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

This study has been completed.
Sponsor:
Collaborator:
Queensland University of Technology
Information provided by:
Essilor International
ClinicalTrials.gov Identifier:
NCT00787579
First received: November 4, 2008
Last updated: November 6, 2008
Last verified: November 2008
History of Changes
  Purpose
  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 Intervention
Myopia
 Device: Bifocal spectacles
Device: Prismatic bifocal spectacles

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Essilor International:

Primary Outcome Measures:
  • Myopia progression, measured by cycloplegic autorefraction [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Axial length, measured by A-scan ultrasonography [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: April 2003
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787579

Locations
Canada, Ontario
Dr. Desmond Cheng & Associates
Mississauga, Ontario, Canada, L5N 7G5
Sponsors and Collaborators
Essilor International
Queensland University of Technology
Investigators
Principal Investigator: Desmond Cheng, OD, MSc Queensland University of Technology
  More Information

No publications provided by Essilor International

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Desmond Cheng, Essilor International
ClinicalTrials.gov Identifier: NCT00787579     History of Changes
Other Study ID Numbers: Essilor
Study First Received: November 4, 2008
Last Updated: November 6, 2008
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Essilor International:
Myopia, bifocal, children

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013