PRESERFLO® MicroShunt Extension Study

Completed

Conditions studied: Primary Open-angle Glaucoma

In brief

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.

Key facts

Study ID

NCT04333433

Run by

InnFocus Inc.

People needed

279

Starts

2020-05-22

Expected to finish

2022-11-24

Last updated by the study team

2024-03-22

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has completed their Month 24 Follow-Up Visit in the INN-005 clinical study conducted under IDE G130028.
• Subject was randomized into the INN-005 study and received the PRESERFLO® MicroShunt device or trabeculectomy. (Subjects who have had the device explanted, or replaced with another device, may be included).
• Subject is willing and able to comply with all study requirements, including signing an informed consent form.

You may not qualify if…

• Subject has exceeded the timeframe for the Month 60 Follow-Up Visit prior to enrollment for participation in this long-term follow-up study.

Where it is running

• Arizona Advance Eye Research Institute, LLC. — Glendale, Arizona, United States
• Vold Vision — Fayetteville, Arkansas, United States
• UCLA Medical Center Jules Stein Eye Institute — Los Angeles, California, United States
• University of California at Davis Eye Center — Sacramento, California, United States
• Ophthalmic Consultants of Connecticut — Meriden, Connecticut, United States
• Intermountain Eye Center — Eagle, Idaho, United States
• Eugene and Marilyn Glick Eye Institute — Indianapolis, Indiana, United States
• Stiles Eye Care Excellence & Glaucoma Institute — Overland Park, Kansas, United States
• Minnesota Eye Consultants, PA — Bloomington, Minnesota, United States
• New York Eye and Ear Infirmary of Mt. Sinai — New York, New York, United States
• Glaucoma Consultants of the Capital Region — Slingerlands, New York, United States
• Cincinnati Eye Institute — Cincinnati, Ohio, United States
• Ophthalmic Surgeons and Consultants of Ohio — Columbus, Ohio, United States
• Dean McGee Eye Institute — Oklahoma City, Oklahoma, United States
• Ophthalmic Partners of Pennsylvania — Bala-Cynwyd, Pennsylvania, United States
• Glaucoma Associates of Texas — Dallas, Texas, United States
• Ophthalmology Associates — Fort Worth, Texas, United States
• University Eye Associates — Houston, Texas, United States
• R&R Eye Research, LLC — San Antonio, Texas, United States
• Pôle Ophtalmologique de la Clinique Mutualiste — Pessac, Bordeaux, France
• A. O.U.P (Azienda Ospedaliere Universitaria Pisana) Stabilimento di Cisanello — Pisa, Cisanello, Italy
• Hospital Clínico San Carlos — Madrid, Spain
• Moorfields Eye Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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