Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients

Mean Intraocular Pressure (IOP)

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.

Time frame: Month 3, Month 6, Month 12 Post-Operative

Change From Baseline in IOP

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.

Time frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative

Percent Change From Baseline in IOP

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.

Time frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative

Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.

Time frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative

Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol.