Recruiting

iStent Infinite & iDose

Sponsor:

Jonathon Myers

Code:

NCT07228221

Conditions

Open Angle Glaucoma

Pigmentary Glaucoma

Pseudoexfoliation Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

iStent infinite trabecular micro-bypass system model iS3

iDose TR (Travoprost intracameral Implant) 75mcg

Study Details

Brief summary:

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.

Conditions

Open Angle Glaucoma

Pigmentary Glaucoma

Pseudoexfoliation Glaucoma

Study ID

NCT07228221

Start date

Jan 5, 2026

Status verified date

Nov, 2025

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Aug 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

iStent infinite trabecular micro-bypass system model iS3

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

iDose TR (Travoprost intracameral Implant) 75mcg

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

Primary outcome measure

  • IOP reduction from baseline [ Time Frame: Diurnal IOP reduction from baseline at 12 months ]

Central Contacts and Locations

Central contacts

Meskerem Divers

215-825-4712mdivers@willseye.org

Jeanne L Molineaux, COA

215-825-4713jmolineaux@willseye.org

Locations

Wills Eye Hosital Glaucoma Dept.

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Meskerem Divers

(215)825-4712mdivers@willseye.org

Jeanne Molineaux, COA

(215)825-4713jmolineaux@willseye.org

Principal Investigator:

Dilru Amarasekera, MD

More Information

Sponsor

Jonathon Myers

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Keywords

  • POAG
  • PG
  • PXG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Jonathon Myers on 2025-11-14.