Effect of Orthokeratology on Myopia Progression in French Children

January 17, 2023 updated by: Professeur Jean-Baptiste CONART, Central Hospital, Nancy, France
To evaluate and to compare the effect of orthokeratology (OK) on axial elongation in French myopic children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France
        • Jean-Baptiste CONART

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

64 consecutive myopic children who underwent OK treatment or single-vision spectacle correction at a private ophthalmology clinic in Nancy from November 2019 to December 2020

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Orthokeratology treatment
Device: orthokeratology
rigid contact lenses
single-vision spectacle correction
Device: single-vision spectacle correction
simple wear of spectacle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in axial length at one year
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in refractive error
Time Frame: one year
one year
changes in choroidal thickness
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2019

Primary Completion (Actual)

June 29, 2020

Study Completion (Actual)

December 24, 2020

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PI090

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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