Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
Not Applicable
Completed
- Conditions
- Myopia
- Interventions
- Device: Bifocal spectaclesDevice: Prismatic bifocal spectacles
- Registration Number
- NCT00787579
- Lead Sponsor
- Essilor International
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bifocal spectacles Bifocal spectacles - Prismatic bifocals Prismatic bifocal spectacles -
- Primary Outcome Measures
Name Time Method Myopia progression, measured by cycloplegic autorefraction Every 6 months
- Secondary Outcome Measures
Name Time Method Axial length, measured by A-scan ultrasonography Every 6 months
Trial Locations
- Locations (1)
Dr. Desmond Cheng & Associates
🇨🇦Mississauga, Ontario, Canada