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Myopia Control With Simultaneous Vision Approach

This study has been completed.
Sponsor:
Information provided by:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT00919334
First received: June 11, 2009
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
  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 1

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:

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 June 17, 2013