NCT05007626

Brief Summary

This study aimed to assess the association of refraction and axial length with near-horizontal heterophoria in a large population-based study of school-aged Chinese children. The study makes a significant contribution to better know the etiology of myopia progression and ocular axial length development. Further, this study will be of interest to the readership of your journal because its noteworthy finding and which could contribute to guide recommendations for targeted interventions to slow myopia progression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15,081

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 29, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

August 9, 2021

Last Update Submit

August 11, 2021

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (1)

  • refractive error

    change from baseline with EDTRS chart at 6 months

Study Arms (1)

zero to six Exo

Other: axial length and refractive error

Interventions

axial length and refractive errorOTHER

Comparing the correlation between heterophoria and refraction, even after age adjustment.

zero to six Exo

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

A total of 15,081 Chinese children between the ages of 6 and 13 years were enrolled in this study. Subjects with eye diseases or strabismus were excluded, so data validated from 11,013 children were used for analysis.

You may qualify if:

  • ages of 6 and 13 years
  • Chinese school children

You may not qualify if:

  • Subjects with eye diseases or strabismus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Eye Hospital

Tianjin, China

Location

Related Publications (2)

  • Grzybowski A, Kanclerz P, Tsubota K, Lanca C, Saw SM. A review on the epidemiology of myopia in school children worldwide. BMC Ophthalmol. 2020 Jan 14;20(1):27. doi: 10.1186/s12886-019-1220-0.

    PMID: 31937276BACKGROUND

  • 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.

    PMID: 26875007BACKGROUND

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

MyopiaRefractive ErrorsEye Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Ophthalmology

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 16, 2021

Study Start

January 29, 2017

Primary Completion

December 30, 2017

Study Completion

December 31, 2017

Last Updated

August 16, 2021

Record last verified: 2021-08

Locations

CN(1)