Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
NCT ID: NCT03868254
Last Updated: 2020-11-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
174 participants
OBSERVATIONAL
2019-04-05
2019-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Implant
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.
XEN Group
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.
Implant + Phaco
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.
Phacoemulsification
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.
Interventions
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XEN Group
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.
Phacoemulsification
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.
Eligibility Criteria
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Inclusion Criteria
* XEN 45 Gel Stent was implanted between 1 January 2014 and 1 October 2015
Exclusion Criteria
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Mini Balaram, MD
Role: STUDY_DIRECTOR
Allergan
Locations
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Clinical Trials Registry Team
Irvine, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CMO-MA-EYE-0590
Identifier Type: -
Identifier Source: org_study_id