XEN Gel Stent Implantation Techniques for Glaucoma

N/A

Waitlist Available

Research Sponsored by Institut de l'oeil des Laurentides

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with maximally tolerated medically treated (MTMT) uncontrolled glaucoma (POAG, PEX G, PDS G)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 minutes by implantation

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at two different ways to do glaucoma surgery, to see which one works better. They will compare how well each method lowers eye pressure, how many medications each method requires, and what side effects occur.

Who is the study for?

This trial is for adults over 18 with uncontrolled glaucoma despite maximum medical treatment. Participants must be in good health, able to follow post-op instructions, and attend scheduled appointments. Excluded are those with recent cancer chemotherapy, participation in other trials within 30 days, certain eye conditions or surgeries, severe allergies to protocol medications or XEN components, systemic corticosteroid use within 30 days (except chronic use), pregnant or nursing women not using contraception.

What is being tested?

The study compares two surgical techniques for implanting a XEN gel microstent to treat glaucoma: the traditional ab interno (inside the eye) approach versus an ab externo (outside the eye) method performed at the slit lamp. Success rates will be measured by changes in intraocular pressure, medication needs, additional procedures needed and adverse events.

What are the potential side effects?

Potential side effects may include complications from surgery such as infection or inflammation of the eye, increased intraocular pressure if stent fails to function properly, discomfort or bleeding at the implantation site and possible need for additional glaucoma medications or surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have glaucoma that hasn't improved despite maximum treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 minutes by implantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 minutes by implantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes by implantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compared the success of interno / externo implantation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Ab interno techniqueExperimental Treatment1 Intervention

Ab Interno is traditional method of stent XEN implantation, where the device will injected through a small corneal incision that closes with the preloaded XEN injector.

Group II: Ab externo techniqueExperimental Treatment1 Intervention

The ab externo approach does this without any incision, less invasive, and the implant is directly injected through the conjunctiva into the anterior chamber of the eye. Both methods create a new way out through the subconjunctival space, which is the traditional target of trabeculectomy.

0 / 1Eligibility criteria met