iStent Infinite Device for Glaucoma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Glaukos Corporation
Disqualifiers: Traumatic glaucoma, Uveitic glaucoma, Neovascular glaucoma, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the iStent Infinite treatment for glaucoma?
Research shows that the iStent Infinite device effectively lowers eye pressure in patients with open angle glaucoma, especially when other treatments haven't worked. It also has a good safety record, reducing the need for additional eye pressure medications.
12345Is the iStent Infinite device safe for use in humans?
The iStent Infinite device has been shown to have a favorable safety profile in patients with open-angle glaucoma, and similar devices like the iStent and iStent inject have been evaluated for safety in combination with cataract surgery, showing positive safety results.
12678How is the iStent Infinite treatment different from other glaucoma treatments?
The iStent Infinite is unique because it is a minimally invasive device that creates a bypass in the eye's drainage system to lower eye pressure, unlike traditional treatments that often rely on medications or more invasive surgeries. It is implanted through a small incision and allows fluid to drain directly, reducing the need for eye pressure-lowering drugs.
1391011Eligibility Criteria
This trial is for adults aged 35 or older with mild to moderate primary open-angle glaucoma. It's suitable for those who haven't had success with standard treatments and are either phakic (natural lens present) or pseudophakic (artificial lens implanted). People with other types of glaucoma, active corneal issues, or unrelated retinal disorders cannot participate.Inclusion Criteria
You have had cataract surgery or have an artificial lens in your eye.
I am 35 years old or older.
I have been diagnosed with primary open-angle glaucoma.
Exclusion Criteria
I have a retinal disorder not related to glaucoma.
I have active inflammation or swelling in my cornea.
My glaucoma is caused by trauma, inflammation, abnormal blood vessels, or a specific eye structure issue.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the iStent Infinite Trabecular Micro-Bypass System
8 weeks
3 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
4 visits (in-person)
Participant Groups
The study is testing the iStent Infinite device in a single group of participants without comparing it to another treatment. This device is designed to help reduce eye pressure in patients by improving fluid drainage from the eyes.
1Treatment groups
Experimental Treatment
Group I: iStent InfiniteExperimental Treatment1 Intervention
iStent Infinite Trabecular Micro-Bypass System
iStent Infinite is already approved in United States for the following indications:
🇺🇸 Approved in United States as iStent infinite for:
- Primary open-angle glaucoma in adult patients who have failed previous medical and surgical treatment
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Glaukos Investigator SiteCincinnati, OH
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Who Is Running the Clinical Trial?
Glaukos CorporationLead Sponsor
References
Effectiveness and Safety of iStent Infinite Trabecular Micro-Bypass for Uncontrolled Glaucoma. [2023]The iStent Infinite Trabecular Micro-Bypass System implanted in patients with open angle glaucoma (OAG) (uncontrolled by prior surgical or medical therapy) was effective in reducing mean diurnal intraocular pressure with a favorable safety profile.
Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract: Two-Year Results. [2022]Evaluate the safety and effectiveness of an ab interno implanted (iStent inject) Trabecular Micro-Bypass System (Glaukos Corporation, San Clemente, CA) in combination with cataract surgery in subjects with mild to moderate primary open-angle glaucoma (POAG).
Glaukos iStent Trabecular Micro-Bypass. [2022]The iStent trabecular micro-bypass system (Glaukos Corp. Laguna Hills, CA) was developed to address the limitations of current medical and surgical therapies for glaucoma treatment. The iStent((R)) is inserted ab interno through a small temporal clear corneal incision, bypassing the trabecular meshwork and placed in Schlemm's canal at the lower nasal quadrant. Implantation of this stent into Schlemm's canal allows aqueous humor to drain directly from the anterior chamber into Schlemm's canal bypassing the obstructed trabecular meshwork. For this review, a Medline search was performed using the terms "trabecular micro-bypass stent" and "trabecular bypass stent." The online abstract database for the American Academy of Ophthalmology was also reviewed. Abstracts which duplicated published articles were excluded. All relevant papers (n is equal to three) and abstracts (n is equal to one) were included in this review. Multiple, prospective multi-country, clinical trials have demonstrated the safety and efficacy of iStent in reducing IOP, when compared to traditional treatment modalities, while reducing/ eliminating the need for ocular antihypertensive drugs when implanted in OAG patients during combined cataract surgery or in patients with glaucoma refractory to traditional treatment modalities.
