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The Safety and Effectiveness of Breath-O Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616600
Recruitment Status : Completed
First Posted : August 6, 2018
Results First Posted : April 13, 2020
Last Update Posted : February 10, 2021
Sponsor:
Collaborator:
SEED Co. Ltd.
Information provided by (Responsible Party):
Henry HL Chan, PhD, The Hong Kong Polytechnic University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myopia Safety Issues Other: Breath-O-Correct Lens Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Effectiveness of Clinical Performance of Breath-O Correct Orthokeratology Lenses
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Wearing the orthokeratology lenses for 3 months
 Other: Breath-O-Correct Lens
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
No Intervention: Control
Not wearing any contact lenses


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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)
  2. Best corrected Visual acuity: monocular ETDRS 0.0 or better
  3. Ocular health: No ocular abnormality, no contra-indications for overnight orthokeratology lens wear, no refractive surgery
  4. General health: No systemic diseases
  5. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616600


Locations
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Hong Kong
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
SEED Co. Ltd.
  Study Documents (Full-Text)

Documents provided by Henry HL Chan, PhD, The Hong Kong Polytechnic University:
Study Protocol and Statistical Analysis Plan  [PDF] March 10, 2019

More Information
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Responsible Party: Henry HL Chan, PhD, Assocaite Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03616600    
Other Study ID Numbers: HongKongPU_Optometry2
First Posted: August 6, 2018    Key Record Dates
Results First Posted: April 13, 2020
Last Update Posted: February 10, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henry HL Chan, PhD, The Hong Kong Polytechnic University:
Myopia
Orthokeratology
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases