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Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers (MR1)

Primary Purpose

Myopic Progression

Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
orthokeratology
Menicon Progent A+B
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopic Progression focused on measuring Myopia progression, Orthokeratology, Replacement modality, Surface deposits

Eligibility Criteria

8 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Optometry, The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Monthly replacement orthokeratology without protein removal

Monthly replacement lenses with weekly protein removal

Yearly replacement lenses with weekly protein removal

Arm Description

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

Subjects will be required to perform both daily cleaning and weekly protein removal for the monthly replacement orthokeratology lenses

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.

Outcomes

Primary Outcome Measures

Axial elongation in 2 years
Cycloplegic examination of the eyeball length using IOLMaster every 6 monthly
Back Surface Lens Deposits
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
Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva in 2 years

Full Information

First Posted
February 29, 2020
Last Updated
July 18, 2022
Sponsor
The Hong Kong Polytechnic University
Collaborators
Menicon Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04295707
Brief Title
Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers
Acronym
MR1
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Menicon Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopic Progression
Keywords
Myopia progression, Orthokeratology, Replacement modality, Surface deposits

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monthly replacement orthokeratology without protein removal
Arm Type
Experimental
Arm Description
Subjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses
Arm Title
Monthly replacement lenses with weekly protein removal
Arm Type
Active Comparator
Arm Description
Subjects will be required to perform both daily cleaning and weekly protein removal for the monthly replacement orthokeratology lenses
Arm Title
Yearly replacement lenses with weekly protein removal
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
orthokeratology
Other Intervention Name(s)
ortho-k, Menicon Z Night lenses, Menicon Z Night Toric lenses, corneal reshaping therapy
Intervention Description
Nightly wear of orthokeratology lenses to correct vision in the daytime
Intervention Type
Device
Intervention Name(s)
Menicon Progent A+B
Other Intervention Name(s)
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
Intervention Description
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.
Primary Outcome Measure Information:
Title
Axial elongation in 2 years
Description
Cycloplegic examination of the eyeball length using IOLMaster every 6 monthly
Time Frame
2 years
Title
Back Surface Lens Deposits
Description
Surface deposits will be graded using a 4-point scale: 0=no deposit; 1=mild; 2=moderate; 3=severe
Time Frame
Every month up to 12 months
Secondary Outcome Measure Information:
Title
Number of participants with serious adverse effects in 2 years
Description
Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva in 2 years
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Cho, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Optometry, The Hong Kong Polytechnic University
City
Kowloon
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
29216865
Citation
Lee YC, Wang JH, Chiu CJ. Effect of Orthokeratology on myopia progression: twelve-year results of a retrospective cohort study. BMC Ophthalmol. 2017 Dec 8;17(1):243. doi: 10.1186/s12886-017-0639-4.
Results Reference
background
PubMed Identifier
22134592
Citation
Stapleton F, Carnt N. Contact lens-related microbial keratitis: how have epidemiology and genetics helped us with pathogenesis and prophylaxis. Eye (Lond). 2012 Feb;26(2):185-93. doi: 10.1038/eye.2011.288. Epub 2011 Dec 2.
Results Reference
background
PubMed Identifier
22969068
Citation
Cho P, Cheung SW. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial. Invest Ophthalmol Vis Sci. 2012 Oct 11;53(11):7077-85. doi: 10.1167/iovs.12-10565.
Results Reference
background
PubMed Identifier
22577080
Citation
Hiraoka T, Kakita T, Okamoto F, Takahashi H, Oshika T. Long-term effect of overnight orthokeratology on axial length elongation in childhood myopia: a 5-year follow-up study. Invest Ophthalmol Vis Sci. 2012 Jun 22;53(7):3913-9. doi: 10.1167/iovs.11-8453.
Results Reference
background
PubMed Identifier
30366778
Citation
Cheung SW, Boost MV, Cho P. Pre-treatment observation of axial elongation for evidence-based selection of children in Hong Kong for myopia control. Cont Lens Anterior Eye. 2019 Aug;42(4):392-398. doi: 10.1016/j.clae.2018.10.006. Epub 2018 Oct 24.
Results Reference
background

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Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers

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