NCT07228221PHASE4Recruiting

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

Jonathon Myers

Start Date

1/5/2026

Completion Date

12/31/2031

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

iStent infinite trabecular micro-bypass system model iS3

DRUG

iDose TR (Travoprost intracameral Implant) 75mcg

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Conditions

Open Angle GlaucomaPigmentary GlaucomaPseudoexfoliation Glaucoma

Locations

Wills Eye Hosital Glaucoma Dept.

Philadelphia, Pennsylvania 19107

United States