Factors Influencing Physiological Hyperopia in Children

July 5, 2024 updated by: Beijing Tongren Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1006

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Beijing Tongren Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 year
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 year
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.
3 year
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.
3 year
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.
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 5, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YH Jiao

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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