NCT02186184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

3 years

First QC Date

June 29, 2014

Last Update Submit

December 17, 2017

Conditions

Myopia

Keywords

Myopia progressionOrthokeratology

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Orthokeratology in the first year

EXPERIMENTAL

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

Device: OrthokeratologyDevice: Spectacle

Spectacle in the first year

ACTIVE COMPARATOR

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

Device: OrthokeratologyDevice: Spectacle

Interventions

OrthokeratologyDEVICE
Orthokeratology in the first yearSpectacle in the first year
SpectacleDEVICE
Also known as: Glasses
Orthokeratology in the first yearSpectacle in the first year

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • Ningli Wang, MD,PhD

    Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 29, 2014

First Posted

July 10, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2017

Study Completion

October 1, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations

CN(1)