Factors Influencing Physiological Hyperopia in Children

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-9
SponsorBeijing Tongren Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 6-9 years old, male or female;

Good cooperation in examination;

Parents cooperate and sign the informed consent form;

Disqualifiers

Children with a history of drug allergy;

Pediatric patients with heart disease, cranial trauma or epilepsy, Down syndrome, or glaucoma will be excluded from the cohort.

Trial population

The research group has already sampled 3-6 years old preschool children from 22 kindergartens in Haidian District, Beijing, and included them in the baseline cohort, which has been followed up continuously for 3 years. The research group will continue to add new samples to the existing cluster sampling cohort and reorganize the cohort of children aged 6-9 years old to conduct this study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • This study was observational with no intervention.

    Other intervention

    This study was observational with no intervention.

Treatment groups

1,006 Participants
are divided into 3 treatment groups
Group A: Group A1 intervention
Group B: Group B1 intervention
Group C: Group C1 intervention

Trial outcomes

Primary outcomes

1

myopia

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.

Time frame
1 year

Secondary outcomes

1

Myopia Prevalence

Myopia is defined as a spherical equivalent refractive (SER) (sphere + 1/2 cylinder) of at least -0.5 diopter (D) in either eye.

Time frame
3 year
2

The change in ocular axis length

The change in ocular axis length was calculated by subtracting each year's measurement from the previous year's measurement.

Time frame
3 year
3

The change in anterior chamber depth

Calculate the change in anterior chamber depth by subtracting each year's measurement from the previous year's measurement.

Time frame
3 year
4

The change in corneal curvature

Calculate the change in corneal curvature by subtracting each year's measurement from the previous year's measurement.

Time frame
3 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.