Monthly Replacement Orthokeratology for Myopia Control in Young Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-07

Study Completion Date

2023-08-31

Brief Summary

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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.

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Detailed Description

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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

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Myopic Progression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Independent examiners will be responsible for the assessment of the primary outcomes, which are the axial length and surface coating.

Study Groups

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Monthly replacement lenses without protein removal

Subjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses

Group Type EXPERIMENTAL

orthokeratology

Intervention Type DEVICE

Nightly wear of orthokeratology lenses to correct vision in the daytime

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

Group Type ACTIVE_COMPARATOR

orthokeratology

Intervention Type DEVICE

Nightly wear of orthokeratology lenses to correct vision in the daytime

Menicon Progent A+B

Intervention Type DEVICE

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.

Interventions

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orthokeratology

Nightly wear of orthokeratology lenses to correct vision in the daytime

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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ortho-k Menicon Z Night lenses Menicon Z Night Toric lenses corneal reshaping therapy Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes