The primary study objective is to compare the effectiveness of the combination of phacoemulsification with intraocular lens implant with ELIOS or competitor device in reducing IOP at 12 months postoperatively.
Male or female subjects.
40 years old or older.
Visually significant cataract eligible for phacoemulsification.
All forms of angle closure glaucoma
Secondary glaucoma, including traumatic, neovascular, uveitic, lens-induced, steroid-induced, angle-recession, glaucoma associated with vascular disorders, and glaucoma associated with increased episcleral venous pressure
Congenital or developmental glaucoma
Prior incisional glaucoma surgery, intraocular surgery or ocular laser treatment of any type with the exception of selective laser trabeculoplasty (SLT) occurring a minimum of 6 months prior to the Screening visit
Parallel
ELIOS
Procedure/SurgeryFollowing cataract surgery, surgeon will proceed to ELIOS treatment.
Competitor Device
Procedure/SurgeryFollowing cataract surgery, surgeon will proceed to Competitor treatment.
PRIMARY EFFECTIVENESS ENDPOINTS : IOP
Mean change in post-washout diurnal IOP from baseline to 12 months.
SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP
Proportion of patients achieving 20% reduction in post-washout diurnal IOP from baseline.
SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications
change in number of hypotensive medications from screening to 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP
Mean change in treated IOP from screening to 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Medications
Proportion of patients Medication free at 12 months
SAFETY ENDPOINTS : adverse events
Rates of ocular adverse events
Safety endpoints: Retinal nerve fiber layer thickness
measurement of Retinal nerve fiber layer thickness
Click on the lead sponsor to view all of their trials.
