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Myopic Control for High Myopes Using Orthokeratology (HM-PRO)

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: NCT00977236
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : July 12, 2013
Sponsor:
Collaborator:
Procornea Nederland B.V.
Information provided by (Responsible Party):
Pauline Cho, The Hong Kong Polytechnic University

Tracking Information
First Submitted Date  ICMJE September 14, 2009
First Posted Date  ICMJE September 15, 2009
Last Update Posted Date July 12, 2013
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
Determine the change in cycloplegic axial length in the study and control groups [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
  • Determine the incidence of adverse effects in cornea, the palpebral, bulbar and tarsal conjunctiva in the study and the control groups [ Time Frame: 2 years ]
  • Rate of regression during the daytime [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myopic Control for High Myopes Using Orthokeratology
Official Title  ICMJE High Myopia - Partial Reduction Orthokeratology Study
Brief Summary The purpose of this study is to evaluate and compare the eyeball elongation in high myopic children using partial correction orthokeratology and single-vision spectacles.
Detailed Description

Orthokeratology (ortho-k) has been shown to have strong potential for retardation of myopic progression in low myopes. To date, clinical experience has shown the technique to be less effective in achieving full myopic reduction in high myopes. Would myopic control be possible for high myopes undergoing partial correction ortho-k treatment?

A randomized, longitudinal study is designed to investigate the efficacy of partial correction ortho-k in retardation of myopic progression in high myopic children. Eye growth in terms of axial length elongation in children wearing ortho-k and over-spectacles (to correct residual refractive errors) (study group) and those wearing single-vision spectacles (control group) will be evaluated and compared.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE
  • Device: Orthokeratology lenses
    Nightly use of orthokeratology to correct the refractive error and over-specs for a period of two years
    Other Name: Corneal reshaping therapy
  • Device: Single-vision spectacle lenses
    Daily use of spectacles to correct the refractive error for a period of two years
    Other Names:
    • Glasses
    • Spectacles
Study Arms  ICMJE
  • Experimental: Orthokeratology lenses
    Children wearing orthokeratology at night for partial correction and spectacles at daytime for residual refractive error will be study group
    Intervention: Device: Orthokeratology lenses
  • Single-vision spectacle lenses
    Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group
    Intervention: Device: Single-vision spectacle lenses
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: July 11, 2013)
52
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2009)
60
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Myopia (refractive sphere): > 5.75D
  • Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
  • Spherical equivalent (SE): > 5.75D
  • 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
  • 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
  • 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 8 Years to 11 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 NCT00977236
Other Study ID Numbers  ICMJE 4-RP3M
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pauline Cho, The Hong Kong Polytechnic University
Study Sponsor  ICMJE The Hong Kong Polytechnic University
Collaborators  ICMJE Procornea Nederland B.V.
Investigators  ICMJE
Principal Investigator: Pauline Cho The Hong Kong Polytechnic University
PRS Account The Hong Kong Polytechnic University
Verification Date July 2013

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