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

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.

Study Overview

• Status: Terminated
• Conditions: Myopia
• Intervention / Treatment: Device: Aspheric lens

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • School of Optometry, The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aspheric lens; An aspheric lens which is supposed to slow myopic progression in children by unique asphericity (proprietary information)	Device: Aspheric lens; By using a special asphericity, MyLens is customized for various prescriptions and vision directions based on specific measurements, intended for myopia correction and control; Other Names: MyLens
No Intervention: Single vision spheric/toric lenses; Control: single vision spheric/toric lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Every 6 months for a period of 1 year

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Shamir Optical Industry Ltd

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 2, 2016
• First Posted (Estimate): March 7, 2016

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Myopia control, aspheric lenses, children
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: HSEARS20160105001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The demographic data of subjects recruited in this study will be disclosed in this website

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No