Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses

• ClinicalTrials.gov Identifier: NCT03919396
• Recruitment Status: Active, not recruiting
• First Posted: April 18, 2019
• Last Update Posted: August 27, 2021
• Sponsor: The Hong Kong Polytechnic University
• Collaborator: SEED Co. Ltd.
• Information provided by (Responsible Party): The Hong Kong Polytechnic University

Tracking Information

• First Submitted Date: April 16, 2019
• First Posted Date: April 18, 2019
• Last Update Posted Date: August 27, 2021
• Actual Study Start Date: April 1, 2019
• Actual Primary Completion Date: October 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2019)

Subjective Refraction [ Time Frame: up to 24 months ]

Refractive Error ( in Diopter )

Original Primary Outcome Measures (submitted: April 16, 2019)

Refractive Errors [ Time Frame: up to 24 months ]

Refractive Errors

Current Secondary Outcome Measures (submitted: April 16, 2019)

Axial Length [ Time Frame: up to 24 months ]

Length of eye ball

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized clinical trial

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Myopia
• Orthokeratology

Intervention

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.

Study Arms

• Experimental: OrthoK
  Group wearing Breath-O corrected orthokeratology lenses for 2 years
  Intervention: Device: Breath-O orthokeratology lenses
• No Intervention: SV Lenses
  Group wearing spectacle with single vision lenses for 2 years

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: April 16, 2019): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2022
• Actual Primary Completion Date: October 31, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years to 12 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT03919396
• Other Study ID Numbers: HongKongPU_Optometry3
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: The Hong Kong Polytechnic University
• Original Responsible Party: Same as current
• Current Study Sponsor: The Hong Kong Polytechnic University
• Original Study Sponsor: Same as current
• Collaborators: SEED Co. Ltd.

Investigators

• Principal Investigator: Henry HL Chan, PhD; The Hong Kong Polytechnic University

• PRS Account: The Hong Kong Polytechnic University
• Verification Date: August 2021