Hydrus Microstent for Glaucoma

(CONFIRM Trial)

Recruiting at 42 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ivantis, Inc.

Must be taking: Topical hypotensives

Disqualifiers: Closed angle glaucoma, Secondary glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

545 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the placement and effects of the Hydrus Microstent, a tiny device used to manage glaucoma, within two years after eye surgery. Participants will undergo cataract surgery, receive a basic lens implant (Monofocal IOL), and then receive the Hydrus Microstent. The trial targets individuals with cataracts affecting vision (20/40 or worse) and primary open-angle glaucoma, who use up to four eye pressure-lowering medications.

As an unphased trial, this study provides participants the opportunity to contribute to valuable research that may enhance future glaucoma treatments.

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 prior data suggests that the Hydrus Microstent is safe for glaucoma patients?

Research has shown that the Hydrus Microstent is generally well-tolerated during cataract surgery. Studies have found that it helps lower eye pressure in people with glaucoma, which is crucial because high eye pressure can damage the optic nerve and lead to vision loss. While most patients do well with the Hydrus Microstent, some risks exist, as with any medical device. The current study examines how often the microstent might be misplaced and any related issues within 24 months after surgery. Overall, the device is approved for use, indicating that the FDA considers it safe for its intended purpose. However, discussing any concerns or questions about its safety with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Hydrus Microstent is unique because it provides a new approach to managing glaucoma by enhancing fluid drainage in the eye, which is different from the traditional medications and surgeries that primarily target eye pressure reduction. This microstent is implanted during cataract surgery, allowing it to address two eye issues at once, potentially reducing the need for multiple surgeries. Researchers are excited because this combined procedure might offer a more efficient and less invasive option, with the possibility of better long-term outcomes for glaucoma patients.

What evidence suggests that the Hydrus Microstent is effective for glaucoma?

Research shows that the Hydrus Microstent, which participants in this trial may receive, works well for people with glaucoma. Studies have found it can lower eye pressure by 26.5% after surgery, which is important because reducing eye pressure helps control glaucoma. In one study, 67% of patients did not need additional surgery after receiving the microstent. Another study found that patients required fewer medications to lower eye pressure after the procedure. Overall, the Hydrus Microstent has helped many patients manage their glaucoma successfully. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Project Lead, CDMA Surgical

Principal Investigator

Alcon Research

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I have secondary glaucoma.

I have closed angle glaucoma.

I have glaucoma that I was born with or developed early in life.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cataract surgery
• Hydrus Microstent
• Monofocal IOL

Trial Overview 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.

How Is the Trial Designed?

Group I: Hydrus Microstent Experimental Treatment 3 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)

Who Is Running the Clinical Trial?

Ivantis, Inc.

Lead Sponsor

Trials

8

Recruited

2,600+

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Published Research Related to This Trial

In a study of 450 patients who underwent intracapsular cataract extraction and 450 who had extracapsular cataract extraction, the extracapsular method showed better outcomes in terms of final visual acuity.

The extracapsular cataract extraction also had a lower incidence of clinical cystoid macular edema compared to the intracapsular method, suggesting it may be a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of ICCE-Binkhorst intraocular lens and ECCE-posterior chamber intraocular lens, thirty-four to forty months postoperatively. Jaffe, NS., Clayman, HM., Jaffe, MS.[2019]

In a study of 3,047 extracapsular cataract extractions, certain types of intraocular lenses were associated with a higher rate of anterior segment complications.

The risk of retinal detachment and cystoid macular edema was significantly lower when the posterior capsule remained intact for one year after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of anterior and posterior segment complications in over 3,000 cases of extracapsular cataract extractions: intact and open capsules. Chambless, WS.[2019]

The study involved 17 patients who underwent extracapsular cataract extraction with lens implantation into the posterior chamber, highlighting the procedure's effectiveness in treating cataracts.

