iStent Inject for Glaucoma

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

358 Participants Needed

Trial Summary

What is the purpose of this trial?

Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting.

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 data supports the effectiveness of the iStent Inject treatment for glaucoma?

Research shows that the iStent Inject treatment can help lower eye pressure in people with glaucoma, especially when other surgeries have not worked. It is also effective when used with cataract surgery, helping to reduce the need for additional eye pressure medications. ^{1 2 3 4 5}

Is the iStent Inject safe for humans?

Research shows that the iStent Inject is generally safe for people with open-angle glaucoma, with studies reporting on its long-term safety and stability in the eye. It has been evaluated in combination with cataract surgery, showing a good safety profile over several years. ^{1 3 4 6 7}

How is the iStent Inject treatment different from other glaucoma treatments?

The iStent Inject is a tiny device implanted in the eye to help lower eye pressure by improving fluid drainage, making it unique as a minimally invasive option compared to traditional surgeries. It works by bypassing the eye's natural drainage system, which can be less invasive and have fewer complications than other surgical treatments for glaucoma. ^{1 2 3 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

iStent inject in phakic open angle glaucoma. [2022]

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

iStent inject as a reasonable alternative procedure following failed trabeculectomy? [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

iStent for Adults With Glaucoma: A Health Technology Assessment. [2022]

4. France pubmed.ncbi.nlm.nih.gov

Safety and efficacy of iStent Inject trabecular micro-bypass stents in combination with phacoemulsification for chronic open angle glaucoma associated with cataract. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Selective Laser Trabeculoplasty after iStent Implantation in Primary Open-Angle Glaucoma. [2021]

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

Long-Term Endothelial Safety Profile With iStent Inject in Patients With Open-Angle Glaucoma. [2023]

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

Short-term Efficacy and Safety of Phacoemulsification Associated with iStent inject W® in Patients with Controlled Open-angle Glaucoma. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Phacoemulsification with and without iStent: A Systematic Review and Meta-Analysis of Comparative Studies. [2023]

9. Nepal pubmed.ncbi.nlm.nih.gov

Anterior Segment Optical Coherence Tomography Signs of Local Dilatation Effect of a Micro-Stent on Schlemm's Canal. [2019]