Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01174420|
Recruitment Status : Unknown
Verified May 2011 by Aeon Astron Europe B.V..
Recruitment status was: Recruiting
First Posted : August 3, 2010
Last Update Posted : May 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Open-angle Glaucoma||Device: Use of ologen Collagen Matrix in trabeculectomy Drug: Use of Mitomycin-C in trabeculectomy||Not Applicable|
ologen® Collagen Matrix (CM) is an artificial extracellular matrix (ECM) specifically configured to support repair in connective and epithelial ocular tissue. The device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. ologen® CM is a biodegradable scaffold matrix, inducing a regenerative non-scarring wound healing process without using anti-fibrotic agents. For application in glaucoma filtration surgery, ologen® CM is designed to prevent scar formation (subconjunctival and scleral flap scarring is the major risk factor for failure of trabeculectomy). After implanting the ologen® CM on top of the scleral flap in the subconjunctival space, a functional bleb can be created.
The aim of the present study is to determine the effectiveness of the ologen® CM and reduce wound scarring, thereby increasing success of trabeculectomy without side effects of MMC. A means of producing better success rate and reduced complications is the purpose of ologen® Collagen Matrix for the aid of glaucoma surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||November 2011|
|Estimated Study Completion Date :||November 2011|
U.S. FDA Resources
|Experimental: ologen Collagen Matrix||
Device: Use of ologen Collagen Matrix in trabeculectomy
After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing
|Active Comparator: Mitomycin-C (MMC)||
Drug: Use of Mitomycin-C in trabeculectomy
After creating a scleral flap, a sponge with Mitomycin-C (0.02%) is applied on the scleral surface for 3 minutes. Afterwards, Mitomycin-C was rinsed out with balanced salt solution.
- Intraocular pressure (IOP) reduction [ Time Frame: 6 months ]
- Incidence of complications [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174420
|Contact: Thomas Dietlein, MD||+49-221-478-5862 ext email@example.com|
|The University Hospital of Cologne||Recruiting|
|Cologne, Germany, 50937|
|Contact: Thomas Dietlein, MD +49-221-478-5862 ext 4300 firstname.lastname@example.org|
|Principal Investigator: Thomas Dietlein, MD|
|Principal Investigator:||Thomas Dietlein, MD||Department of Ophthalmology, University of Cologne, Germany|