RECRUITINGPhase 4INTERVENTIONAL
Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma
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)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
iStent infinite trabecular micro-bypass system model iS3
surgery perfomed using the iStent infinite trabecular micro-bypass system model iS3
DRUG
iDose TR (Travoprost intracameral Implant) 75mcg
surgery performed using the iDose TR (Travoprost intracameral Implant) 75mcg
Locations (1)
Wills Eye Hosital Glaucoma Dept.
Philadelphia, Pennsylvania, United States