Hydrus Microstent vs Goniotomy for Glaucoma

Overseen By Michael M Lin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Eye and Ear Infirmary

Must not be taking: Anticoagulants, Oral steroids

Disqualifiers: Prior glaucoma surgery, Other glaucoma, Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

243 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three treatments for glaucoma, a condition that increases eye pressure and can lead to vision loss. The treatments compared are the Hydrus Microstent (a tiny device implanted in the eye), incisional goniotomy, and excisional goniotomy, all performed with cataract surgery. The goal is to determine which treatment most effectively lowers eye pressure and which is the safest. Candidates for this trial have mild to moderate open-angle glaucoma and plan to undergo cataract surgery. As an unphased trial, this study provides a unique opportunity to enhance understanding of the best treatment options for glaucoma patients undergoing cataract surgery.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are taking certain medications like oral steroids or oral medications that affect eye pressure. It's best to discuss your current medications with the trial team.

What prior data suggests that these microinvasive glaucoma surgeries are safe?

Research shows that the Hydrus Microstent, used in eye surgeries, is generally safe. It can lower eye pressure and reduce the need for glaucoma medication. Although some patients required additional surgery, this was uncommon.

Studies have shown excisional goniotomy to be safe. Over six years, it successfully maintained low eye pressure in 46% of cases without major safety issues.

Incisional goniotomy also appears safe. Research indicates it effectively lowers eye pressure when combined with cataract surgery. Unwanted effects are rare and not serious.

Overall, these treatments are well-tolerated and have a good safety record in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The Hydrus Microstent is unique because it offers a minimally invasive approach to treating glaucoma, a condition often managed with eye drops or more invasive surgeries like trabeculectomy. Unlike traditional options, the Hydrus Microstent is implanted into the eye's drainage canal to improve fluid outflow and reduce intraocular pressure. This method is particularly exciting for researchers because it targets the underlying fluid dynamics of the eye, potentially offering a safer and more effective long-term solution compared to conventional surgeries. Additionally, the microstent's size and design allow for a less invasive procedure with a quicker recovery time, making it an appealing option for patients seeking a less disruptive treatment.

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

This trial will compare the Hydrus Microstent with excisional and incisional goniotomy for managing glaucoma. Research has shown that the Hydrus Microstent, one of the treatments in this trial, effectively lowers eye pressure when used with cataract surgery, significantly reducing eye pressure and the need for glaucoma medications. Excisional goniotomy, another treatment arm in this trial, has demonstrated successful outcomes, including long-term reduction in eye pressure and improved eye health, with a high success rate in lowering eye pressure and reducing medication use. Incisional goniotomy, also studied in this trial, has proven effective, with reports of a 26% decrease in eye pressure and a 44% reduction in medication use. These treatments all show promising results for managing glaucoma when combined with cataract surgery. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with mild to moderate open-angle glaucoma who also need cataract surgery. They should have a certain level of visual field mean deviation and intraocular pressure (IOP) between 10 to 31 mm Hg. Participants must understand the study and commit to follow-up exams.

Inclusion Criteria

I am scheduled for cataract surgery due to vision problems.

I can attend all follow-up visits after surgery as required.

Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery

Exclusion Criteria

I am not on blood thinners except for low-dose aspirin.

I have been diagnosed with normal tension glaucoma.

I am not taking oral medications that can affect eye pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo one of three microinvasive glaucoma surgeries (Hydrus Microstent, incisional goniotomy, or excisional goniotomy) in combination with cataract surgery

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Excisional goniotomy
• Hydrus Microstent
• Incisional goniotomy

Trial Overview The trial compares three microinvasive glaucoma surgeries: Hydrus Microstent, incisional goniotomy, and excisional goniotomy, each combined with cataract surgery. It aims to see which one better lowers eye pressure and has fewer risks.

How Is the Trial Designed?

Group I: Incisional goniotomy Experimental Treatment 1 Intervention

Group II: Hydrus Microstent Experimental Treatment 1 Intervention

Group III: Excisional goniotomy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

Citations

1. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(25)00220-9/pdf

Two-Year Outcomes of Goniotomy After Failed Surgery for ... Primary open-angle glaucoma was negatively associated with qualified success (odds ratio = 0.18; 95% confidence interval, 0.04—0.84; P = 0.029).

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666914525002209

Two-year outcomes of goniotomy following failed surgery ... Among these, complete success was achieved in 26 eyes (42.6%), and qualified success in 52 eyes (85.2%). Mean IOP dropped from 26.4 ± 6.2 mmHg ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10926857/

Long-Term Efficacy of Successful Excisional Goniotomy ... Successful excisional goniotomy with the KDB can be expected to improve long-term glaucoma-related visual outcomes through IOP reduction.

4. meddocsonline.org meddocsonline.org/annals-of-ophthalmology-and-visual-sciences/3-year-outcomes-of-excisional-goniotomy-with-the-kahook-dual-blade-for-glaucoma-in-bolivia.pdf

3-year-outcomes-of-excisional-goniotomy-with-the-kahook- ... Excisional goniotomy with the KDB can safety provide long- term reductions in IOP and the need for IOP-lowering medica- tions in Bolivian ...

5. tandfonline.com tandfonline.com/doi/full/10.2147/OPTH.S476076

Full article: Six-Month Outcomes of Goniotomy Performed ... In conclusion, phaco-TDB goniotomy using a serrated trapezoidal dual blade (TrabEx) safely decreased IOP and AGM use over a 6-month follow-up ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11408425/

Clinical Outcomes of Excisional Goniotomy with the ... The outcomes of this study demonstrate an exceptional safety profile and a 46% success rate over 6 years of follow-up. This work underscores the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7340474/

Twelve-Month Outcomes of Stand-Alone Excisional ... Standalone excisional goniotomy with the KDB has been shown to produce mean IOP reductions of 24% and medication reductions of 44% in a prior ...

8. nature.com nature.com/articles/s41598-021-90223-5

Long term outcome of combined phacoemulsification and ... Across all time points, IOP reductions of ≥ 20% were achieved by 73.0–83.3% of eyes, IOP ≤ 18 mmHg by 89.2–97.3% of eyes, and IOP ≤ 15 mmHg by ...