RecruitingPhase 4NCT07228221

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)


Sponsor

Jonathon Myers

Enrollment

20 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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

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


Locations(1)

Wills Eye Hosital Glaucoma Dept.

Philadelphia, Pennsylvania, United States

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NCT07228221


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