Effect of Orthokeratology Versus Spectacles on Myopia Progression in Chinese Children: A Crossover Trial

Effect of Orthokeratology on Myopia Progression in Chinese Children

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02186184

Enrollment

100

Registered

2014-07-10

Start date

2014-06-30

Completion date

2017-10-31

Last updated

2017-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Myopia progression, Orthokeratology

Brief summary

Orthokeratology is becoming popular for the treatment of myopia children. Many studies have shown that orthokeratology is effective in temporarily reducing refractive error, and is also helpful for controlling myopia progression. However, the mechanism for its slowing myopia progression and rebound effect after the treatment have not been clearly studied. In addition, the effect of orthokeratology among Chinese children has not been evaluated with randomized controlled trial.This study is to assess the effect of orthokeratology versus spectacles on myopia progression in school-aged Chinese children during two years.

Interventions

DEVICEOrthokeratology

DEVICESpectacle

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

7 Years to 14 Years

Healthy volunteers

Yes

Inclusion criteria

* Ages Eligible for Study: 7 Years to 14 Years * Genders Eligible for Study: Both * Visual acuity 20/20 or better in each eye * Spherical error ranging from -0.5 D to -5.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes * No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development

Exclusion criteria

* Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on) * Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing

Design outcomes

Primary

Measure	Time frame	Description
Refraction	Change from baseline at 1 year	The participants will be measured for their cycloplegic central refractive error before and after wearing the orthokeratology. Peripheral refraction will also be measured by WAM-5500.
Axial length	Change from baseline at 1 year	The Lenstar will be used to measure the axial length.

Secondary

Measure	Time frame
Tear film break up time(BUT)	Change from baseline at 1 year
Self evaluation of comfortableness	Change from baseline at 1 year
Corneal endothelial cell density	Change from baseline at 1 year
Self evaluation of comfortness	Change from baseline at 2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026