Status:
COMPLETED
Myopic Control for High Myopes Using Orthokeratology
Lead Sponsor:
The Hong Kong Polytechnic University
Collaborating Sponsors:
Procornea Nederland B.V.
Conditions:
Myopia
Eligibility:
All Genders
8-11 years
Phase:
NA
Brief Summary
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.
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 achi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00977236
Start Date
July 1 2008
End Date
December 1 2012
Last Update
July 12 2013
Active Locations (1)
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1
School of Optometry, The Hong Kong Polytechnic University
Hong Kong SAR, China