PRESERFLO® MicroShunt Extension Study

InnFocus

Status: Completed

Conditions: Primary Open-angle Glaucoma

Treatments: Device: PRESERFLO® MicroShunt; Procedure: Trabeculectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT04333433

INN005 - EXT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 279 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

279 participants in 2 patient groups

MicroShunt treatment group

Description:

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

Treatment:

Device: PRESERFLO® MicroShunt

Trabeculectomy control arm

Description:

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

Treatment:

Procedure: Trabeculectomy