Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

NACompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
Glaucoma
Interventions
PROCEDURE

Trabeculectomy

"Standard trabeculectomy procedure~1. Creation of a fornix or limbal based conjunctival flap in upper quadrants~2. Creation of a limbal-based scleral flap extending into clear cornea~3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)~4. Creation of fistula 1mm x 2mm in size~5. Iridectomy~6. Suturing the scleral flap~7. Repositioning of conjunctiva with sutures After procedure, antibiotics \& steroids are administered topically; eye is covered with a pad - patient is discharged."

DEVICE

Ex-PRESS mini shunt

"Ex-PRESS implantation procedure:~1. Creation of a fornix or limbal based conjunctival flap in upper quadrants~2. Creation of limbal-based scleral flap extending into clear cornea~3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)~4. Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus~5. Prior to implantation, a thorough mobility check should be performed~6. Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision~7. Withdrawal of introducer~8. Tucking plate under the scleral flap, and verification of its position~9. Suturing scleral flap After implantation procedure, antibiotics \& steroids administered topically; eye is covered with a pad - patient is discharged."

Trial Locations (8)

15212

Allegheny Ophthalmic & Orbital Associates, P.C., Pittsburgh

19066

Wills EYE Institute, Philadelphia

32610

University of Florida, Gainesville

38163

University of Tennessee, Memphis

63110

Washington University, St Louis

73104

Dean A. McGee Eye Institute, Oklahoma City

94143-0730

University of California, San Francisco

L5B 1N5

Osler Eyecare, Mississauga

All Listed Sponsors
lead

University of Virginia

OTHER

NCT00444080 - Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma | Biotech Hunter | Biotech Hunter