Peripheral Optics in Myopia and Orthokeratology

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by The Hong Kong Polytechnic University.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Menicon Co., Ltd.

Information provided by:

The Hong Kong Polytechnic University

ClinicalTrials.gov Identifier:

NCT00978679

First received: September 16, 2009

Last updated: June 22, 2011

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 16, 2009

Last Updated Date

June 22, 2011

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00978679 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Peripheral Optics in Myopia and Orthokeratology

Official Title ^ICMJE

Peripheral Refraction and Aberration in Myopic Progression and Myopic Control

Brief Summary

The primary objective of the current study is to investigate changes in peripheral refraction and aberration in children wearing orthokeratology lenses and single-vision spectacles.

Detailed Description

Apart from being effective in reducing low to moderate myopia, orthokeratology has been shown to have potential in retarding myopic progression. The central cornea is flattened and peripheral optics altered in orthokeratology and it has been suggested that orthokeratology slows myopic progression through the alteration of peripheral optics. The aim of the current study is to investigate the changes in peripheral refraction and aberration in children wearing orthokeratology (study group) and single-vision spectacles (control group).

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Myopia

Intervention ^ICMJE

Device: Orthokeratology lenses
Nightly use of orthokeratology lenses to correct the refractive errors
Other Names:
- Menicon Z Night Lens 2
- Menicon Z Night Lens 2 Toric
Device: Spectacles
Daily use of single vision lenses to correct refractive errors
Other Names:
- Glasses
- Eyeglasses

Study Arm (s)

Experimental: Orthokeratology
Myopic children wearing orthokeratology at night will be the study group

Intervention: Device: Orthokeratology lenses
Others
Myopic children wearing single-vision spectacles in the daytime will serve as control group

Intervention: Device: Spectacles

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

December 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Myopia (refractive sphere): > 0.50D and ≤ 6.00D
Astigmatism: with-the-rule astigmatism (axes 180 +/- 30) ≤ 1.50D; astigmatism of other axes ≤ 0.50D
Spherical equivalent (SE): > 0.50D and ≤ 6.75D (myopia)
Best corrected monocular visual acuity: equal to or better than 6/7.5 in Snellen scale
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 myopic control treatment (e.g. refractive therapy or progressive 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)

Gender

Both

Ages

6 Years to 9 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00978679

Other Study ID Numbers ^ICMJE

G-RGVM

Has Data Monitoring Committee

Responsible Party

Dr Pauline Cho, School of Optometry, The Hong Kong Polytechnic University

Study Sponsor ^ICMJE

The Hong Kong Polytechnic University

Collaborators ^ICMJE

Menicon Co., Ltd.

Investigators ^ICMJE

Principal Investigator:

Pauline Cho, PhD

School of Optometry, The Hong Kong Polytechnic University

Information Provided By

The Hong Kong Polytechnic University

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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