RECRUITINGINTERVENTIONAL
Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial of the Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
About This Trial
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Who May Be Eligible (Plain English)
Who May Qualify:
- Open angle, pseudoexfoliative or pigmentary glaucoma
- IOP at preoperative visit of ≥ 20mmHg and ≤ 40mmHg
- Visual field mean deviation score of -3dB or worse
- Area of healthy, free and mobile conjunctiva in the target quadrant
- Shaffer angle grade ≥ 2 in the target quadrant
Who Should NOT Join This Trial:
- Angle closure glaucoma
- Congenital, neovascular or other secondary glaucomas
- Previous intraocular surgery, with the exception of uncomplicated cataract surgery
- Previous glaucoma shunt/valve in the target quadrant
- Clinically significant inflammation or infection in the study eye within 30 days prior to the operative visit
- History of corneal surgery, corneal opacities or corneal disease
- Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Open angle, pseudoexfoliative or pigmentary glaucoma
* IOP at preoperative visit of ≥ 20mmHg and ≤ 40mmHg
* Visual field mean deviation score of -3dB or worse
* Area of healthy, free and mobile conjunctiva in the target quadrant
* Shaffer angle grade ≥ 2 in the target quadrant
Exclusion Criteria:
* Angle closure glaucoma
* Congenital, neovascular or other secondary glaucomas
* Previous intraocular surgery, with the exception of uncomplicated cataract surgery
* Previous glaucoma shunt/valve in the target quadrant
* Clinically significant inflammation or infection in the study eye within 30 days prior to the operative visit
* History of corneal surgery, corneal opacities or corneal disease
* Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition
Treatments Being Tested
DEVICE
VisiPlate Glaucoma Implant
Implant (micro-shunt) for glaucoma patients
Locations (12)
Arizona Advanced Eye Research
Glendale, Arizona, United States
Sacramento Eye Consultants
Sacramento, California, United States
ICON Eye Care
Grand Junction, Colorado, United States
Mile High Eye Institute
Sheridan, Colorado, United States
Cleveland Clinic- Cole Eye Institute
Cleveland, Ohio, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
The Eye Centers of Racine & Kenosha
Kenosha, Wisconsin, United States
Lynette Venter
Bloemfontein, South Africa
Pretoria Eye Institute
Pretoria, South Africa