Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle Glaucoma
Public ClinicalTrials.gov record NCT05411198. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Ab Externo Implantation of Glaucoma Gel Stent
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab externo approach. Adverse events and intraocular pressure will be assessed. XEN45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). XEN45 implanted using the ab externo approach (outside the eye) is being studied in this study. Approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the United States. All participants will receive XEN45 implanted using the ab externo approach on Day 1 and will be followed for 12 months. Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.
Study identification
- NCT ID
- NCT05411198
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 74 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 45 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 22, 2022 (Actual)
- Primary completion
- Feb 4, 2026 (Actual)
- Completion
- Feb 4, 2026 (Actual)
- Last update posted
- Feb 27, 2026
2022 – 2026
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Vold Vision /ID# 245285 | Fayetteville | Arkansas | 72704 | — |
| UCLA Doheny Eye Center /ID# 227587 | Pasadena | California | 91105 | — |
| Ventura Ophthalmology /ID# 227585 | Ventura | California | 93003 | — |
| East Coast Institute for Research /ID# 255508 | Jacksonville | Florida | 32256-9680 | — |
| Center for Sight - Sarasota /ID# 227577 | Sarasota | Florida | 34239 | — |
| New Vision Eye Center /ID# 261053 | Vero Beach | Florida | 32960-6551 | — |
| Georgia Eye Partners /ID# 245203 | Atlanta | Georgia | 30342 | — |
| Stiles Eyecare Excellence /ID# 227576 | Overland Park | Kansas | 66213 | — |
| The Johns Hopkins Wilmer Eye Institute - Bethesda /ID# 245355 | Bethesda | Maryland | 20817 | — |
| Vance Thompson Vision /ID# 261125 | Alexandria | Minnesota | 56308-3408 | — |
| Washington University-School of Medicine /ID# 245452 | St Louis | Missouri | 63110 | — |
| NYU Langone Medical Center /ID# 227583 | New York | New York | 10016-6402 | — |
| Fichte Endl & Elmer Eyecare /ID# 245165 | Niagara Falls | New York | 14304 | — |
| Oklahoma Eye Surgeons /ID# 246840 | Oklahoma City | Oklahoma | 73112 | — |
| Ophthalmic Partners, PC /ID# 245367 | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Kremer Eye Center - King of Prussia /ID# 245573 | King of Prussia | Pennsylvania | 19406 | — |
| Vance Thompson Vision /ID# 260892 | Sioux Falls | South Dakota | 57108 | — |
| Glaucoma Associates of Texas /ID# 227580 | Dallas | Texas | 75231 | — |
| University of Texas Southwestern Medical Center /ID# 246848 | Dallas | Texas | 75390-7208 | — |
| El Paso Eye Surgeons, P.A. /ID# 227575 | El Paso | Texas | 79902 | — |
| Eye associates /ID# 227572 | San Antonio | Texas | 78229 | — |
| University of Utah /ID# 245324 | Salt Lake City | Utah | 84112-5500 | — |
| Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925 | Falls Church | Virginia | 22042-3013 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05411198, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 27, 2026 · Synced Nov 1, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05411198 live on ClinicalTrials.gov.