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Study of iStent infinite and iDose TR for Moderate to Severe Open Angle Glaucoma

This study is looking at how well two treatments, the iStent infinite (a tiny device implanted during surgery) and iDose TR (a drug implant that releases medicine over time), work together to lower eye pressure in people with moderate to severe open angle glaucoma. This includes common types like primary open angle glaucoma (POAG), pigmentary glaucoma (PG), and pseudoexfoliation glaucoma (PXG). You might be able to join if your glaucoma hasn't responded to other treatments and your doctor is considering incisional surgery. The main goal is to see how much eye pressure is reduced after 12 months. The current status of this study is unclear, and it plans to enroll 20 participants.

Study design
This interventional study plans to enroll 20 participants. It is testing two treatments given during surgery: the iStent infinite device and the iDose TR drug implant.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures eye pressure reduction at 12 months, suggesting participants will be followed for at least this long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07228221

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

Recruiting
PHASE4Ages 18+InterventionalSupportive care
Jonathon Myers
~20 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:iStent infinite trabecular micro-bypass system model iS3iDose TR (Travoprost intracameral Implant) 75mcg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
IOP reduction from baseline
Measured over Diurnal IOP reduction from baseline at 12 months

Conditions

Open Angle Glaucoma
Pigmentary Glaucoma
Pseudoexfoliation Glaucoma

Explore related trials

Exfoliation SyndromeOpen Angle Glaucoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Dilru Amarasekera, MD · PRINCIPAL_INVESTIGATOR · Wills Eye Hospital Glaucoma Research

Who to contact

Meskerem Divers
[email protected]
215-825-4712
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • IOP reduction from baselineDiurnal 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.