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

NCT ID: NCT06726499

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-09

Study Completion Date

2024-06-12

Brief Summary

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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

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Conditions

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Myopia Progression

Keywords

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myopia; orthok

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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spherical design

Group Type EXPERIMENTAL

Spherical CRT

Intervention Type DEVICE

Contact lens for myopia progression

Toric Design

Group Type EXPERIMENTAL

Toric CRT

Intervention Type DEVICE

Contact lens for myopia progression

Interventions

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Spherical CRT

Contact lens for myopia progression

Intervention Type DEVICE

Toric CRT

Contact lens for myopia progression

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Ocular diseases
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Gonzalo Carracedo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Complutense of Madrid

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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16/371-E

Identifier Type: -

Identifier Source: org_study_id