Effect of Orthokeratology on Myopia Progression in French Children

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT05700240
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Actual Duration (Months): 13.7
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myopia Progression	Device: orthokeratology; Device: single-vision spectacle correction

Study Design

• Study Type: Observational
• Actual Enrollment: 64 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Effect of Orthokeratology on Myopia Progression in French Children
• Actual Study Start Date: Nov 2, 2019
• Actual Primary Completion Date: Jun 29, 2020
• Actual Study Completion Date: Dec 24, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in axial length at one year [one year]

Secondary Outcome Measures

1. changes in refractive error [one year]

2. changes in choroidal thickness [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jean-Baptiste CONART	Nancy		France

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Professeur Jean-Baptiste CONART, Professeur, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT05700240
• Other Study ID Numbers: 2022PI090
• First Posted: Jan 26, 2023
• Last Update Posted: Jan 26, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myopia; Disease Progression

Study Results

No Results Posted as of Jan 26, 2023