Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: iStent infinite trabecular micro-bypass system model iS3, iDose TR (Travoprost intracameral Implant) 75mcg.
- Who it may be relevant to
- Registry conditions: Open Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation Glaucoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Detailed 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.
Interventions
- Device iStent infinite trabecular micro-bypass system model iS3
surgery perfomed using the iStent infinite trabecular micro-bypass system model iS3 - Drug iDose TR (Travoprost intracameral Implant) 75mcg
surgery performed using the iDose TR (Travoprost intracameral Implant) 75mcg
Primary outcome measures
- IOP reduction from baseline [Time frame: Diurnal IOP reduction from baseline at 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Wills Eye Hosital Glaucoma Dept. — Philadelphia
Identifiers
NCT: NCT07228221 · WEH IRB #2025-51