Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)

Allergan

Status: Completed

Conditions: Glaucoma

Treatments: Procedure: Phacoemulsification; Device: XEN Group

Study type: Observational

Funder types: Industry

Identifiers

NCT03868254

CMO-MA-EYE-0590

Details and patient eligibility

About

A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with phacoemulsification from 1 January 2014 to 1 October 2015.

Enrollment: 174 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Eye treated with XEN 45 Gel Stent for primary open angle glaucoma as a standalone procedure or in combination with phacoemulsification
• XEN 45 Gel Stent was implanted between 1 January 2014 and 1 October 2015

Exclusion Criteria

• None

Trial design

174 participants in 2 patient groups

Implant

Description:

Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.

Treatment:

Device: XEN Group

Implant + Phaco

Description:

Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.

Treatment:

Procedure: Phacoemulsification