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

Jonathon Myers

Status and phase: Enrolling; Phase 4

Conditions: Open Angle Glaucoma; Pigmentary Glaucoma; Pseudoexfoliation Glaucoma

Treatments: Drug: iDose TR (Travoprost intracameral Implant) 75mcg; Device: iStent infinite trabecular micro-bypass system model iS3

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07228221

WEH IRB #2025-51

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Surgery for patients with medically uncontrolled POAG

Experimental group

Description:

surgery using combined minimally invasive surgical iStent infinite trabecular micro-bypass systme model iS3 and drug depot iDose TR (Travoprost Intracameral Implant) 75mcg

Treatment:

Device: iStent infinite trabecular micro-bypass system model iS3

Drug: iDose TR (Travoprost intracameral Implant) 75mcg