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| Name | Class |
|---|---|
| Menicon Co., Ltd. | INDUSTRY |
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The two-year prospective study aims at investigating the benefits of frequent replacement (monthly) orthokeratology lenses in myopia control in terms of effectiveness in control and prevention of ocular complications. The secondary objective will be investigating the use of weekly protein removal system in monthly replacement modality orthokeratology lenses on surface deposit.
This is a two-year randomized trial. Existing orthokeratology lens wearers (aged 8-13 years), who have completed a 2-year myopia control using orthokeratology, will be recruited and monitored for another two years. Eligible subjects will be randomly assigned to monthly or yearly replacement modality. Axial elongation and ocular conditions will be compared between the monthly and yearly replacement groups.
Subjects on monthly replacement lenses 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. All subjects on yearly replacement lenses will be required to performed intensive cleaning such that they will follow normal daily cleaning and disinfection as well as weekly protein removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monthly replacement orthokeratology 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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| Yearly replacement lenses with weekly protein removal | Active Comparator | Subjects will be prescribed with orthokeratology lenses which will be replaced at least every 12 months during the study period. They will be required to perform both daily cleaning and weekly protein removal for their 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 | Cycloplegic examination of the eyeball length using IOLMaster every 6 monthly | 2 years |
| 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 12 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 2 years | 2 years |
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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 randomly assigned to use monthly or yearly replacement orthokeratology for a period of 24 months. Subjects on monthly replacement modality 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.
Intensive cleaning is indicated for yearly replacement modality, thus, no randomization of care procedures in this group.
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The outcome assessor was responsible for measuring the axial length and was unaware of the replacement modality of intervention used by the subjects. Another independent examiner will be responsible for grading surface coating from the images taken without disclosure of the information on the cleaning procedures.
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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. |