Monthly Replacement Orthokeratology for Myopia Control in Young Children

Overview

The one-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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2021

Detailed Description

In this one-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.

Interventions

  • Device: orthokeratology
    • Nightly wear of orthokeratology lenses to correct vision in the daytime
  • Device: Menicon Progent A+B
    • 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.

Arms, Groups and Cohorts

  • Experimental: Monthly replacement lenses without protein removal
    • Subjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Axial elongation in 1 year
    • Time Frame: 12 months
    • Elongation of the eyeball in 12 months
  • Changes in Back Surface Lens Deposits
    • Time Frame: Every month up to 12 months
    • Surface deposits will be graded using a 4-point scale: 0=no deposit; 1=mild; 2=moderate; 3=severe

Secondary Measures

  • Number of participants with serious adverse effects in 1 year
    • Time Frame: 12 months
    • Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva in 12 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Hong Kong Polytechnic University
  • Collaborator
    • Menicon Co., Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pauline Cho, Professor – The Hong Kong Polytechnic University
  • Overall Official(s)
    • Pauline Cho, PhD, Principal Investigator, The Hong Kong Polytechnic University
  • Overall Contact(s)
    • Pauline Cho, PhD, (852) 2766 6100, pauline.cho@polyu.edu.hk

References

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. Review.

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.

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.

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