Discontinuation of Lens Wear in New Ortho-k Children (DOEE2)
Recruitment status was Recruiting
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Purpose
This study aims at investigating the efficacy of myopic control using ortho-k in younger and older children.
| Condition | Intervention |
|---|---|
|
Myopia |
Procedure: Switching of single-vision spectacles to orthokeratology |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (2) Discontinuation of Lens Wear in New Ortho-k Children |
- Axial length [ Time Frame: 14 months ] [ Designated as safety issue: No ]To determine and compare the rate of axial elongation in spectacle lens and contact lens wear periods
- Incidence of adverse effects [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]To determine the incidence of adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva
| Estimated Enrollment: | 90 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Switching to ortho-k
Children wearing single-vision spectacles will be switched to ortho-k for correction of refractive errors
|
Procedure: Switching of single-vision spectacles to orthokeratology
Switching from single-vision spectacles to orthokeratology to correct the refractive errors
|
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 children (aged 6-10 years old) may have the faster increase in myopia than old myopic children (aged 11-15 years old), i.e. the rate of myopic progression may be different in different age groups and in children with different refractive status (Edwards 1999; Fan et al. 2004; Cheng et al. 2007). Although the refractive correction with ortho-k has been well documented, it is unknown whether the efficiency and reversibility of ortho-k for myopic reduction as well as myopic control are similar in children of different age and refractive groups.
In this 14-month study, the eyeball length in 45 younger (6-10 years old) and 45 older (11-15 years old) myopic children before and after ortho-k will be evaluated. Eyeball elongation will be determined for the first 7 months when single-vision glasses will be prescribed (Phase I) and the next 7 months when ortho-k will be prescribed (Phase I). Rate of myopic progression will be determined and compared between the two groups of children in the two phases.
Eligibility| Ages Eligible for Study: | 6 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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)
Contacts and Locations| Contact: Pauline Cho, PhD | (852) 2766 6100 | sopaulin@inet.polyu.edu.hk |
| Contact: Sin Wan Cheung, MPhil | (852) 2766 4462 | sopeggy@inet.polyu.edu.hk |
| China | |
| School of Optometry, The Hong Kong Polytechnic University | Recruiting |
| Hong Kong SAR, China | |
| Contact: Pauline Cho, PhD (852) 2766 6100 sopaulin@inet.polyu.edu.hk | |
| Contact: Sin Wan Cheung, MPhil (852) 2766 4662 sopeggy@inet.polyu.edu.hk | |
| Principal Investigator: Pauline Cho, PhD | |
| Principal Investigator: | Pauline Cho, PhD | The Hong Kong Polytechnic University |
More Information
Publications:
| Responsible Party: | Dr Pauline Cho, School of Optometry, The Hong Kong Polytechnic University |
| ClinicalTrials.gov Identifier: | NCT01236755 History of Changes |
| Other Study ID Numbers: | H-ZG50-2 |
| Study First Received: | November 8, 2010 |
| Last Updated: | June 23, 2011 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by The Hong Kong Polytechnic University:
|
children corneal reshaping myopia myopia progression orthokeratology |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on June 18, 2013