NCT05637827

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 5, 2022

Status Verified

November 1, 2022

Enrollment Period

3.2 years

First QC Date

November 26, 2022

Last Update Submit

November 26, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • The changes of refractive error

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

    Every 6 months for a period 3 years

  • The changes of axial length

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

    Every 6 months for a period 3 years

Study Arms (3)

children with hyperopia

The refractive error and axial length of eye were observed

Other: No intervention

children with emmetropia

The refractive error and axial length of eye were observed

Other: No intervention

children with myopia

The refractive error and axial length of eye were observed

Other: No intervention

Interventions

There was no intervention in each group, and only the natural development was observed

children with emmetropiachildren with hyperopiachildren with myopia

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Healthy children with hyperopia, emmetropia and myopia

You may qualify if:

  • students in grades 1-3
  • Can cooperate with the examination of students

You may not qualify if:

  • Obvious strabismus and amblyopia
  • Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
  • History of ocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Related Publications (3)

  • Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

  • Rose KA, French AN, Morgan IG. Environmental Factors and Myopia: Paradoxes and Prospects for Prevention. Asia Pac J Ophthalmol (Phila). 2016 Nov/Dec;5(6):403-410. doi: 10.1097/APO.0000000000000233.

  • Seidemann A, Schaeffel F. An evaluation of the lag of accommodation using photorefraction. Vision Res. 2003 Feb;43(4):419-30. doi: 10.1016/s0042-6989(02)00571-0.

MeSH Terms

Conditions

MyopiaRefractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2022

First Posted

December 5, 2022

Study Start

November 1, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 5, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations