Excimer Laser Trabeculostomy Glaucoma Treatment Study

A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma Undergoing Cataract Surgery

Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG) undergoing cataract surgery

Inclusion Criteria:

• Diagnosis of mild to moderate POAG
• Operable cataract, eligible for phacoemulsification with a BCVA of 20/40 or worse
• Medicated IOP of <=24 mmHg
• Unmedicated diurnal IOP of >=22 mmHg and <=34 mmHg
• Shaffer angle grade of III or IV
• CD ratio <=0.8
• At least 45 years old

Exclusion Criteria:

• Closed-angle and secondary glaucomas
• Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery
• Cannot undergo medication washout in the study eye
• Diagnosis of degenerative visual disorders
• Non-study eye with BCVA worse than 20/80
• Known corticosteroid responder
• Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control