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

NCT06726499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-12-10

No results posted yet for this study

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

DEVICE

Spherical CRT

Contact lens for myopia progression

DEVICE

Toric CRT

Contact lens for myopia progression

Sponsors & Collaborators

  • Universidad Complutense de Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-09
Primary Completion
2018-06-15
Completion
2024-06-12
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06726499 on ClinicalTrials.gov