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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-05

Study Completion Date

2031-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Open Angle Glaucoma Pigmentary Glaucoma Pseudoexfoliation Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each patient will have surgery using the iStent infinite Trabecular Micro-bypass model iS3 and the iDose TR (Travoprost Intracameral Implant) 75mcg

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

iStent infinite trabecular micro-bypass system model iS3

Intervention Type DEVICE

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

iDose TR (Travoprost intracameral Implant) 75mcg

Intervention Type DRUG

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

Interventions

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iStent infinite trabecular micro-bypass system model iS3

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

Intervention Type DEVICE

iDose TR (Travoprost intracameral Implant) 75mcg

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No