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

Capital Medical University

Status and phase: Completed; Phase 4

Conditions: Myopia

Treatments: Device: Orthokeratology; Device: Spectacle

Study type: Interventional

Funder types: Other

Identifiers

NCT02186184

2014CB504601

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 7 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Orthokeratology in the first year

Experimental group

Description:

The participants would wear orthokeratology in the first year and then switch to spectacle in the second year

Treatment:

Device: Orthokeratology

Device: Spectacle

Spectacle in the first year

Active Comparator group

Description:

The participants would wear spectacle in the first year and then changed to orthokeratology in the second year

Treatment:

Device: Orthokeratology

Device: Spectacle