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Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma
NCT07228221 · Wills Eye
In plain English
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Official title
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)
About this study
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.
Eligibility criteria
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 target: 20 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-05
Estimated completion: 2031-12-31
Last updated: 2025-11-14
Interventions
Device: iStent infinite trabecular micro-bypass system model iS3Drug: iDose TR (Travoprost intracameral Implant) 75mcg
Primary outcomes
- • IOP reduction from baseline (Diurnal IOP reduction from baseline at 12 months)
Sponsor
Jonathon Myers · other
With: Glaukos Corporation
Contacts & investigators
ContactMeskerem Divers · contact · mdivers@willseye.org · 215-825-4712
ContactJeanne L Molineaux, COA · contact · jmolineaux@willseye.org · 215-825-4713
InvestigatorDilru Amarasekera, MD · principal_investigator, Wills Eye Hospital Glaucoma Research
All locations (1)
Wills Eye Hosital Glaucoma Dept.Recruiting
Philadelphia, Pennsylvania, United States