Oculusgen (Ologen) Glaucoma MMC Control in Estonia
Summary
To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery.
The ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. The MMC application is as the standard.
Description
Ologen collagen matrix is implanted on the top of sclera flap after the loose stich sclera flap is done for the filtering surgery. The concept of ologen collagen matrix is to creat the subconjunctiva bleb and modulate the wound healing for the surgery. By implanting ologen collagen matrix in the place, subconjuctival and trabdoor scars might be prevented. This is because the ologen collagen matrix is a 3-D scaffold porous structure that can guide fibroblast to grow randomly, instead of linear alignment. This can reduce the scar formation.
Doctors apply MMC for the glaucoma surgery is also trying to inhibite the scar formation. But MMC has been long time used and glaucoma specialists have not found anything to replace it.
Ologen collagen matrix concept is not INHIBITION, it is guiding and creating a physiological tissue. The successful of ologen collagen matrix may be on par with MMC but the safety and side effects will be much less.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Open Angle Glaucoma
Intervention
ologen (oculusgen) collagen matrix
Location
Tartu University Clinics
Tartu
Estonia
Status
Recruiting
Source
Pro Top & Mediking Company Limited
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00524758
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Glaucoma, Open-angle
Glaucoma in which the angle of the anterior chamber is open and the trabecular meshwork does not encroach on the base of the iris.
Hydrophthalmos
Congenital open-angle glaucoma that results from dysgenesis of the angle structures accompanied by increased intraocular pressure and enlargement of the eye. Treatment is both medical and surgical.
Matrix Metalloproteinase 9
An endopeptidase that is structurally similar to MATRIX METALLOPROTEINASE 2. It degrades GELATIN types I and V; COLLAGEN TYPE IV; and COLLAGEN TYPE V.
Collagen Type Vi
A non-fibrillar collagen that forms a network of MICROFIBRILS within the EXTRACELLULAR MATRIX of CONNECTIVE TISSUE. The alpha subunits of collagen type VI assemble into antiparallel, overlapping dimers which then align to form tetramers.
Matrix Metalloproteinase 8
A member of the MATRIX METALLOPROTEINASES that cleaves triple-helical COLLAGEN types I, II, and III.
Clinical Trials
Ologen (OculusGen)-Glaucoma MMC Control in Pakistan
The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.
Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in Beijing Remin Hospital
The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.
Ologen (OculusGen)-Glaucoma Case Control Trial in India
The purpose of this study is to compare the safety and effectiveness of trabeculectomy with ologen (OculusGen) Biodegradable Collagen Matrix Implant and trabeculectomy without antifibotic...
Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Zhong-Shan Hospital
The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery.
Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Beijing Hospital
The purpose of this study is to determine whether the OculusGen Collagen Matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.
PubMed Articles
Imaging of blebs after phacotrabeculectomy with Ologen collagen matrix implants.
Objective To analyse blebs of phacotrabeculectomies performed with Ologen collagen implants (ProTop & MediKing, Taipei, Taiwan) and to compare these with blebs of mitomycin C (MMC)-augmented phacotrab...
PurposeThe aim of this study is to assess the efficacy and complications of trabeculectomy with a biodegradable implant (ologen implant) vstrabeculectomy using mitomycin C (MMC) in patients with medic...
Comparison of outcomes of trabeculectomy with mitomycin C vs. ologen implant in primary glaucoma.
Purpose: To compare the safety and efficacy of trabeculectomy with Ologen implant vs. trabeculectomy with Mitomycin C (MMC). Materials and Methods: In a prospective, randomized, pilot study, 39 eyes o...
Determination of Collagen Nanostructure from Second-Order Susceptibility Tensor Analysis.
A model is proposed to describe the polarization dependence of second harmonic generation (SHG) from type I collagen fibrils. The model is based on sum-frequency vibrational spectrum experiments that...
The aim of this study was to evaluate the effects of increased collagen-matrix density on the mechanical properties and in vivo absorbability of porous hydroxyapatite (HAp)-collagen composites as arti...
