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

NCT02700139 | Terminated

• 1 other identifier: HSEARS20160105001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

Myopia control, aspheric lenses, children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Aspheric lens

EXPERIMENTAL

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

Device: Aspheric lens

Single vision spheric/toric lenses

NO INTERVENTION

Control: single vision spheric/toric lenses

Interventions

Aspheric lens DEVICE

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

Also known as: MyLens

Aspheric lens

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Shamir Optical Industry Ltd: collaborator

Study Sites (1)

School of Optometry, The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

Related Publications (5)

• 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.

  PMID: 12202502 BACKGROUND

• 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.

  PMID: 12657584 BACKGROUND

• 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.

  PMID: 25270192 BACKGROUND

• 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.

  PMID: 18579755 BACKGROUND

• 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.

  PMID: 19154279 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Pauline Cho, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 7, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)