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OpenTrials
Completed

NCT Number: NCT05700240

Effect of Orthokeratology on Myopia Progression in French Children

To evaluate and to compare the effect of orthokeratology (OK) on axial elongation in French myopic children.

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Key information

Conditions

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jean-Baptiste CONART

Nancy, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 7 to 17 years old
  • Myopia between 0,50 D and 7.00 D
  • Astigmatism ≤ 4.00 D with-the-rule 180+-20
  • Anisometropia ≤ 1.50 D
  • Myopia evolution ≥ 0.25 D over 6 months
  • Best-corrected visual acuity (BCVA) ≥ 20/20 (Snellen equivalent)
  • Follow-up period > 6 months

Exclusion criteria

  • Prior history of any other myopia control treatment (except for single vision distance spectacles)
  • Contraindication for contact lens wear or orthokeratology
  • Preexisting ocular (amblyopia, strabismus, ocular inflammation, trauma, or surgery) or systemic disease
  • Poor compliance to lens wear, examination or follow-up

Treatment and study plan

Orthokeratology

Device

rigid contact lenses

single-vision spectacle correction

Device

simple wear of spectacle

Primary outcomes

  1. Changes in axial length at one year

    Time frame: one year

Secondary outcomes

  1. changes in refractive error

    Time frame: one year

  2. changes in choroidal thickness

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2023
Registry last updated
Jan 26, 2023

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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