Summary

Eligibility
for people ages 40-85 (full criteria)
Location
at UC Davis UCLA
Dates
study started
estimated completion

Description

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.

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.

Details

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.

Keywords

Primary Open-angle Glaucoma POAG Glaucoma Glaucoma, Open-Angle PRESERFLO® MicroShunt Trabeculectomy

Eligibility

You can join if…

Open to people ages 40-85

  1. Subject has completed their Month 24 Follow-Up Visit in the INN-005 clinical study conducted under IDE G130028.
  2. 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).
  3. Subject is willing and able to comply with all study requirements, including signing an informed consent form.

You CAN'T join if...

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

Locations

  • UCLA Medical Center Jules Stein Eye Institute
    Los Angeles California 90095 United States
  • University of California at Davis Eye Center
    Sacramento California 95817 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
InnFocus Inc.
ID
NCT04333433
Study Type
Observational
Participants
Expecting 300 study participants
Last Updated