MR1: Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04295707

Collaborator

Menicon Co., Ltd. (Industry)

Enrollment

Location

Arms

40.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myopic Progression	Device: orthokeratology Device: Menicon Progent A+B	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Accrued Effect of Orthokeratology for Myopia Control in Children and the Effectiveness of Myopia Control Using an Innovative Orthokeratology Modality. Experiment 1. Effect in Existing Ortho-k Wearers

Actual Study Start Date :

Mar 11, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Monthly replacement orthokeratology without protein removal Subjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses	Device: orthokeratology Nightly wear of orthokeratology lenses to correct vision in the daytime Other Names: ortho-k Menicon Z Night lenses Menicon Z Night Toric lenses corneal reshaping therapy
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	Device: orthokeratology Nightly wear of orthokeratology lenses to correct vision in the daytime Other Names: ortho-k Menicon Z Night lenses Menicon Z Night Toric lenses corneal reshaping therapy 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. Other Names: Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
Active Comparator: 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.	Device: orthokeratology Nightly wear of orthokeratology lenses to correct vision in the daytime Other Names: ortho-k Menicon Z Night lenses Menicon Z Night Toric lenses corneal reshaping therapy 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. Other Names: Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

Arm

Intervention/Treatment

Experimental: Monthly replacement orthokeratology without protein removal

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

Device: orthokeratology

Nightly wear of orthokeratology lenses to correct vision in the daytime

Other Names:

ortho-k

Menicon Z Night lenses

Menicon Z Night Toric lenses

corneal reshaping therapy

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

Device: orthokeratology

Nightly wear of orthokeratology lenses to correct vision in the daytime

Other Names:

ortho-k

Menicon Z Night lenses

Menicon Z Night Toric lenses

corneal reshaping therapy

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.

Other Names:

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

Active Comparator: 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.

Device: orthokeratology

Nightly wear of orthokeratology lenses to correct vision in the daytime

Other Names:

ortho-k

Menicon Z Night lenses

Menicon Z Night Toric lenses

corneal reshaping therapy

Device: Menicon Progent A+B

Other Names:

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

Outcome Measures

Primary Outcome Measures

Axial elongation in 2 years [2 years]
Cycloplegic examination of the eyeball length using IOLMaster every 6 monthly
Back Surface Lens Deposits [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 Outcome Measures

Number of participants with serious adverse effects in 2 years [2 years]
Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva in 2 years

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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