Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children

Study Overview
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Brief Summary
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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-vision glasses.

Detailed Description
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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 showed that the effect of myopic control was most significant during the first six months of the treatment. It is unknown whether the myopic control effect would dissipate upon the discontinuation of the treatment or whether the myopic control effect only happened in the first six month of lens wear and was maintained thereafter. The current study aims at evaluating the effect of discontinuation of ortho-k treatment on myopic control in children who are currently on the treatment. This knowledge is necessary and important as patients/parents have concerns about the permanent dependency on ortho-k once they enrolled in the treatment. Children who have been on the treatment for two years and have recently completed the myopic control studies at The Hong Kong Polytechnic University, i.e. the ROMIO, TO-SEE and HM-PRO studies, will be invited to participate in this 14-month study. Ortho-k subjects will be randomly assigned to study group or the ortho-k control group. The study group subjects will be required to stop lens wear for 7 months at the completion of the previous study (Phase I) and resume lens wear for next 7 months (Phase II). The ortho-k control group subjects will be required to continue the current treatment for another 14 months. Control subjects in the existing myopic control studies will be required to continue using the same treatment, i.e. single-vision glasses, for another 14 months. Rate of myopic progression among the 3 groups and at the two study phases will be determined and compared.

Official Title
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Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (1) Discontinuation of Lens Wear in Existing Ortho-k Children

Conditions
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Myopia

Intervention / Treatment
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* Device: ortho-k lenses
* Device: single-vision glasses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-vision glasses and ortho-k lenses<br>Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months | Device: ortho-k lenses<br>* nightly wear of orthokeratology lenses to correct vision<br>* Other names: Menicon Z Night Toric lenses;Device: single-vision glasses<br>* daily wear of spectacle glasses to correct vision<br>* Other names: CR-39 lenses;|
| Active Comparator: ortho-k lenses<br>Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group | Device: ortho-k lenses<br>* nightly wear of orthokeratology lenses to correct vision<br>* Other names: Menicon Z Night Toric lenses;|
| Other: single-vision glasses<br>Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group | Device: single-vision glasses<br>* daily wear of spectacle glasses to correct vision<br>* Other names: CR-39 lenses;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Axial Length | To determine the changes in axial length in the first 7 months and the last 7 months in the three groups of subjects | Baseline, 7 months, and 14 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Effects | The observation of serious and non-serious adverse events in the 14 months of study period | 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, corneal reshaping, myopia, myopia progression, orthokeratology