drugset / Trial / NCT03312257
Bifocal & Atropine in Myopia (BAM) Study
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-07
- Primary completion
- 2020-06
- Completion
- 2020-06
Outcome
Missed primary endpoint
registry analysis (other test); Multifocal D +2.50 Add & 0.01% Atropine; p = 0.70; Mean Difference (Final Values) 0.03 (95% CI -0.14 to 0.21) NCT03312257 ↗
paper SIGNIFICANCE: Combining 0.01% atropine with soft multifocal contact lenses (SMCLs) failed to demonstrate better myopia control than SMCLs alone. PMID 35511120 ↗
Publications
- Jones JH, Mutti DO, Jones-Jordan LA, Walline JJ. Effect of Combining 0.01% Atropine with Soft Multifocal Contact Lenses on Myopia Progression in Children. Optom Vis Sci. 2022 May 1;99(5):434-442. doi: 10.1097/OPX.0000000000001884. Epub 2022 Feb 25.
- Huang J, Mutti DO, Jones-Jordan LA, Walline JJ. Bifocal & Atropine in Myopia Study: Baseline Data and Methods. Optom Vis Sci. 2019 May;96(5):335-344. doi: 10.1097/OPX.0000000000001378.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atropine | Other / unclassified | 0.01 % | Other |