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OpenTrials
Completed

NCT Number: NCT03919396

Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Optometry, Hong Kong Polytechnic University

Hong Kong, 00000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breath-O orthokeratology lenses

Device

Specially designed rigid gas permeable lenses which

  • reshapes corneal profile for myopia control
  • has higher elasticity compared to traditional lens material.

Primary outcomes

  1. Subjective Refraction

    Time frame: up to 24 months

    Refractive Error ( in Diopter )

Secondary outcomes

  1. Axial Length

    Time frame: up to 24 months

    Length of eye ball

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • SEED Co. Ltd.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2022
First posted
Apr 18, 2019
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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