Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
65 participants
INTERVENTIONAL
2013-01-31
2016-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
NCT03362931
Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
NCT00809848
Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension
NCT06964191
Study of Exchange of Travoprost Intraocular Implant
NCT04615403
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
NCT00287521
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.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AqueSys XEN 45 Glaucoma Implant
AqueSys XEN 45 Glaucoma Implant
Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AqueSys XEN 45 Glaucoma Implant
Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg
* Visual field mean deviation score of -3 dB or worse
* Shaffer Angle Grade ≥ 3
* Area of free, healthy and mobile conjunctiva in the targeted quadrant
Exclusion Criteria
* Previous glaucoma shunt/valve in the targeted quadrant
* History of corneal surgery, opacities or disease/pathology
* Anticipated need for ocular surgery
* Non-study eye with BCVA of 20/200 or worse
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
AqueSys, Inc.
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.
Richard A Lewis, M.D.
Role: STUDY_CHAIR
Grutzmacher, Lewis & Sierra Surgical Eye Specialists
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
George R. Reiss, MD PC
Glendale, Arizona, United States
Vold Vision
Fayetteville, Arkansas, United States
Montebello Eye Center
Montebello, California, United States
San Diego Eye Care Center
Oceanside, California, United States
Palo Alto Eye Group
Palo Alto, California, United States
Eye Center of Northern Colorado
Fort Collins, Colorado, United States
Stiles Eyecare Excellence & Glaucoma Institute
Overland Park, Kansas, United States
Washington University in St. Louis, Department of Ophthalmology
St Louis, Missouri, United States
New York Eye and Ear Infirmary
New York, New York, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
R and R Eye Research, LLC
San Antonio, Texas, United States
Spokane Eye Clinic
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ozal SA, Kaplaner O, Basar BB, Guclu H, Ozal E. An innovation in glaucoma surgery: XEN45 gel stent implantation. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):382-385. doi: 10.5935/0004-2749.20170093.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P13-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.