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History of Changes for Study: NCT00919334
Myopia Control With Simultaneous Vision Approach
Latest version (submitted July 2, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 11, 2009 None (earliest Version on record)
2 June 16, 2009 Outcome Measures, Arms and Interventions, Sponsor/Collaborators and Study Status
3 June 30, 2011 Recruitment Status, Arms and Interventions, Study Status, Outcome Measures, Contacts/Locations, Study Design, Study Description, Eligibility and Conditions
4 July 2, 2014 Sponsor/Collaborators, Arms and Interventions, Study Status, References and Eligibility
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Study NCT00919334
Submitted Date:  June 11, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: GRF5438/06M
Brief Title: Myopia Control With Simultaneous Vision Approach
Official Title: Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2009
Overall Status: Recruiting
Study Start: July 2007
Primary Completion: June 2010 [Anticipated]
Study Completion:
First Submitted: June 11, 2009
First Submitted that
Met QC Criteria:
June 11, 2009
First Posted: June 12, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 11, 2009
Last Update Posted: June 12, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: The Hong Kong Polytechnic University
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief 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. Simultaneous vision bifocal contact lens provide simultaneous vision for both distance (correction of refractive error) and near (myopic defocus). The near zone correction provides constant myopic defocus to stimulate emmetropization for all distances and to slow down myopia progression in Hong Kong myopic children.
Detailed Description:
Open or close this module Conditions
Conditions: Myopia Progression
Keywords: Myopia progression
Myopia control
Simultaneous vision
Myopic defocus
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 162 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: SVB contact lenses
Use of SVB contact lenses to slow down myopia progression
Device: simultaneous vision bifocal soft contact lens
Use of simultaneous vision bifocal soft contact lenses with add powers to control the progression of myopia
Other Names:
  • myopia control
  • myopia progression
  • Simultaneous vision
  • bifocal contact lens
Placebo Comparator: control
single vision soft contact lenses
Device: single vision soft contact lenses
single vision soft contact lenses
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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 ]

Secondary Outcome Measures:
1. 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 ]

Open or close this module Eligibility
Minimum Age: 8 Years
Maximum Age: 13 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Age 8.5-13 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
Open or close this module Contacts/Locations
Central Contact Person: Carly SY Lam, PhD
Telephone: 852 27666091
Email: socarly@polyu.edu.hk
Study Officials: Carly SY Lam, PhD
Principal Investigator
School of Optometry, The Hong Kong PolyU
Locations: China
Optometry Clinic, School of Optometry, The Hong Kong PolyU
[Recruiting]
Hong Kong, China
Contact:Contact: Carly SY Lam, PhD 852 27666091 socarly@polyu.edu.hk
Contact:Sub-Investigator: Chi-ho To, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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