iStent Inject for Glaucoma

Not currently recruiting at 2 trial locations

Overseen By Jason Schmitt, O.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Glaukos Corporation

Disqualifiers: Angle closure glaucoma, others

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

Compensation: Varies

Number of Visits: 37

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety of the iStent Inject for people with glaucoma after its market approval. The iStent Inject, a tiny device implanted during cataract surgery, helps reduce eye pressure in individuals with mild to moderate primary open-angle glaucoma. Those with this type of glaucoma who are already scheduled for cataract surgery might be suitable for the trial. Participants should commit to attending follow-up exams for three years post-surgery. As an unphased trial, this study allows participants to contribute to understanding the long-term benefits of an already approved 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.

What prior data suggests that the iStent Inject implantation is safe for glaucoma patients?

Research has shown that the iStent Inject, used during cataract surgery, is generally safe. Over seven years of studies, only about 4.84% of patients experienced significant vision loss, and no additional surgeries were needed to control eye pressure.

However, some common side effects have been observed. Blockage of the stent occurred in 6.2% of cases, and eye inflammation was reported in 5.7% of cases. Evidence suggests that while some risks exist, most patients tolerate the iStent Inject well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The iStent Inject treatment is unique because it offers a new approach to managing glaucoma by using a tiny device implanted during cataract surgery to improve eye fluid drainage. Unlike traditional treatments, like eye drops or laser therapy, which focus on reducing fluid production or enhancing outflow through existing pathways, the iStent Inject creates a direct bypass through the trabecular meshwork, the main drainage site in the eye. Researchers are excited about this because it could potentially lower eye pressure more effectively and consistently, with fewer side effects and less reliance on daily medication.

What evidence suggests that the iStent Inject is effective for glaucoma?

Research has shown that the iStent Inject, which participants in this trial will receive, can help lower eye pressure in people with glaucoma. In one study, almost 74% of patients who received the iStent during cataract surgery no longer needed their glaucoma medication. Another study found that eye pressure dropped by at least 20% within a year without requiring additional surgeries or medications. A 5-year study demonstrated that this reduced eye pressure persisted, and patients needed fewer eye drops. Additionally, the iStent has proven to be safe, with very few individuals experiencing serious vision problems over seven years. These findings suggest that the iStent could be a promising way to manage glaucoma. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This study is for men and women over the age of 22 with mild to moderate primary open-angle glaucoma who are scheduled for cataract surgery. Participants must be able to attend follow-up exams for three years and give written consent. Those with conditions like angle closure glaucoma or elevated episcleral venous pressure due to other diseases cannot join.

Inclusion Criteria

I am scheduled for cataract surgery.

I had a successful cataract surgery without complications.

I have been diagnosed with mild to moderate open-angle glaucoma.

Exclusion Criteria

My glaucoma is caused by trauma, cancer, inflammation, abnormal blood vessels, or birth defects in the eye.

I have a condition that increases pressure in my eye veins.

I have angle closure glaucoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on iStent inject placement and stability

36 months

Regular visits over 36 months

What Are the Treatments Tested in This Trial?

Interventions

• iStent Inject Implantation

Trial Overview The trial is examining the safety of a device called iStent Inject when implanted during post-market use. It aims to track any significant complications that might arise after the device placement in patients undergoing cataract surgery.

How Is the Trial Designed?

Group I: Implantation Experimental Treatment 1 Intervention

Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device.

Who Is Running the Clinical Trial?

Glaukos Corporation

Lead Sponsor

Trials

69

Recruited

9,500+

Thomas Burns

Glaukos Corporation

Chief Executive Officer since 2002

B.A. from Yale University

Dr. Tomas Navratil

Glaukos Corporation

Chief Medical Officer since 2022

MD from Harvard Medical School

Published Research Related to This Trial

The iStent inject® device, used in a 74-year-old patient with glaucoma, successfully reduced intraocular pressure and medication use after cataract surgery, demonstrating its efficacy in managing glaucoma.

Using anterior segment optical coherence tomography (AS-OCT), the study revealed that the iStent inject® significantly dilated Schlemm's canal, suggesting that its pressure-lowering effect may involve both bypassing the trabecular meshwork and enhancing canal diameter.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior Segment Optical Coherence Tomography Signs of Local Dilatation Effect of a Micro-Stent on Schlemm's Canal. Gillmann, K., Bravetti, GE., Mansouri, K., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12069763/

Five-Year Outcomes of iStent inject Implantation With or ... This 5-year real-world study showed significant and sustained reductions in IOP and topical medication burden following iStent inject trabecular micro-bypass.

2. glaukos.com glaukos.com/glaucoma/istent-inject-w-clinical-data/

Clinical Data on iStent Surgery | Interventional Glaucoma A 36 mo. study noted previously 74% of patients who received iStent during cataract procedure were able to stop taking their glaucoma medication after ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667376224000556

Real-world assessment of second-generation trabecular ... A successful outcome post Istent was defined as ≥ 20% reduction in intraocular pressure (IOP) at 12 months without additional glaucoma surgery or medications, ...

4. link.springer.com link.springer.com/article/10.1007/s12325-024-02788-y

7-Year Efficacy and Safety of iStent inject Trabecular Micro- ... Safety outcomes were favorable, with no filtration surgeries and only 4.84% of eyes experiencing clinically significant visual field loss over 7 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10287603/

Efficacy and Safety of Pairing iStent Inject Trabecular Micro ... The data demonstrated significant IOP reductions and favorable safety through 3 months postoperative in both groups. However, pairing stent ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38363465/

7-Year Efficacy and Safety of iStent inject Trabecular Micro- ... Safety outcomes were favorable, with no filtration surgeries and only 4.84% of eyes experiencing clinically significant visual field loss over 7 ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170043b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Implanted in conjunction with cataract surgery, the iStent inject Trabecular Micro-Bypass System offers a safer surgical option with the aim ...