Orthokeratology Lens Decentration with Two Designs of Corneal Refractive Therapy™ Lenses: a One-year Prospective Study

Not Applicable

Completed

• Conditions: Myopia Progression

• Registration Number: NCT06726499
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

Background/Objectives: To examine the trend of treatment zone (TZ) decentration over 12 months of Orthokeratology (OK) wear using two corneal refractive therapy (CRT) lens designs: standard (STD) and dual axis (DA). Methods: A prospective, randomized, longitudinal study was conducted at the Optometry Clinic of the Complutense University of Madrid. Subjects were fitted with STD or DA designs in one of the eyes, randomly. Refraction, uncorrected visual acuity (VA) and corneal topography were performed at baseline, 1-night, 1-week, 1-, 3-, 6- and 12-month of lens wear. Subjects requiring lens parameter adjustments or replacements after 3 months were excluded. Decentration was measured by subtracting pre-OK from post-OK tangential curvature maps at each visit, with decentration distance and corneal optical TZ measured using MATLAB. Correlations between decentration and visual acuity (VA) were also analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-09
• Primary Completion: 2018-06-15
• Study Completion: 2024-06-12
• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age between 8 to 17 years old
• Myopia up -6.00 D

Exclusion Criteria

• Ocular diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
contact lens centration	1 year

Trial Locations

Locations (1)

University Complutense of Madrid; 🇪🇸 Madrid, Spain