Effect of Orthokeratology on Myopia Progression in French Children

Completed

• Conditions: Myopia Progression
• Interventions: Device: orthokeratology; Device: single-vision spectacle correction

• Registration Number: NCT05700240
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-02
• Primary Completion: 2020-06-29
• Study Completion: 2020-12-24
• Status Verified: 2023-01
• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-17
• Last Update Submitted: 2023-01-17
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Orthokeratology treatment	orthokeratology	-
single-vision spectacle correction	single-vision spectacle correction	-

Primary Outcome Measures

Name	Time	Method
Changes in axial length at one year	one year

Secondary Outcome Measures

Name	Time	Method
changes in refractive error	one year
changes in choroidal thickness	one year

Trial Locations

Locations (1)

Jean-Baptiste CONART; 🇫🇷 Nancy, France