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

This study has been completed.

First Received: November 4, 2008 Last Updated: November 6, 2008 History of Changes

Sponsors and Collaborators:	Essilor International Queensland University of Technology
Information provided by:	Essilor International
ClinicalTrials.gov Identifier:	NCT00787579

Purpose

To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.
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.
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

MedlinePlus related topics: Eye Wear

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

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

Keywords provided by Essilor International:

Myopia, bifocal, children

Study placed in the following topic categories:

Eye Diseases
Myopia
Refractive Errors

Additional relevant MeSH terms:

Eye Diseases
Myopia
Refractive Errors

ClinicalTrials.gov processed this record on May 07, 2009