Clinical Trial: Myopia Control With Simultaneous Vision Approach

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach

Brief Summary: To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach.

Detailed Summary: The investigators hypothesize that the natural process of emmetropization in human is regulated by the equilibrium between the opposite hyperopic and myopic defocus. A sharp focus of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. The DISC lens is a custom-made multi-zone bifocal soft contact lens which is based on simultaneously provides clear vision and defocus at all viewing distances. It comprises of correcting zones for correcting distant prescription(correction of refractive error, and defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.
Sponsor: The Hong Kong Polytechnic University

Current Primary Outcome: The changes of cycloplegic refractive errors [ Time Frame: every 6 months for 2 years ]

Refractive error was measured using Shin-Nippon NVision-K 5001 autorefractor The changes of cycloplegic objective refractive errors between the treatment and the control were compared.


Original Primary Outcome: Compare the refractive changes/myopia progression in children wearing simultaneous vision bifocal (SVB) contact lenses (treatment group) with those wearing single vision contact lenses (control group) [ Time Frame: 2.5 years ]

Current Secondary Outcome: The changes of axial length [ Time Frame: every 6 months for 2 years ]

Axial length was measured after cycloplegia using IOL Master


Original Secondary Outcome: Associations among the changes in refractive error, changes in axial length and other related ocular parameters will be investigated between the treatment and control groups [ Time Frame: 2.5 years ]

Information By: The Hong Kong Polytechnic University

Dates:
Date Received: June 11, 2009
Date Started: July 2007
Date Completion:
Last Updated: July 2, 2014
Last Verified: July 2014