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Completed

NCT Number: NCT03616600

The Safety and Effectiveness of Breath-O Lenses

In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression. One of the most successful treatments for myopia is orthokeratology. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors Safety Issues

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

About this study

Short-sightedness (myopia) is the most common refractive error in the world. In Hong Kong, approximately 80% of children are myopic by the end of childhood. Current treatment strategies to control (i.e. slow) myopia progression in children are primarily designed to harness the natural "emmetropization" process, in which visual feedback from retinal image clarity regulates the rate of eye growth. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression, not least since this approach permits clear central vision. One of the most successful treatments for myopia is orthokeratology, which is a therapy of using custom-made rigid gas permeable contact lens. The special design of this contact lens can reshape the corneal profile to minimize the central refractive error while producing beneficial peripheral defocus. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Refractive error: Spherical: normally -1.00D to -4.00D (maximum up to -5.00D); Cylindrical: normally half of Sph (against-the-rule Astigmatism.: lower than -0.75D) (maximum up to -1.50D)
  • Best corrected Visual acuity: monocular ETDRS 0.0 or better
  • Ocular health: No ocular abnormality, no contra-indications for overnight orthokeratology lens wear, no refractive surgery
  • General health: No systemic diseases
  • Requirement: No history of orthokeratology lens wearing. Agree to participate in this study and willing to wear the orthokeratology lenses overnight in accordance with the instructions given and to come back for follow up within the study period

Treatment and study plan

Breath-O-Correct Lens

Other

Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material

Primary outcomes

  1. Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor

    Time frame: Baseline, 1st Month, 3rd Month

    measured by ocular response analyser

  2. Corneal Endothelial Health in Terms of Endothelial Cell Density

    Time frame: Baseline, 1st Month, 3rd Month

    measured by specular microscope

  3. Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size

    Time frame: Baseline, 1st Month, 3rd Month

    measured by specular microscope

  4. Anterior Ocular Health in Terms of Limbal and Bulbar Redness

    Time frame: Baseline, 1st Month, 3rd Month

    measured by OCULUS Keratograph® 5M and graded by JENVIS redness grading system It is a scale of 0 to 4, the higher the score, the more redness the ocular surface manifests

  5. Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)

    Time frame: Baseline, 1st Month, 3rd Month

    measured by OCULUS Keratograph® 5M

Secondary outcomes

  1. Best Corrected Visual Acuity in Terms of High and Low Contrast

    Time frame: Baseline, 1st Month and the 3rd Month

    The best corrected visual acuity was measured in LogMAR (Snellen 20/20 vision = 0.00 in LogMAR ; each readable letter add -0.02 to the score, the smaller the number i.e. more negative, the better visual acuity)

  2. Reduction of the Refractive Power After Wearing the Breath-O-correct Lens

    Time frame: Baseline, 1st Week, 1st Month, 3rd Month

    Refractive errors were determined by subjective refraction for treatment group (Breath-O correct lens wearer), the outcome was represented as mean spherical equivalent refraction with unit in diopter (SER, = 1/2 Cylindrical power + spherical power)

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • SEED Co. Ltd.

Registry information

Official study title

The Safety and Effectiveness of Clinical Performance of Breath-O Correct Orthokeratology Lenses

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 6, 2018
Registry last updated
Feb 10, 2021

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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