Status:
COMPLETED
Discontinuation of Lens Wear in New Ortho-k Children (DOEE2)
Lead Sponsor:
The Hong Kong Polytechnic University
Collaborating Sponsors:
Menicon Co., Ltd.
Conditions:
Myopia
Eligibility:
All Genders
6-15 years
Phase:
NA
Brief Summary
This study aims at investigating the efficacy of myopic control using ortho-k in younger and older children.
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). Younger myopic ch...
Eligibility Criteria
Inclusion
- Age: between 6 to 15 years old
- Myopia: between 1.50D and 4.50D in at least one eye
- Spherical equivalent (SE): between -1.00D to -4.50D in both eyes
- Astigmatism: ≤ 3.00D of axes 180 +/- 30 or ≤ 1.00D of other axes; and the amount is less than refractive sphere
- 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 to wear contact lenses or spectacles on a daily basis
- Can obtain good ortho-k results with the study lenses
- Availability for follow-up for at least 14 months
Exclusion
- Strabismus at distance or near
- 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)
- Prior experience with the use of rigid lenses (including ortho-k)
- Prior experience with myopia control treatment (e.g. refractive therapy or progressive spectacles)
- Non-compliance to the follow up schedule
- Non-compliance to the use of the prescribed optical correction
- Poor ocular response to ortho-k lens wear
- Significant residual refractive error after ortho-k treatment resulting in poor unaided vision (worse than 0.18 in logMAR scale)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01236755
Start Date
October 1 2010
End Date
December 1 2013
Last Update
March 11 2020
Active Locations (1)
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1
School of Optometry, The Hong Kong Polytechnic University
Hong Kong, Hong Kong, China