Glaucoma Clinical Trial
Official title:
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys XEN 45 Glaucoma Implant in Subjects With Refractory Glaucoma
Verified date | May 2017 |
Source | AqueSys, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.
Status | Completed |
Enrollment | 65 |
Est. completion date | August 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of Refractory Glaucoma - 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: - Active Neovascular Glaucoma - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Glaucoma Associates of Texas | Dallas | Texas |
United States | Vold Vision | Fayetteville | Arkansas |
United States | Eye Center of Northern Colorado | Fort Collins | Colorado |
United States | George R. Reiss, MD PC | Glendale | Arizona |
United States | Montebello Eye Center | Montebello | California |
United States | New York Eye and Ear Infirmary | New York | New York |
United States | San Diego Eye Care Center | Oceanside | California |
United States | Stiles Eyecare Excellence & Glaucoma Institute | Overland Park | Kansas |
United States | Palo Alto Eye Group | Palo Alto | California |
United States | Washington University in St. Louis, Department of Ophthalmology | Saint Louis | Missouri |
United States | R and R Eye Research, LLC | San Antonio | Texas |
United States | Spokane Eye Clinic | Spokane | Washington |
Lead Sponsor | Collaborator |
---|---|
AqueSys, Inc. | Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications | Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis. | 12 Months | |
Primary | Mean Change in IOP From Baseline | Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention. | 12 Months |
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