The Initiating Factors of Myopia Among Primary and Secondary School Students in Tianjin

• Sponsor: Tianjin Eye Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05637827
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 38
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

There was a prospective cohort observational study. Forty hyperopic children, 40 myopic children and 120 emmetropia children were randomly selected from grade 1 to grade 3, and were followed up every six months for 3 years. All patients received cycloplegic refraction examination, ocular biological test, binocular visual function test and a questionnaire related to daily eye habits. A multi-level and multi-dimensional data analysis model was constructed to explore the possible factors affecting the occurrence and development of myopia in children.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Refractive Error	Other: No intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Initiating Factors of Myopia Among Primary and Secondary School Students in Tianjin
• Actual Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
children with hyperopia The refractive error and axial length of eye were observed	Other: No intervention; There was no intervention in each group, and only the natural development was observed
children with emmetropia The refractive error and axial length of eye were observed	Other: No intervention; There was no intervention in each group, and only the natural development was observed
children with myopia The refractive error and axial length of eye were observed	Other: No intervention; There was no intervention in each group, and only the natural development was observed

Outcome Measures

Primary Outcome Measures

1. The changes of refractive error [Every 6 months for a period 3 years]

   The changes of refractive error between visit time in every 6 months

2. The changes of axial length [Every 6 months for a period 3 years]

   The changes of axial length between visit time in every 6 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 11 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• students in grades 1-3

• 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	Tianjin Eye Hospital	Tianjin	Tianjin	China	300020

Sponsors and Collaborators

• Tianjin Eye Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tianjin Eye Hospital
• ClinicalTrials.gov Identifier: NCT05637827
• Other Study ID Numbers: Tianjin children myopia
• First Posted: Dec 5, 2022
• Last Update Posted: Dec 5, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myopia; Refractive Errors

Study Results

No Results Posted as of Dec 5, 2022