N/A
N=86
Bifocal Soft Contact Lenses and Their Effect on Myopia Progression in Children and Adolescents.
Myopia · Esophoria · Fixation Disparity
Bottom Line
View on ClinicalTrials.gov: NCT00214487 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Changes in Cycloplegic Autorefraction in One Year. — -0.22; -0.78 Diopters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bifocal Contact Lenses (Device); Placebo Control (Device)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Aller, Thomas A., OD
- Primary completion
- Mar 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Cycloplegic Autorefraction in One Year. |
-0.22; -0.78 | — |
| SECONDARY Keratometric Changes at One Year. |
— | — |
| SECONDARY Changes in Manifest Refraction at One Year. |
— | — |
| SECONDARY Relationship Between Residual Fixation Disparity and Myopia Progression. |
— | — |
| SECONDARY Changes in Cycloplegic Subjective Refraction in One Year |
— | — |
| SECONDARY Changes in Axial Length at One Year. |
— | — |
Summary
The purpose of this study is to determine whether bifocal soft contact lenses are effective in controlling the progression of myopia in children and adolescents that exhibit a tendency to excessively cross their eyes while reading (esophoria or eso fixation disparity). Several studies have demonstrated that bifocal or progressive multifocal spectacles are effective in slowing the progression of myopia in children either with near point esophoria and/or with inadequate focusing at near. A prominent theory for one cause of myopia progression is that poorly focused images on the back of the eye (retina) cause the eye to lengthen, causing an increase in myopia. Bifocal contact lenses may reduce this retinal defocus, reducing the stimulus to eye elongation, and thus may reduce myopia progression.
Eligibility Criteria
Inclusion Criteria
- Myopia between -0.50 and -6.00
- Eso fixation disparity at 33cm with distance correction
- Astigmatism 1.00 or less
- Ability to wear soft contact lenses
Exclusion Criteria
- Presence of ocular disease preventing wear of contacts
- Pregnancy or nursing
- Use of certain medications
Data sourced from ClinicalTrials.gov (NCT00214487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.