NCT05700240

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 17, 2023

Last Update Submit

January 17, 2023

Conditions

Myopia Progression

Outcome Measures

Primary Outcomes (1)

  • Changes in axial length at one year

    one year

Secondary Outcomes (2)

  • changes in refractive error

    one year

  • changes in choroidal thickness

    one year

Study Arms (2)

Orthokeratology treatment

Device: orthokeratology

single-vision spectacle correction

Device: single-vision spectacle correction

Interventions

orthokeratologyDEVICE

rigid contact lenses

Orthokeratology treatment
single-vision spectacle correctionDEVICE

simple wear of spectacle

single-vision spectacle correction

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean-Baptiste CONART

Nancy, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start

November 2, 2019

Primary Completion

June 29, 2020

Study Completion

December 24, 2020

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

FR(1)