Near Horizontal Heterophoria in Chinese Children

Completed

• Conditions: Myopia, Progressive
• Interventions: Other: axial length and refractive error

• Registration Number: NCT05007626
• Lead Sponsor: Tianjin Eye Hospital

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.

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 Timeline

• Study Start: 2017-01-29
• Primary Completion: 2017-12-30
• Study Completion: 2017-12-31
• Status Verified: 2021-08
• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Study First Posted: 2021-08-16
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15081

Inclusion Criteria

• ages of 6 and 13 years
• Chinese school children

Exclusion Criteria

• Subjects with eye diseases or strabismus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
zero to six Exo	axial length and refractive error	-

Primary Outcome Measures

Name	Time	Method
refractive error	change from baseline with EDTRS chart at 6 months

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China