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Oculusgen (Ologen) Glaucoma MMC Control in Estonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00524758
First Posted: September 5, 2007
Last Update Posted: June 27, 2017
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.
Information provided by (Responsible Party):
Pro Top & Mediking Company Limited
  Purpose

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.


Condition Intervention Phase
Open Angle Glaucoma Angle Closure Glaucoma Uveitis Glaucoma Young Age Glaucoma Neovascular Glaucoma High Risk Patient Device: ologen (oculusgen) collagen matrix Drug: MMC in Trabeculectomy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

Resource links provided by NLM:


Further study details as provided by Pro Top & Mediking Company Limited:

Primary Outcome Measures:
  • IOP <21mmHg without anti glaucoma medication [ Time Frame: 180 days ]

Secondary Outcome Measures:
  • IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication [ Time Frame: 180-day ]

Estimated Enrollment: 20
Study Start Date: July 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ologen in Trabeculectomy
Ologen in Trabeculectomy
Device: ologen (oculusgen) collagen matrix
Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.
Other Names:
  • ologen collagen matrix
  • oculusgen collagen matrix
Active Comparator: MMC in Trabeculectomy
MMC in Trabeculectomy
Drug: MMC in Trabeculectomy
MMC in Trabeculectomy

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Max anti glaucoma medication failed,

Exclusion Criteria:

  • Age less than 18, woman in pregnant, hemodialysis patient
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00524758


Locations
Estonia
Tartu University Clinics
Tartu, Estonia
Sponsors and Collaborators
Pro Top & Mediking Company Limited
Investigators
Principal Investigator: Kuldar Kaljurand, MD University of Tartu
  More Information

Responsible Party: Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier: NCT00524758     History of Changes
Other Study ID Numbers: oculusgen 2006-02-20
First Submitted: September 4, 2007
First Posted: September 5, 2007
Last Update Posted: June 27, 2017
Last Verified: June 2017

Keywords provided by Pro Top & Mediking Company Limited:
ologen
oculusgen
collagen matrix
trabeculectomy
filtering surgery
mitomycin-C
MMC
Aeon Astron

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Uveitis
Glaucoma, Angle-Closure
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases
Uveal Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors