Hydrus Microstent for Glaucoma
(CONFIRM Trial)
Recruiting in Palo Alto (17 mi)
+42 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ivantis, Inc.
Must be taking: Topical hypotensives
Disqualifiers: Closed angle glaucoma, Secondary glaucoma, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is evaluating the placement and effects of a tiny device called the Hydrus Microstent in patients having cataract surgery. The device helps drain fluid from the eye to reduce pressure. The study will monitor patients over time to see how well the device works and if there are any issues. The Hydrus Microstent is designed to increase fluid drainage from the eye and lower eye pressure.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must not be using more than 4 eye pressure-lowering medications to qualify.
What data supports the effectiveness of the Hydrus Microstent treatment for glaucoma?
The research indicates that extracapsular cataract extraction with posterior chamber intraocular lens implantation is a highly successful procedure, suggesting that combining it with the Hydrus Microstent could be effective for glaucoma treatment. Additionally, the use of monofocal intraocular lenses, like those mentioned in the trial, is standard in cataract surgery and has been shown to improve visual outcomes.
12345Is the Hydrus Microstent safe for humans?
The Hydrus Microstent has been studied for safety in combination with cataract surgery, and research shows it is generally safe for use in humans. Multiple studies, including a two-year multicenter study and the three-year HORIZON trial, have evaluated its safety in patients with glaucoma.
678910How is the Hydrus Microstent treatment for glaucoma different from other treatments?
The Hydrus Microstent is unique because it is a minimally invasive device that is implanted during cataract surgery to help lower eye pressure in glaucoma patients by improving fluid drainage. This combination of cataract surgery and microstent placement offers a dual benefit of vision improvement and glaucoma management, which is not typically achieved with standard treatments.
78111213Eligibility Criteria
This study is for people with primary open-angle glaucoma, using up to 4 eye pressure-lowering meds, and having a cataract affecting vision. They must have an eye pressure under 31 mmHg on medication. Not eligible if they've had certain previous eye surgeries or more than 4 medications.Inclusion Criteria
Medicated IOP less than or equal to 31 millimeters mercury (mmHg);
I have primary open angle glaucoma and use up to 4 eye drops for it.
Your intraocular pressure (IOP) is below 31 mmHg, and you meet any other requirements stipulated by the protocol.
+3 more
Exclusion Criteria
I have secondary glaucoma.
I have glaucoma that I was born with or developed early in life.
I have closed angle glaucoma.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 visit
1 visit (in-person)
Surgical
Participants undergo cataract surgery with placement of a monofocal intraocular lens (IOL) and implantation of the Hydrus Microstent
Day 0
1 visit (in-person)
Postoperative Follow-up
Participants attend scheduled postoperative visits to monitor for device malposition and other ocular adverse events
24 months
8 visits (in-person) at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24
Participant Groups
The trial tests the Hydrus Microstent's position and effects after two years in patients getting cataract surgery with a new lens implant. It checks how well the stent works in controlling glaucoma following the procedure.
1Treatment groups
Experimental Treatment
Group I: Hydrus MicrostentExperimental Treatment3 Interventions
Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL)
Cataract surgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Cataract surgery for:
- Visually significant cataracts causing impaired vision
- Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
🇺🇸 Approved in United States as Cataract surgery for:
- Cataracts causing visual impairment
- Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
- Preparation for vitrectomy or retinal detachment repair
🇨🇦 Approved in Canada as Cataract surgery for:
- Visually significant cataracts
- Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
🇯🇵 Approved in Japan as Cataract surgery for:
- Cataracts causing visual impairment
- Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
🇨🇳 Approved in China as Cataract surgery for:
- Visually significant cataracts
- Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
🇨🇭 Approved in Switzerland as Cataract surgery for:
- Cataracts causing visual impairment
- Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Coastal VisionOrange, CA
North Suburban Eye SpecialistsCoon Rapids, MN
The Eye Centers of Racine and Kenosha LTDKenosha, WI
Sacramento Eye Consultants, A Medical CorporationSacramento, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Ivantis, Inc.Lead Sponsor
Alcon ResearchLead Sponsor
References
Cataract extraction with multifocal intraocular lens implantation: a multinational clinical trial evaluating clinical, functional, and quality-of-life outcomes. [2022]Two million cataract extractions are performed annually in the United States. The procedure is nearly always accompanied by implantation of a monofocal intraocular lens (IOL), which corrects the patient's distance vision. The authors' objective was to measure visual function and quality-of-life outcomes associated with bilateral implantation of a multifocal IOL, which corrects distance and near vision, and to compare the outcomes with those of the standard therapy.
