Age and Refraction in Predicting Myopia Progression in COVID-19

The Effect of Age and Refraction in Predicting Myopia Progression With Risk Under COVID-19 in a 3-year Follow-up of a Chinese Cohort

To determine the longitudinal changes of age and refraction in predicting myopia progression with risk under the coronavirus disease 2019 (COVID-19) pandemic in a 3-year follow-up of a Chinese cohort.

Study Overview

• Status: Completed
• Conditions: Myopia; Refraction Error
• Intervention / Treatment: Other: screening

Detailed Description

This was part of the large-scale Tianjin Eye Study, a population-based cohort study that longitudinally investigates the relationship between the age, refraction, and development of childhood RE in Tianjin, China.

• Study Type: Observational
• Enrollment (Actual): 34400

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300020
    • Tianjin Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study includes 34,400 schoolchildren, with a 36-month follow-up from 2019 to 2021. In addition to RE considerations, the inclusion criteria were: no concurrent eye disease; age 6-15 years. The exclusion criteria were: significant systemic illnesses or ocular conditions that could affect the corneal curvature, including congenital corneal diseases, pterygium, keratoconus, other corneal degeneration or dystrophy conditions, media opacity, uveitis, glaucoma or a history of intraocular surgery, refractive surgery, neurologic or retinal diseases, current corneal refractive therapy (ortho-K), or low-dose atropine therapy for myopia control. The ethics board of the Tianjin Eye Hospital, Tianjin, China, approved this school-based cohort study (No: 2022018).

Description

Inclusion Criteria:

• no concurrent eye disease;
• age 6-15 years.

Exclusion Criteria:

• significant systemic illnesses
• ocular conditions that could affect the corneal curvature, including congenital corneal diseases,
• pterygium, keratoconus, other corneal degeneration or dystrophy conditions,
• media opacity, uveitis, glaucoma
• a history of intraocular surgery, refractive surgery,
• neurologic or retinal diseases, current corneal refractive therapy (ortho-K),
• low-dose atropine therapy for myopia control

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
2019 screening; 34,400 schoolchildren with a 36-month follow-up from 2019 to 2021.	Other: screening; This study included 34,400 students, as part of the Tianjin Eye Study who performed a 3-year follow-up from 2019 to 2021. All participants underwent yearly noncycloplegic refraction and ocular examinations. Time-related changes in sphere, cylinder, and spherical equivalent (SE) measurements in both sexes were analyzed.
2020 screening; 34,400 schoolchildren with a 36-month follow-up from 2019 to 2021.	Other: screening; This study included 34,400 students, as part of the Tianjin Eye Study who performed a 3-year follow-up from 2019 to 2021. All participants underwent yearly noncycloplegic refraction and ocular examinations. Time-related changes in sphere, cylinder, and spherical equivalent (SE) measurements in both sexes were analyzed.
2021 screening; 34,400 schoolchildren with a 36-month follow-up from 2019 to 2021.	Other: screening; This study included 34,400 students, as part of the Tianjin Eye Study who performed a 3-year follow-up from 2019 to 2021. All participants underwent yearly noncycloplegic refraction and ocular examinations. Time-related changes in sphere, cylinder, and spherical equivalent (SE) measurements in both sexes were analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of sphere	changes of sphere	change from baseline at 36 months
changes of cylinder	changes of cylinder	change from baseline at 36 months
changes of spherical equivalent	changes of spherical equivalent	change from baseline at 36 months
changes and distribution of visual acuity	changes and distribution of visual acuity	change from baseline at 36 months

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital
• Investigators: Study Chair: Yan Wang, director, Tianjin Eye Hospital

Publications and helpful links

General Publications

• Hu Y, Zhao F, Ding X, Zhang S, Li Z, Guo Y, Feng Z, Tang X, Li Q, Guo L, Lu C, Yang X, He M. Rates of Myopia Development in Young Chinese Schoolchildren During the Outbreak of COVID-19. JAMA Ophthalmol. 2021 Oct 1;139(10):1115-1121. doi: 10.1001/jamaophthalmol.2021.3563. Erratum In: JAMA Ophthalmol. 2021 Oct 21;:
• Ma D, Wei S, Li SM, Yang X, Cao K, Hu J, Fan S, Zhang L, Wang N. Progression of myopia in a natural cohort of Chinese children during COVID-19 pandemic. Graefes Arch Clin Exp Ophthalmol. 2021 Sep;259(9):2813-2820. doi: 10.1007/s00417-021-05305-x. Epub 2021 Jul 21.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 2022018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No