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Oculusgen (Ologen) Glaucoma MMC Control in Estonia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Pro Top & Mediking Company Limited.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:
NCT00524758
First received: September 4, 2007
Last updated: October 24, 2011
Last verified: October 2011

September 4, 2007
October 24, 2011
July 2007
October 2011   (final data collection date for primary outcome measure)
IOP <21mmHg without anti glaucoma medication [ Time Frame: 180 days ] [ Designated as safety issue: No ]
IOP <21mmHg without anti glaucoma medication [ Time Frame: 180 days ]
Complete list of historical versions of study NCT00524758 on ClinicalTrials.gov Archive Site
IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication [ Time Frame: 180-day ] [ Designated as safety issue: No ]
IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication [ Time Frame: 180-day ]
Not Provided
Not Provided
 
Oculusgen (Ologen) Glaucoma MMC Control in Estonia
Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Open Angle Glaucoma
  • Angle Closure Glaucoma
  • Uveitis Glaucoma
  • Young Age Glaucoma
  • Neovascular Glaucoma
  • High Risk Patient
  • 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
  • Drug: MMC in Trabeculectomy
    MMC in Trabeculectomy
  • Experimental: Ologen in Trabeculectomy
    Ologen in Trabeculectomy
    Intervention: Device: ologen (oculusgen) collagen matrix
  • Active Comparator: MMC in Trabeculectomy
    MMC in Trabeculectomy
    Intervention: Drug: MMC in Trabeculectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Max anti glaucoma medication failed,

Exclusion Criteria:

  • Age less than 18, woman in pregnant, hemodialysis patient
Both
19 Years and older
No
Contact: Arslan Tsai, Pharma/ MSc EFM +886 2 27088558 ext 116 arslan.tsai@aeonastron.net
Estonia
 
NCT00524758
oculusgen 2006-02-20
Yes
Pro Top & Mediking Company Limited
Pro Top & Mediking Company Limited
Not Provided
Principal Investigator: Kuldar Kaljurand, MD University of Tartu
Pro Top & Mediking Company Limited
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP