Status:
COMPLETED
Bifocal & Atropine in Myopia (BAM) Study
Lead Sponsor:
Jenny Jones
Conditions:
Refractive Errors
Eligibility:
All Genders
7-11 years
Phase:
NA
Brief Summary
This study will test whether the combined treatment of 0.01% atropine and soft bifocal contact lens wear produces slower myopia progression and axial elongation compared to soft bifocal contact lenses...
Detailed Description
Both atropine and soft bifocal contact lenses have been shown to slow myopia progression, and both can cause changes in choroidal thickness. But the relationship between these mechanisms is unclear. T...
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
- Finish at least 71% of 0.01% atropine during the run-in period
Exclusion
- Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
- Previous intraocular or corneal surgery
- 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 :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03312257
Start Date
July 1 2016
End Date
June 1 2020
Last Update
December 9 2022
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