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Myopia Control With Simultaneous Vision Approach

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Completed
CT.gov ID
NCT00919334
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
47
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
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 :
Jul 1, 2007
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

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

    Primary Outcome Measures

    1. The changes of cycloplegic refractive errors [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 [every 6 months for 2 years]

      Axial length was measured after cycloplegia using IOL Master

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 13 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carly Lam, Head of School, The Hong Kong Polytechnic University
    ClinicalTrials.gov Identifier:
    NCT00919334
    Other Study ID Numbers:
    • GRF5438/06M
    First Posted:
    Jun 12, 2009
    Last Update Posted:
    Jul 3, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by Carly Lam, Head of School, The Hong Kong Polytechnic University
    Myopia progression
    Myopia control
    Simultaneous vision
    Myopic defocus
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Jul 3, 2014