The outlook for intraocular lenses through 1990. [2019]Extracapsular cataract extraction with posterior chamber intraocular lens implantation has become the most successful intraocular procedure ever practiced. The number of cataract extractions and intraocular lenses implanted have increased enormously over the past decade. One might ask if a saturation point is near. The progress of cataract extraction and intraocular lens implantation is reviewed from 1973 to 1983 and an attempt to predict their volume to 1990 is made. Significant research and development factors and their impact on the domestic and foreign markets are presented. Because of these and demographic factors, it is concluded that we are not nearing the saturation point in cataract surgery or the intraocular lens industry.
Incidence of anterior and posterior segment complications in over 3,000 cases of extracapsular cataract extractions: intact and open capsules. [2019]The results of 3,047 extracapsular cataract extractions are analyzed. They indicate that anterior segment complications are greater with certain types of intraocular lenses, and the incidence of retinal detachment and cystoid macular edema is lower when the posterior capsule is intact for one year postoperatively.
A comparison of ICCE-Binkhorst intraocular lens and ECCE-posterior chamber intraocular lens, thirty-four to forty months postoperatively. [2019]A retrospective study of 450 consecutive intracapsular cataract extractions with a Binkhorst lens implant, and 450 consecutive extracapsular cataract extractions with a posterior chamber lens implant, was performed. All patients were examined between 34 and 40 months postoperatively, except for those patients who died before this time, those lost to followup, or those who were otherwise unavailable during this time. The results suggest that the extracapsular series had a more favorable outcome than the intracapsular series, especially with regard to final visual acuity and the incidence of clinical cystoid macular edema.
[Personal experience with extracapsular extraction and lens implantation into the posterior chamber]. [2009]Author operated on 17 patients and describes the performance of the extracapsular cataract extraction together with the implantation of the lens into the posterior chamber, some peroperative and postoperative complications. Advantages of this kind of cataract surgery for operated patients were discussed.
Evaluation of a Schlemm canal scaffold microstent combined with phacoemulsification in routine clinical practice: Two-year multicenter study. [2022]To evaluate the efficacy and the safety of a new Schlemm canal scaffold microstent (Hydrus) combined with cataract surgery in routine clinical practice.
A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma. [2022]To assess the safety and effectiveness of the Hydrus Microstent (Ivantis, Inc, Irvine, CA) with concurrent cataract surgery (CS) for reducing intraocular pressure (IOP) in open-angle glaucoma (OAG).
Real-world efficacy of the Hydrus microstent in Black and Afro-Latinx patients with glaucoma: a retrospective study. [2022]The purpose was to determine the real-world efficacy of phacoemulsification cataract surgery and Hydrus microstent in Black and Afro-Latinx patients with glaucoma.
Comparison of Efficacy of Combined Phacoemulsification and iStent Inject versus Combined Phacoemulsification and Hydrus Microstent. [2023]This study aims to compare the efficacy and safety of combined phacoemulsification with iStent inject (Phaco-iStent) and Hydrus microstent (Phaco-Hydrus).
Three-Year Findings of the HORIZON Trial: A Schlemm Canal Microstent for Pressure Reduction in Primary Open-Angle Glaucoma and Cataract. [2021]To report 3-year outcomes of the HORIZON study comparing cataract surgery (CS) with Hydrus Microstent (Ivantis, Inc) implantation versus CS alone.
The Hydrus Microstent in Pseudophakic Patients With Medically Refractory Open-angle Glaucoma. [2021]Minimally invasive glaucoma surgery (MIGS) is an emerging therapy for glaucoma. The Hydrus Microstent is a MIGS device that stents Schlemm's canal, thereby increasing aqueous drainage and lowering intraocular pressure (IOP). This article describes the use of the microstent in pseudophakic patients with medically refractory glaucoma, a patient population undocumented in the current literature.
Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy. [2023]Minimally invasive glaucoma surgeries (MIGS) are now a consolidated reality in many surgical units. The Hydrus Microstent is one of several MIGS devices bypassing trabecular outflow and had excellent results over the years. This article aims to review the key features of the Hydrus Microstent in terms of design, efficacy, and safety.
Cost Utility of Schlemm's Canal Microstent Injection With Cataract Surgery for Open-angle Glaucoma in the US Medicare System. [2023]Hydrus microstent (HMS) implantation at the time of cataract surgery appears to be cost-effective in mild-to-moderate glaucoma. However, long-term follow-up is essential for a full assessment of device performance, safety and cost-effectiveness.