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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787579
• Other study ID #: Essilor
• Status: Completed
• Phase: N/A
• First received: November 4, 2008
• Last updated: November 6, 2008
• Start date: April 2003

Study information

• Verified date: November 2008
• Source: Essilor International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 13 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Bifocal spectacles
+1.50D bifocal spectacles
• Prismatic bifocal spectacles
+1.50D bifocal spectacles combined with 3? base-in prisms

Locations

Country	Name	City	State
Canada	Dr. Desmond Cheng & Associates	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Essilor International	Queensland University of Technology

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myopia progression, measured by cycloplegic autorefraction		Every 6 months	No
Secondary	Axial length, measured by A-scan ultrasonography		Every 6 months	No