Effect of Orthokeratology Versus Spectacles on Myopia Progression in Chinese Children: A Crossover Trial
Phase 4
Completed
- Conditions
- Myopia
- Registration Number
- NCT02186184
- Lead Sponsor
- Beijing Tongren Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Axial length Change from baseline at 2 years Refraction Change from baseline at 2 years
- Secondary Outcome Measures
Name Time Method Tear film break up time(BUT) Change from baseline at 2 years Self evaluation of comfortableness Change from baseline at 1 year Corneal endothelial cell density Change from baseline at 2 years Self evaluation of comfortness Change from baseline at 2 years
Trial Locations
- Locations (1)
Beijing Tongren Hospital
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital🇨🇳Beijing, Beijing, China