PRESERFLO® MicroShunt Extension Study
Public ClinicalTrials.gov record NCT04333433. 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, Concurrent Controlled, Open-Label, Multicenter Clinical Study to Assess the Long-Term Safety of the PRESERFLO® MicroShunt in Subjects With Primary Open-Angle Glaucoma Who Have Completed Participation in the INN-005 Randomized Controlled Study.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.
Study identification
- NCT ID
- NCT04333433
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 279 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 22, 2020 (Actual)
- Primary completion
- Nov 24, 2022 (Actual)
- Completion
- Nov 24, 2022 (Actual)
- Last update posted
- Mar 22, 2024
2020 – 2022
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Advance Eye Research Institute, LLC. | Glendale | Arizona | 85306 | — |
| Vold Vision | Fayetteville | Arkansas | 72704 | — |
| UCLA Medical Center Jules Stein Eye Institute | Los Angeles | California | 90095 | — |
| University of California at Davis Eye Center | Sacramento | California | 95817 | — |
| Ophthalmic Consultants of Connecticut | Meriden | Connecticut | 06450 | — |
| Intermountain Eye Center | Eagle | Idaho | 83616 | — |
| Eugene and Marilyn Glick Eye Institute | Indianapolis | Indiana | 46290 | — |
| Stiles Eye Care Excellence & Glaucoma Institute | Overland Park | Kansas | 66213 | — |
| Minnesota Eye Consultants, PA | Bloomington | Minnesota | 55431 | — |
| New York Eye and Ear Infirmary of Mt. Sinai | New York | New York | 10003 | — |
| Glaucoma Consultants of the Capital Region | Slingerlands | New York | 12159 | — |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | — |
| Ophthalmic Surgeons and Consultants of Ohio | Columbus | Ohio | 43215 | — |
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73014 | — |
| Ophthalmic Partners of Pennsylvania | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Glaucoma Associates of Texas | Dallas | Texas | 75231 | — |
| Ophthalmology Associates | Fort Worth | Texas | 76102 | — |
| University Eye Associates | Houston | Texas | 77030 | — |
| R&R Eye Research, LLC | San Antonio | Texas | 78229 | — |
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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04333433, 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 Mar 22, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04333433 live on ClinicalTrials.gov.