Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children | NCT00787579 | Trialant
CompletedInterventionalNot ApplicableUpdated Nov 7, 2008
Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
ClinicalTrials.gov ID
NCT00787579
Lead Sponsor
Essilor InternationalINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
135Actual
Last Update Posted
Nov 7, 2008Estimated
Start Date
Apr 2003
Primary Completion Date
Apr 2008Actual
Official Title
Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
Brief Summary
To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.
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.
To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.
Myopia
Bifocal spectacles
Prismatic bifocal spectacles
Ages Eligible for Study
Child (0-17)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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