Peripheral Optics in Myopia and Orthokeratology

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 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:
NCT00978679
First received: September 16, 2009
Last updated: June 22, 2011
Last verified: September 2009
  Purpose

The primary objective of the current study is to investigate changes in peripheral refraction and aberration in children wearing orthokeratology lenses and single-vision spectacles.


Condition Intervention
Myopia
Device: Orthokeratology lenses
Device: Spectacles

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peripheral Refraction and Aberration in Myopic Progression and Myopic Control

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Orthokeratology
Myopic children wearing orthokeratology at night will be the study group
Device: Orthokeratology lenses
Nightly use of orthokeratology lenses to correct the refractive errors
Other Names:
  • Menicon Z Night Lens 2
  • Menicon Z Night Lens 2 Toric
Others
Myopic children wearing single-vision spectacles in the daytime will serve as control group
Device: Spectacles
Daily use of single vision lenses to correct refractive errors
Other Names:
  • Glasses
  • Eyeglasses

Detailed Description:

Apart from being effective in reducing low to moderate myopia, orthokeratology has been shown to have potential in retarding myopic progression. The central cornea is flattened and peripheral optics altered in orthokeratology and it has been suggested that orthokeratology slows myopic progression through the alteration of peripheral optics. The aim of the current study is to investigate the changes in peripheral refraction and aberration in children wearing orthokeratology (study group) and single-vision spectacles (control group).

  Eligibility

Ages Eligible for Study:   6 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Myopia (refractive sphere): > 0.50D and ≤ 6.00D
  • Astigmatism: with-the-rule astigmatism (axes 180 +/- 30) ≤ 1.50D; astigmatism of other axes ≤ 0.50D
  • Spherical equivalent (SE): > 0.50D and ≤ 6.75D (myopia)
  • Best corrected monocular visual acuity: equal to or better than 6/7.5 in Snellen scale
  • 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 myopic control treatment (e.g. refractive therapy or progressive 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: NCT00978679

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

Publications:
Responsible Party: Dr Pauline Cho, School of Optometry, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00978679     History of Changes
Other Study ID Numbers: G-RGVM
Study First Received: September 16, 2009
Last Updated: June 22, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The Hong Kong Polytechnic University:
Children
Peripheral refraction
Aberration
Eyeball length
Myopic control
Myopia
Corneal reshaping
Orthokeratology

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014