Status:
COMPLETED
Retardation of Myopia in Orthokeratology
Lead Sponsor:
The Hong Kong Polytechnic University
Collaborating Sponsors:
Menicon Co., Ltd.
Conditions:
Myopia
Eligibility:
All Genders
6-10 years
Phase:
NA
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00962208
Start Date
March 1 2008
End Date
December 1 2011
Last Update
October 28 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
School of Optometry, The Hong Kong Polytechnic University
Hong Kong, Hong Kong, China