Oculusgen (Ologen) Glaucoma MMC Control in Estonia
![]() |
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: NCT00524758 |
Recruitment Status
:
Completed
First Posted
: September 5, 2007
Last Update Posted
: June 27, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | 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 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
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 |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
---|---|
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:
|
Active Comparator: MMC in Trabeculectomy
MMC in Trabeculectomy
|
Drug: MMC in Trabeculectomy
MMC in Trabeculectomy
|
- IOP <21mmHg without anti glaucoma medication [ Time Frame: 180 days ]
- IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication [ Time Frame: 180-day ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Max anti glaucoma medication failed,
Exclusion Criteria:
- Age less than 18, woman in pregnant, hemodialysis patient

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
Estonia | |
Tartu University Clinics | |
Tartu, Estonia |
Principal Investigator: | Kuldar Kaljurand, MD | University of Tartu |
Responsible Party: | Pro Top & Mediking Company Limited |
ClinicalTrials.gov Identifier: | NCT00524758 History of Changes |
Other Study ID Numbers: |
oculusgen 2006-02-20 |
First Posted: | September 5, 2007 Key Record Dates |
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 |