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Completed

NCT Number: NCT02186184

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthokeratology

Device

Spectacle

Device

Other names: Glasses

Primary outcomes

  1. Refraction

    Time frame: Change from baseline at 1 year

    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.

  2. Axial length

    Time frame: Change from baseline at 1 year

    The Lenstar will be used to measure the axial length.

  3. Refraction

    Time frame: Change from baseline at 2 years

  4. Axial length

    Time frame: Change from baseline at 2 years

Secondary outcomes

  1. Tear film break up time(BUT)

    Time frame: Change from baseline at 1 year

  2. Self evaluation of comfortableness

    Time frame: Change from baseline at 1 year

  3. Corneal endothelial cell density

    Time frame: Change from baseline at 1 year

  4. Tear film break up time(BUT)

    Time frame: Change from baseline at 2 years

  5. Self evaluation of comfortness

    Time frame: Change from baseline at 2 years

  6. Corneal endothelial cell density

    Time frame: Change from baseline at 2 years

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

Effect of Orthokeratology on Myopia Progression in Chinese Children

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 10, 2014
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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