Effect of Orthokeratology on Myopia Progression in French Children

Myopia Progression Clinical Trial

Official title:

Effect of Orthokeratology on Myopia Progression in French Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05700240
• Other study ID #: 2022PI090
• Status: Completed
• Start date: November 2, 2019
• Est. completion date: December 24, 2020

Study information

• Verified date: January 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 24, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Myopia
• Myopia Progression

Intervention

Device:
• orthokeratology
rigid contact lenses
• single-vision spectacle correction
simple wear of spectacle

Locations

Country	Name	City	State
France	Jean-Baptiste CONART	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in axial length at one year		one year
Secondary	changes in refractive error		one year
Secondary	changes in choroidal thickness		one year