Myopia Control With Simultaneous Vision Approach - Full Text View

Sponsor:	The Hong Kong Polytechnic University
Information provided by:	The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:	NCT00919334

Purpose

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

Condition	Intervention	Phase
Myopia	Device: Defocus Incorporated Soft Contact (DISC) lens	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear Refractive Errors

U.S. FDA Resources

Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:

The changes of cycloplegic refractive errors [ Time Frame: every 6 months for 2 years ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

The changes of axial length [ Time Frame: every 6 months for 2 years ] [ Designated as safety issue: Yes ]
Axial length was measured after cycloplegia using IOL Master

Enrollment:	100
Study Start Date:	July 2007
Study Completion Date:	June 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: single vision soft contact lens Single vision soft contact lenses with same materials of the DISC lens	Device: Defocus Incorporated Soft Contact (DISC) lens Use of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia Other Names: myopia control myopia progression Simultaneous vision bifocal contact lens
Experimental: Defocus Incorporated Soft Contact (DISC) lens The use of DISC lens to slow down the progression of myopia	Device: Defocus Incorporated Soft Contact (DISC) lens Use of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia Other Names: myopia control myopia progression Simultaneous vision bifocal contact lens

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	8 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 8-13 years
Myopia (SE) between -1.00D to -5.00D
Astigmatism less than or equal to -1D
Anisometropia: less than or equal to 1.25D
aided VA (monocular): 0.00 log MAR or better
willingness to wear contact lens constantly
availability for follow-up for at least 2.5 years
parents' understanding and acceptance
willing to provide refractive status of grandparents

Exclusion Criteria:

Severe ocular or systemic allergies
Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
Ocular or systemic condition that might affect refractive development
Strabismus at distance or near
Prior use of bifocal or progressive lenses
Prior use of RGP and OrthK lenses

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919334

Locations

China
Optometry Clinic, School of Optometry, The Hong Kong PolyU
Hong Kong, China

Sponsors and Collaborators

The Hong Kong Polytechnic University

Investigators

Principal Investigator:

Carly SY Lam, PhD

School of Optometry, The Hong Kong PolyU

More Information

No publications provided

Responsible Party:	Research Grants Council of Hong Kong, China, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:	NCT00919334 History of Changes
Other Study ID Numbers:	GRF5438/06M
Study First Received:	June 11, 2009
Last Updated:	June 30, 2011
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by The Hong Kong Polytechnic University:

Myopia progression
Myopia control
Simultaneous vision
Myopic defocus

Additional relevant MeSH terms:

Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012