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NCT Number: NCT07228221

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

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.

Recruiting

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Key information

Conditions

Open Angle Glaucoma Exfoliation Syndrome Eye Diseases Glaucoma Glaucoma, Open-Angle Iris Diseases Ocular Hypertension Pigmentary Glaucoma Pseudoexfoliation Glaucoma Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iStent infinite trabecular micro-bypass system model iS3

Device

surgery perfomed using the iStent infinite trabecular micro-bypass system model iS3

iDose TR (Travoprost intracameral Implant) 75mcg

Drug

surgery performed using the iDose TR (Travoprost intracameral Implant) 75mcg

Primary outcomes

  1. IOP reduction from baseline

    Time frame: Diurnal IOP reduction from baseline at 12 months

    a logistic regression model will be used for the imputation of missing values, using the 12-month performance outcome as dependent variable, and sex, race, age, baseline IOP, number of IOP-lowering medications used at baseline, last IOP and number of medications at the 6-month visit or later as explanatory variables.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeanne L Molineaux, COA

CONTACT

[email protected]

215-825-4713

Meskerem Divers

CONTACT

[email protected]

215-825-4712

Sponsors and collaborators

Lead sponsor

Jonathon Myers

Other

Collaborators

  • Glaukos Corporation

Registry information

Official study title

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)

Acronym: POAG

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Nov 14, 2025
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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