Myopic Progression
Conditions
Keywords
Myopia progression, Orthokeratology, Replacement modality, Surface deposits
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.
Interventions
DEVICEorthokeratology
Nightly wear of orthokeratology lenses to correct vision in the daytime
DEVICEMenicon 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.
Sponsors
Menicon Co., Ltd.
The Hong Kong Polytechnic University
Study design
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial elongation in 2 years | 12 months | Elongation of the eyeball in 24 months |
| Changes in Back Surface Lens Deposits | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with serious adverse effects in 2 years | 24 months | Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva in 12 months |
Countries
Hong Kong
Outcome results
None listed