Monthly Replacement Orthokeratology for Myopia Control in Young Children

Not Applicable

• Conditions: Myopic Progression
• Interventions: Device: orthokeratology; Device: Menicon Progent A+B

• Registration Number: NCT04293328
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

The two-year prospective study aims at investigating frequently replacement effect on myopia control in young children, and the use of weekly protein removal system in monthly replacement modality orthokeratology lenses on surface deposit.

Detailed Description

In this two-year prospective study, low myopic children, aged 6-8 years, who have no prior experience in contact lens wear and myopia control treatment will be recruited. They will be prescribed with monthly replacement orthokeratology lenses for a period of one year. Axial elongation and ocular conditions during the study will be determined. Subjects 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.

Study Timeline

• Study First Submitted: 2020-02-29
• Study First Submitted QC: 2020-02-29
• Study First Posted: 2020-03-03
• Study Start: 2020-07-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20
• Primary Completion: 2023-06
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Aged 6-10 years
• Normal ocular and general condition and not on medication which may contraindicate ortho-k lens wear
• Refractive sphere between -0.75 to -4.00 D, refractive cylinder ≤ -1.50 D and anisometropia ≤ -1.00 D
• Best correctable vision better than 0.08 logMAR in the worse eye
• Normal binocular function and accommodative status
• No prior experience in contact lens wear and myopia control treatment

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monthly replacement lenses without protein removal	orthokeratology	Subjects will be required to perform daily cleaning for the monthly replacement orthokeratology lenses
Monthly replacement lenses with weekly protein removal	orthokeratology	Subjects will be required to perform both daily cleaning and weekly protein removal for the monthly replacement orthokeratology lenses
Monthly replacement lenses with weekly protein removal	Menicon Progent A+B	Subjects will be required to perform both daily cleaning and weekly protein removal for the monthly replacement orthokeratology lenses

Primary Outcome Measures

Name	Time	Method
Changes in Back Surface Lens Deposits	Every month up to 24 months	Surface deposits will be graded using a 4-point scale: 0=no deposit; 1=mild; 2=moderate; 3=severe
Axial elongation in 2 years	12 months	Elongation of the eyeball in 24 months

Secondary Outcome Measures

Name	Time	Method
Number of participants with serious adverse effects in 2 years	24 months	Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva in 12 months

Trial Locations

Locations (1)

School of Optometry, The Hong Kong Polytechnic University; 🇭🇰 Kowloon, Hong Kong