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Retardation of Myopia in Orthokeratology

NCT ID: NCT00962208

Last Updated: 2013-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-12-31

Brief Summary

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The primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.

Detailed Description

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Prevalence of myopia is high in Asian countries like Hong Kong. Orthokeratology has shown potential in slowing myopic progression but the efficacy is yet to be confirmed by a randomized clinical trial (RCT). The current RCT aims at studying the efficacy of orthokeratology in retardation of myopic progression by comparing the eye growth in terms of axial length elongation in children wearing orthokeratology lenses (study group) and those wearing single-vision spectacles (control group).

Conditions

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Myopia

Keywords

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children corneal reshaping myopia myopia control orthokeratology

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 correcting of refractive error will be study group

Group Type EXPERIMENTAL

orthokeratology lenses

Intervention Type DEVICE

Nightly use of orthokeratology to correct the refractive error 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 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 Menicon Z Night Lens CR-39 lenses

Eligibility Criteria

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Inclusion Criteria

* Myopia (refractive sphere): \> 0.50D and ≤ 4.00D
* Astigmatism: \< ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
* Spherical equivalent (SE): \> 0.75D and ≤ 4.50D
* 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
* Willingness to wear contact lenses or spectacles on a daily basis
* 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
* Prior experience with the use of rigid lenses (including orthokeratology)
* Prior experience with myopia control treatment (e.g. refractive therapy or progressive add spectacles)
* 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

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Menicon Co., Ltd.

INDUSTRY

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Pauline Cho

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pauline Cho, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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School of Optometry, The Hong Kong Polytechnic University

Hong Kong, Hong Kong, China

Site Status

Countries

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China

References

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Cho P, Cheung SW, Edwards M. The longitudinal orthokeratology research in children (LORIC) in Hong Kong: a pilot study on refractive changes and myopic control. Curr Eye Res. 2005 Jan;30(1):71-80. doi: 10.1080/02713680590907256.

Reference Type BACKGROUND
PMID: 15875367 (View on PubMed)

Walline JJ, Jones LA, Sinnott LT. Corneal reshaping and myopia progression. Br J Ophthalmol. 2009 Sep;93(9):1181-5. doi: 10.1136/bjo.2008.151365. Epub 2009 May 4.

Reference Type BACKGROUND
PMID: 19416935 (View on PubMed)

Cho P, Cheung SW. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial. Invest Ophthalmol Vis Sci. 2012 Oct 11;53(11):7077-85. doi: 10.1167/iovs.12-10565.

Reference Type RESULT
PMID: 22969068 (View on PubMed)

Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.

Reference Type DERIVED
PMID: 36809645 (View on PubMed)

Cheung SW, Cho P. Validity of axial length measurements for monitoring myopic progression in orthokeratology. Invest Ophthalmol Vis Sci. 2013 Mar 5;54(3):1613-5. doi: 10.1167/iovs.12-10434.

Reference Type DERIVED
PMID: 23361504 (View on PubMed)

Chan KY, Cheung SW, Cho P. Clinical performance of an orthokeratology lens fitted with the aid of a computer software in Chinese children. Cont Lens Anterior Eye. 2012 Aug;35(4):180-4. doi: 10.1016/j.clae.2012.01.004. Epub 2012 Mar 3.

Reference Type DERIVED
PMID: 22390958 (View on PubMed)

Other Identifiers

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H-ZG13

Identifier Type: -

Identifier Source: org_study_id