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Shamir Aspheric Ophthalmic Lenses (MyLens) for Myopic Control Clinical Trial

Primary Purpose

Myopia

Status

Terminated

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Aspheric lens

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia control, aspheric lenses, children

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Myopia between 0.75 ~ - 4.50 D and with-the-rule astigmatism not more than 1.50 D
Difference between eyes, no more than 1.25 spherical equivalent
Best corrected visual acuity (VA) is equal to or better than 0.10 in logMAR scale (Snellen VA 6/7.5 or better)
Eyes straight at distance and near with best subjective correction
Willing to be randomized and wear the study spectacles according to the instructions from practitioner
Willing to come back for follow up in the Optometry Clinic during the study period

Exclusion Criteria:

Abnormal ocular and general health
Prior myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
History of rigid contact lenses (including orthokeratology lenses) wearing
Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
Ocular conditions which might affect the refractive error (for example, cataract, ptosis).

Sites / Locations

School of Optometry, The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aspheric lens

Single vision spheric/toric lenses

Arm Description

An aspheric lens which is supposed to slow myopic progression in children by unique asphericity (proprietary information)

Control: single vision spheric/toric lenses

Outcomes

Primary Outcome Measures

Changes in axial length in 6-12 months

Evaluate the changes in cycloplegic axial length in the eye with aspheric lens (MyLens) compared to the other eye with single vision spheric/toric lens

Secondary Outcome Measures

Full Information

NCT ID

NCT02700139

First Posted

March 2, 2016

Last Updated

February 21, 2019

Sponsor

The Hong Kong Polytechnic University

Collaborators

Shamir Optical Industry Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02700139

Brief Title

Shamir Aspheric Ophthalmic Lenses (MyLens) for Myopic Control Clinical Trial

Official Title

Shamir Aspheric Ophthalmic Lenses (MyLens) for Myopic Control Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Terminated

Why Stopped

A corporate decision to terminate the study

Study Start Date

January 2016 (Actual)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hong Kong Polytechnic University

Collaborators

Shamir Optical Industry Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this clinical trial is to compare the rate of myopic progression in children wearing aspheric (MyLens) and spherical/ toric ophthalmic lenses. The proposed lens design is an aspheric lens which is supposed to slow myopic progression in children by unique asphericity (proprietary information). Myopic progression is quantified by changes in axial length (AL) and cycloplegic refractive error (Rx) will be monitored for 6-12 months (6 months crossover) with double-masking. Peripheral refraction and ocular aberration will be evaluated.

Detailed Description

Visual manipulation induced by progressive addition lenses (PALs) have been shown to inhibit eye growth and myopia development in children with up to 11% to 21% efficacy compared to single vision lenses. However, the treatment effect of PALs is statistically significant but clinically insufficient. The current study aims at investigating the use of spectacle lenses with a unique novel design for myopia control in children. This prospective one-year randomized clinical study will evaluate axial elongation and myopia progression in eyes using the novel lens design compared to those using the conventional single-vision design. It is a double-masked, cross-over study. One eye will be fitted with the study lens and the other eye will be fitted with the single-vision lens. Subjects will be asked to wear the spectacles for 6 months and the two lens designs will be swapped in the next 6 months after a wash-out period of 2 weeks. Both the subjects and examiners will not aware the lens design being used by the subjects in each phase.

6. Conditions and Keywords

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

Myopia

Keywords

Myopia control, aspheric lenses, children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aspheric lens

Arm Type

Experimental

Arm Description

An aspheric lens which is supposed to slow myopic progression in children by unique asphericity (proprietary information)

Arm Title

Single vision spheric/toric lenses

Arm Type

No Intervention

Arm Description

Control: single vision spheric/toric lenses

Intervention Type

Device

Intervention Name(s)

Aspheric lens

Other Intervention Name(s)

MyLens

Intervention Description

By using a special asphericity, MyLens is customized for various prescriptions and vision directions based on specific measurements, intended for myopia correction and control

Primary Outcome Measure Information:

Title

Changes in axial length in 6-12 months

Description

Evaluate the changes in cycloplegic axial length in the eye with aspheric lens (MyLens) compared to the other eye with single vision spheric/toric lens

Time Frame

Every 6 months for a period of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Myopia between 0.75 ~ - 4.50 D and with-the-rule astigmatism not more than 1.50 D Difference between eyes, no more than 1.25 spherical equivalent Best corrected visual acuity (VA) is equal to or better than 0.10 in logMAR scale (Snellen VA 6/7.5 or better) Eyes straight at distance and near with best subjective correction Willing to be randomized and wear the study spectacles according to the instructions from practitioner Willing to come back for follow up in the Optometry Clinic during the study period Exclusion Criteria: Abnormal ocular and general health Prior myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period History of rigid contact lenses (including orthokeratology lenses) wearing Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome) Ocular conditions which might affect the refractive error (for example, cataract, ptosis).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pauline Cho, PhD

Organizational Affiliation

The Hong Kong Polytechnic University

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Optometry, The Hong Kong Polytechnic University

City

Kowloon

Country

Hong Kong

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The demographic data of subjects recruited in this study will be disclosed in this website

Citations:

PubMed Identifier

12202502

Citation

Edwards MH, Li RW, Lam CS, Lew JK, Yu BS. The Hong Kong progressive lens myopia control study: study design and main findings. Invest Ophthalmol Vis Sci. 2002 Sep;43(9):2852-8.

Results Reference

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PubMed Identifier

12657584

Citation

Gwiazda J, Hyman L, Hussein M, Everett D, Norton TT, Kurtz D, Leske MC, Manny R, Marsh-Tootle W, Scheiman M. A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1492-500. doi: 10.1167/iovs.02-0816.

Results Reference

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PubMed Identifier

25270192

Citation

Hasebe S, Jun J, Varnas SR. Myopia control with positively aspherized progressive addition lenses: a 2-year, multicenter, randomized, controlled trial. Invest Ophthalmol Vis Sci. 2014 Sep 30;55(11):7177-88. doi: 10.1167/iovs.12-11462.

Results Reference

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PubMed Identifier

18579755

Citation

Hasebe S, Ohtsuki H, Nonaka T, Nakatsuka C, Miyata M, Hamasaki I, Kimura S. Effect of progressive addition lenses on myopia progression in Japanese children: a prospective, randomized, double-masked, crossover trial. Invest Ophthalmol Vis Sci. 2008 Jul;49(7):2781-9. doi: 10.1167/iovs.07-0385.

Results Reference

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PubMed Identifier

19154279

Citation

Yang Z, Lan W, Ge J, Liu W, Chen X, Chen L, Yu M. The effectiveness of progressive addition lenses on the progression of myopia in Chinese children. Ophthalmic Physiol Opt. 2009 Jan;29(1):41-8. doi: 10.1111/j.1475-1313.2008.00608.x.

Results Reference

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Shamir Aspheric Ophthalmic Lenses (MyLens) for Myopic Control Clinical Trial

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