NCT07228221

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)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jonathon Myers · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Open Angle Glaucoma
• Pigmentary Glaucoma
• Pseudoexfoliation Glaucoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-05
• Primary completion: 2031-08-30
• Completion: 2031-12-31
• First posted: 2025-11-14
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study