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Myopic Control for High Myopes Using Orthokeratology (HM-PRO)

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:
Procornea Nederland B.V.
Information provided by:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT00977236
First received: September 14, 2009
Last updated: November 12, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention
Myopia
 Device: Orthokeratology lenses, DreamLite 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: High Myopia - Partial Reduction Orthokeratology Study

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 ]
  • Rate of regression during the daytime [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, DreamLite 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

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.

  Eligibility

Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977236

Locations
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
Principal Investigator: Pauline Cho The Hong Kong Polytechnic University
  More Information

Publications:

Responsible Party: Dr Pauline Cho, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00977236     History of Changes
Other Study ID Numbers: 4-RP3M
Study First Received: September 14, 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