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Retardation of Myopia in Orthokeratology (ROMIO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 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:
NCT00962208
First received: August 18, 2009
Last updated: November 12, 2010
Last verified: November 2010
History of Changes
  Purpose

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


Condition Intervention
Myopia
 Device: Orthokeratology lenses, Menicon Z Night Lens
Device: spherical plastic lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Orthokeratology for Myopic Control in Chinese Children - a Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Determine the change in cycloplegic axial length in the study and control groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Determine changes in other ocular parameters (e.g. corneal biomechanics and aberration) associated with orthokeratology lens wear [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Orthokeratology lenses
Children wearing orthokeratology at night for correcting of refractive error will be study group
 Device: Orthokeratology lenses, Menicon Z Night Lens
Nightly use of orthokeratology to correct the refractive error 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: spherical plastic lenses
Daily use of spectacles to correct the refractive error for a period of two years
Other Name: Glasses

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).

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962208

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

Publications:

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

Responsible Party: Dr Pauline Cho, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00962208     History of Changes
Other Study ID Numbers: H-ZG13
Study First Received: August 18, 2009
Last Updated: November 12, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The Hong Kong Polytechnic University:
children
corneal reshaping
myopia
myopia control
orthokeratology

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013