Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses

NCT ID: NCT03919396

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-12-31

Brief Summary

This is a 24-month longitudinal randomized controlled trial aiming to evaluate the effectiveness of myopia control by Breath-O correct orthokeratology lenses in different myopia progression groups classified according to their initial electro-retinal responses.

Detailed Description

Myopia is the most common refractive error in the world. In Hong Kong, the number of children in myopia is on the rise and approximately 80% of children are myopic by the end of childhood. Orthokeratology is one of the most successful myopia control methods adopting the strategy of peripheral defocus, in which the natural emmetropization process is harnessed by the myopic defocus induced by the orthokeratology lenses.Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with higher elasticity as compared traditional lens material.

A recent study has shown young children with an initial weakened central electrical signal from the inner retina had faster myopia progression as measured by multifocal electroretinogram(ERG). We will classify the slow and fast progression group based on the ERG results, so as to evaluate the clinical effectiveness of the newly designed lenses in controlling myopia in children with different rates of progression.

Conditions

Myopia; Orthokeratology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OrthoK (orthokeratology)

Group wearing Breath-O corrected orthokeratology lenses for 2 years

Group Type: EXPERIMENTAL

Breath-O orthokeratology lenses

Intervention Type: DEVICE

Specially designed rigid gas permeable lenses which

1. reshapes corneal profile for myopia control

2. has higher elasticity compared to traditional lens material.

SV Lenses (Single vision)

Group wearing spectacle with single vision lenses for 2 years

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Breath-O orthokeratology lenses

Specially designed rigid gas permeable lenses which

1. reshapes corneal profile for myopia control

2. has higher elasticity compared to traditional lens material.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Refractive error: Spherical: -1.00D to -4.00D; Cylindrical: half of Sph (against-the-rule Astig.: less than -0.75D)
• Best corrected Visual acuity: monocular ETDRS 0.1 or better

Exclusion Criteria

• Ocular abnormality
• Contra-indicated for overnight orthokeratology lens wear
• History of refractive surgery
• Systemic diseases
• History of orthokeratology lenses wearing or other myopia control methods

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SEED Co. Ltd.

UNKNOWN

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry HL Chan, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

School of Optometry, Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

HongKongPU_Optometry3

Identifier Type: -

Identifier Source: org_study_id