PRESERFLO® MicroShunt Extension Study

Completed

Conditions: Primary Open-angle Glaucoma

Interventions: Device: PRESERFLO® MicroShunt
Procedure: Trabeculectomy

Registration Number: NCT04333433

Lead Sponsor: InnFocus Inc.

Brief Summary: 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.

Detailed Description: The objective of this study is to evaluate the long-term safety of the PRESERFLO® MicroShunt in subjects with Primary Open-Angle Glaucoma who have completed their Month 24 Follow-Up Visit in the INN-005 clinical study, by collecting safety data through 5 years post-operative follow-up.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 279

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MicroShunt treatment group	PRESERFLO® MicroShunt	Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device
Trabeculectomy control arm	Trabeculectomy	Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure

Primary Outcome Measures

Name	Time	Method
Incidence of Sight-threatening Adverse Events	Month 36 thru Month 60	Sight-threatening Adverse events (AEs) that were started after enrollment in the INN-005-EXT study through Month 60.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (23): Ophthalmic Consultants of Connecticut
🇺🇸
Meriden, Connecticut, United States
Arizona Advance Eye Research Institute, LLC.
🇺🇸
Glendale, Arizona, United States
Vold Vision
🇺🇸
Fayetteville, Arkansas, United States
University Eye Associates
🇺🇸
Houston, Texas, United States
Moorfields Eye Hospital
🇬🇧
London, United Kingdom
Stiles Eye Care Excellence & Glaucoma Institute
🇺🇸
Overland Park, Kansas, United States
University of California at Davis Eye Center
🇺🇸
Sacramento, California, United States
Cincinnati Eye Institute
🇺🇸
Cincinnati, Ohio, United States
Dean McGee Eye Institute
🇺🇸
Oklahoma City, Oklahoma, United States
R&R Eye Research, LLC
🇺🇸
San Antonio, Texas, United States
UCLA Medical Center Jules Stein Eye Institute
🇺🇸
Los Angeles, California, United States
Intermountain Eye Center
🇺🇸
Eagle, Idaho, United States
Eugene and Marilyn Glick Eye Institute
🇺🇸
Indianapolis, Indiana, 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
Ophthalmic Partners of Pennsylvania
🇺🇸
Bala-Cynwyd, Pennsylvania, United States
Ophthalmic Surgeons and Consultants of Ohio
🇺🇸
Columbus, Ohio, United States
Glaucoma Associates of Texas
🇺🇸
Dallas, Texas, United States
Pôle Ophtalmologique de la Clinique Mutualiste
🇫🇷
Pessac, Bordeaux, France
Hospital Clínico San Carlos
🇪🇸
Madrid, Spain
A. O.U.P (Azienda Ospedaliere Universitaria Pisana) Stabilimento di Cisanello
🇮🇹
Pisa, Cisanello, Italy
Ophthalmology Associates
🇺🇸
Fort Worth, Texas, United States