N/A N=49 Treatment

Bifocal & Atropine in Myopia (BAM) Study

Refractive Errors

Bottom Line

View on ClinicalTrials.gov: NCT03312257 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2022

Primary outcome: Primary: Refractive Error Progression — -3.50 Diopter — p=0.70

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Multifocal D +2.50 add & 0.01% atropine (Combination_product)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: Jenny Jones
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Refractive Error Progression	-3.50	0.70
SECONDARY Axial Length Progression	22	0.054

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 alone in children ages 7 to 11 years old.

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
Finish at least 71% of 0.01% atropine during the run-in period

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03312257). 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.