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

Not Applicable
Active, not recruiting
Conditions
Myopia
High Myopia
Registration Number
NCT05691296
Lead Sponsor
Tianjin Eye Hospital
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
4000
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
The rate of new-onset myopiaThrough study completion, an average of 1 year

The number of new children with myopia was counted

The changes of refractive errorEvery 6 months, up to 3 years

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

The changes of axial lengthEvery 6 months, up to 3 years

The axial length was measured by a biological measuring instrument.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Tiajin Eye Hospital

🇨🇳

Tianjin, Tianjin, China

Tiajin Eye Hospital
🇨🇳Tianjin, Tianjin, China

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