Peripheral Relative Refractive Power of Orthokeratology Lenses

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

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-10

Study Completion Date

2021-10-19

Brief Summary

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Orthokeratology (OK) has been demonstrated to be an effective intervention for slowing axial elongation in children with myopia. The proposed mechanism of action is the induction of peripheral myopic defocus, which reduces relative peripheral hyperopia on the retina.

This study aims to evaluate changes in relative peripheral retinal refraction before and after OK lens wear using wide-field multispectral retinal refractive topography. The study will also investigate the relationship between these retinal refractive changes and the effectiveness of OK in controlling axial elongation.

Detailed Description

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Conditions

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Myopia; Refractive Error Myopia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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orthokeratology

All participants will be fitted with orthokeratology lenses of the same design. The primary objective is to assess changes in relative peripheral retinal refraction before and after lens wear.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 8 to 15 years old
* myopia of -4.00D or lower,
* regular astigmatism ≤1.50D and non-regular astigmatism ≤1.00D
* intraocular pressure ≤21mmHg
* understand the purpose of the study and have good hygiene and regular follow-up

Exclusion Criteria

* unilateral
* immunocompromised subjects with systemic diseases (such as acute or chronic sinusitis, diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric patients, etc.)
* complicated with other eye diseases that affect OK lens wearing, such as dacryocystitis, blepharitis and other inflammation, glaucoma, etc.
* BCVA more than 1.0
* children with corneal curvature less than 40.00D or higher than 46.00D.

Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xiaoyan Yang

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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OK RPR

Identifier Type: -

Identifier Source: org_study_id