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Factors Influencing Physiological Hyperopia in Children

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Capital Medical University

Status

Enrolling

Conditions

Myopia Progression

Treatments

Other: This study was observational with no intervention.

Study type

Observational

Funder types

Other

Identifiers

NCT06498947
YH Jiao

Details and patient eligibility

About

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.

Enrollment

1,006 estimated patients

Sex

All

Ages

6 to 9 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

1,006 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Huaying Xu, MD; YH Jiao, Ph D.

Data sourced from clinicaltrials.gov

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