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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691296
• Other study ID #: Tianjin myopia Intervention
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Tianjin Eye Hospital
• Contact: Xiaoyan Yang, MD
• Phone: +86-22-27306525
• Email: yanzitjsykyy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• High Myopia
• Myopia

Intervention

Behavioral:
• Home training
Letter Chart Accomodative Rock Training for 2 minutes each time
• School training
Letter Chart Accomodative Rock Training for 2 minutes each time

Locations

Country	Name	City	State
China	Tiajin Eye Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Jonas JB, Ang M, Cho P, Guggenheim JA, He MG, Jong M, Logan NS, Liu M, Morgan I, Ohno-Matsui K, Parssinen O, Resnikoff S, Sankaridurg P, Saw SM, Smith EL 3rd, Tan DTH, Walline JJ, Wildsoet CF, Wu PC, Zhu X, Wolffsohn JS. IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):6. doi: 10.1167/iovs.62.5.6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of new-onset myopia	The number of new children with myopia was counted	Through study completion, an average of 1 year
Primary	The changes of refractive error	The changes of refractive error between visit time and baseline which was obtained with a computer refractometer.	Every 6 months, up to 3 years
Primary	The changes of axial length	The axial length was measured by a biological measuring instrument.	Every 6 months, up to 3 years