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

Essilor International135 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

135

Conditions

Myopia

Interventions

Bifocal spectaclesDEVICE

+1.50D bifocal spectacles

Prismatic bifocal spectaclesDEVICE

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

Eligibility

Sex: ALLMin age: 8 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dr. Desmond Cheng & Associates

Mississauga, Ontario, Canada

Outcomes

Primary Outcomes

Myopia progression, measured by cycloplegic autorefraction

Time frame: Every 6 months

Secondary Outcomes

Axial length, measured by A-scan ultrasonography

Time frame: Every 6 months

Data from ClinicalTrials.gov

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