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

Myopia Clinical Trial

Official title:

Effect of Orthokeratology on Myopia Progression in Chinese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186184
• Other study ID #: 2014CB504601
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2014
• Last updated: December 17, 2017
• Start date: June 2014
• Est. completion date: October 2017

Study information

• Verified date: December 2017
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Myopia

Intervention

Device:
• Orthokeratology

• Spectacle

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refraction	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.	Change from baseline at 1 year
Primary	Axial length	The Lenstar will be used to measure the axial length.	Change from baseline at 1 year
Primary	Refraction		Change from baseline at 2 years
Primary	Axial length		Change from baseline at 2 years
Secondary	Tear film break up time(BUT)		Change from baseline at 1 year
Secondary	Self evaluation of comfortableness		Change from baseline at 1 year
Secondary	Corneal endothelial cell density		Change from baseline at 1 year
Secondary	Tear film break up time(BUT)		Change from baseline at 2 years
Secondary	Self evaluation of comfortness		Change from baseline at 2 years
Secondary	Corneal endothelial cell density		Change from baseline at 2 years