Monthly Replacement Orthokeratology for Myopia Control in Young Children (MR2)
Primary Purpose
Myopic Progression
Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
orthokeratology
Menicon Progent A+B
Sponsored by
About this trial
This is an interventional treatment trial for Myopic Progression focused on measuring Myopia progression, Orthokeratology, Replacement modality, Surface deposits
Eligibility Criteria
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
Sites / Locations
- School of Optometry, The Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Monthly replacement lenses without protein removal
Monthly replacement lenses with weekly protein removal
Arm Description
Subjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses
Subjects will be required to perform both daily cleaning and weekly protein removal for the monthly replacement orthokeratology lenses
Outcomes
Primary Outcome Measures
Axial elongation in 2 years
Elongation of the eyeball in 24 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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04293328
First Posted
February 29, 2020
Last Updated
July 18, 2022
Sponsor
The Hong Kong Polytechnic University
Collaborators
Menicon Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04293328
Brief Title
Monthly Replacement Orthokeratology for Myopia Control in Young Children
Acronym
MR2
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Menicon Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopic Progression
Keywords
Myopia progression, Orthokeratology, Replacement modality, Surface deposits
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Independent examiners will be responsible for the assessment of the primary outcomes, which are the axial length and surface coating.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monthly replacement lenses without protein removal
Arm Type
Experimental
Arm Description
Subjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses
Arm Title
Monthly replacement lenses with weekly protein removal
Arm Type
Active Comparator
Arm Description
Subjects will be required to perform both daily cleaning and weekly protein removal for the monthly replacement orthokeratology lenses
Intervention Type
Device
Intervention Name(s)
orthokeratology
Other Intervention Name(s)
ortho-k, Menicon Z Night lenses, Menicon Z Night Toric lenses, corneal reshaping therapy
Intervention Description
Nightly wear of orthokeratology lenses to correct vision in the daytime
Intervention Type
Device
Intervention Name(s)
Menicon Progent A+B
Other Intervention Name(s)
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
Intervention Description
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.
Primary Outcome Measure Information:
Title
Axial elongation in 2 years
Description
Elongation of the eyeball in 24 months
Time Frame
12 months
Title
Changes in Back Surface Lens Deposits
Description
Surface deposits will be graded using a 4-point scale: 0=no deposit; 1=mild; 2=moderate; 3=severe
Time Frame
Every month up to 24 months
Secondary Outcome Measure Information:
Title
Number of participants with serious adverse effects in 2 years
Description
Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva in 12 months
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Cho, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Optometry, The Hong Kong Polytechnic University
City
Kowloon
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
29216865
Citation
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.
Results Reference
background
PubMed Identifier
22134592
Citation
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.
Results Reference
background
PubMed Identifier
22969068
Citation
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.
Results Reference
background
PubMed Identifier
22577080
Citation
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.
Results Reference
background
PubMed Identifier
30366778
Citation
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.
Results Reference
background
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Monthly Replacement Orthokeratology for Myopia Control in Young Children
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