ClinicalTrials.gg
RecruitingNCT06498947Updated Jul 12, 2024

Factors Influencing Physiological Hyperopia in Children

An observational study in Myopia Progression, sponsored by Beijing Tongren Hospital. Recruiting at 1 site in China. Open to participants aged 6 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by Beijing Tongren Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,006
Ages
6 Years to 9 Years
Sex
All
01

Study 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.

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Conditions studied

  • Myopia Progression
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In context

Lead sponsor

Beijing Tongren Hospital is the lead sponsor of 163 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,006 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherThis study was observational with no intervention.

    This study was observational with no intervention.

06

What researchers measure

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

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

    Calculate the change in the ratio of axial length to corneal curvature by subtracting each year's measurement from the previous year's measurement.

    Time frame: 3 year

07

Study locations

1 of 1 sites recruiting
  • Beijing Tongren Hospital
    Beijing, Beijing Municipality 100005, China
    Recruiting
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References and documents

Publications

  • Wang J, Li Y, Musch DC, Wei N, Qi X, Ding G, Li X, Li J, Song L, Zhang Y, Ning Y, Zeng X, Hua N, Li S, Qian X. Progression of Myopia in School-Aged Children After COVID-19 Home Confinement. JAMA Ophthalmol. 2021 Mar 1;139(3):293-300. doi: 10.1001/jamaophthalmol.2020.6239. PubMed 33443542 ↗
  • Saxena R, Vashist P, Tandon R, Pandey RM, Bhardawaj A, Menon V, Mani K. Prevalence of myopia and its risk factors in urban school children in Delhi: the North India Myopia Study (NIM Study). PLoS One. 2015 Feb 26;10(2):e0117349. doi: 10.1371/journal.pone.0117349. eCollection 2015. PubMed 25719391 ↗
  • He M, Xiang F, Zeng Y, Mai J, Chen Q, Zhang J, Smith W, Rose K, Morgan IG. Effect of Time Spent Outdoors at School on the Development of Myopia Among Children in China: A Randomized Clinical Trial. JAMA. 2015 Sep 15;314(11):1142-8. doi: 10.1001/jama.2015.10803. PubMed 26372583 ↗
  • Saw SM, Tong L, Chua WH, Chia KS, Koh D, Tan DT, Katz J. Incidence and progression of myopia in Singaporean school children. Invest Ophthalmol Vis Sci. 2005 Jan;46(1):51-7. doi: 10.1167/iovs.04-0565. PubMed 15623754 ↗
  • Thomson K, Game J, Karouta C, Morgan IG, Ashby R. Correlation between small-scale methylation changes and gene expression during the development of myopia. FASEB J. 2022 Jan;36(1):e22129. doi: 10.1096/fj.202101487R. PubMed 34958689 ↗
  • Hysi PG, Choquet H, Khawaja AP, Wojciechowski R, Tedja MS, Yin J, Simcoe MJ, Patasova K, Mahroo OA, Thai KK, Cumberland PM, Melles RB, Verhoeven VJM, Vitart V, Segre A, Stone RA, Wareham N, Hewitt AW, Mackey DA, Klaver CCW, MacGregor S; Consortium for Refractive Error and Myopia; Khaw PT, Foster PJ; UK Eye and Vision Consortium; Guggenheim JA; 23andMe Inc.; Rahi JS, Jorgenson E, Hammond CJ. Meta-analysis of 542,934 subjects of European ancestry identifies new genes and mechanisms predisposing to refractive error and myopia. Nat Genet. 2020 Apr;52(4):401-407. doi: 10.1038/s41588-020-0599-0. Epub 2020 Mar 30. PubMed 32231278 ↗
  • O'Donoghue L, Kapetanankis VV, McClelland JF, Logan NS, Owen CG, Saunders KJ, Rudnicka AR. Risk Factors for Childhood Myopia: Findings From the NICER Study. Invest Ophthalmol Vis Sci. 2015 Feb 5;56(3):1524-30. doi: 10.1167/iovs.14-15549. PubMed 25655799 ↗
  • Flitcroft DI, He M, Jonas JB, Jong M, Naidoo K, Ohno-Matsui K, Rahi J, Resnikoff S, Vitale S, Yannuzzi L. IMI - Defining and Classifying Myopia: A Proposed Set of Standards for Clinical and Epidemiologic Studies. Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M20-M30. doi: 10.1167/iovs.18-25957. PubMed 30817826 ↗
  • Zadnik K, Sinnott LT, Cotter SA, Jones-Jordan LA, Kleinstein RN, Manny RE, Twelker JD, Mutti DO; Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study Group. Prediction of Juvenile-Onset Myopia. JAMA Ophthalmol. 2015 Jun;133(6):683-9. doi: 10.1001/jamaophthalmol.2015.0471. PubMed 25837970 ↗
  • Matsumura H, Hirai H. Prevalence of myopia and refractive changes in students from 3 to 17 years of age. Surv Ophthalmol. 1999 Oct;44 Suppl 1:S109-115. doi: 10.1016/s0039-6257(99)00094-6. PubMed 10548123 ↗
  • French AN, Morgan IG, Mitchell P, Rose KA. Risk factors for incident myopia in Australian schoolchildren: the Sydney adolescent vascular and eye study. Ophthalmology. 2013 Oct;120(10):2100-8. doi: 10.1016/j.ophtha.2013.02.035. Epub 2013 May 11. PubMed 23672971 ↗
  • Morgan IG, French AN, Ashby RS, Guo X, Ding X, He M, Rose KA. The epidemics of myopia: Aetiology and prevention. Prog Retin Eye Res. 2018 Jan;62:134-149. doi: 10.1016/j.preteyeres.2017.09.004. Epub 2017 Sep 23. PubMed 28951126 ↗
  • Cui Y, Zhang L, Zhang M, Yang X, Zhang L, Kuang J, Zhang G, Liu Q, Guo H, Meng Q. Prevalence and causes of low vision and blindness in a Chinese population with type 2 diabetes: the Dongguan Eye Study. Sci Rep. 2017 Sep 11;7(1):11195. doi: 10.1038/s41598-017-11365-z. PubMed 28894238 ↗
  • Iwase A, Araie M, Tomidokoro A, Yamamoto T, Shimizu H, Kitazawa Y; Tajimi Study Group. Prevalence and causes of low vision and blindness in a Japanese adult population: the Tajimi Study. Ophthalmology. 2006 Aug;113(8):1354-62. doi: 10.1016/j.ophtha.2006.04.022. PubMed 16877074 ↗
  • Wong TY, Ferreira A, Hughes R, Carter G, Mitchell P. Epidemiology and disease burden of pathologic myopia and myopic choroidal neovascularization: an evidence-based systematic review. Am J Ophthalmol. 2014 Jan;157(1):9-25.e12. doi: 10.1016/j.ajo.2013.08.010. Epub 2013 Oct 5. PubMed 24099276 ↗
  • 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. PubMed 24160405 ↗
  • Xu H, Pu J, Bian S, Mi X, Zhou Z, Chen W, Jiao Y. Factors Influencing the Transition From Physiological Hyperopia to Myopia in Children: Protocol for a Prospective Nested Case-Control Study. JMIR Res Protoc. 2026 Mar 24;15:e84888. doi: 10.2196/84888. PubMed 41875210 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06498947
Responsible party
Sponsor
First posted
Jul 12, 2024
Start date
Jun 1, 2024
Primary completion
Jan 1, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 12, 2024

Study contacts

Huaying Xu, MD
Contact
xuhuaying99@163.com
18813072901
YH Jiao, Ph D.
Contact
yhjiao2001@aliyun.com
13051612248

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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