Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany
NCT ID: NCT01174420
Last Updated: 2011-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2009-11-30
2011-11-30
Brief Summary
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Detailed Description
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The aim of the present study is to determine the effectiveness of the ologen® CM and reduce wound scarring, thereby increasing success of trabeculectomy without side effects of MMC. A means of producing better success rate and reduced complications is the purpose of ologen® Collagen Matrix for the aid of glaucoma surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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ologen Collagen Matrix
Use of ologen Collagen Matrix in trabeculectomy
After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing
Mitomycin-C (MMC)
Use of Mitomycin-C in trabeculectomy
After creating a scleral flap, a sponge with Mitomycin-C (0.02%) is applied on the scleral surface for 3 minutes. Afterwards, Mitomycin-C was rinsed out with balanced salt solution.
Interventions
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Use of ologen Collagen Matrix in trabeculectomy
After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing
Use of Mitomycin-C in trabeculectomy
After creating a scleral flap, a sponge with Mitomycin-C (0.02%) is applied on the scleral surface for 3 minutes. Afterwards, Mitomycin-C was rinsed out with balanced salt solution.
Eligibility Criteria
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Inclusion Criteria
* Uncontrolled open-angle glaucoma
* Subject is willing to sign informed consent
* Subject is able and willing to complete post-operative follow-up requirements
Exclusion Criteria
* Angle-closure glaucoma
* Secondary glaucoma with anatomical malformations of the eye
* Subjects having single functional eye
* Previous conjunctival surgery
* Known allergic reactions to ingredients of ologen Collagen Matrix
* Excessive myopia (axial length (AL)\> 27 mm or more than -10 diopters)
* Previous vitrectomy eye surgery
* Subjects do not consent to participate
18 Years
ALL
No
Sponsors
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Aeon Astron Europe B.V.
INDUSTRY
Responsible Party
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Department of Ophthalmology, University of Cologne, Germany
Principal Investigators
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Thomas Dietlein, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, University of Cologne, Germany
Locations
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The University Hospital of Cologne
Cologne, , Germany
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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AAE-CT-DEU-2009-01
Identifier Type: -
Identifier Source: org_study_id
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