- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04293328
Monthly Replacement Orthokeratology for Myopia Control in Young Children (MR2)
July 18, 2022 updated by: Pauline Cho, The Hong Kong Polytechnic University
Accrued Effect of Orthokeratology for Myopia Control in Children and the Effectiveness of Myopia Control Using an Innovative Orthokeratology Modality. Experiment 2. Effect in New Ortho-k Wearers
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kowloon, Hong Kong
- School of Optometry, The Hong Kong Polytechnic University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 6-10 years
- Normal ocular and general condition and not on medication which may contraindicate ortho-k lens wear
- Refractive sphere between -0.75 to -4.00 D, refractive cylinder ≤ -1.50 D and anisometropia ≤ -1.00 D
- Best correctable vision better than 0.08 logMAR in the worse eye
- Normal binocular function and accommodative status
- No prior experience in contact lens wear and myopia control treatment
Exclusion Criteria:
- Strabismus at distance or near
- Contraindication for ortho-k lens wear
- Prior history of ocular surgery, trauma, or chronic ocular disease
- Systemic or ocular conditions that may interfere refractive development
- Systemic or ocular conditions that may interfere tear quality and contact lens wear
- Poor response to the use of study lenses
- Poor compliance to test procedures
- Poor compliance to the use of ortho-k lenses (e.g. use of solution, use of lenses)
- Poor compliance to follow-up schedule
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Monthly replacement lenses without protein removal
Subjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses
|
Nightly wear of orthokeratology lenses to correct vision in the daytime
Other Names:
|
Active Comparator: Monthly replacement lenses with weekly protein removal
Subjects will be required to perform both daily cleaning and weekly protein removal for the monthly replacement orthokeratology lenses
|
Nightly wear of orthokeratology lenses to correct vision in the daytime
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Axial elongation in 2 years
Time Frame: 12 months
|
Elongation of the eyeball in 24 months
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12 months
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Changes in Back Surface Lens Deposits
Time Frame: Every month up to 24 months
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Surface deposits will be graded using a 4-point scale: 0=no deposit; 1=mild; 2=moderate; 3=severe
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Every month up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with serious adverse effects in 2 years
Time Frame: 24 months
|
Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva in 12 months
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 7, 2020
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
February 29, 2020
First Submitted That Met QC Criteria
February 29, 2020
First Posted (Actual)
March 3, 2020
Study Record Updates
Last Update Posted (Actual)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 18, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20190926004-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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