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The Safety and Effectiveness of Breath-O Lenses

Primary Purpose

Myopia, Safety Issues

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Breath-O-Correct Lens
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia, Orthokeratology

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

Wearing the orthokeratology lenses for 3 months

Not wearing any contact lenses

Outcomes

Primary Outcome Measures

Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
measured by ocular response analyser
Corneal Endothelial Health in Terms of Endothelial Cell Density
measured by specular microscope
Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size
measured by specular microscope
Anterior Ocular Health in Terms of Limbal and Bulbar Redness
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
Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
measured by OCULUS Keratograph® 5M

Secondary Outcome Measures

Best Corrected Visual Acuity in Terms of High and Low Contrast
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)
Reduction of the Refractive Power After Wearing the Breath-O-correct Lens
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)

Full Information

First Posted
March 15, 2018
Last Updated
January 26, 2021
Sponsor
The Hong Kong Polytechnic University
Collaborators
SEED Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03616600
Brief Title
The Safety and Effectiveness of Breath-O Lenses
Official Title
The Safety and Effectiveness of Clinical Performance of Breath-O Correct Orthokeratology Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
January 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
SEED Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Safety Issues
Keywords
Myopia, Orthokeratology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Wearing the orthokeratology lenses for 3 months
Arm Title
Control
Arm Type
No Intervention
Arm Description
Not wearing any contact lenses
Intervention Type
Other
Intervention Name(s)
Breath-O-Correct Lens
Intervention Description
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 Outcome Measure Information:
Title
Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
Description
measured by ocular response analyser
Time Frame
Baseline, 1st Month, 3rd Month
Title
Corneal Endothelial Health in Terms of Endothelial Cell Density
Description
measured by specular microscope
Time Frame
Baseline, 1st Month, 3rd Month
Title
Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size
Description
measured by specular microscope
Time Frame
Baseline, 1st Month, 3rd Month
Title
Anterior Ocular Health in Terms of Limbal and Bulbar Redness
Description
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
Time Frame
Baseline, 1st Month, 3rd Month
Title
Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
Description
measured by OCULUS Keratograph® 5M
Time Frame
Baseline, 1st Month, 3rd Month
Secondary Outcome Measure Information:
Title
Best Corrected Visual Acuity in Terms of High and Low Contrast
Description
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)
Time Frame
Baseline, 1st Month and the 3rd Month
Title
Reduction of the Refractive Power After Wearing the Breath-O-correct Lens
Description
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)
Time Frame
Baseline, 1st Week, 1st Month, 3rd Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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The Safety and Effectiveness of Breath-O Lenses

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