Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery

PHASE4CompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

December 31, 2013

Study Completion Date

December 31, 2015

Conditions
Glaucoma
Interventions
DEVICE

Use of ologen Collagen Matrix in trabeculectomy (ologen)

Place ologen CM on the top of the loosely-sutured scleral flap under conjunctiva before suturing. It is recommended to suture the scleral flap with 1 or 2 stiches loosely for the convenience of future suture lysis and to coordinate with the tamponading effect of ologen CM to create a fluctuating scleral flap that prevents bleb wound adhesion and modulates aqueous humor outflow for ideal IOP control without leakage.

DRUG

Use of Mitomycin-C (MMC) in trabeculectomy

After outlining and creating a superficial scleral flap, a cellulose sponge soaked with MMC(0.4mg/mL) is applied for up to 3 mins according to physician's routine method of application. The area treated is copiously irrigated with balanced isotonic solution. Alternatively, 15mcg of MMC may be injected intra-Tenon's at the end of the procedure. Patients receiving mitomycin will be billed as per operating room practice.

Trial Locations (8)

10003

Glaucoma Associates of New York, New York

New York Eye and Ear Infirmary, New York

19107

Wills Eye Institue, Philadelphia

60611

Northwestern Memorial Hospital, Chicago

72756

VoldVision-Holf Eye Clinic, Rogers

73104

Dean McGee Eye Institue, Oklahoma City

75231

Glaucoma Associates of Texas, Dallas

07103

Institue of Ophthalmology and Visual Science, Newark

All Listed Sponsors
collaborator

The New York Eye & Ear Infirmary

OTHER

collaborator

Robert Ritch, MD, LLC.

OTHER

lead

Aeon Astron Europe B.V.

INDUSTRY

NCT01440751 - Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery | Biotech Hunter | Biotech Hunter