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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

Tracking Information
First Submitted Date  ICMJE June 11, 2009
First Posted Date  ICMJE June 12, 2009
Last Update Posted Date July 3, 2014
Study Start Date  ICMJE July 2007
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2011)
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 Measures  ICMJE
 (submitted: June 11, 2009)
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: 2.5years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2011)
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 Measures  ICMJE
 (submitted: June 11, 2009)
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: 2.5years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myopia Control With Simultaneous Vision Approach
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Device: Defocus Incorporated Soft Contact (DISC) lens
Publications * Lam CS, Tang WC, Tse DY, Tang YY, To CH. Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomised clinical trial. Br J Ophthalmol. 2014 Jan;98(1):40-5. doi: 10.1136/bjophthalmol-2013-303914. Epub 2013 Oct 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2011)
100
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2009)
162
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00919334
Other Study ID Numbers  ICMJE GRF5438/06M
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Carly Lam, The Hong Kong Polytechnic University
Original Responsible Party Research Grant Council, The Hong Kong Polytechnic University
Current Study Sponsor  ICMJE The Hong Kong Polytechnic University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carly SY Lam, PhD School of Optometry, The Hong Kong PolyU
PRS Account The Hong Kong Polytechnic University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP