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NCT Number: NCT06498947

Factors Influencing Physiological Hyperopia in Children

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.

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Key information

Conditions

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100005, China

Location status: Recruiting

Location contact

Yonghong Jiao, MD, Ph D.

CONTACT

[email protected]

13051612248

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

This study was observational with no intervention.

Other

This study was observational with no intervention.

Primary outcomes

  1. myopia

    Time frame: 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 outcomes

  1. Myopia Prevalence

    Time frame: 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.

  2. The change in ocular axis length

    Time frame: 3 year

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

  3. The change in anterior chamber depth

    Time frame: 3 year

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

  4. The change in corneal curvature

    Time frame: 3 year

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

  5. The change in the ratio of axial length to corneal curvature

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huaying Xu, MD

CONTACT

[email protected]

18813072901

YH Jiao, Ph D.

CONTACT

[email protected]

13051612248

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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