Overview

This trial is active, not recruiting.

Condition primary open angle glaucoma
Treatments xen gel stent, xen gel stent with cataract surgery
Phase phase 4
Sponsor AqueSys, Inc.
Start date January 2014
End date February 2017
Trial size 200 participants
Trial identifier NCT02006693, MS-001

Summary

The objective of this study is to evaluate the AqueSys XEN Implant for the treatment of moderate primary open angle glaucoma patients when medications have failed to control intraocular pressure (IOP). Effectiveness will be evaluated by comparing medicated preoperative, intraocular pressure to postoperative values. Additionally, the number of IOP lowering medications subjects are on at each study visit will be compared to preoperative medication.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
The XEN Gel Stent will be placed as a standalone procedure.
xen gel stent XEN Glaucoma Implant
The XEN Gel Stent will be placed as a standalone procedure.
(Other)
The XEN Gel Stent with cataract surgery, only will occur if the patient is diagnosed with a cataract..
xen gel stent with cataract surgery Cataract combo
Patient has been diagnosed with a cataract and has elected to have cataract surgery. The XEN Gel Stent will be placed along with cataract surgery.

Primary Outcomes

Measure
The number of IOP lowering medications compared to the number of preoperative IOP lowering medications.
time frame: 24 month visit
The number of IOP lowering medications compared to the number of preoperative IOP lowering medications.
time frame: 12 month visit
Comparing the intraocular pressure to the preoperative medicated intraocular pressure.
time frame: 24 month visit
Comparing the intraocular pressure to the preoperative medicated intraocular pressure.
time frame: 12 month visit

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of primary open angle glaucoma - Subjects are taking at least one and no more than four IOP lowering medications. Exclusion Criteria: - Angle Closure Glaucoma - Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders - Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) - Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant

Additional Information

Official title Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AqueSys, Inc..