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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ologen in Trabeculectomy | Experimental | Ologen in Trabeculectomy |
|
| MMC in Trabeculectomy | Active Comparator | MMC in Trabeculectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ologen (oculusgen) collagen matrix | Device | Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed. |
| Measure | Description | Time Frame |
|---|---|---|
| IOP <21mmHg without anti glaucoma medication | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication | 180-day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kuldar Kaljurand, MD | University of Tartu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Clinics | Tartu | Estonia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36912740 | Derived | Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3. |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D015812 | Glaucoma, Angle-Closure |
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| MMC in Trabeculectomy | Drug | MMC in Trabeculectomy |
|