Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses
Primary Purpose
Myopia, Orthokeratology
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Breath-O orthokeratology lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring Myopia, Myopia Control, Orthokeratology, Electroretinogram, Multifocal Electroretinogram
Eligibility Criteria
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
Sites / Locations
- School of Optometry, Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
OrthoK (orthokeratology)
SV Lenses (Single vision)
Arm Description
Group wearing Breath-O corrected orthokeratology lenses for 2 years
Group wearing spectacle with single vision lenses for 2 years
Outcomes
Primary Outcome Measures
Subjective Refraction
Refractive Error ( in Diopter )
Secondary Outcome Measures
Axial Length
Length of eye ball
Full Information
NCT ID
NCT03919396
First Posted
April 16, 2019
Last Updated
February 27, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
SEED Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03919396
Brief Title
Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses
Official Title
Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses in Different Myopia Progression Groups
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Orthokeratology
Keywords
Myopia, Myopia Control, Orthokeratology, Electroretinogram, Multifocal Electroretinogram
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OrthoK (orthokeratology)
Arm Type
Experimental
Arm Description
Group wearing Breath-O corrected orthokeratology lenses for 2 years
Arm Title
SV Lenses (Single vision)
Arm Type
No Intervention
Arm Description
Group wearing spectacle with single vision lenses for 2 years
Intervention Type
Device
Intervention Name(s)
Breath-O orthokeratology lenses
Intervention Description
Specially designed rigid gas permeable lenses which
reshapes corneal profile for myopia control
has higher elasticity compared to traditional lens material.
Primary Outcome Measure Information:
Title
Subjective Refraction
Description
Refractive Error ( in Diopter )
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Axial Length
Description
Length of eye ball
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry HL Chan, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Optometry, Hong Kong Polytechnic University
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses
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