Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03919396
• Other study ID #: HongKongPU_Optometry3
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Orthokeratology

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	School of Optometry, Hong Kong Polytechnic University	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	SEED Co. Ltd.

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Refraction	Refractive Error ( in Diopter )	up to 24 months
Secondary	Axial Length	Length of eye ball	up to 24 months