Bifocal & Atropine in Myopia (BAM) Study (BAM)
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|ClinicalTrials.gov Identifier: NCT03312257|
Recruitment Status : Active, not recruiting
First Posted : October 17, 2017
Last Update Posted : November 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Refractive Errors||Combination Product: Multifocal D +2.50 add & 0.01% atropine||Not Applicable|
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. The central hypothesis to be tested in the BAM Study is that atropine and soft bifocal contact lenses each exert their anti-progression actions through a common pathway that involves the choroid. If this is correct, then adding atropine treatment to soft bifocal contact lens wear will lead to a more effective slowing of myopia progression than prescribing soft bifocal contact lenses alone due to the additive effects in the common pathway.
The BAM Study is an ancillary study of an NIH sponsored multi-center, randomized clinical trial, the Bifocal Lenses In Nearsighted Kids (BLINK) Study (NIH: U10EY023208; NCT: NCT02255474). The BLINK Study compares myopia progression between subjects who wear single vision contact lenses and those wearing soft bifocal contact lenses. The BAM Study enrolls an additional 49 subjects that are age-matched with the participants who are wearing +2.50D add soft bifocal contact lenses in the BLINK Study. The subjects in the BAM Study wear +2.50D add soft bifocal contact lenses in combination with daily administration of one drop of 0.01% atropine in each eye for three years. The rates of myopia progression and axial elongation will be compared to the rates in participants who are receiving treatment with +2.50D add soft bifocal contact lenses alone in the BLINK Study.
Two specific aims will be addressed: Aim 1: To 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 over 3 years. Aim 2: To test whether early changes in choroidal thickness can be used as predictors of long-term myopia progression / axial elongation. The results of this study will have significant implications for future studies to develop and test new therapeutic regimes that optimize the effect of myopia control through combined pharmacological and optical interventions. The outcomes will also aid in understanding the potential role of short-term changes of choroidal thickness in long- term regulation of myopia progression and ocular growth.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Myopia Control in Children With Low-dose Atropine and Soft Bifocal Contact Lenses|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Multifocal D +2.50 add & 0.01% atropine
The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine.
Combination Product: Multifocal D +2.50 add & 0.01% atropine
Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.
- Refractive error progression [ Time Frame: 3 years ]Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the combination treatment (+2.50 D add soft bifocal lens and 0.01% atropine) group and the historical control group (+2.50 D add soft bifocal lens only) in the BLINK Study.
- Axial length progression [ Time Frame: 3 years ]Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the combination treatment (+2.50 D add soft bifocal lens and 0.01% atropine) group and the historical control group (+2.50 D add soft bifocal lens only) in the BLINK Study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312257
|Principal Investigator:||Juan Huang, PhD, OD||The Ohio State Univeristy|