732
Participants
Start Date
December 15, 2015
Primary Completion Date
January 15, 2020
Study Completion Date
January 15, 2020
Glaucoma Surgery
"An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a fornix-based conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure."
InnFocus MicroShunt
"An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a fornix-based conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure."
New York Eye and Ear Infirmary of Mt. Sinai, New York
Glaucoma Consultants of the Capital Region, Slingerlands
Ophthalmic Partners of Pennsylvania, Bala-Cynwyd
Washington Eye Physicians and Surgeons, Chevy Chase
Hospital Clínico San Carlos, Madrid
Pole Ophtalmologique de la Clinique Mutualiste, Pessac
Ophthalmic Surgeons and Consultants of Ohio, Columbus
Cincinnati Eye Institute, Cincinnati
Eugene and Marilyn Glick Eye Institute, Indianapolis
Minnesota Eye Consultants, PA, Bloomington
Pisa University Hospital Cisanello, Pisa
Chicago Glaucoma Consultants and CGC Eye Center, Glenview
Stiles Eyecare Excellence, Overland Park
Midwest Eye Surgery Center, Omaha
Vold Vision, Fayetteville
Dean McGee Eye Institute, Oklahoma City
Glaucoma Associates of Texas, Dallas
Ophthalmology Associates, Fort Worth
The Robert Cizik Eye Clinic, Houston
Rashid, Rice, Flynn and Reilley Eye Associates, San Antonio
Inter-Mountain Eye Care, Eagle
Eye Physicians and Surgeons of Arizona, Glendale
Arizona Eye Consultants, Tucson
UCLA Jules Stein Eye Institute, Los Angeles
University of California at Davis Eye Center, Davis
Specialty Eye Care, Bellevue
Ophthalmic Consultants of Connecticut, Fairfield
University Eye Clinic Maastricht, Maastricht
Moorfields Eye Hospital, London
Lead Sponsor
InnFocus Inc.
INDUSTRY