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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06726499
Enrollment
70
Registered
2024-12-10
Start date
2018-06-09
Completion date
2024-06-12
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia Progression

Keywords

myopia; orthok

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.

Interventions

DEVICESpherical CRT

Contact lens for myopia progression

DEVICEToric CRT

Contact lens for myopia progression

Sponsors

Universidad Complutense de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Ocular diseases

Design outcomes

Primary

MeasureTime frame
contact lens centration1 year

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026