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

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ClinicalTrials.gov Identifier: NCT05637827
Recruitment Status : Recruiting
First Posted : December 5, 2022
Last Update Posted : December 5, 2022
Sponsor:
Information provided by (Responsible Party):
Tianjin Eye Hospital

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
Myopia; Refractive Error Other: No intervention

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Study Type : Observational
Estimated 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 : November 1, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. The changes of refractive error [ Time Frame: 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 [ Time Frame: Every 6 months for a period 3 years ]
    The changes of axial length between visit time in every 6 months.



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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Healthy children with hyperopia, emmetropia and myopia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05637827


Contacts
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Contact: yan wang +86-22-27305083 wangyan7143@vip.sina.com

Locations
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China, Tianjin
Tianjin Eye Hospital Recruiting
Tianjin, Tianjin, China, 300020
Contact: yan wang, director    +86-22-27305083    wangyan7143@vip.sina.com   
Sponsors and Collaborators
Tianjin Eye Hospital
Publications of Results:
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Responsible Party: Tianjin Eye Hospital
ClinicalTrials.gov Identifier: NCT05637827    
Other Study ID Numbers: Tianjin children myopia
First Posted: December 5, 2022    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases