Near Horizontal Heterophoria in Chinese Children

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05007626
Collaborator
(none)
15,081
1
11
1366.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: axial length and refractive error

Detailed Description

Myopia is becoming a global public health burden which is believed to have a multifactorial etiology. The relationship between heterophoria and refraction remains controversial. We describe the association of refraction and axial length (AL) with heterophoria in a large population-based study of school-aged Chinese children. Eleven thousand thirteen elementary school children grades 1-6, were included in this school-based, cross-sectional study. Near phoria data was quantified by using Maddox rod test and prism at 33 cm. Children in each grade level were sorted into three groups based upon phoria: 1) those with more than six prism diopters (PD) exophoria, 2) those with zero to six PD exophoria, and 3) those with any amount of esophoria. Autorefraction was measured by autorefractor (Topcon KR8900, Japan) and AL was measured by Optical Biometer AL-Scan (Nidek AL-Scan, Japan). A generalized additive model (GAM) was applied with a Gaussian link to explore the association between the refractive error or axial length and heterophoria. An additional age-adjusted model was also employed for analysis.

Study Design

Study Type:
Observational
Actual Enrollment :
15081 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Association of Axial Length and Refraction With Near Horizontal Heterophoria in Chinese Children
Actual Study Start Date :
Jan 29, 2017
Actual Primary Completion Date :
Dec 30, 2017
Actual Study Completion Date :
Dec 31, 2017

Arms and Interventions

Arm Intervention/Treatment
zero to six Exo

Other: axial length and refractive error
Comparing the correlation between heterophoria and refraction, even after age adjustment.

Outcome Measures

Primary Outcome Measures

  1. refractive error [change from baseline with EDTRS chart at 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • ages of 6 and 13 years

  • Chinese school children

Exclusion Criteria:
  • Subjects with eye diseases or strabismus

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Tianjin Eye Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yan Wang, Director, Head of Ophthalmology, Tianjin Eye Hospital
ClinicalTrials.gov Identifier:
NCT05007626
Other Study ID Numbers:
  • 2021020
First Posted:
Aug 16, 2021
Last Update Posted:
Aug 16, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2021