Retardation of Myopia in Orthokeratology (ROMIO)

This study has been completed.
Sponsor:
Collaborator:
Menicon Co., Ltd.
Information provided by (Responsible Party):
Pauline Cho, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT00962208
First received: August 18, 2009
Last updated: September 21, 2013
Last verified: July 2013
  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
Device: single-vision spectacle 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:


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

Primary Outcome Measures:
  • Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • 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 ]

Enrollment: 102
Study Start Date: March 2008
Study Completion Date: December 2011
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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962208

Locations
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
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: Pauline Cho, Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00962208     History of Changes
Other Study ID Numbers: H-ZG13
Study First Received: August 18, 2009
Results First Received: July 17, 2013
Last Updated: September 21, 2013
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 September 18, 2014