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Myopic ProgressionMR1NCT04295707

Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 8 to 15 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
80 participants
Where
1 siteHong Kong
Study dates
11 Mar 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 8 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Aged 8-15 years
  • Have completed a two-year myopia control study using ortho-k
  • Normal ocular and general condition and not on medication which may contraindicate ortho-k lens wear
  • Pre-ortho-k refractive sphere between -0.75 to -4.00 DS, refractive cylinder ≤ -1.50 DC and anisometropia ≤ -1.00 D
  • Best correctable vision better than 0.08 logMAR in the worse eye
  • Normal binocular function and accommodative status

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

Other trials in Hong Kong

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 1. Effect in Existing Ortho-k Wearers

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.

Read the detailed description

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.

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 groups in NCT04295707
Study groupRoleWhat they receive
Monthly replacement orthokeratology without protein removalExperimentalSubjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses
Receives: Device: orthokeratology
Monthly replacement lenses with weekly protein removalActive comparatorSubjects 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
Yearly replacement lenses with weekly protein removalActive comparatorSubjects 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.
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.

  1. Axial elongation in 2 years

    Cycloplegic examination of the eyeball length using IOLMaster every 6 monthly

    Measured: 2 years

  2. 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 12 months

Secondary outcomes (1)

  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 2 years

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2020
  2. Study start11 Mar 2020
  3. Primary completionJun 2023 (estimated)
  4. Study completionAug 2023 (estimated)

Resources

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 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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04295707
Sponsor's protocol ID
HSEARS20190926004-1
Acronym
MR1
Status last verified
Jul 2022
First submitted
29 Feb 2020
Last updated
19 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 29216865

  • 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.

    PubMed 22134592

  • 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.

    PubMed 22969068

  • 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.

    PubMed 22577080

  • 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.

    PubMed 30366778

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 19 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: 2 years). 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 NCT04295707, 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 19 Jul 2022.

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