Clinical trial NCT05305274: Age and Refraction in Predicting Myopia Progression in COVID-19
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refraction Error
Myopia
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 34400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes of sphere
timeFrame: change from baseline at 36 months
measure: changes of cylinder
timeFrame: change from baseline at 36 months
measure: changes of spherical equivalent
timeFrame: change from baseline at 36 months
measure: changes and distribution of visual acuity
timeFrame: change from baseline at 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
affiliation: Tianjin Eye Hospital
name: Yan Wang, director
role: STUDY_CHAIR
References:
citation: 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.
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.