Streamline Surgical System vs iStent for Open-Angle Glaucoma

(VENICE Trial)

Recruiting at 20 trial locations

Overseen By Matthew Rouse, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New World Medical, Inc.

Disqualifiers: Other glaucoma types, ocular hypertension

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate procedure

150 Participants Needed

Trial Summary

What is the purpose of this trial?

A study of the Streamline Surgical System versus competitor

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 treatment iStent Inject W for open-angle glaucoma?

Research shows that the iStent inject W, when used with cataract surgery, is effective and safe for patients with open-angle glaucoma, helping to lower eye pressure and improve outcomes. ^{1 2 3 4 5}

Is the iStent inject W safe for use in humans?

The iStent inject W has been studied in combination with cataract surgery for open-angle glaucoma, and these studies generally report it as safe for use in humans, with no major safety concerns noted in the short-term follow-up. ^{1 2 4 5 6}

How does the iStent inject treatment differ from other treatments for open-angle glaucoma?

The iStent inject is a microinvasive glaucoma surgery (MIGS) device that reduces eye pressure by creating a bypass for fluid drainage, minimizing trauma to the eye. It is unique because it allows for the implantation of two stents simultaneously, enhancing its effectiveness in lowering intraocular pressure compared to traditional methods. ^{1 3 7 8 9}

Research Team

Elysia Ison, OD

Principal Investigator

New World Medical, Inc.

Eligibility Criteria

This trial is for people with mild to moderate Primary Open-Angle Glaucoma. It's not open to those with other glaucoma types like normal tension, pseudoexfoliative, narrow angle, traumatic, congenital, malignant, uveitic or neovascular glaucoma or just ocular hypertension.

Inclusion Criteria

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

Exclusion Criteria

I have high eye pressure.

I have a specific type of glaucoma, not the most common one.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Streamline Surgical System procedure or receive the iStent Inject W implant

Immediate procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• iStent Inject W
• Streamline Surgical System

Trial Overview The study compares two treatments for Open-Angle Glaucoma: the Streamline Surgical System and iStent Inject W. Patients will receive one of these interventions to see which is more effective.

Participant Groups

Group I: Streamline Surgical System Experimental Treatment 1 Intervention

Streamline Surgical System procedure administered

Group II: iStent Inject W Active Control 1 Intervention

iStent Inject W implanted

Who Is Running the Clinical Trial?

New World Medical, Inc.

Lead Sponsor

Trials

8

Recruited

610+

Findings from Research

The second-generation iStent inject is a microinvasive glaucoma surgery device that allows for the implantation of two stents simultaneously, potentially leading to greater reductions in intraocular pressure (IOP) compared to the first-generation iStent.

Both the iStent and iStent inject have been shown to be safe and effective for managing open-angle glaucoma, with minimal trauma and complications, making them promising options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iStent inject: comprehensive review. Shalaby, WS., Jia, J., Katz, LJ., et al.[2021]

In an ex vivo whole human eye perfusion model, a single iStent reduced intraocular pressure (IOP) by 6.0 mmHg, and adding a second iStent further decreased IOP by 2.9 mmHg, totaling an 8.9 mmHg reduction, demonstrating its efficacy in lowering IOP.

Computational fluid dynamics modeling indicated that flow through the iStent devices is smooth and laminar, with negligible flow resistance, suggesting that these devices can effectively improve aqueous outflow and provide titratable options for achieving lower target IOPs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of micro-invasive trabecular bypass stents by ex vivo perfusion and computational flow modeling. Hunter, KS., Fjield, T., Heitzmann, H., et al.[2022]

References

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

iStent inject in phakic open angle glaucoma. [2022]

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

Combined phacoemulsification and iStent inject implantation in Asian eyes. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Influence of Selective Laser Trabeculoplasty (SLT) on the iStent inject® outcomes. [2021]

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

Intraoperative iStent versus postoperative selective laser trabeculoplasty in early glaucoma patients undergoing cataract surgery: A retrospective comparative study. [2023]

5. 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]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of the iStent Inject® versus the iStent Inject® W-Both in Combination with Cataract Surgery-In Open-Angle Glaucoma. [2023]

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

iStent inject: comprehensive review. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

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

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

Characterization of micro-invasive trabecular bypass stents by ex vivo perfusion and computational flow modeling. [2022]