Clinical trial NCT02700139: 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
Overall status: TERMINATED
Phase: NA
Conditions: Myopia
Keywords: Myopia control, aspheric lenses, children
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Shamir Optical Industry Ltd
First posted: 2016-03-07
Enrollment: 61
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Changes in axial length in 6-12 months
timeFrame: Every 6 months for a period of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: School of Optometry, The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Pauline Cho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.