Factors Influencing Physiological Hyperopia in Children

Official title

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

Overview

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.

Interventions

• Other This study was observational with no intervention.
  This study was observational with no intervention.

Primary outcome measures

• myopia [Time frame: 1 year]

Secondary outcome measures (5)

• Myopia Prevalence [Time frame: 3 year]
• The change in ocular axis length [Time frame: 3 year]
• The change in anterior chamber depth [Time frame: 3 year]
• The change in corneal curvature [Time frame: 3 year]
• The change in the ratio of axial length to corneal curvature [Time frame: 3 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

China · 1 center

• Beijing Tongren Hospital — Beijing

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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-a PMID 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. PMID 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. PMID 30817826

Identifiers

NCT: NCT06498947 · YH Jiao

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