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| Name | Class |
|---|---|
| Menicon Co., Ltd. | INDUSTRY |
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The two-year prospective study aims at investigating frequently replacement effect on myopia control in young children, and the use of weekly protein removal system in monthly replacement modality orthokeratology lenses on surface deposit.
In this two-year prospective study, low myopic children, aged 6-8 years, who have no prior experience in contact lens wear and myopia control treatment will be recruited. They will be prescribed with monthly replacement orthokeratology lenses for a period of one year. Axial elongation and ocular conditions during the study will be determined. Subjects will be randomly assigned to normal cleaning and intensive cleaning groups. Subjects in normal cleaning group will be provided with complimentary contact lenses solutions for daily cleaning and disinfection. In addition to the daily procedures for lens case, subjects in the intensive cleaning group will be required to perform weekly protein removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monthly replacement lenses without protein removal | Experimental | Subjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses |
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| Monthly replacement lenses with weekly protein removal | Active Comparator | Subjects will be required to perform both daily cleaning and weekly protein removal for the monthly replacement orthokeratology lenses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orthokeratology | Device | Nightly wear of orthokeratology lenses to correct vision in the daytime |
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| Measure | Description | Time Frame |
|---|---|---|
| Axial elongation in 2 years | Elongation of the eyeball in 24 months | 12 months |
| Changes in Back Surface Lens Deposits | Surface deposits will be graded using a 4-point scale: 0=no deposit; 1=mild; 2=moderate; 3=severe | Every month up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with serious adverse effects in 2 years | Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva in 12 months | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pauline Cho, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry, The Hong Kong Polytechnic University | Kowloon | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29216865 | Background | Lee YC, Wang JH, Chiu CJ. Effect of Orthokeratology on myopia progression: twelve-year results of a retrospective cohort study. BMC Ophthalmol. 2017 Dec 8;17(1):243. doi: 10.1186/s12886-017-0639-4. | |
| 22134592 | Background | Stapleton F, Carnt N. Contact lens-related microbial keratitis: how have epidemiology and genetics helped us with pathogenesis and prophylaxis. Eye (Lond). 2012 Feb;26(2):185-93. doi: 10.1038/eye.2011.288. Epub 2011 Dec 2. |
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All subjects will be prescribed with monthly replacement orthokeratology for a period of 12 months. They will be randomly assigned to normal cleaning and intensive cleaning groups on 1:1 basis. All subjects follow the same daily cleaning procedures and subjects in intensive cleaning group will be required to perform weekly protein removal in addition to the daily routine.
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Independent examiners will be responsible for the assessment of the primary outcomes, which are the axial length and surface coating.
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| Menicon Progent A+B | Device | Menicon Progent A+B is a commercially available protein remover for rigid lenses. It has received FDA clearance and been launched in Hong Kong for over a decade. The product contains two separate sterile solutions, one with sodium hypochlorite and the other with potassium bromide. By mixing the two solutions in a special vial, it can clean and remove protein deposits on the lenses. Parents of subjects assigned to use weekly protein remover will be required to soak the cleansed lenses in the solution mixture for not more than 30 mins every week. All lenses must be rinsed thoroughly with saline and cleansed with daily cleaner again before daily disinfection. |
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| 22969068 | Background | Cho P, Cheung SW. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial. Invest Ophthalmol Vis Sci. 2012 Oct 11;53(11):7077-85. doi: 10.1167/iovs.12-10565. |
| 22577080 | Background | Hiraoka T, Kakita T, Okamoto F, Takahashi H, Oshika T. Long-term effect of overnight orthokeratology on axial length elongation in childhood myopia: a 5-year follow-up study. Invest Ophthalmol Vis Sci. 2012 Jun 22;53(7):3913-9. doi: 10.1167/iovs.11-8453. |
| 30366778 | Background | Cheung SW, Boost MV, Cho P. Pre-treatment observation of axial elongation for evidence-based selection of children in Hong Kong for myopia control. Cont Lens Anterior Eye. 2019 Aug;42(4):392-398. doi: 10.1016/j.clae.2018.10.006. Epub 2018 Oct 24. |