Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers

Myopic Progression Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04295707
• Other study ID #: HSEARS20190926004-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: August 2023

Study information

• Verified date: July 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Myopia
• Myopic Progression

Intervention

Device:
• orthokeratology
Nightly wear of orthokeratology lenses to correct vision in the daytime
• 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.

Locations

Country	Name	City	State
Hong Kong	School of Optometry, The Hong Kong Polytechnic University	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Menicon Co., Ltd.

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial elongation in 2 years	Cycloplegic examination of the eyeball length using IOLMaster every 6 monthly	2 years
Primary	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	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	2 years