Satisfaction With XEN Gel Stent Versus Trabeculectomy for the Treatment of Glaucoma
NCT ID: NCT03852810
Last Updated: 2021-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
28 participants
OBSERVATIONAL
2019-02-25
2020-12-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Receiving surgical intervention via XEN Gel Stent (XEN)
Patient Reported Outcomes (PRO) will be collected before and after this particular procedure
No interventions assigned to this group
Receiving surgical intervention via trabeculectomy
Patient Reported Outcomes (PRO) will be collected before and after this particular procedure
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Scheduled to receive surgical treatment with either XEN (Xen gel stent) or trabeculectomy in the study eye
* Access to an electronic device with internet capabilities and an email address for completion of PROs (Patient Reported Outcomes)
* Be willing and able to complete PROs (Patient Reported Outcomes) at the specified time points
* Able to provide voluntary, informed consent to participate in this study
Exclusion Criteria
* Presence of a secondary glaucoma, pseudoexfoliation glaucoma, or pigmentary glaucoma
* Presence of neovascular, uveitic, or angle recession glaucoma or any glaucoma associate with vascular disorders
* Prior incisional glaucoma surgery, canal-based surgery, suprachoroidal space-based surgery (trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.) or a cilio-ablative procedure
* Clinically significant inflammation or infection in the study eye within 30 days prior to the baseline visit (e.g. blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)
* History of corneal surgery, corneal opacities, or corneal disease
* Prior intraocular surgery in either eye ≤ 3 months prior to study enrollment with the exception of uncomplicated cataract surgery in either eye ≥ 1 month prior to study enrollment
* Anticipated ocular surgery in either eye within 6 months of baseline
* Concomitant cataract surgery scheduled at the time of glaucoma procedure
The study eye is defined as the eye receiving surgical intervention with either XEN or trabeculectomy.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joanna Campbell, Ph.D
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dalhousie University
Halifax, Nova Scotia, Canada
Galen Eye Center
Kingston, Ontario, Canada
Prism Eye Institute
Mississauga, Ontario, Canada
Toronto Ophthalmic Research Innovation Centre, Inc
Toronto, Ontario, Canada
Universitat Augenklinik
Mainz, , Germany
Ludwig-Maximilians-Universität München
Munich, , Germany
University of Tübingen
Tübingen, , Germany
Addenbrooke's Hospital
Cambridge, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
Southend University Hospital
Southend-on-Sea, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P-2016-6380
Identifier Type: -
Identifier Source: org_study_id