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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Open Angle Glaucoma; Pseudoexfoliation Glaucoma; Pigmentary Glaucoma
• Intervention / Treatment: Device: iStent infinite trabecular micro-bypass system model iS3; Drug: iDose TR (Travoprost intracameral Implant) 75mcg

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jeanne L Molineaux, COA; Phone Number: 215-825-4713; Email: jmolineaux@willseye.org
• Study Contact Backup: Name: Meskerem Divers; Phone Number: 215-825-4712; Email: mdivers@willseye.org

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Wills Eye Hosital Glaucoma Dept.
      • Contact: Meskerem Divers; Phone Number: (215)825-4712; Email: mdivers@willseye.org
      • Contact: Jeanne Molineaux, COA; Phone Number: (215)825-4713; Email: jmolineaux@willseye.org
      • Principal Investigator: Dilru Amarasekera, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery for patients with medically uncontrolled POAG; surgery using combined minimally invasive surgical iStent infinite trabecular micro-bypass systme model iS3 and drug depot iDose TR (Travoprost Intracameral Implant) 75mcg	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP reduction from baseline	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.	Diurnal IOP reduction from baseline at 12 months

Collaborators and Investigators

• Sponsor: Jonathon Myers
• Collaborators: Glaukos Corporation
• Investigators: Principal Investigator: Dilru Amarasekera, MD, Wills Eye Hospital Glaucoma Research

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2026
• Primary Completion (Estimated): August 30, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 14, 2025

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: POAG; PG; PXG
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Ocular Hypertension; Glaucoma; Iris Diseases; Glaucoma, Open-Angle; Exfoliation Syndrome
• Other Study ID Numbers: WEH IRB #2025-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, Statistical Analysis Plan (SAP), informed Consent Form, and deidentified participant and group data will be kept on file at Wills Eye Hospital for 7 years. Researchers can request this data by email to glaucoma@willseye.org with a description of their planned use.
• IPD Sharing Time Frame: This is a 5 year study with anticipated completion of enrollment and data December 2031.
• IPD Sharing Access Criteria: Researchers can request the study protocol, Statistical Analysis Plan (SAP), informed Consent Form, and deidentified participant and group data with a description of their planned use
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes