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NCT05348369 Clinical Trial

The Relationship of Relative Corneal Refractive Power Shift and Axial Length in Adolescents With Orthokeratology Lens

Myopia Clinical Trial

Official title:
The Relationship of Relative Corneal Refractive Power Shift and Axial Length in Adolescents With Orthokeratology Lens

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05348369
Other study ID # 2022020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2019

Study information
Verified date April 2022
Source Tianjin Eye Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Orthokeratology lens is an effective method for myopia control. This study analyzed the relationship between the relative corneal refractive power shift and change of axial length in adolescents with orthokeratology lens.

Description:

Orthokeratology lens is an effective method for myopia control. This study aimed to investigate the relationship between the relative corneal refractive power shift and changes of axial length in adolescents with orthokeratology lens in 1 year. Other factors that may affect axial growth were also analyzed.

Recruitment information / eligibility
Status Completed
Enrollment 364
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers
Gender All
Age group 8 Years to 15 Years
Eligibility Inclusion Criteria: - age from 8 to 15years - spherical equivalent(SE) was range from -1.00D to -5.00D - conform to the standard of wearing orthokeratology lens Exclusion Criteria: - ocular diseases and systemic diseases - visual acuity was less than 20/20 - unable to follow visitors on time

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Tianjin Eye Hospital Tianjin Tianjin

Sponsors (1)
Lead Sponsor Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Guo B, Cheung SW, Kojima R, Cho P. One-year results of the Variation of Orthokeratology Lens Treatment Zone (VOLTZ) Study: a prospective randomised clinical trial. Ophthalmic Physiol Opt. 2021 Jul;41(4):702-714. doi: 10.1111/opo.12834. Epub 2021 May 15. — View Citation

Vincent SJ, Cho P, Chan KY, Fadel D, Ghorbani-Mojarrad N, González-Méijome JM, Johnson L, Kang P, Michaud L, Simard P, Jones L. CLEAR - Orthokeratology. Cont Lens Anterior Eye. 2021 Apr;44(2):240-269. doi: 10.1016/j.clae.2021.02.003. Epub 2021 Mar 25. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The change of axial length The axial length was measured by AL-scan, its expressed in mm The change of baseline and 1years
Secondary Relative corneal refractive power shift(RCRPS) The value of RCRPS was obtained and calculated from a corneal topography up to 1 year
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