Myopia Control Using Optimized Optical Defocus RCTs | NCT03681366

Studies
Myopia Control Using Optimized Optical Defocus RCTs

NCT03681366

Sponsor

The Hong Kong Polytechnic University

Status

Completed

Last Update Posted

Aug 24, 2022Actual

Enrollment

167Actual

Phase

Not Applicable

Conditions

Myopia

Interventions

DISC3.5 plus

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 25, 2018Actual

Primary Completion Date

May 8, 2021Actual

Completion Date

Jun 24, 2022Actual

First Submitted Date

Sep 20, 2018

First Submission Date that Met QC Criteria

Sep 20, 2018

First Posted Date

Sep 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2022

Last Update Posted Date

Aug 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

167Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single vision soft contact lens	No Intervention	single vision, spherical soft contact lens
DISC3.5 Plus lens	Experimental	A soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.	Device: DISC3.5 plus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DISC3.5 plus	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cycloplegic Refraction Change in SER	Change in cycloplegic autorefraction in spherical equivalent (SER)	12 months

Secondary Outcomes

Measure	Description	Time Frame
Axial length	Axial length (mm) was measured after cycloplegia	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carly SY Lam, phD	School of Optometry, The Hong Kong Polytechnic University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Centre of Myopia Ressearch, School of Optometry, The Hong Kong PolyU		Hong Kong			China

ID	Term
D009216	Myopia

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Masking Info

Masking

Double

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.

Who Masked

ParticipantInvestigator