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

Universidad Complutense de Madrid

Status: Completed

Conditions: Myopia Progression

Treatments: Device: Toric CRT; Device: Spherical CRT

Study type: Interventional

Funder types: Other

Identifiers

NCT06726499

16/371-E

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: Under 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Ocular diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

spherical design

Experimental group

Treatment:

Device: Spherical CRT

Toric Design

Experimental group

Treatment:

Device: Toric CRT