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Peripheral Optics in Myopia and Orthokeratology

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ClinicalTrials.gov Identifier: NCT00978679
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
Menicon Co., Ltd.
Information provided by (Responsible Party):
Pauline Cho, The Hong Kong Polytechnic University

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.

Condition or disease Intervention/treatment Phase
Myopia Device: Orthokeratology lenses Device: Spectacles Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peripheral Refraction and Aberration in Myopic Progression and Myopic Control
Study Start Date : March 2008
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Orthokeratology
Myopic children wearing orthokeratology at night will be the study group
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
Others
Myopic children wearing single-vision spectacles in the daytime will serve as control group
Device: Spectacles
Daily use of single vision lenses to correct refractive errors
Other Names:
  • Glasses
  • Eyeglasses



Primary Outcome Measures :
  1. Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length [ Time Frame: 2 years ]


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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978679


Locations
China, Hong Kong
School of Optometry, The Hong Kong Polytechnic University
Hong Kong, Hong Kong, China, 000000
Sponsors and Collaborators
The Hong Kong Polytechnic University
Menicon Co., Ltd.
Investigators
Principal Investigator: Pauline Cho, PhD School of Optometry, The Hong Kong Polytechnic University

Publications of Results:
Other Publications:
Responsible Party: Pauline Cho, Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00978679     History of Changes
Other Study ID Numbers: G-RGVM
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Pauline Cho, The Hong Kong Polytechnic University:
Children
Peripheral refraction
Aberration
Eyeball length
Myopic control
Myopia
Corneal reshaping
Orthokeratology

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases