MINIject™ Implant for Glaucoma (STAR-V Trial)
Recruiting in Palo Alto (17 mi)
+35 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: iSTAR Medical
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a small device called the MINIject™ implant, which is designed to help lower eye pressure in people with primary open-angle glaucoma. The device works by making it easier for fluid to drain from the eye, reducing pressure and potentially preventing vision loss.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the MINIject™ Implant treatment for glaucoma?
The MINIject™ Implant is a new type of glaucoma treatment designed to lower eye pressure. While specific data on MINIject™ is limited, similar implants like the ExPRESS have shown success in reducing eye pressure in patients with different types of glaucoma, suggesting potential effectiveness for MINIject™ as well.
12345Is the MINIject™ Implant generally safe for humans?
The MINIject™ Implant has been studied for safety in humans with glaucoma, showing it is generally safe for use in patients with uncontrolled open-angle glaucoma. Additionally, studies in rabbits have evaluated its biocompatibility, indicating it integrates well with eye tissues.
15678What makes the MINIject™ Implant treatment unique for glaucoma?
The MINIject™ Implant is unique because it is a minimally invasive device placed in the supraciliary space (between the eye's layers) to lower eye pressure in glaucoma patients. It is designed to be biocompatible, reducing the risk of fibrous tissue formation that can block drainage, which is a common issue with other implants.
12569Eligibility Criteria
This trial is for men and women aged 46 or older with primary open-angle glaucoma who have had successful cataract surgery. It's suitable for those needing medical therapy, laser treatment, or surgery for glaucoma. People with eye inflammation, infections, degenerative visual disorders, or other types of glaucoma cannot participate.Inclusion Criteria
I am 46 years old or older.
I have primary open-angle glaucoma and can undergo treatment or surgery.
I'm sorry, but "Key" is not a screening criterion. It is not possible to provide a summary or rewrite without additional context. Please provide more information.
I have had successful cataract surgery and now have an artificial lens.
Exclusion Criteria
I have been diagnosed with a condition that is causing my vision to worsen over time.
I have a specific type of glaucoma.
I have a serious eye infection or inflammation.
Participant Groups
The MINIject™ Implant by iSTAR Medical is being tested to see if it can safely lower intraocular pressure in patients with primary open-angle glaucoma. The study aims to evaluate its effectiveness compared to standard treatments.
1Treatment groups
Experimental Treatment
Group I: Implant GroupExperimental Treatment1 Intervention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Arizona Advanced Eye Research InstituteGlendale, AZ
Beverly Hills Institute of OphthalmologyBeverly Hills, CA
Reeve Woods Eye CenterChico, CA
Sacramento Eye Consultants, A Medical CorporationSacramento, CA
More Trial Locations
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Who is running the clinical trial?
iSTAR MedicalLead Sponsor
References
Biocompatibility of the Ex-PRESS miniature glaucoma drainage implant. [2019]Based on lessons learned from earlier attempts, a novel miniature glaucoma implant, Ex-PRESS, was developed in 1998. The current study summarizes the histopathologic evaluation of this device implanted in the eyes of rabbits.
Results of a New Technique for Implantation of Nonrestrictive Glaucoma Devices. [2022]To describe and present results of an original technique for nonvalved glaucoma implants.
[Management of uncontrolled secondary glaucoma with ExPRESS glaucoma minishunt implantation]. [2018]The aim of the study was to evaluate the decrease of intraocular pressure and reduction of local as well as total therapy by patients with uncontrolled secondary glaucoma after antiglaucomatous surgery with mini implant ExPRESS. From the total of 61 eyes with this implant, operated in our clinic between years 2009-2012, were 20 patients (22 eyes) with secondary glaucoma. Of which 7 eyes with neovascular glaucoma, 4 eyes with posttraumatic, 6 eyes with postuveitic, 4 with postoperative and 1 patient with pseudo-exfoliative glaucoma. 10 patients were after pars plana vitrectomy. In our group of patients was proven significant reduction of IOP and reduction of local and total therapy after surgery with the implant ExPRESS.
[Comment on indications of Ex-Press miniature implant surgery]. [2017]Ex-Press miniature implant surgery (Ex-Press implantation) is a new alternative anti-glaucoma surgery. It is clinically important to clarify its indications. Ex-Press implantation has been indicated appropriate in primary open-angle glaucoma and should not be used in narrow angle-closure glaucoma and in high risk of failed scarring cases. More evidence-based studies are still needed to convince the pros and cons in other conditions including aphakia or pseudo-phakia glaucoma, secondary open-angle glaucoma and refractory glaucoma.
A novel suprachoroidal microinvasive glaucoma implant: in vivo biocompatibility and biointegration. [2022]A major challenge for any glaucoma implant is their ability to provide long-term intraocular pressure lowering efficacy. The formation of a low-permeability fibrous capsule around the device often leads to obstructed drainage channels, which may impair the drainage function of devices. These foreign body-related limitations point to the need to develop biologically inert biomaterials to improve performance in reaching long-term intraocular pressure reduction. The aim of this study was to evaluate in vivo (in rabbits) the ocular biocompatibility and tissue integration of a novel suprachoroidal microinvasive glaucoma implant, MINIject™ (iSTAR Medical, Wavre, Belgium).
Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial. [2022]The current study evaluates the efficacy and safety of the stand-alone implantation of the MINIject (iSTAR Medical, Wavre, Belgium) supraciliary, microinvasive glaucoma drainage device in patients with medically uncontrolled open-angle glaucoma.
A First-in-Human Study of the Efficacy and Safety of MINIject in Patients with Medically Uncontrolled Open-Angle Glaucoma (STAR-I). [2021]To describe the safety and efficacy of a novel, supraciliary, microinvasive glaucoma surgery drainage system, MINIject (iSTAR Medical, Wavre, Belgium), in the study.
Long-term Outcomes of a Modified Technique Using the Baerveldt Glaucoma Implant for the Treatment of Refractory Glaucoma. [2018]The purpose of the study was to evaluate the long-term effectiveness and safety profile of Baerveldt glaucoma implant (BGI) in patients with refractory glaucoma operated using a modified technique to avoid postoperative complications.
A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II). [2022]In this European study (STAR-II), MINIject, a novel, ab-interno, supraciliary minimally invasive glaucoma surgery device, effectively lowered intraocular pressure (IOP) and the need for IOP-lowering medications in patients with primary open-angle glaucoma.