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Myopia Control With Simultaneous Vision Approach

Primary Purpose

Myopia

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Defocus Incorporated Soft Contact (DISC) lens

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia progression, Myopia control, Simultaneous vision, Myopic defocus

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 8-13 years
Myopia (SE) between -1D to -5D
Astigmatism less than or equal to -1D
Anisometropia: less than or equal to 1.25D
aided VA (monocular): 0.00 log MAR or better
willingness to wear contact lens constantly
availability for follow-up for at least 2.5 years
parents' understanding and acceptance
willing to provide refractive status of grandparents

Exclusion Criteria:

Severe ocular or systemic allergies
Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
Ocular or systemic condition that might affect refractive development
Strabismus at distance or near
Prior use of bifocal or progressive lenses
Prior use of rigid gas permeable lenses and Ortho-K lenses

Sites / Locations

Optometry Clinic, School of Optometry, The Hong Kong PolyU

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

single vision soft contact lens

Defocus Incorporated Soft Contact (DISC) lens

Arm Description

Single vision soft contact lenses with same materials of the DISC lens

The use of DISC lens to slow down the progression of myopia

Outcomes

Primary Outcome Measures

The changes of cycloplegic refractive errors

Refractive error was measured using Shin-Nippon NVision-K 5001 autorefractor The changes of cycloplegic objective refractive errors between the treatment and the control were compared.

Secondary Outcome Measures

The changes of axial length

Axial length was measured after cycloplegia using IOL Master

Full Information

NCT ID

NCT00919334

First Posted

June 11, 2009

Last Updated

July 2, 2014

Sponsor

The Hong Kong Polytechnic University

1. Study Identification

Unique Protocol Identification Number

NCT00919334

Brief Title

Myopia Control With Simultaneous Vision Approach

Official Title

Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach.

Detailed Description

The investigators hypothesize that the natural process of emmetropization in human is regulated by the equilibrium between the opposite hyperopic and myopic defocus. A sharp focus of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. The DISC lens is a custom-made multi-zone bifocal soft contact lens which is based on simultaneously provides clear vision and defocus at all viewing distances. It comprises of correcting zones for correcting distant prescription(correction of refractive error, and defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

Keywords

Myopia progression, Myopia control, Simultaneous vision, Myopic defocus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single vision soft contact lens

Arm Type

No Intervention

Arm Description

Single vision soft contact lenses with same materials of the DISC lens

Arm Title

Defocus Incorporated Soft Contact (DISC) lens

Arm Type

Experimental

Arm Description

The use of DISC lens to slow down the progression of myopia

Intervention Type

Device

Intervention Name(s)

Defocus Incorporated Soft Contact (DISC) lens

Other Intervention Name(s)

myopia control, myopia progression, Simultaneous vision, bifocal contact lens

Intervention Description

Use of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia

Primary Outcome Measure Information:

Title

The changes of cycloplegic refractive errors

Description

Refractive error was measured using Shin-Nippon NVision-K 5001 autorefractor The changes of cycloplegic objective refractive errors between the treatment and the control were compared.

Time Frame

every 6 months for 2 years

Secondary Outcome Measure Information:

Title

The changes of axial length

Description

Axial length was measured after cycloplegia using IOL Master

Time Frame

every 6 months for 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 8-13 years Myopia (SE) between -1D to -5D Astigmatism less than or equal to -1D Anisometropia: less than or equal to 1.25D aided VA (monocular): 0.00 log MAR or better willingness to wear contact lens constantly availability for follow-up for at least 2.5 years parents' understanding and acceptance willing to provide refractive status of grandparents Exclusion Criteria: Severe ocular or systemic allergies Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial Ocular or systemic condition that might affect refractive development Strabismus at distance or near Prior use of bifocal or progressive lenses Prior use of rigid gas permeable lenses and Ortho-K lenses

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carly SY Lam, PhD

Organizational Affiliation

School of Optometry, The Hong Kong PolyU

Official's Role

Principal Investigator

Facility Information:

Facility Name

Optometry Clinic, School of Optometry, The Hong Kong PolyU

City

Hong Kong

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

24169657

Citation

Lam CS, Tang WC, Tse DY, Tang YY, To CH. Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomised clinical trial. Br J Ophthalmol. 2014 Jan;98(1):40-5. doi: 10.1136/bjophthalmol-2013-303914. Epub 2013 Oct 29.

Results Reference

result

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Myopia Control With Simultaneous Vision Approach

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