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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes in Back Surface Lens Deposits
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Independent examiners will be responsible for the assessment of the primary outcomes, which are the axial length and surface coating.
Eligibility Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Monthly replacement lenses without protein removal
Subjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses
Intervention: orthokeratology (Device)
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
Intervention: orthokeratology (Device)
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
Intervention: Menicon Progent A+B (Device)
Outcomes
Primary Outcomes
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
Axial elongation in 2 years
Time Frame: 12 months
Elongation of the eyeball in 24 months
Secondary Outcomes
- Number of participants with serious adverse effects in 2 years(24 months)
Investigators
Pauline Cho
Professor
The Hong Kong Polytechnic University