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Myopia Control With Simultaneous Vision Approach

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ClinicalTrials.gov Identifier: NCT00919334
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Carly Lam, The Hong Kong Polytechnic University

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

Condition or disease Intervention/treatment Phase
Myopia Device: Defocus Incorporated Soft Contact (DISC) lens Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach
Study Start Date : July 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: single vision soft contact lens
Single vision soft contact lenses with same materials of the DISC 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The changes of axial length [ Time Frame: every 6 months for 2 years ]
    Axial length was measured after cycloplegia using IOL Master


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 8-13 years
  • Myopia (SE) between -1D to -5D
  • 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 rigid gas permeable lenses and Ortho-K lenses
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919334


Locations
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China
Optometry Clinic, School of Optometry, The Hong Kong PolyU
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Carly SY Lam, PhD School of Optometry, The Hong Kong PolyU
More Information
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Publications of Results:

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Responsible Party: Carly Lam, Head of School, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00919334    
Other Study ID Numbers: GRF5438/06M
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014
Keywords provided by Carly Lam, The Hong Kong Polytechnic University:
Myopia progression
Myopia control
Simultaneous vision
Myopic defocus
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases