PRESERFLO® MicroShunt Extension Study

NCT04333433 | Completed Results DMC FDA Device

• 1 other identifier: INN005 - EXT
• Study Type: observational
• Target: 279
• Locations: 5 countries
• Sites: 23

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.

Conditions

Primary Open-angle Glaucoma

Keywords

POAG

Outcome Measures

Primary Outcomes (1)

• Incidence of Sight-threatening Adverse Events

  Sight-threatening Adverse events (AEs) that were started after enrollment in the INN-005-EXT study through Month 60.

  Month 36 thru Month 60

Study Arms (2)

MicroShunt treatment group

Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device

Device: PRESERFLO® MicroShunt

Trabeculectomy control arm

Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure

Procedure: Trabeculectomy

Interventions

PRESERFLO® MicroShunt DEVICE

Device surgically implanted

Also known as: InnFocus MicroShunt® Glaucoma Drainage System

MicroShunt treatment group

Trabeculectomy PROCEDURE

The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.

Trabeculectomy control arm

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes all living subjects who have completed the Month 24 Follow-Up Visit of the INN-005 clinical study after randomization to either the PRESERFLO® MicroShunt treatment arm or the Trabeculectomy control arm, and who are willing and able to extend their study participation and return for up to three (3) additional annual follow-up visits through post-operative Month 60. Up to 629 subjects may be enrolled at up to 24 sites located in the United States and at up to 5 sites located in Europe

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.

Sponsors & Collaborators

• InnFocus Inc.: lead

Study Sites (23)

Arizona Advance Eye Research Institute, LLC.

Glendale, Arizona, 85306, United States

Location

Vold Vision

Fayetteville, Arkansas, 72704, United States

Location

UCLA Medical Center Jules Stein Eye Institute

Los Angeles, California, 90095, United States

Location

University of California at Davis Eye Center

Sacramento, California, 95817, United States

Location

Ophthalmic Consultants of Connecticut

Meriden, Connecticut, 06450, United States

Location

Intermountain Eye Center

Eagle, Idaho, 83616, United States

Location

Eugene and Marilyn Glick Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Stiles Eye Care Excellence & Glaucoma Institute

Overland Park, Kansas, 66213, United States

Location

Minnesota Eye Consultants, PA

Bloomington, Minnesota, 55431, United States

Location

New York Eye and Ear Infirmary of Mt. Sinai

New York, New York, 10003, United States

Location

Glaucoma Consultants of the Capital Region

Slingerlands, New York, 12159, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Ophthalmic Surgeons and Consultants of Ohio

Columbus, Ohio, 43215, United States

Location

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73014, United States

Location

Ophthalmic Partners of Pennsylvania

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Glaucoma Associates of Texas

Dallas, Texas, 75231, United States

Location

Ophthalmology Associates

Fort Worth, Texas, 76102, United States

Location

University Eye Associates

Houston, Texas, 77030, United States

Location

R&R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

Pôle Ophtalmologique de la Clinique Mutualiste

Pessac, Bordeaux, 33600, France

Location

A. O.U.P (Azienda Ospedaliere Universitaria Pisana) Stabilimento di Cisanello

Pisa, Cisanello, 56124, Italy

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Edith van Dijkman
• Organization: Santen, Inc.

edith.vandijkman@santen.com

+31683667357

Study Officials

• Paul Palmberg, MD, PhD

  Bascolm Palmer Eye Institute

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: May 22, 2020
• Primary Completion: November 24, 2022
• Study Completion: November 24, 2022
• Last Updated: March 22, 2024
• Results First Posted: March 22, 2024

Record last verified: 2023-09

Locations

IT (1); FR (1); US (19); ES (1); GB (1)