Streamline Surgical System vs iStent for Open-Angle Glaucoma

(VENICE Trial)

Recruiting at 22 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for individuals with mild to moderate primary open-angle glaucoma, a common eye condition that can lead to vision loss. The study evaluates the effectiveness of the Streamline Surgical System, a surgical procedure, against the iStent Inject W, a tiny implantable device. Participants will undergo one of these procedures to determine which better manages their condition. It is suitable for those diagnosed with mild to moderate primary open-angle glaucoma, excluding other types of glaucoma. As an unphased trial, this study allows participants to contribute to important research that could enhance future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the Streamline Surgical System and the iStent Inject W are generally well-tolerated by individuals with open-angle glaucoma, a common eye condition that can lead to vision loss. Studies have found that the Streamline Surgical System safely lowers eye pressure in about 68.8% of cases, with no serious side effects reported.

The iStent Inject W, already approved by the FDA for treating glaucoma, also presents reassuring safety data. It is widely used and carries a low risk of serious side effects.

Overall, while no treatment is completely without risk, current research suggests that both the Streamline Surgical System and iStent Inject W are safe options. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for open-angle glaucoma focus on lowering intraocular pressure through medications or surgical procedures. The Streamline Surgical System is unique because it offers a minimally invasive approach to enhance fluid outflow in the eye, potentially reducing pressure more effectively and with fewer complications compared to traditional surgeries. Researchers are excited about this system because it promises a safer, less intrusive option that could improve patients' quality of life and outcomes. On the other hand, the iStent Inject W is already known for its ability to create a permanent opening in the eye's drainage system, but the addition of Streamline could offer even more targeted and efficient pressure control. Together, these innovations may offer a more comprehensive solution for managing glaucoma.

What evidence suggests that this trial's treatments could be effective for open-angle glaucoma?

This trial will compare the Streamline Surgical System with the iStent Inject W for treating open-angle glaucoma. In a previous study, the Streamline Surgical System showed promising results, with about 68.8% of patients experiencing surgical success, meaning their eye pressure dropped significantly. This success occurred in patients with mild, moderate, and severe cases of glaucoma. Meanwhile, the iStent Inject W has a proven track record over five years, helping many patients lower their eye pressure and reduce their need for medications. Specifically, one study found that 75.8% of patients experienced at least a 20% drop in eye pressure without needing medicine. Both treatments in this trial have demonstrated their ability to lower eye pressure, which is crucial for managing glaucoma. ^{2 3 6 7 8}

Who Is on the Research Team?

Elysia Ison, OD

Principal Investigator

New World Medical, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12378677/

One year clinical outcomes with a novel canaloplasty ... The primary outcome was surgical success, defined as achieving ≥20% intraocular pressure (IOP) reduction and/or a reduction of ≥1 glaucoma ...

2. sciopen.com sciopen.com/article/10.18240/ijo.2025.09.08

One year clinical outcomes with a novel canaloplasty ... Surgical success at one year was achieved in 68.8% of eyes, with 67.6% success in mild, 80.0% in moderate, and 66.7% in severe OAG cases. IOP ...

3. dovepress.com dovepress.com/safety-and-efficacy-of-streamline-canaloplasty-with-phacoemulsificatio-peer-reviewed-fulltext-article-OPTH

Safety and Efficacy of STREAMLINE Canaloplasty with ... The primary outcome was the proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥ 20% from Baseline at Month 12.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05280366

Study Details | NCT05280366 | STREAMLINE®SURGICAL ... ... STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma. Conditions. Open Angle Glaucoma. Open Angle Glaucoma. Open Angle ...

5. ophthalmologytimes.com ophthalmologytimes.com/view/ags-2025-constance-okeke-md-highlights-1-year-streamline-canaloplasty-outcomes

AGS 2025: Constance Okeke, MD, highlights 1-year ... AGS 2025: Constance Okeke, MD, highlights 1-year Streamline canaloplasty outcomes · Mild OAG: 21.5% decrease · Moderate OAG: 26.5% decrease ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11687135/

Safety and Efficacy of STREAMLINE Canaloplasty with ... The primary outcome was the proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20% from Baseline at Month 12.

7. tandfonline.com tandfonline.com/doi/full/10.2147/OPTH.S481945

A Randomized Controlled Trial Comparing STREAMLINE ... In this analysis, we evaluated the short-term, 6-month, safety and IOP-lowering efficacy of the STREAMLINE Surgical System versus iStent inject ...

8. dovepress.com dovepress.com/post-operative-outcomes-at-one-year-of-streamline-microinvasive-glauco-peer-reviewed-fulltext-article-OPTH

Post-Operative Outcomes at One Year of STREAMLINE ... Examining the MIGS procedure's effect on intraocular pressure (IOP) and number of glaucoma medications throughout one post-operative year.