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

Essilor

Status: Completed

Conditions: Myopia

Treatments: Device: Prismatic bifocal spectacles; Device: Bifocal spectacles

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00787579

Essilor

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 8 to 13 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 3 patient groups

Bifocal spectacles

Active Comparator group

Treatment:

Device: Bifocal spectacles

Prismatic bifocals

Active Comparator group

Treatment:

Device: Prismatic bifocal spectacles

Single vision spectacles

No Intervention group