Factors Influencing Physiological Hyperopia in Children

NCT06498947 | Recruiting

• 1 other identifier: YH Jiao
• Study Type: observational
• Target: 1,006
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  1 year

Secondary Outcomes (5)

• Myopia Prevalence

  3 year

• The change in ocular axis length

  3 year

• The change in anterior chamber depth

  3 year

• The change in corneal curvature

  3 year

• The change in the ratio of axial length to corneal curvature

  3 year

Study Arms (3)

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.

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.

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.

Interventions

This study was observational with no intervention. OTHER

This study was observational with no intervention.

Group A; Group B; Group C

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Related Publications (16)

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  PMID: 34958689 RESULT

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  PMID: 25655799 RESULT

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  PMID: 30817826 RESULT

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  PMID: 28951126 RESULT

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  PMID: 24099276 RESULT

• Li SM, Liu LR, Li SY, Ji YZ, Fu J, Wang Y, Li H, Zhu BD, Yang Z, Li L, Chen W, Kang MT, Zhang FJ, Zhan SY, Wang NL, Mitchell P; Anyang Childhood Eye Study Group. Design, methodology and baseline data of a school-based cohort study in Central China: the Anyang Childhood Eye Study. Ophthalmic Epidemiol. 2013 Dec;20(6):348-59. doi: 10.3109/09286586.2013.842596. Epub 2013 Oct 25.

  PMID: 24160405 RESULT

Central Study Contacts

Huaying Xu, MD

CONTACT

18813072901; xuhuaying99@163.com

YH Jiao, Ph D.

CONTACT

13051612248; yhjiao2001@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 12, 2024

Record last verified: 2024-01

Locations

CN (1)