Myopia Control Using Optimized Optical Defocus RCTs

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Completed

CT.gov ID

NCT03681366

Collaborator

(none)

167

Enrollment

Location

Arms

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: DISC3.5 plus	N/A

Detailed Description

The purpose of the current study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.

The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.

The efficacy of the DISC3.5 Plus lens in slowing myopia progression (change in refractive error) will be compared to a spherical (front and back surface) single vision soft contact lenses in this one-year prospective, randomised and double-masked clinical trial. The hypothesis of this study is that the DISC3.5 Plus will slow myopia progression more than spherical single vision soft contact lenses.

Study Design

Study Type:

Interventional

Actual Enrollment :

167 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double masked design: The investigator(s) who were responsible for refracting and performing relevant ocular data measurement were masked from the grouping of the subjects. The unmasked investigator(s) were responsible for group allocation, spectacle-dispensing work, measuring lens visual performance, record keeping, data entry and compliance checking. Data input was carefully checked by the unmasked investigator and the other researchers independently. The children and their parents were also masked to group allocation until the data analysis was completed.

Primary Purpose:

Treatment

Official Title:

Myopia Control Using Optimized Optical Defocus in Schoolchildren - a Randomized Double Masked Control Trial

Actual Study Start Date :

Oct 25, 2018

Actual Primary Completion Date :

May 8, 2021

Actual Study Completion Date :

Jun 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Single vision soft contact lens single vision, spherical soft contact lens
Experimental: DISC3.5 Plus lens A soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.	Device: DISC3.5 plus The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.

Arm

Intervention/Treatment

No Intervention: Single vision soft contact lens

single vision, spherical soft contact lens

Experimental: DISC3.5 Plus lens

A soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.

Device: DISC3.5 plus

The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.

Outcome Measures

Primary Outcome Measures

Cycloplegic Refraction Change in SER [12 months]
Change in cycloplegic autorefraction in spherical equivalent (SER)

Secondary Outcome Measures

Axial length [12 months]
Axial length (mm) was measured after cycloplegia

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age at enrolment: 8-13 year; Hong Kong Chinese
Spherical equivalent refractions (SER): -1.00 to -5.00D
Astigmatism: -1.00D or less
Anisometropia: 1.25D or less
Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
Contact lens corrected monocular VA: 0.1 logMAR or better
Normal binocular function
Willingness to wear contact lenses regularly
Parents' understanding and acceptance of random allocation of grouping and masking

Exclusion Criteria:

Prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
Strabismus or decompensated phoria (checked by cover test at far and near in screening)
Known contraindications for contact lens wear
Have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Centre of Myopia Ressearch, School of Optometry, The Hong Kong PolyU	Hong Kong		China

Sponsors and Collaborators

The Hong Kong Polytechnic University

Investigators

Principal Investigator: Carly SY Lam, phD, School of Optometry, The Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carly Lam, Professor, The Hong Kong Polytechnic University

ClinicalTrials.gov Identifier:

NCT03681366

Other Study ID Numbers:

HSEARS20180711001

First Posted:

Sep 24, 2018

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2022

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

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

Keywords provided by Carly Lam, Professor, The Hong Kong Polytechnic University

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Aug 24, 2022