Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses

Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses in Different Myopia Progression Groups

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.

Study Overview

• Status: Completed
• Conditions: Myopia; Orthokeratology
• Intervention / Treatment: Device: Breath-O orthokeratology lenses

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
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00000
    • School of Optometry, Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OrthoK (orthokeratology); Group wearing Breath-O corrected orthokeratology lenses for 2 years	Device: Breath-O orthokeratology lenses; Specially designed rigid gas permeable lenses which; reshapes corneal profile for myopia control; has higher elasticity compared to traditional lens material.
No Intervention: SV Lenses (Single vision); Group wearing spectacle with single vision lenses for 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Refraction	Refractive Error ( in Diopter )	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial Length	Length of eye ball	up to 24 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: SEED Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Myopia; Orthokeratology; Electroretinogram; Multifocal Electroretinogram; Myopia Control
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: HongKongPU_Optometry3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No