The author discusses both peroperative and postoperative complications, as well as the advantages of this surgical approach, suggesting it may offer benefits for patient recovery and visual outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Personal experience with extracapsular extraction and lens implantation into the posterior chamber]. Janula, J.[2009]

The Hydrus Microstent, when used alongside cataract surgery, significantly reduced intraocular pressure (IOP) in patients with open-angle glaucoma, with 80% of patients experiencing a 20% or more decrease in IOP at 24 months compared to 46% in the cataract surgery alone group.

There were no significant safety concerns associated with the Hydrus Microstent, as visual acuity remained stable and adverse events were similar between both treatment groups, indicating it is a safe option for managing IOP in glaucoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma. Pfeiffer, N., Garcia-Feijoo, J., Martinez-de-la-Casa, JM., et al.[2022]

In a retrospective case series of 11 pseudophakic patients with medically refractory open-angle glaucoma, the Hydrus Microstent significantly reduced intraocular pressure (IOP) by 43.8% at 12 months and 34.1% at 24 months, demonstrating its efficacy in managing glaucoma.

The use of the Hydrus Microstent also led to a substantial reduction in medication burden by 75.6% at both 12 and 24 months, indicating its potential to simplify treatment for patients while maintaining safety, as complications were minor and resolved without lasting effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Hydrus Microstent in Pseudophakic Patients With Medically Refractory Open-angle Glaucoma. Coventon, J., Cronin, B.[2021]

The Hydrus Microstent is a minimally invasive glaucoma surgery device that effectively reduces intraocular pressure (IOP) and decreases the need for antiglaucoma eyedrops, supported by extensive clinical studies.

Its design allows it to cover a significant portion of Schlemm's canal, which not only confirms correct implantation but also enhances the potential for effective outflow by targeting multiple collector channels, making it particularly beneficial for patients with limited prior use of glaucoma medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy. Fea, AM., Ricardi, F., Cariola, R., et al.[2023]

Implanting the Hydrus microstent (HMS) during cataract surgery is cost-effective for patients with mild-to-moderate open-angle glaucoma, with a cost-utility ratio of approximately USD 38,346 per utility gained over a 2-year period.

The effectiveness of the HMS must be at least 85.60% compared to published data to remain cost-effective, highlighting the need for long-term safety and efficacy data to fully assess its performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost Utility of Schlemm's Canal Microstent Injection With Cataract Surgery for Open-angle Glaucoma in the US Medicare System. Atik, A., Rhodes, LA., Samuels, BC., et al.[2023]

In a study of 556 patients with cataract and primary open-angle glaucoma, the combination of cataract surgery and Hydrus Microstent implantation was found to be safe and more effective in lowering intraocular pressure (IOP) compared to cataract surgery alone over a 3-year period.

Patients receiving the microstent required fewer glaucoma medications, with 73% being medication-free at 3 years, and had a significantly lower risk of needing further incisional glaucoma surgery (0.6% vs. 3.9% for the CS only group).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Year Findings of the HORIZON Trial: A Schlemm Canal Microstent for Pressure Reduction in Primary Open-Angle Glaucoma and Cataract. Ahmed, IIK., Rhee, DJ., Jones, J., et al.[2021]

In a study of 76 Black and Afro-Latinx patients with glaucoma, phacoemulsification cataract surgery combined with Hydrus microstent placement significantly reduced the average number of glaucoma medications from 2.6 to 0.72 within 6 months, with 74% of patients becoming medication-free.

The procedure also improved visual acuity significantly, while maintaining intraocular pressure (IOP) levels, and no serious complications were reported, indicating a safe and effective treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world efficacy of the Hydrus microstent in Black and Afro-Latinx patients with glaucoma: a retrospective study. Laroche, D., Nkrumah, G., Ng, C.[2022]

The Hydrus microstent, when combined with cataract surgery, significantly reduced intraocular pressure (IOP) in patients with primary open-angle glaucoma, achieving a mean IOP of 15.7 mm Hg at 2 years compared to a baseline of 19.4 mm Hg.

