Effect of Orthokeratology on Myopia Progression in French... | NCT05700240

Studies
Effect of Orthokeratology on Myopia Progression in French Children

NCT05700240

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Jan 26, 2023Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Myopia Progression

Interventions

orthokeratology
single-vision spectacle correction

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2, 2019Actual

Primary Completion Date

Jun 29, 2020Actual

Completion Date

Dec 24, 2020Actual

First Submitted Date

Jan 17, 2023

First Submission Date that Met QC Criteria

Jan 17, 2023

First Posted Date

Jan 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2023

Last Update Posted Date

Jan 26, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Professeur Jean-Baptiste CONART, Professeur, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Orthokeratology treatment			Device: orthokeratology
single-vision spectacle correction			Device: single-vision spectacle correction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
orthokeratology	Device	rigid contact lenses	Orthokeratology treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in axial length at one year		one year

Secondary Outcomes

Measure	Description	Time Frame
changes in refractive error		one year
changes in choroidal thickness		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

17 Years

Standard Ages

Child

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

Sampling Method

Non-Probability Sample