Myopic ProgressionMR2NCT04293328
Monthly Replacement Orthokeratology for Myopia Control in Young Children
A study testing orthokeratology and Menicon Progent A+B in people with Myopic Progression, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopic Progression
- What is being tested?
- orthokeratology and Menicon Progent A+B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Jul 2020to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Optometry, The Hong Kong Polytechnic University
Kowloon
About this study
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
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.
Read the 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.
- Conditions
- Myopic Progression
- Being tested
- orthokeratology, Menicon Progent A+B
- Keywords
- Myopia progression, Orthokeratology, Replacement modality, Surface deposits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthokeratologyDevice
Also called ortho-k, Menicon Z Night lenses, Menicon Z Night Toric lenses, corneal reshaping therapy
Nightly wear of orthokeratology lenses to correct vision in the daytime
Menicon Progent A+BDevice
Also called Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
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.
| Study group | Role | What they receive |
|---|---|---|
| Monthly replacement lenses without protein removal | Experimental | Subjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses Receives: Device: orthokeratology |
| 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 Receives: Device: orthokeratology; Device: Menicon Progent A+B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial elongation in 2 years
Elongation of the eyeball in 24 months
Measured: 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
Measured: Every month up to 24 months
Secondary outcomes (1)
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start7 Jul 2020
- Primary completionJun 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myopic ProgressionStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Menicon Co., Ltd.
- Responsible party
- Principal investigator, Pauline Cho, The Hong Kong Polytechnic University
- Investigators
- Pauline Cho, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293328
- Sponsor's protocol ID
- HSEARS20190926004-2
- Acronym
- MR2
- Status last verified
- Jul 2022
- First submitted
- 29 Feb 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29216865Stapleton 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.
PubMed 22134592Cho 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.
PubMed 22969068Hiraoka 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.
PubMed 22577080Cheung 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.
PubMed 30366778
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04293328
- Acronym / sponsor ID
- MR2 / HSEARS20190926004-2
- Conditions
- Myopic Progression
- Keywords
- Myopia progression, Orthokeratology, Replacement modality, Surface deposits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Menicon Co., Ltd.
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Monthly replacement lenses without protein removal | Experimental | Device: orthokeratologySubjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses |
| Monthly replacement lenses with weekly protein removal | Active comparator | Device: orthokeratology, Device: Menicon Progent A+BSubjects will be required to perform both daily cleaning and weekly protein removal for the monthly replacement orthokeratology lenses |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orthokeratologyAlso: ortho-k, Menicon Z Night lenses, Menicon Z Night Toric lenses, corneal reshaping therapyNightly wear of orthokeratology lenses to correct vision in the daytime | Device | Monthly replacement lenses with weekly protein removal, Monthly replacement lenses without protein removal |
| Menicon Progent A+BAlso: Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesMenicon 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. | Device | Monthly replacement lenses with weekly protein removal |
Primary outcome
Axial elongation in 2 years
Time frame: 12 months
Elongation of the eyeball in 24 months
Changes in Back Surface Lens Deposits
Time frame: Every month up to 24 months
Surface deposits will be graded using a 4-point scale: 0=no deposit; 1=mild; 2=moderate; 3=severe
1 secondary outcome
Number of participants with serious adverse effects in 2 years
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 29216865Lee 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.
- Background: PubMed 22134592Stapleton 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.
- Background: PubMed 22969068Cho 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.
- Background: PubMed 22577080Hiraoka 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.
- Background: PubMed 30366778Cheung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline Cho, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthokeratology and Menicon Progent A+B in people with Myopic Progression, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial elongation in 2 years (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293328, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.