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

Summary

The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in uncontrolled treated glaucoma cases, the efficacy being the primary objective and the safety being the secondary.

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.

Sponsors & Collaborators

• The New York Eye & Ear Infirmary

  collaborator OTHER

• Robert Ritch, MD, LLC.

  collaborator OTHER

• Aeon Astron Europe B.V.

  lead INDUSTRY

Principal Investigators

• Robert Ritch, MD · Robert Ritch, MD, LLC.

• Steven Sarkisian, MD · Dean McGee Eye Institute

• Robert Fechtner, MD · Institute of Ophthalmology and Visual Science

• Michael Pro, MD · Wills Eye Institue

• Steven Vold, MD · Boozman-Hof Eye Clinic

• Angelo Tanna, MD · Northwestern Memorial Hospital

• David Godfrey, MD · Glaucoma Associates of Texas

• Paul Sidoti, MD · New York Eye and Ear Infirmiry

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2013-12-31

Completion

2015-12-31

Countries

• United States

Study Locations