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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{7 8 11 12 13}

Research Team

Clinical Project Lead, CDMA Surgical

Principal Investigator

Alcon Research

Eligibility 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.

Exclusion Criteria

I have secondary glaucoma.

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

I have closed angle glaucoma.

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

Treatment Details

Interventions

• Cataract surgery (Procedure)
• Hydrus Microstent (Microstent)
• Monofocal IOL (Intraocular Lens)

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.

Participant Groups

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 Canada, Japan, China, Switzerland for the following indications:

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

Findings from Research

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]

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 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]

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]

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 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]

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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

The outlook for intraocular lenses through 1990. [2019]

3. United States 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. Czech Republic pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Schlemm canal scaffold microstent combined with phacoemulsification in routine clinical practice: Two-year multicenter study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Real-world efficacy of the Hydrus microstent in Black and Afro-Latinx patients with glaucoma: a retrospective study. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of Efficacy of Combined Phacoemulsification and iStent Inject versus Combined Phacoemulsification and Hydrus Microstent. [2023]

10. United States 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

The Hydrus Microstent in Pseudophakic Patients With Medically Refractory Open-angle Glaucoma. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy. [2023]

13. United States 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. [2023]