iStent infinite plus iDose TR for moderate-to-severe open-angle glaucoma
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)
Run by Wills Eye · NCT07228221 · Data updated 2026-11-12
This trial will see if placing an iStent infinite device together with an iDose TR travoprost implant can lower eye pressure and reduce glaucoma eye drops for people with moderate to severe open-angle glaucoma not controlled by medication or laser.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Wills Eye Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | January 5, 2026 |
| Main results expected | August 30, 2031 |
| Study ends | December 31, 2031 |
| Registry record updated | November 14, 2025 |
| Trial ID | NCT07228221 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with moderate-to-severe open-angle glaucoma (including POAG, pigmentary, or pseudoexfoliation glaucoma), open angles (Shaffer grade ≥3), visual acuity of hand motions or better, visual field mean deviation ≤ -6 dB, who have failed topical or laser therapy and are considering incisional surgery.
✕Probably not a fit
Patients with angle-closure, uveitic, neovascular or traumatic glaucoma, prior incisional glaucoma surgery, active ocular inflammation, clinically significant corneal disease, recent laser within 90 days, or corneal pathology preventing accurate applanation tonometry are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4, interventional study enrolls patients with moderate to severe open-angle glaucoma who have failed medical and/or laser therapy and for whom incisional surgery is being considered. Participants will undergo standalone implantation of the iStent infinite trabecular micro-bypass system and the iDose TR intracameral travoprost implant. Investigators will measure mean intraocular pressure change from baseline, change in number of glaucoma medications, the proportion needing additional incisional glaucoma surgery, and the incidence of adverse events over the study period. The hypothesis is that the combined minimally invasive device plus drug depot will produce a safe and meaningful reduction in intraocular pressure and medication burden compared with baseline.
Why it matters
Potential benefit: If successful, the combined device-and-drug approach could lower intraocular pressure, reduce or eliminate daily glaucoma medications, and decrease the need for more invasive filtering surgery.
How similar studies have gone: Previous studies of trabecular micro-bypass stents and of intracameral travoprost implants have shown intraocular pressure and medication reductions, but combining the standalone iStent infinite and iDose TR as a single procedure is a relatively new approach with limited published data.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Wills Eye Hosital Glaucoma Dept.
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Dilru Amarasekera, MD — Wills Eye Hospital Glaucoma Research
- Study coordinator: Meskerem Divers
- Email: mdivers@willseye.org
- Phone: 215-825-4712
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.