N/A
N=294
Bifocal Lenses In Nearsighted Kids
Refractive Errors
Bottom Line
View on ClinicalTrials.gov: NCT02255474 ↗Enrolled (actual)
294
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Refractive Error Progression — -3.46; -3.32; -2.84 Diopters — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biofinity Multifocal D +1.50 add (Device); Biofinity Multifocal D +2.50 add (Device); Biofinity (Device)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Refractive Error Progression |
-3.46; -3.32; -2.84 | <0.01 sig |
| SECONDARY Ocular Shape Change and Eye Growth |
24.92; 24.94; 24.64; 24.86; 24.90; 24.60 | 0.05 |
| SECONDARY Association of Peripheral Defocus to Myopic Progression |
-1.01; -0.85; -0.56 | 0.05 |
| SECONDARY Axial Length Progression |
25.08; 25.12; 24.81 | 0.05 |
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 bifocal lenses will decrease the amount of change in nearsightedness that the children experience.
Eligibility Criteria
Inclusion Criteria
- 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
- 0.1 logMAR or better best-corrected visual acuity in each eye
- 0.1 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02255474). 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.