Status:
COMPLETED
Bifocal Lenses In Nearsighted Kids
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
University of Houston
National Eye Institute (NEI)
Conditions:
Refractive Errors
Eligibility:
All Genders
7-11 years
Phase:
NA
Brief Summary
This study will evaluate the use of two different bifocal contact lens add powers to prevent further nearsighted progression in children ages 7 to 11 years old. It is theorized that the profile of the...
Detailed Description
The primary goal of this project is to determine whether a commercially available soft bifocal contact lens with a distance-center design can slow myopia progression in children. Using soft bifocal co...
Eligibility Criteria
Inclusion
- 7 to 11 years, inclusive, at baseline examination
- -0.75 to -5.00 D, inclusive, spherical component, cycloplegic autorefraction
- ≤1.00 DC, cycloplegic autorefraction
- ≥ 2.00 D difference between the sphere components of the two eyes (anisometropia), cycloplegic autorefraction
- 1 logMAR or better best-corrected visual acuity in each eye
- 1 logMAR or better visual acuity OU distance and near with a +2.50 D add contact lens
- +2.50 D add lens provides adequate fit with respect to movement and centration
Exclusion
- Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
- Systemic disease that may affect vision, vision development, or contact lens wear (eg, diabetes, Down syndrome, etc.)
- Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL spectacle wear (longer than 1 month of wear)
- Previous or current participation in myopia control studies
- Chronic use of medications that may affect immunity, such as oral or ophthalmic corticosteroids for ocular or systemic diseases
- Issues that may interfere with the ability to participate over the next 3 years
Key Trial Info
Start Date :
September 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2019
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT02255474
Start Date
September 22 2014
End Date
June 24 2019
Last Update
March 10 2021
Active Locations (2)
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1
Ohio State University College of Optometry
Columbus, Ohio, United States, 43210
2
University of Houston College of Optometry
Houston, Texas, United States, 77204