Patients also experienced a significant decrease in the number of glaucoma medications needed, with 64% of patients being medication-free at the 2-year follow-up, indicating both safety and efficacy in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Schlemm canal scaffold microstent combined with phacoemulsification in routine clinical practice: Two-year multicenter study. Fea, AM., Rekas, M., Au, L.[2022]

Extracapsular cataract extraction with intraocular lens implantation is the most successful eye surgery, with a significant increase in procedures performed over the past decade.

The review suggests that due to ongoing research, development, and demographic trends, the demand for cataract surgeries and intraocular lenses will continue to grow, indicating that we are not close to a saturation point in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The outlook for intraocular lenses through 1990. Jaffe, NS.[2019]

In a study of 245 cataract patients, those who received bilateral multifocal intraocular lenses (IOLs) showed significantly better near and distance visual acuity compared to those with monofocal IOLs, with 96% achieving excellent vision without glasses.

Patients with multifocal IOLs reported improved quality of life and less dependency on glasses, although they experienced more glare or halo effects compared to those with monofocal IOLs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cataract extraction with multifocal intraocular lens implantation: a multinational clinical trial evaluating clinical, functional, and quality-of-life outcomes. Javitt, JC., Steinert, RF.[2022]

Both Phaco-iStent and Phaco-Hydrus procedures showed comparable surgical success rates and reductions in intraocular pressure and antiglaucoma medication use after 12 months, indicating similar efficacy in treating glaucoma.

However, the Phaco-Hydrus group experienced a higher rate of hyphema and device obstruction compared to the Phaco-iStent group, suggesting some differences in safety profiles, although most complications resolved without further intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Efficacy of Combined Phacoemulsification and iStent Inject versus Combined Phacoemulsification and Hydrus Microstent. Chee, WK., Yip, VCH., Tecson, IO., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0008418225004065

Five-year outcomes of a Schlemm's canal microstent ... Surgical success ranged from 91% to 25%, depending on the criteria. Six eyes (9%) required secondary glaucoma surgery, and selective laser ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41027555/

Five-year outcomes of a Schlemm's canal microstent ... Surgical success ranged from 91% to 25%, depending on the criteria. Six eyes (9%) required secondary glaucoma surgery, and selective laser ...

3. ophthalmologyglaucoma.org ophthalmologyglaucoma.org/article/S2589-4196(25)00116-4/fulltext

Outcomes of Hydrus Microstent with Cataract Surgery in ... The primary outcome was medication reduction from baseline at 1 year. Secondary outcomes were medication reduction in subsequent years, ...

4. aao.org aao.org/eyenet/article/real-world-outcomes-with-hydrus-stent

Real-World Outcomes With Hydrus Stent Overall, 67% of eyes met all success criteria, with only 14% needing additional surgery. IOP decreased 26.5% following surgery, from 18.9 ± 4.8 ...

5. link.springer.com link.springer.com/article/10.1007/s40123-025-01126-x

The INTEGRITY Study | Ophthalmology and Therapy Both iStent infinite and Hydrus eyes demonstrated a reduction in the need for IOP-lowering medication, with 0.0 ± 0.18 IOP-lowering medications ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2589419625001802

Clinical outcomes of Hydrus Microstent implantation for ... Our data demonstrate that Hydrus Microstent implantation combined with cataract surgery reduces IOP, reduces glaucoma medication burden, and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11126590/

Mid-term real world outcomes of the Hydrus® Microstent in ... Kaplan–Meier survival was defined as a reduction in IOP of ≥20% compared to baseline. Secondary endpoints were reduction in number of glaucoma ...

8. myalcon.com myalcon.com/professional/glaucoma/hydrus-microstent/

Hydrus® Microstent MIGS Device | Alcon Professional The Hydrus Microstent is a revolutionary canal-based MIGS device for adult patients with mild to moderate primary open-angle glaucoma.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01539239

Safety & Effectiveness Study of the Hydrus Microstent for ... The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout. Official Title.

10. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170034B.pdf

summary of safety and effectiveness data (ssed) The Hydrus® Microstent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult ...