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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

September 16, 2009
June 22, 2011
March 2008
June 2012   (final data collection date for primary outcome measure)
Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00978679 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Peripheral Optics in Myopia and Orthokeratology
Peripheral Refraction and Aberration in Myopic Progression and Myopic Control

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.

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).

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myopia
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2012
June 2012   (final data collection date for primary outcome measure)

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)
Both
6 Years to 9 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00978679
G-RGVM
No
Dr Pauline Cho, School of Optometry, The Hong Kong Polytechnic University
The Hong Kong Polytechnic University
Menicon Co., Ltd.
Principal Investigator: Pauline Cho, PhD School of Optometry, The Hong Kong Polytechnic University
The Hong Kong Polytechnic University
September 2009

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