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

November 6, 2008 updated by: Essilor International
  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L5N 7G5
        • Dr. Desmond Cheng & Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myopia progression, measured by cycloplegic autorefraction
Time Frame: Every 6 months
Every 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Axial length, measured by A-scan ultrasonography
Time Frame: Every 6 months
Every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essilor International

Collaborators

Queensland University of Technology

Investigators

  • Principal Investigator: Desmond Cheng, OD, MSc, Queensland University of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

April 1, 2008

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

November 4, 2008

First Submitted That Met QC Criteria

November 6, 2008

First Posted (Estimate)

November 7, 2008

Study Record Updates

Last Update Posted (Estimate)

November 7, 2008

Last Update Submitted That Met QC Criteria

November 6, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Essilor

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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