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Effectiveness of Myopia Control by Breath-O Correct Orthokeratology 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: NCT03919396
Recruitment Status : Active, not recruiting
First Posted : April 18, 2019
Last Update Posted : August 27, 2021
Sponsor:
Collaborator:
SEED Co. Ltd.
Information provided by (Responsible Party):
The Hong Kong Polytechnic University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myopia Orthokeratology Device: Breath-O orthokeratology lenses Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses in Different Myopia Progression Groups
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : October 31, 2019
Estimated Study Completion Date : March 31, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: OrthoK
Group wearing Breath-O corrected orthokeratology lenses for 2 years
 Device: Breath-O orthokeratology lenses

Specially designed rigid gas permeable lenses which

  1. reshapes corneal profile for myopia control
  2. has higher elasticity compared to traditional lens material.
No Intervention: SV Lenses
Group wearing spectacle with single vision lenses for 2 years


Outcome Measures
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Primary Outcome Measures :
  1. Subjective Refraction [ Time Frame: up to 24 months ]
    Refractive Error ( in Diopter )


Secondary Outcome Measures :
  1. Axial Length [ Time Frame: up to 24 months ]
    Length of eye ball


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT03919396


Locations
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Hong Kong
School of Optometry, Hong Kong Polytechnic University
Hong Kong, Hong Kong, 00000
Sponsors and Collaborators
The Hong Kong Polytechnic University
SEED Co. Ltd.
Investigators
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Principal Investigator: Henry HL Chan, PhD The Hong Kong Polytechnic University
More Information
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Responsible Party: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03919396    
Other Study ID Numbers: HongKongPU_Optometry3
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 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 The Hong Kong Polytechnic University:
Myopia
Myopia Control
Orthokeratology
Electroretinogram
Multifocal Electroretinogram
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases