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

July 18, 2022 updated by: Pauline Cho, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • School of Optometry, The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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:
  • corneal reshaping therapy
  • Menicon Z Night lenses
  • Menicon Z Night Toric lenses
  • ortho-k
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:
  • corneal reshaping therapy
  • Menicon Z Night lenses
  • Menicon Z Night Toric lenses
  • ortho-k
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:
  • corneal reshaping therapy
  • Menicon Z Night lenses
  • Menicon Z Night Toric lenses
  • ortho-k
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial elongation in 2 years
Time Frame: 2 years
Cycloplegic examination of the eyeball length using IOLMaster every 6 monthly
2 years
Back Surface Lens Deposits
Time Frame: 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
Every month up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with serious adverse effects in 2 years
Time Frame: 2 years
Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva in 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Menicon Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 11, 2020

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

February 29, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (ACTUAL)

March 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20190926004-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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