Effect of Orthokeratology on Myopia Progression in French Children

NCT ID: NCT05700240

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-02

Study Completion Date

2020-12-24

Brief Summary

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

Detailed Description

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Conditions

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Myopia Progression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Orthokeratology treatment

orthokeratology

Intervention Type DEVICE

rigid contact lenses

single-vision spectacle correction

single-vision spectacle correction

Intervention Type DEVICE

simple wear of spectacle

Interventions

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orthokeratology

rigid contact lenses

Intervention Type DEVICE

single-vision spectacle correction

simple wear of spectacle

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Professeur Jean-Baptiste CONART

Professeur

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jean-Baptiste CONART

Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2022PI090

Identifier Type: -

Identifier Source: org_study_id

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