Back to resultsEffect of Orthokeratology Versus Spectacles on Myopia Progression in Chinese Children: A Crossover Trial
Primary Purpose
Myopia
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Orthokeratology
Spectacle
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring Myopia progression, Orthokeratology
Eligibility Criteria
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
Sites / Locations
- Beijing Tongren Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Orthokeratology in the first year
Spectacle in the first year
Arm Description
The participants would wear orthokeratology in the first year and then switch to spectacle in the second year
The participants would wear spectacle in the first year and then changed to orthokeratology in the second year
Outcomes
Primary Outcome Measures
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.
Axial length
The Lenstar will be used to measure the axial length.
Refraction
Axial length
Secondary Outcome Measures
Tear film break up time(BUT)
Self evaluation of comfortableness
Corneal endothelial cell density
Tear film break up time(BUT)
Self evaluation of comfortness
Corneal endothelial cell density
Full Information
NCT ID
NCT02186184
First Posted
June 29, 2014
Last Updated
December 17, 2017
Sponsor
Beijing Tongren Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02186184
Brief Title
Effect of Orthokeratology Versus Spectacles on Myopia Progression in Chinese Children: A Crossover Trial
Official Title
Effect of Orthokeratology on Myopia Progression in Chinese Children
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia progression, Orthokeratology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orthokeratology in the first year
Arm Type
Experimental
Arm Description
The participants would wear orthokeratology in the first year and then switch to spectacle in the second year
Arm Title
Spectacle in the first year
Arm Type
Active Comparator
Arm Description
The participants would wear spectacle in the first year and then changed to orthokeratology in the second year
Intervention Type
Device
Intervention Name(s)
Orthokeratology
Intervention Type
Device
Intervention Name(s)
Spectacle
Other Intervention Name(s)
Glasses
Primary Outcome Measure Information:
Title
Refraction
Description
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.
Time Frame
Change from baseline at 1 year
Title
Axial length
Description
The Lenstar will be used to measure the axial length.
Time Frame
Change from baseline at 1 year
Title
Refraction
Time Frame
Change from baseline at 2 years
Title
Axial length
Time Frame
Change from baseline at 2 years
Secondary Outcome Measure Information:
Title
Tear film break up time(BUT)
Time Frame
Change from baseline at 1 year
Title
Self evaluation of comfortableness
Time Frame
Change from baseline at 1 year
Title
Corneal endothelial cell density
Time Frame
Change from baseline at 1 year
Title
Tear film break up time(BUT)
Time Frame
Change from baseline at 2 years
Title
Self evaluation of comfortness
Time Frame
Change from baseline at 2 years
Title
Corneal endothelial cell density
Time Frame
Change from baseline at 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ningli Wang, MD,PhD
Organizational Affiliation
Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Orthokeratology Versus Spectacles on Myopia Progression in Chinese Children: A Crossover Trial
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