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Clinical Trials/NCT05691296
NCT05691296
Active, not recruiting
Not Applicable

The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin

Tianjin Eye Hospital1 site in 1 country4,000 target enrollmentMay 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
Tianjin Eye Hospital
Enrollment
4000
Locations
1
Primary Endpoint
The changes of axial length
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia.

Detailed Description

The incidence of myopia is high in China. At present, the mechanism of myopia is unclear, and the main theories are genetic and environmental aspects. Many factors may affect the occurrence and development of myopia in students, such as ocular biological parameters, peripheral refractive state, differences in binocular vision function, eye habits, and outdoor time. In this study, the multi-factor information on pre-clinical myopia in school-age children was collected to find out the initial factors and warning signals of myopia.

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All students in grades 1 to 4
  • Can cooperate with the examination of students

Exclusion Criteria

  • Obvious strabismus and amblyopia
  • Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
  • History of ocular surgery

Outcomes

Primary Outcomes

The changes of axial length

Time Frame: Every 6 months, up to 3 years

The axial length was measured by a biological measuring instrument.

The rate of new-onset myopia

Time Frame: Through study completion, an average of 1 year

The number of new children with myopia was counted

The changes of refractive error

Time Frame: Every 6 months, up to 3 years

The changes of refractive error between visit time and baseline which was obtained with a computer refractometer.

Study Sites (1)

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