Age and Refraction in Predicting Myopia Progression in COVID-19

Completed

• Conditions: Refraction Error; Myopia
• Interventions: Other: screening

• Registration Number: NCT05305274
• Lead Sponsor: Tianjin Eye Hospital

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.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2021 screening	screening	34,400 schoolchildren with a 36-month follow-up from 2019 to 2021.
2019 screening	screening	34,400 schoolchildren with a 36-month follow-up from 2019 to 2021.
2020 screening	screening	34,400 schoolchildren with a 36-month follow-up from 2019 to 2021.

Primary Outcome Measures

Name	Time	Method
changes of sphere	change from baseline at 36 months	changes of sphere
changes of spherical equivalent	change from baseline at 36 months	changes of spherical equivalent
changes and distribution of visual acuity	change from baseline at 36 months	changes and distribution of visual acuity
changes of cylinder	change from baseline at 36 months	changes of cylinder

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China