Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery
NCT ID: NCT00538590
Last Updated: 2012-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2007-07-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MITOMYCIN-C
Following ethics committee approval, 20 patients with uncontrolled glaucoma will be will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with Mitomycin-C.
Mitomycin-C(MMC) and glaucoma filtering surgery
If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.
ologen (Oculusgen)
20 patients will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with ologen implant. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Collagen Matrix in Glaucoma Filtering Surgery
Collagen Matrix implantation in Glaucoma Filtering Surgery
Interventions
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Collagen Matrix in Glaucoma Filtering Surgery
Collagen Matrix implantation in Glaucoma Filtering Surgery
Mitomycin-C(MMC) and glaucoma filtering surgery
If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Maxima anti-glaucoma medication failed
* Age\>18
* Able to complete the follow up
Exclusion Criteria
* Angle closure glaucoma
* Deformity glaucoma
* One eye glaucoma
* Previous conjunctiva opened
* Allergy to collagen
18 Years
ALL
No
Sponsors
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Pro Top & Mediking Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Dietlein, Ph. D, MD
Role: PRINCIPAL_INVESTIGATOR
Universität Köln
Locations
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Hospital of Universität Köln
Cologne, , Germany
Countries
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References
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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.
Related Links
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Publication on Eye
Other Identifiers
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ologen-Koln
Identifier Type: -
Identifier Source: org_study_id
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