iStent Infinite and iDose TR for Management of Moderate to Severe Primary Open Angle Glaucoma Are a Safe and Effective Alternative to Filtering Surgery for IOP Reduction in Patients With Medically Uncontrolled Glaucoma. (POAG)
Jonathon Myers
Summary
The Investigators will investigate the efficacy of combining the standalone iStent infinite and iDose that are minimally invasive surgical and drug depot options are a safe and effective alternative to filtering surgery for intraocuar pressure reduction in patients with medically uncontrolled open angle glaucoma.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 inflamma…
Interventions
- DeviceiStent infinite trabecular micro-bypass system model iS3
surgery perfomed using the iStent infinite trabecular micro-bypass system model iS3
- DrugiDose TR (Travoprost intracameral Implant) 75mcg
surgery performed using the iDose TR (Travoprost intracameral Implant) 75mcg
Location
- Wills Eye Hosital Glaucoma Dept.Philadelphia, Pennsylvania