Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
1 other identifier
observational
174
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2019
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedStudy Start
First participant enrolled
April 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2019
CompletedResults Posted
Study results publicly available
November 17, 2020
CompletedNovember 17, 2020
October 1, 2020
7 months
March 7, 2019
October 25, 2020
October 25, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation
Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation
IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy.
Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation
Secondary Outcomes (7)
Change From Baseline in Mean IOP to 48 Months After Implantation
Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation
Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation
Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation
Percentage of Eyes Achieving Qualified Success at Month 36
Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36
Percentage of Eyes Achieving Qualified Success at Month 48
Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48
Percentage of Eyes Achieving Complete Success at Month 36
Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36
- +2 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
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.
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
Participant eyes that underwent XEN 45 Gel Stent implantation from 1 January 2014 until 1 October 2015.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Clinical Trials Registry Team
Irvine, California, 92622, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Mini Balaram, MD
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2019
First Posted
March 11, 2019
Study Start
April 5, 2019
Primary Completion
October 25, 2019
Study Completion
October 25, 2019
Last Updated
November 17, 2020
Results First Posted
November 17, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share