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Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses

Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses in Different Myopia Progression Groups

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03919396
Enrollment
91
Registered
2019-04-18
Start date
2019-04-01
Completion date
2022-12-31
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Orthokeratology

Keywords

Myopia, Myopia Control, Orthokeratology, Electroretinogram, Multifocal Electroretinogram

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.

Interventions

DEVICEBreath-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.

Sponsors

SEED Co. Ltd.
CollaboratorUNKNOWN
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Subjective Refractionup to 24 monthsRefractive Error ( in Diopter )

Secondary

MeasureTime frameDescription
Axial Lengthup to 24 monthsLength of eye ball

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026