Goniotomy for Glaucoma

DA
CR
Overseen ByCalvin Robbins, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Henry Ford Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of three different devices used for goniotomy, a procedure to treat glaucoma during cataract surgery. The goal is to determine which device best controls eye pressure and reduces the need for glaucoma medication in the months following surgery. Individuals with open-angle glaucoma, a common type of glaucoma, scheduled for cataract surgery with goniotomy may be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future glaucoma treatments.

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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these goniotomy devices are safe for treating glaucoma?

A previous study found SION goniotomy to be mostly safe. Some patients experienced mild issues such as bleeding in the eye (hyphema) and temporary increases in eye pressure, which resolved quickly. Research on goniotomy using a bent needle showed similar results, with hyphema as the most common issue, clearing up within a week. Studies on the Tanito hook reported mild complications like hyphema and temporary eye pressure increases, which also resolved without lasting problems.

Overall, all three treatments—SION, bent needle, and Tanito hook—appear well-tolerated. Any side effects seem minor and temporary, suggesting these procedures are generally safe for people with glaucoma undergoing cataract surgery.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the goniotomy technique for treating glaucoma because it offers a new approach to managing intraocular pressure, which is crucial in slowing the progression of the disease. Unlike traditional treatments like eye drops or laser therapy, goniotomy directly targets the trabecular meshwork, where fluid drainage occurs in the eye. The trial is exploring different tools for performing goniotomy: the SION, bent needle (BANG), and Tanito hook, each with its unique design and potential advantages in precision and effectiveness. This direct surgical approach could provide an alternative for patients who don't respond well to conventional therapies.

What evidence suggests that this trial's devices for goniotomy could be effective for glaucoma?

Studies have shown that goniotomy effectively lowers eye pressure in people with glaucoma. This trial will compare different tools used in goniotomy. Research indicates that the SION device can reduce eye pressure by 14.5% to 36%. In another study, patients who underwent bent needle goniotomy experienced a 26% drop in eye pressure six months post-surgery. The Tanito hook also proved effective, with reductions of about 38.8% after eight months. Each tool, tested in separate arms of this trial, has shown promise in safely lowering eye pressure, crucial for managing glaucoma.12467

Who Is on the Research Team?

DA

David A Crandall, MD

Principal Investigator

Henry Ford Health

Are You a Good Fit for This Trial?

This trial is for adults (18+) with open-angle glaucoma who are scheduled to have cataract surgery combined with goniotomy. People can't join if they've had prior glaucoma surgery in the study eye, only need goniotomy without cataract surgery, have angle-closure glaucoma, or can't attend follow-up visits.

Inclusion Criteria

Able to provide informed consent
I have been diagnosed with open-angle glaucoma.
I am scheduled for cataract surgery with a planned goniotomy.
See 1 more

Exclusion Criteria

Inability to comply with follow-up schedule
I have had glaucoma surgery in my study eye.
I am scheduled to have only a goniotomy procedure.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo combined cataract surgery and goniotomy using one of three devices

1 day
1 visit (in-person)

Follow-up

Participants are monitored for intraocular pressure control and glaucoma medication use

6 months
5 visits (in-person) at 1 day, 1 week, 1 month, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Goniotomy

Trial Overview

The study compares three different devices used for goniotomy during cataract surgery to see which best controls eye pressure and reduces the need for glaucoma medications over six months. All participants receive both procedures and regular follow-ups.

How Is the Trial Designed?

3

Treatment groups

Active Control

Group I: SIONActive Control1 Intervention
Group II: BANGActive Control1 Intervention
Group III: TanitoActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials
334
Recruited
2,197,000+

Citations

SION Goniotomy with Dr. Nathan Radcliffe

In this installment of Interventional Mindset, Dr. Radcliffe discusses SION goniotomy fundamentals and pearls for success.

Safety and efficacy of resident-performed SION goniotomy at ...

The primary aim was to determine whether resident-performed SION goniotomy demonstrated operating times and complication rates similar to those of Kahook Dual ...

3.

sightsciences.com

sightsciences.com/us/sion/

SION - United States

The SION® Surgical Instrument represents a new chapter in goniotomy innovation, designed to enable a smooth and gentle procedure.

Two-Year Outcomes of Goniotomy After Failed Surgery for ...

Conclusions. Goniotomy proves to be a safe and effective procedure for patients with previous failed glaucoma surgery over the 24-month study period.

OPTH

Results: Baseline IOP was 17.2 (standard error 0.7) in the KDB-Phaco group using a mean of 1.9 (0.2) medications; at Month 6, mean IOP was 14.8 ...

Twelve-Month Outcomes of Stand-Alone Excisional ... - PMC

Standalone excisional goniotomy with the KDB has been shown to produce mean IOP reductions of 24% and medication reductions of 44% in a prior study. In the ...

NCT07550868 | Goniotomy in Primary Congenital Glaucoma

Secondary outcomes include various safety indicators such as intraoperative and postoperative complications, the number of intraocular pressure- ...