Near Horizontal Heterophoria in Chinese Children

Myopia, Progressive Clinical Trial

Official title:

Association of Axial Length and Refraction With Near Horizontal Heterophoria in Chinese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05007626
• Other study ID #: 2021020
• Status: Completed
• Start date: January 29, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2021
• Source: Tianjin Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15081
• Est. completion date: December 31, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

Inclusion Criteria:

• ages of 6 and 13 years

• Chinese school children

Exclusion Criteria:

• Subjects with eye diseases or strabismus

Related Conditions & MeSH terms

• Myopia, Degenerative
• Myopia, Progressive

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

References & 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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	refractive error		change from baseline with EDTRS chart at 6 months