Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
1 other identifier
interventional
135
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 4, 2008
CompletedFirst Posted
Study publicly available on registry
November 7, 2008
CompletedNovember 7, 2008
November 1, 2008
5 years
November 4, 2008
November 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myopia progression, measured by cycloplegic autorefraction
Every 6 months
Secondary Outcomes (1)
Axial length, measured by A-scan ultrasonography
Every 6 months
Study Arms (3)
Bifocal spectacles
ACTIVE COMPARATORPrismatic bifocals
ACTIVE COMPARATORSingle vision spectacles
NO INTERVENTIONInterventions
+1.50D bifocal spectacles combined with 3Δ base-in prisms
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Strabismus
- Ocular diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Essilor Internationallead
- Queensland University of Technologycollaborator
Study Sites (1)
Dr. Desmond Cheng & Associates
Mississauga, Ontario, L5N 7G5, Canada
Related Publications (3)
Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
PMID: 36809645DERIVEDCheng 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.
PMID: 24435660DERIVEDCheng 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.
PMID: 20065211DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Desmond Cheng, OD, MSc
Queensland University of Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 4, 2008
First Posted
November 7, 2008
Study Start
April 1, 2003
Primary Completion
April 1, 2008
Last Updated
November 7, 2008
Record last verified: 2008-11