Monthly Replacement Orthokeratology for Myopia Control in Young Children (MR2)

The Hong Kong Polytechnic University

Status: Active, not recruiting

Conditions: Myopic Progression

Treatments: Device: orthokeratology; Device: Menicon Progent A+B

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04293328

HSEARS20190926004-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Monthly replacement lenses without protein removal

Experimental group

Description:

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

Treatment:

Device: orthokeratology

Monthly replacement lenses with weekly protein removal

Active Comparator group

Description:

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

Treatment:

Device: Menicon Progent A+B

Device: orthokeratology