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OpenTrials
Completed

NCT Number: NCT00787579

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Desmond Cheng & Associates

Mississauga, Ontario, L5N 7G5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifocal Spectacles

Device

+1.50D bifocal spectacles

Prismatic bifocal spectacles

Device

+1.50D bifocal spectacles combined with 3Δ base-in prisms

Primary outcomes

  1. Myopia progression, measured by cycloplegic autorefraction

    Time frame: Every 6 months

Secondary outcomes

  1. Axial length, measured by A-scan ultrasonography

    Time frame: Every 6 months

Sponsors and collaborators

Lead sponsor

Essilor International

Industry

Collaborators

  • Queensland University of Technology

Registry information

Important dates

Study start
2003
Primary completion
2008
First posted
Nov 7, 2008
Registry last updated
Nov 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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