year's measurement from the previous year's measurement.
The change in anterior chamber depth3 yearCalculate the change in anterior chamber depth by subtracting each year's measurement from the previous year's measurement.
The change in corneal curvature3 yearCalculate the change in corneal curvature by subtracting each year's measurement from the previous year's measurement.
The change in the ratio of axial length to corneal curvature3 yearCalculate the change in the ratio of axial length to corneal curvature by subtracting each year's measurement from the previous year's measurement.

Countries

China

Contacts

Primary ContactHuaying Xu, MD
xuhuaying99@163.com18813072901
Backup ContactYH Jiao, Ph D.
yhjiao2001@aliyun.com13051612248

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026