NCT06726499

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopia Progression

Interventions

Type	Name	Description
DEVICE	Spherical CRT	Contact lens for myopia progression
DEVICE	Toric CRT	Contact lens for myopia progression

Timeline

• Start date: 2018-06-09
• Primary completion: 2018-06-15
• Completion: 2024-06-12
• First posted: 2024-12-10
• Last updated: 2024-12-10

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study