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Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children

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ClinicalTrials.gov Identifier: NCT00787579
Recruitment Status : Completed
First Posted : November 7, 2008
Last Update Posted : November 7, 2008
Sponsor:
Collaborator:
Queensland University of Technology
Information provided by:
Essilor International

Study Description
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Brief Summary:
  1. To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.
  2. To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children.
  3. To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.

Condition or disease Intervention/treatment Phase
Myopia Device: Bifocal spectacles Device: Prismatic bifocal spectacles Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
Study Start Date : April 2003
Actual Primary Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bifocal spectacles Device: Bifocal spectacles
+1.50D bifocal spectacles
Active Comparator: Prismatic bifocals Device: Prismatic bifocal spectacles
+1.50D bifocal spectacles combined with 3Δ base-in prisms
No Intervention: Single vision spectacles


Outcome Measures
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Primary Outcome Measures :
  1. Myopia progression, measured by cycloplegic autorefraction [ Time Frame: Every 6 months ]

Secondary Outcome Measures :
  1. Axial length, measured by A-scan ultrasonography [ Time Frame: Every 6 months ]

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 to 13 years
  • Myopia: -1.00 to -5.00 D
  • Myopia progression: at least 0.50 D/yr
  • Astigmatism and anisometropia: not more than 1.50 D
  • Distance monocular visual acuity: 6/6 or better
  • Near monocular visual acuity: 0.4 M or better
  • Stereoacuity: not more than 40 sec of arc at 40 cm

Exclusion Criteria:

  • Strabismus
  • Ocular diseases
Contacts and Locations
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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): NCT00787579


Locations
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Canada, Ontario
Dr. Desmond Cheng & Associates
Mississauga, Ontario, Canada, L5N 7G5
Sponsors and Collaborators
Essilor International
Queensland University of Technology
Investigators
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Principal Investigator: Desmond Cheng, OD, MSc Queensland University of Technology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Desmond Cheng, Essilor International
ClinicalTrials.gov Identifier: NCT00787579    
Other Study ID Numbers: Essilor
First Posted: November 7, 2008    Key Record Dates
Last Update Posted: November 7, 2008
Last Verified: November 2008
Keywords provided by Essilor International:
Myopia, bifocal, children
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases