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Retardation of Myopia in Orthokeratology (ROMIO)

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: NCT00962208
Recruitment Status : Completed
First Posted : August 19, 2009
Results First Posted : September 20, 2013
Last Update Posted : October 28, 2013
Sponsor:
Collaborator:
Menicon Co., Ltd.
Information provided by (Responsible Party):
Pauline Cho, The Hong Kong Polytechnic University

Study Description
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Brief Summary:
The primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.

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

Detailed Description:
Prevalence of myopia is high in Asian countries like Hong Kong. Orthokeratology has shown potential in slowing myopic progression but the efficacy is yet to be confirmed by a randomized clinical trial (RCT). The current RCT aims at studying the efficacy of orthokeratology in retardation of myopic progression by comparing the eye growth in terms of axial length elongation in children wearing orthokeratology lenses (study group) and those wearing single-vision spectacles (control group).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Orthokeratology for Myopic Control in Chinese Children - a Randomized Clinical Trial
Study Start Date : March 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

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 correcting of refractive error will be study group
 Device: orthokeratology lenses
Nightly use of orthokeratology to correct the refractive error for a period of two years
Other Names:
  • Corneal reshaping therapy
  • Menicon Z Night Lens
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 Name: CR-39 lenses


Outcome Measures
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Primary Outcome Measures :
  1. Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study [ Time Frame: 2 years ]
    Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer.


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. Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Myopia (refractive sphere): > 0.50D and ≤ 4.00D
  • Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
  • Spherical equivalent (SE): > 0.75D and ≤ 4.50D
  • 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
  • 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 myopia control treatment (e.g. refractive therapy or progressive add 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)
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): NCT00962208


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

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pauline Cho, Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00962208    
Other Study ID Numbers: H-ZG13
First Posted: August 19, 2009    Key Record Dates
Results First Posted: September 20, 2013
Last Update Posted: October 28, 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