This trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Bimatoprost Implant System used in combination with the SpyGlass IOL
SpyGlass Intraocular Lens
Timolol Maleate Ophthalmic Solution, 0.5% BID
Houston Eye Associates
Houston, Texas, United States
RECRUITINGMean IOP Reduction from Baseline (mmHg)
Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints
Time frame: Weeks 2 and 6, and Month 3
BCDVA 20/40 or better
Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better
Time frame: Month 6
Mean IOP Reduction from Baseline (mmHg)
Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints
Time frame: Month 6, 9 and 12
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