Age and Refraction in Predicting Myopia Progression in COVID-19

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305274
• Other study ID #: 2022018
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2022
• Source: Tianjin Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34400
• Est. completion date: December 1, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Refraction Error
• Refractive Errors

Intervention

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.

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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;:. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of sphere	changes of sphere	change from baseline at 36 months
Primary	changes of cylinder	changes of cylinder	change from baseline at 36 months
Primary	changes of spherical equivalent	changes of spherical equivalent	change from baseline at 36 months
Primary	changes and distribution of visual acuity	changes and distribution of visual acuity	change from baseline at 36 months