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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02700139
• Other study ID #: HSEARS20160105001
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: February 2019
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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).

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
Hong Kong	School of Optometry, The Hong Kong Polytechnic University	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Shamir Optical Industry Ltd

Country where clinical trial is conducted

Hong Kong, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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