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

Effect of Orthokeratology on Myopia Progression in Chinese Children

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Spectacle; Device: Orthokeratology

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orthokeratology in the first year; The participants would wear orthokeratology in the first year and then switch to spectacle in the second year	Device: Spectacle; Other Names: Glasses; Device: Orthokeratology
Active Comparator: Spectacle in the first year; The participants would wear spectacle in the first year and then changed to orthokeratology in the second year	Device: Spectacle; Other Names: Glasses; Device: Orthokeratology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Axial length	The Lenstar will be used to measure the axial length.	Change from baseline at 1 year
Refraction		Change from baseline at 2 years
Axial length		Change from baseline at 2 years

Secondary Outcome Measures

Outcome 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
Tear film break up time(BUT)	Change from baseline at 2 years
Self evaluation of comfortness	Change from baseline at 2 years
Corneal endothelial cell density	Change from baseline at 2 years

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Principal Investigator: Ningli Wang, MD,PhD, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: June 29, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 17, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Orthokeratology; Myopia progression
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Refractive Errors; Disease Progression; Myopia
• Other Study ID Numbers: 2014CB504601