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NCT05365373 Clinical Trial

The Effect of Treatment Zone Decentration on Axial Length Elongation After Orthokeratology

Myopia Clinical Trial

Official title:
The Effect of Treatment Zone Decentration on Axial Length Elongation After Orthokeratology

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05365373
Other study ID # 2022005
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2019

Study information
Verified date May 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 effects of treatment zone decentration on axial length elongation in adolescents with orthokeratology lens.

Description:

Orthokeratology lens is an effective method for myopia control. This study aimed to investigate the effects of treatment zone decentration on axial length elongation in adolescents with orthokeratology lens in 1 year. Other factors that may affect axial growth were also analyzed.

Recruitment information / eligibility
Status Completed
Enrollment 251
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers 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 - stop wearing for =7 days for any reason during the follow-up period - keratoconjunctival complications, glare, diplopia, or any other symptoms during follow-up

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, 

Outcome
Type Measure Description Time frame Safety issue
Primary The change of axial length The axial length was measured by IOL-Master 500, its expressed in mm The change of baseline?6 months and 12months
Secondary the decentration magnitudes of the treatment zone The value of decentration magnitudes was obtained and calculated from a corneal topography up to 1 year
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