Research Studies
A Prospective, Multicenter, Randomized, Masked, Controlled Study
to Evaluate the Safety and Efficacy of the Bimatoprost ImplantSystem (78 mcg) used in combination with the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%.
Primary Objective: The objective of this clinical study is to evaluate and compare the safety and intraocular pressure (IOP)-lowering efficacy, and best corrected distance visual acuity (BCDVA) efficacy of the BIS/IOL Combo versus Timolol Maleate Ophthalmic Solution, United States Pharmacopeia (USP), 0.5% used in combination with “commercial IOL” in participants with mild to moderate OAG or OHT undergoing cataract surgery.
ROTATIONAL STABILITY OF THE RXSIGHT LIGHT ADJUSTABLE LENS (LAL) AND RXSIGHT LIGHT ADJUSTABLE LENS+ (LAL+)
Study objective: The primary objective of this study is to evaluate the LAL/LAL+ axis misalignment between the intended axis of orientation and the implanted lens axis, immediately at the end of surgery and at 1-3 weeks postoperatively.
Additional information for patients: Patients who require cataract extraction and intraocular lens implantation will be screened for eligibility. If it is determined that the patient may be eligible to participate, study staff will explain the study purpose, procedures, risks/benefits and subject responsibilities to the potential participant. Written informed consent will be obtained prior to any study specific testing. The patient is enrolled upon signing the informed consent. Subjects should be screened for eligibility and only eyes meeting all inclusion and none of the exclusion criteria will qualify for participation.