Myopic Control for High Myopes Using Orthokeratology

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to evaluate and compare the eyeball elongation in high myopic children using partial correction orthokeratology and single-vision spectacles.

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Detailed Description

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Orthokeratology (ortho-k) has been shown to have strong potential for retardation of myopic progression in low myopes. To date, clinical experience has shown the technique to be less effective in achieving full myopic reduction in high myopes. Would myopic control be possible for high myopes undergoing partial correction ortho-k treatment?

A randomized, longitudinal study is designed to investigate the efficacy of partial correction ortho-k in retardation of myopic progression in high myopic children. Eye growth in terms of axial length elongation in children wearing ortho-k and over-spectacles (to correct residual refractive errors) (study group) and those wearing single-vision spectacles (control group) will be evaluated and compared.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Orthokeratology lenses

Children wearing orthokeratology at night for partial correction and spectacles at daytime for residual refractive error will be study group

Group Type EXPERIMENTAL

Orthokeratology lenses

Intervention Type DEVICE

Nightly use of orthokeratology to correct the refractive error and over-specs for a period of two years

Single-vision spectacle lenses

Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group

Group Type OTHER

Single-vision spectacle lenses

Intervention Type DEVICE

Daily use of spectacles to correct the refractive error for a period of two years

Interventions

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Orthokeratology lenses

Nightly use of orthokeratology to correct the refractive error and over-specs for a period of two years

Intervention Type DEVICE

Single-vision spectacle lenses

Daily use of spectacles to correct the refractive error for a period of two years

Intervention Type DEVICE

Other Intervention Names

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Corneal reshaping therapy Glasses Spectacles

Eligibility Criteria

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Inclusion Criteria

* Myopia (refractive sphere): \> 5.75D
* Astigmatism: \< ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
* Spherical equivalent (SE): \> 5.75D
* Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE
* Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes
* Willingness for randomization
* Availability for follow-up for at least 2 years

Exclusion Criteria

* Strabismus at distance or near
* Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
* Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
* Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)

Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes