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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bifocal spectacles
Prismatic bifocal spectacles
Sponsored by
Essilor International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia, bifocal, children

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dr. Desmond Cheng & Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Bifocal spectacles

Prismatic bifocals

Single vision spectacles

Arm Description

Outcomes

Primary Outcome Measures

Myopia progression, measured by cycloplegic autorefraction

Secondary Outcome Measures

Axial length, measured by A-scan ultrasonography

Full Information

First Posted
November 4, 2008
Last Updated
November 6, 2008
Sponsor
Essilor International
Collaborators
Queensland University of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00787579
Brief Title
Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
Official Title
Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Essilor International
Collaborators
Queensland University of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia, bifocal, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bifocal spectacles
Arm Type
Active Comparator
Arm Title
Prismatic bifocals
Arm Type
Active Comparator
Arm Title
Single vision spectacles
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Bifocal spectacles
Intervention Description
+1.50D bifocal spectacles
Intervention Type
Device
Intervention Name(s)
Prismatic bifocal spectacles
Intervention Description
+1.50D bifocal spectacles combined with 3Δ base-in prisms
Primary Outcome Measure Information:
Title
Myopia progression, measured by cycloplegic autorefraction
Time Frame
Every 6 months
Secondary Outcome Measure Information:
Title
Axial length, measured by A-scan ultrasonography
Time Frame
Every 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desmond Cheng, OD, MSc
Organizational Affiliation
Queensland University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Desmond Cheng & Associates
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5N 7G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24435660
Citation
Cheng D, Woo GC, Drobe B, Schmid KL. Effect of bifocal and prismatic bifocal spectacles on myopia progression in children: three-year results of a randomized clinical trial. JAMA Ophthalmol. 2014 Mar;132(3):258-64. doi: 10.1001/jamaophthalmol.2013.7623.
Results Reference
derived
PubMed Identifier
20065211
Citation
Cheng D, Schmid KL, Woo GC, Drobe B. Randomized trial of effect of bifocal and prismatic bifocal spectacles on myopic progression: two-year results. Arch Ophthalmol. 2010 Jan;128(1):12-9. doi: 10.1001/archophthalmol.2009.332.
Results Reference
derived

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

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