Clincosm LogoSign in Get a demo

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

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05691296
Collaborator
(none)
4,000
Enrollment
1
Location
3
Arms
44
Anticipated Duration (Months)
90.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Home training
  • Behavioral: School training
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
4000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin
Actual Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Home-school training group

There was a Letter Chart Accomodative Rock Training for accommodation facility at home and school everyday. This training usually lasted 2 minutes each time.

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

Behavioral: School training
Letter Chart Accomodative Rock Training for 2 minutes each time
Experimental: School training group

There was a Letter Chart Accomodative Rock Training for accommodation facility only at school everyday. This training usually lasted 2 minutes each time.

Behavioral: School training
Letter Chart Accomodative Rock Training for 2 minutes each time
No Intervention: No training group

There was no such treatment for students.

Outcome Measures

Primary Outcome Measures

  1. The rate of new-onset myopia [Through study completion, an average of 1 year]

    The number of new children with myopia was counted

  2. The changes of refractive error [Every 6 months, up to 3 years]

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

  3. The changes of axial length [Every 6 months, up to 3 years]

    The axial length was measured by a biological measuring instrument.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tiajin Eye Hospital Tianjin Tianjin China 300020

Sponsors and Collaborators

  • Tianjin Eye Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tianjin Eye Hospital
ClinicalTrials.gov Identifier:
NCT05691296
Other Study ID Numbers:
  • Tianjin myopia Intervention
First Posted:
Jan 20, 2023
Last Update Posted:
Jan 20, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Jan 20, 2023