Standalone iStent Trabecular Micro-bypass Glaucoma Surgery: A Systematic Review and Meta-Analysis. [2021]Standalone trabecular micro-bypass glaucoma surgery with the iStent devices is associated with clinically relevant reductions in intraocular pressure (IOP) sustained over a reasonably long-term while simultaneously reducing medication burden and a relatively favorable safety profile.
The iStent trabecular micro-bypass stent: a case series. [2022]To evaluate the safety and effectiveness of a trabecular micro-bypass stent, the iStent (Glaukos, USA), for reduction of intraocular pressure in patients with open angle glaucoma.
One-year analysis of the iStent trabecular microbypass in secondary glaucoma. [2022]To evaluate the midterm efficacy and safety of the iStent(®) glaucoma device in patients with secondary open-angle glaucoma.
Intermediate Results of iStent or iStent inject Implantation Combined with Cataract Surgery in a Real-World Setting: A Longitudinal Retrospective Study. [2020]In this real-world, retrospective, comparative study we evaluated 6-month performance and safety in consecutive eyes following implantation of the iStent® or iStent inject® trabecular micro-bypass device with concomitant cataract surgery.
Real-world Case Series of iStent or iStent inject Trabecular Micro-Bypass Stents Combined with Cataract Surgery. [2021]Label="INTRODUCTION" NlmCategory="BACKGROUND">This real-world retrospective case series assessed 12-month effectiveness and safety following implantation of iStent® or iStent inject® trabecular micro-bypass with cataract surgery.
Ocular Antihypertensive Medication Use After iStent Implantation Concurrent With Cataract Surgery vs Cataract Surgery Alone in a Large US Health Care Claims Database. [2020]The iStent Trabecular Micro-Bypass (Glaukos Corporation) is a minimally invasive glaucoma implant used in conjunction with cataract surgery to lower intraocular pressure.
Characterization of micro-invasive trabecular bypass stents by ex vivo perfusion and computational flow modeling. [2022]Micro-invasive glaucoma surgery with the Glaukos iStent® or iStent inject® (Glaukos Corporation, Laguna Hills, CA, USA) is intended to create a bypass through the trabecular meshwork to Schlemm's canal to improve aqueous outflow through the natural physiologic pathway. While the iStent devices have been evaluated in ex vivo anterior segment models, they have not previously been evaluated in whole eye perfusion models nor characterized by computational fluid dynamics. Intraocular pressure (IOP) reduction with the iStent was evaluated in an ex vivo whole human eye perfusion model. Numerical modeling, including computational fluid dynamics, was used to evaluate the flow through the stents over physiologically relevant boundary conditions. In the ex vivo model, a single iStent reduced IOP by 6.0 mmHg from baseline, and addition of a second iStent further lowered IOP by 2.9 mmHg, for a total IOP reduction of 8.9 mmHg. Computational modeling showed that simulated flow through the iStent or iStent inject is smooth and laminar at physiological flow rates. Each stent was computed to have a negligible flow resistance consistent with an expected significant decrease in IOP. The present perfusion results agree with prior clinical and laboratory studies to show that both iStent and iStent inject therapies are potentially titratable, providing clinicians with the opportunity to achieve lower target IOPs by implanting additional stents.
Anterior Segment Optical Coherence Tomography Signs of Local Dilatation Effect of a Micro-Stent on Schlemm's Canal. [2019]The iStent inject® (Glaukos Corporation, CA, USA) is a relatively new device designed to be implanted ab-interno through the trabecular meshwork. This is, to the best of our knowledge, the first in-vivo description of a trabecular bypass device visualised with anterior segment optical coherence tomography (AS-OCT), and report of its structural effect on Schlemm's canal.