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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myopia Device: Orthokeratology lenses Device: Single-vision spectacle lenses Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: High Myopia - Partial Reduction Orthokeratology Study
Study Start Date : July 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Orthokeratology lenses
Children wearing orthokeratology at night for partial correction and spectacles at daytime for residual refractive error will be study group
 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
Single-vision spectacle lenses
Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group
 Device: Single-vision spectacle lenses
Daily use of spectacles to correct the refractive error for a period of two years
Other Names:
  • Glasses
  • Spectacles


Outcome Measures
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Primary Outcome Measures :
  1. Determine the change in cycloplegic axial length in the study and control groups [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Rate of regression during the daytime [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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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): NCT00977236


Locations
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China
School of Optometry, The Hong Kong Polytechnic University
Hong Kong SAR, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Procornea Nederland B.V.
Investigators
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Principal Investigator: Pauline Cho The Hong Kong Polytechnic University
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Pauline Cho, Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00977236    
Other Study ID Numbers: 4-RP3M
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: July 12, 2013
Last Verified: July 2013
Keywords provided by Pauline Cho, The Hong Kong Polytechnic University:
children
corneal reshaping
myopia
myopia control
orthokeratology
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases