Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-11

Study Completion Date

2023-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myopic Progression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcome assessor was responsible for measuring the axial length and was unaware of the replacement modality of intervention used by the subjects. Another independent examiner will be responsible for grading surface coating from the images taken without disclosure of the information on the cleaning procedures.

Study Groups

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Monthly replacement orthokeratology 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.

Yearly replacement lenses with weekly protein removal

Subjects 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.

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 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

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

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes