InnFocus MicroShunt Versus Trabeculectomy Study

NACompletedINTERVENTIONAL
Enrollment

732

Participants

Timeline

Start Date

December 15, 2015

Primary Completion Date

January 15, 2020

Study Completion Date

January 15, 2020

Conditions
Primary Open Angle Glaucoma
Interventions
PROCEDURE

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."

DEVICE

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."

Trial Locations (29)

10003

New York Eye and Ear Infirmary of Mt. Sinai, New York

12159

Glaucoma Consultants of the Capital Region, Slingerlands

19004

Ophthalmic Partners of Pennsylvania, Bala-Cynwyd

20815

Washington Eye Physicians and Surgeons, Chevy Chase

28040

Hospital Clínico San Carlos, Madrid

33600

Pole Ophtalmologique de la Clinique Mutualiste, Pessac

43215

Ophthalmic Surgeons and Consultants of Ohio, Columbus

45242

Cincinnati Eye Institute, Cincinnati

46290

Eugene and Marilyn Glick Eye Institute, Indianapolis

55431

Minnesota Eye Consultants, PA, Bloomington

56126

Pisa University Hospital Cisanello, Pisa

60026

Chicago Glaucoma Consultants and CGC Eye Center, Glenview

66213

Stiles Eyecare Excellence, Overland Park

68131

Midwest Eye Surgery Center, Omaha

72704

Vold Vision, Fayetteville

73104

Dean McGee Eye Institute, Oklahoma City

75231

Glaucoma Associates of Texas, Dallas

76102

Ophthalmology Associates, Fort Worth

77030

The Robert Cizik Eye Clinic, Houston

78229

Rashid, Rice, Flynn and Reilley Eye Associates, San Antonio

83616

Inter-Mountain Eye Care, Eagle

85306

Eye Physicians and Surgeons of Arizona, Glendale

85710

Arizona Eye Consultants, Tucson

90095

UCLA Jules Stein Eye Institute, Los Angeles

95817

University of California at Davis Eye Center, Davis

98004

Specialty Eye Care, Bellevue

06824

Ophthalmic Consultants of Connecticut, Fairfield

6229 HX

University Eye Clinic Maastricht, Maastricht

EC1V 2PD

Moorfields Eye Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

InnFocus Inc.

INDUSTRY