Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers

NCT04295707 | Unknown

• 1 other identifier: HSEARS20190926004-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopic Progression

Keywords

Myopia progression; Orthokeratology; Replacement modality; Surface deposits

Outcome Measures

Primary Outcomes (2)

• Axial elongation in 2 years

  Cycloplegic examination of the eyeball length using IOLMaster every 6 monthly

  2 years

• Back Surface Lens Deposits

  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 Outcomes (1)

• Number of participants with serious adverse effects in 2 years

  2 years

Study Arms (3)

Monthly replacement orthokeratology without protein removal

EXPERIMENTAL

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

Device: orthokeratology

Monthly replacement lenses with weekly protein removal

ACTIVE COMPARATOR

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

Device: orthokeratology; Device: Menicon Progent A+B

Yearly replacement lenses with weekly protein removal

ACTIVE COMPARATOR

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; Device: Menicon Progent A+B

Interventions

orthokeratology DEVICE

Nightly wear of orthokeratology lenses to correct vision in the daytime

Also known as: ortho-k, Menicon Z Night lenses, Menicon Z Night Toric lenses, corneal reshaping therapy

Monthly replacement lenses with weekly protein removal; Monthly replacement orthokeratology without protein removal; Yearly replacement lenses with weekly protein removal

Menicon Progent A+B 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.

Also known as: Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

Monthly replacement lenses with weekly protein removal; Yearly replacement lenses with weekly protein removal

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Menicon Co., Ltd.: collaborator

Study Sites (1)

School of Optometry, The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

Related Publications (5)

• 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.

  PMID: 29216865 BACKGROUND

• 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.

  PMID: 22134592 BACKGROUND

• 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.

  PMID: 22969068 BACKGROUND

• 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.

  PMID: 22577080 BACKGROUND

• 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.

  PMID: 30366778 BACKGROUND

Study Officials

• Pauline Cho, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 4, 2020
• Study Start: March 11, 2020
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

HK (1)