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Implantable Device

XEN Gel Stent Implantation Techniques for Glaucoma

N/A

Recruiting

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compared the success of interno / externo implantation

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

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Who is running the clinical trial?

Institut de l'oeil des LaurentidesLead Sponsor

Media Library

XEN Gel Microstent (Implantable Device) Clinical Trial Eligibility Overview. Trial Name: NCT04943185 — N/A

Ab Externo and Interno Implantation Research Study Groups: Ab interno technique, Ab externo technique

Ab Externo and Interno Implantation Clinical Trial 2023: XEN Gel Microstent Highlights & Side Effects. Trial Name: NCT04943185 — N/A

XEN Gel Microstent (Implantable Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04943185 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being accepted into this research program?

"This medical research is actively recruiting participants according to the records available on clinicaltrials.gov; it was first posted on August 1st 2021 and updated as recently as June 28th 2021."

Answered by AI

What is the size of the cohort being enrolled in this study?

"Affirmative. Clinicaltrials.gov records that this study, which was initially made public on the 8th of August 2021, is currently searching for participants. 50 applicants need to be sourced from a single facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Prospective, Single Surgeon, Randomized Control Study Comparing ab Interno XEN Gel Microstent Implantation vs Closed Conjunctiva ab Externo Implantation Performed at the Slit Lamp for the Treatment of Uncontrolled Glaucoma

2021. "A Prospective, Single Surgeon, Randomized Control Study Comparing ab Interno XEN Gel Microstent Implantation vs Closed Conjunctiva ab Externo Implantation Performed at the Slit Lamp for the Treatment of Uncontrolled Glaucoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04943185.

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