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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00787579
Enrollment
135
Registered
2008-11-07
Start date
2003-04-30
Completion date
Unknown
Last updated
2008-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Myopia, bifocal, children

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.

Interventions

+1.50D bifocal spectacles

DEVICEPrismatic bifocal spectacles

+1.50D bifocal spectacles combined with 3Δ base-in prisms

Sponsors

Queensland University of Technology
CollaboratorOTHER
Essilor International
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Myopia progression, measured by cycloplegic autorefractionEvery 6 months

Secondary

MeasureTime frame
Axial length, measured by A-scan ultrasonographyEvery 6 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026