Factors Influencing Physiological Hyperopia in Children

NCT ID: NCT06498947

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1006 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-12-31

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.

Conditions

Myopia Progression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

This study was observational with no intervention.

Intervention Type: OTHER

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).

This study was observational with no intervention.

Intervention Type: OTHER

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.

This study was observational with no intervention.

Intervention Type: OTHER

This study was observational with no intervention.

Interventions

This study was observational with no intervention.

This study was observational with no intervention.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huaying Xu, MD

Role: CONTACT

xuhuaying99@163.com

18813072901

YH Jiao, Ph D.

Role: CONTACT

yhjiao2001@aliyun.com

13051612248

Facility Contacts

Yonghong Jiao, MD, Ph D.

Role: primary

yhjiao2001@aliyun.com

13051612248

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Other Identifiers

YH Jiao

Identifier Type: -

Identifier Source: org_study_id