Status:
COMPLETED
Satisfaction With XEN Gel Stent Versus Trabeculectomy for the Treatment of Glaucoma
Lead Sponsor:
Allergan
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, observational, non-interventional study of patients scheduled to receive surgical intervention either via XEN or trabeculectomy for open-angle glaucoma. The decision to treat pa...
Eligibility Criteria
Inclusion
- Diagnosed with OAG (Open Angle Glaucoma) and using at least 2 topical IOP-lowering medication classes in the study eye
- 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
- Diagnosed with angle closure glaucoma in the study eye
- 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.
- Patients who have received prior laser trabeculoplasty will be permitted to participate if all other inclusion/exclusion criteria are met.
Key Trial Info
Start Date :
February 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 9 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03852810
Start Date
February 25 2019
End Date
December 9 2020
Last Update
October 20 2021
Active Locations (10)
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1
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 2Y9
2
Galen Eye Center
Kingston, Ontario, Canada, K7K 6Z6
3
Prism Eye Institute
Mississauga, Ontario, Canada, L5L1W8
4
Toronto Ophthalmic Research Innovation Centre, Inc
Toronto, Ontario, Canada, M5G 1Z5