Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03919396

Collaborator

SEED Co. Ltd. (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia Orthokeratology	Device: Breath-O orthokeratology lenses	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized clinical trialRandomized 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 :

Apr 1, 2019

Actual Primary Completion Date :

Oct 31, 2019

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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 reshapes corneal profile for myopia control has higher elasticity compared to traditional lens material.

No Intervention: SV Lenses

Group wearing spectacle with single vision lenses for 2 years

Outcome Measures

Primary Outcome Measures

Subjective Refraction [up to 24 months]
Refractive Error ( in Diopter )

Secondary Outcome Measures

Axial Length [up to 24 months]
Length of eye ball

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	School of Optometry, Hong Kong Polytechnic University	Hong Kong		Hong Kong	00000

Sponsors and Collaborators

The Hong Kong Polytechnic University
SEED Co. Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Hong Kong Polytechnic University

ClinicalTrials.gov Identifier:

NCT03919396

Other Study ID Numbers:

HongKongPU_Optometry3

First Posted:

Apr 18, 2019

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The Hong Kong Polytechnic University

Multifocal Electroretinogram

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Aug 24, 2022