Efficacy and Safety of XEN63 Gel Implant
NCT06844240 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 96
Last updated 2025-02-25
Summary
The study is prospective, observational, multicenter and has the aim of evaluating the efficacy and safety of the XEN63 implant in patients with primary or secondary glaucoma who require surgery in association or not with cataract surgery, for IOP not controlled by medical therapy, disease progression or intolerance to topical therapy, comparing IOP values before and 24 months after implantation.
Conditions
Sponsors & Collaborators
-
Mario Stirpe
lead OTHER
Principal Investigators
-
Francesco Oddone, MD, PhD · IRCCS-Fondazione GB Bietti
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-28
- Primary Completion
- 2030-12-31
- Completion
- 2030-12-31
Countries
- Italy
Study Locations
More Related Trials
-
XEN Glaucoma Gel Stent Versus Trabeculectomy
NCT05439161 ·Status: RECRUITING ·Phase: NA
-
Real World Evidence of Xen45 Gel Implant in Pseudoexfoliation Glaucoma
NCT06993311 ·Status: COMPLETED
-
Satisfaction With XEN Gel Stent Versus Trabeculectomy for the Treatment of Glaucoma
NCT03852810 ·Status: COMPLETED
-
Real-world Evidence Study of XEN in Chinese Patients With Refractory Glaucoma
NCT04303897 ·Status: COMPLETED
-
The Effect of Trabeculectomy & Ex-PRESS Glaucoma Drainage Implant on the Corneal Biomechanical Properties
NCT04648943 ·Status: COMPLETED ·Phase: NA
-
Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent
NCT03151577 ·Status: UNKNOWN ·Phase: NA
-
A Prospective, Single Surgeon, Randomized Control Study Comparing ab Interno XEN Gel Microstent Implantation vs Closed Conjunctiva ab Externo Implantation Performed at the Slit Lamp for the Treatment of Uncontrolled Glaucoma
NCT04943185 ·Status: UNKNOWN ·Phase: NA
-
MINIject Glaucoma Implant in European Patients
NCT03624361 ·Status: COMPLETED ·Phase: NA
-
Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach
NCT04406467 ·Status: COMPLETED
-
Evaluation of the Xen Implant in Glaucoma Surgery
NCT03733600 ·Status: COMPLETED
-
Study Comparing the Kinetics of Endothelial Cell Loss Associated With the XEN® Implant Versus Traditional Filtering Surgery for Glaucoma
NCT04781283 ·Status: WITHDRAWN ·Phase: NA
-
XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)
NCT03654885 ·Status: COMPLETED ·Phase: PHASE4
-
A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma
NCT00911924 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects
NCT00326040 ·Status: COMPLETED ·Phase: PHASE4
-
Early Evaluation of the Beacon Aqueous Microshunt in Patients Refractory to Drug Therapy in the European Union
NCT03634319 ·Status: TERMINATED ·Phase: NA
-
A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
NCT00326014 ·Status: COMPLETED ·Phase: PHASE4
-
Assessment of Effectiveness Ex-Press Surgery Modification
NCT03800589 ·Status: COMPLETED ·Phase: NA
-
Early Feasibility Study of the Brown Glaucoma Implant in Patients With Severe Visual Impairment or No Light Perceived
NCT03469297 ·Status: COMPLETED ·Phase: NA
-
Changes in Corneal Endothelial Cell Density After Transscleral ab Interno Glaucoma Gel Stent Implantation
NCT04547036 ·Status: COMPLETED
-
Investigation of the iStent Inject® Devices in Open-Angle Glaucoma
NCT03624699 ·Status: COMPLETED ·Phase: NA
-
Analysis of Conjunctival Changes as Indicators for Ab-interno Gelatin Microstent Implantation Surgery Outcomes
NCT04727411 ·Status: COMPLETED ·Phase: NA
-
iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications
NCT03478293 ·Status: TERMINATED ·Phase: NA
-
Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy
NCT04417920 ·Status: COMPLETED ·Phase: NA
-
Safety and Efficacy of an Ab Interno Gelatin Stent (XEN63) With or Without Mitomycin C
NCT04750447 ·Status: UNKNOWN
-
A Study to Evaluate Adverse Events and Change in Disease Activity With the XEN45 Glaucoma Treatment System Implantation In Adult Participants With Open-Angle Glaucoma in China
NCT05821855 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4