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Peripheral Optics in Myopia and Orthokeratology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 16, 2009
First Posted Date  ICMJE September 17, 2009
Last Update Posted Date February 23, 2016
Study Start Date  ICMJE March 2008
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2009)
Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Arms  ICMJE
  • 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 Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2016)
90
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2009)
100
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00978679
Other Study ID Numbers  ICMJE G-RGVM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Pauline Cho, The Hong Kong Polytechnic University
Original Responsible Party Dr Pauline Cho, School of Optometry, The Hong Kong Polytechnic University
Current Study Sponsor  ICMJE The Hong Kong Polytechnic University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Menicon Co., Ltd.
Investigators  ICMJE
Principal Investigator: Pauline Cho, PhD School of Optometry, The Hong Kong Polytechnic University
PRS Account The Hong Kong Polytechnic University
Verification Date February 2016

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