Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany
A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy
1 other identifier
interventional
40
1 country
1
Brief Summary
The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 2, 2010
CompletedFirst Posted
Study publicly available on registry
August 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedMay 9, 2011
May 1, 2011
2 years
August 2, 2010
May 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraocular pressure (IOP) reduction
6 months
Secondary Outcomes (1)
Incidence of complications
6 months
Study Arms (2)
ologen Collagen Matrix
EXPERIMENTALMitomycin-C (MMC)
ACTIVE COMPARATORInterventions
After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing
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
You may qualify if:
- Age 18 years or over
- Uncontrolled open-angle glaucoma
- Subject is willing to sign informed consent
- Subject is able and willing to complete post-operative follow-up requirements
You may not qualify if:
- Inflammatory eye diseases
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University Hospital of Cologne
Cologne, 50937, Germany
Related Publications (1)
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.
PMID: 36912740DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Dietlein, MD
Department of Ophthalmology, University of Cologne, Germany
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 2, 2010
First Posted
August 3, 2010
Study Start
November 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
May 9, 2011
Record last verified: 2011-05