Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma

The Investigators will assess the mean intraocular pressure change from baseline, the change in the number of medications from baseline, the proportion of patients needing additional incisional surgery, and the incidence of adverse events. The Investigators hypothesize that patients receiving the combined standalone iStent infinite and iDose will experience a safe and significant reduction in mean intraocular pressure and number of medications during the study time period.

• iStent infinite trabecular micro-bypass system model iS3 (Device): surgery perfomed using the iStent infinite trabecular micro-bypass system model iS3
• iDose TR (Travoprost intracameral Implant) 75mcg (Drug): surgery performed using the iDose TR (Travoprost intracameral Implant) 75mcg

Primary outcomes

• IOP reduction from baseline [Diurnal IOP reduction from baseline at 12 months]: a logistic regression model will be used for the imputation of missing values, using the 12-month performance outcome as dependent variable, and sex, race, age, baseline IOP, number of IOP-lowering medications used at baseline, last IOP and number of medications at the 6-month visit or later as explanatory variables.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Moderate to severe open angle glaucoma (including POAG, PG, and PXG)
* Open angle configuration (Shaffer grade ≥ 3), normal angle anatomy9
* Visual acuity HM or better
* VF MD -6dB or worse
* Failed medical therapy and/or laser treatment
* Incisional glaucoma surgery contemplated as next intervention
* Phakic or pseudophakic

Exclusion Criteria:

* Traumatic, uveitic, neovascular glaucoma, or angle closure glaucoma
* Previous incisional glaucoma surgery
* ALT; History of iridotomy, SLT, or micropulse laser trabeculoplasty within the prior 90 days
* Active ocular inflammation or edema, clinically significant corneal dystrophy
* Corneal or other pathology preventing accurate Goldmann applanation tonometry

• Dilru Amarasekera, MD, Principal investigator, Wills Eye Hospital Glaucoma Research