Status:
COMPLETED
Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children
Lead Sponsor:
The Hong Kong Polytechnic University
Collaborating Sponsors:
Menicon Co., Ltd.
Conditions:
Myopia
Eligibility:
All Genders
8-14 years
Phase:
NA
Brief Summary
The primary aim of this study is to compare eyeball elongation in existing ortho-k subjects who stop the treatment with subjects who continue ortho-k lens wear and control subjects wearing single-visi...
Detailed Description
Children wearing ortho-k have been shown to have slower rate of myopic progression than those wearing single-vision spectacles (Cho et al. 2005) or soft lenses (Walline et al. 2009). Both studies show...
Eligibility Criteria
Inclusion
- Age 8-14 years old (inclusive)
- Subjects who have completed the ROMIO, TO-SEE or HM-PRO studies at The Hong Kong Polytechnic University
- Willingness to be randomized into groups (for ortho-k subjects)
- Availability for follow-up for at least 14 months
Exclusion
- Non-compliance to the follow up schedule
- Non-compliance to the assigned optical correction (i.e. single-vision glasses or ortho-k lenses)
- Contraindication for contact lens wear and ortho-k (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 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01236742
Start Date
July 1 2010
End Date
June 1 2013
Last Update
December 18 2017
Active Locations (1)
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1
School of Optometry, The Hong Kong Polytechnic University
Hong Kong, Hong Kong, China