Effect of Orthokeratology on Myopia Progression in French NCT05700240

Updated 05/28/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT05700240
Other study ID #	2022PI090
Secondary ID
Status	Completed
Phase
First received
Last updated
Start date	November 2, 2019
Est. completion date	December 24, 2020

Study information
Verified date	January 2023
Source	Central Hospital, Nancy, France
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status	Completed
Enrollment	64
Est. completion date	December 24, 2020
Est. primary completion date	June 29, 2020
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	7 Years to 17 Years
Eligibility	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

Related Conditions & MeSH terms

Intervention

Device:
• orthokeratology
rigid contact lenses
• single-vision spectacle correction
simple wear of spectacle

Locations
Country	Name	City	State
France	Jean-Baptiste CONART	Nancy

Sponsors *(1)*
Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Changes in axial length at one year		one year
Secondary	changes in refractive error		one year
Secondary	changes in choroidal thickness		one year

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT06034327` - Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens	N/A
	Not yet recruiting	`NCT06265454` - Low Dose Atropine Eye Drops in Myopic Egyptian Children	Phase 2
	Recruiting	`NCT02623543` - Effectiveness of Orthokeratology in Decreasing Myopic Progression in a Young Adult Population Enrolled in a Professional Optometric Curriculum	Phase 2
	Active, not recruiting	`NCT05893979` - Myopia Control Spectacle Lens Cessation Study	N/A
	Active, not recruiting	`NCT05617794` - Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness	N/A
	Active, not recruiting	`NCT03952702` - Overminus Lens Therapy in Intermittent
	Completed	`NCT05650190` - Spectacle Lens Visual Acuity Assessments Study	N/A
	Completed	`NCT02130167` - Low Concentration Atropine for Myopia Progression in School Children	N/A
	Not yet recruiting	`NCT03381079` - Efficacy and Safety of Posterior Scleral Reinforcement on Controlling Myopia in Adults With High Myopia	Phase 2