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

NCT02700139 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2019-02-25

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Shamir Optical Industry Ltd

    collaborator INDUSTRY

  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Pauline Cho, PhD · The Hong Kong Polytechnic University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02700139 on ClinicalTrials.gov