Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery
NCT ID: NCT01440751
Last Updated: 2017-11-01
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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COMPLETED
PHASE4
99 participants
INTERVENTIONAL
2011-09-30
2015-12-31
Brief Summary
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Detailed Description
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Results of ologen CM studies have been published at conferences and published in peer-reviewed journals; ologen CM is approved in Europe as an aid for tissue repair, and by the FDA in the US as an adjunct in wound management(K080868). In general, over 6,000 ologen CM have been implanted worldwide during the past two years with good results and excellent safety profile.
The clinical trial is a phase-IV post-marketing FDA approved device study designed as open-label, randomised, parallel, and comparative. 128 patients at 8 sites are anticipated to be recruited according to the enrollment criteria, while randomisation will be assigned by a sealed envelope system after the patient has signed consent. Trabeculectomy is performed thereafter with either MMC or ologen CM applications as described in the protocol with postoperative parameters to be measured and analysed with non-parametric tests(Chi-square, Fisher's exact, Wilcoxon, and Mann-Whitney tests) as well as Kaplan-Meier survival models.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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ologen Collagen Matrix
When performing glaucoma surgery, a trabeculectomy, use ologen Collagen Matrix instead of MMC before closing the conjunctiva
Use of ologen Collagen Matrix in trabeculectomy (ologen)
Place ologen CM on the top of the loosely-sutured scleral flap under conjunctiva before suturing. It is recommended to suture the scleral flap with 1 or 2 stiches loosely for the convenience of future suture lysis and to coordinate with the tamponading effect of ologen CM to create a fluctuating scleral flap that prevents bleb wound adhesion and modulates aqueous humor outflow for ideal IOP control without leakage.
Mitomycin-C (MMC)
When performing glaucoma surgery, a trabeculectomy, use MMC as antifibrotic agent before closing the conjunctiva
Use of Mitomycin-C (MMC) in trabeculectomy
After outlining and creating a superficial scleral flap, a cellulose sponge soaked with MMC(0.4mg/mL) is applied for up to 3 mins according to physician's routine method of application. The area treated is copiously irrigated with balanced isotonic solution. Alternatively, 15mcg of MMC may be injected intra-Tenon's at the end of the procedure. Patients receiving mitomycin will be billed as per operating room practice.
Interventions
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Use of ologen Collagen Matrix in trabeculectomy (ologen)
Place ologen CM on the top of the loosely-sutured scleral flap under conjunctiva before suturing. It is recommended to suture the scleral flap with 1 or 2 stiches loosely for the convenience of future suture lysis and to coordinate with the tamponading effect of ologen CM to create a fluctuating scleral flap that prevents bleb wound adhesion and modulates aqueous humor outflow for ideal IOP control without leakage.
Use of Mitomycin-C (MMC) in trabeculectomy
After outlining and creating a superficial scleral flap, a cellulose sponge soaked with MMC(0.4mg/mL) is applied for up to 3 mins according to physician's routine method of application. The area treated is copiously irrigated with balanced isotonic solution. Alternatively, 15mcg of MMC may be injected intra-Tenon's at the end of the procedure. Patients receiving mitomycin will be billed as per operating room practice.
Eligibility Criteria
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Inclusion Criteria
* Uncontrolled treated glaucoma requiring trabeculectomy
* Subject must be able and willing to cooperate with investigation plan
* Subject must be able and willing to complete postoperative follow-up requirements
* subject must be willing to sign informed consent form
Exclusion Criteria
* Neovascular, uveitic, aphakic glaucoma, previous incisional glaucoma surgery
* Prior cataract unless clear corneal incision
* Previous conjunctival or strabismus surgery
* Participation in an investigational study during 30 days prior to trabeculectomy
* Ocular infection within 14 days prior to trabeculectomy
* Pregnant or breast-feeding women
30 Years
ALL
No
Sponsors
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The New York Eye & Ear Infirmary
OTHER
Robert Ritch, MD, LLC.
OTHER
Aeon Astron Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Ritch, MD
Role: PRINCIPAL_INVESTIGATOR
Robert Ritch, MD, LLC.
Steven Sarkisian, MD
Role: STUDY_DIRECTOR
Dean McGee Eye Institute
Robert Fechtner, MD
Role: STUDY_DIRECTOR
Institute of Ophthalmology and Visual Science
Michael Pro, MD
Role: STUDY_DIRECTOR
Wills Eye Institue
Steven Vold, MD
Role: STUDY_DIRECTOR
Boozman-Hof Eye Clinic
Angelo Tanna, MD
Role: STUDY_DIRECTOR
Northwestern Memorial Hospital
David Godfrey, MD
Role: STUDY_DIRECTOR
Glaucoma Associates of Texas
Paul Sidoti, MD
Role: STUDY_DIRECTOR
New York Eye and Ear Infirmiry
Locations
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VoldVision-Holf Eye Clinic
Rogers, Arkansas, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Institue of Ophthalmology and Visual Science
Newark, New Jersey, United States
Glaucoma Associates of New York
New York, New York, United States
New York Eye and Ear Infirmary
New York, New York, United States
Dean McGee Eye Institue
Oklahoma City, Oklahoma, United States
Wills Eye Institue
Philadelphia, Pennsylvania, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
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.
Tanna AP, Rademaker AW, de Moraes CG, Godfrey DG, Sarkisian SR Jr, Vold SD, Ritch R. Collagen matrix vs mitomycin-C in trabeculectomy and combined phacoemulsification and trabeculectomy: a randomized controlled trial. BMC Ophthalmol. 2016 Dec 29;16(1):217. doi: 10.1186/s12886-016-0393-z.
Other Identifiers
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AAE-CT-USA-2010-02
Identifier Type: -
Identifier Source: org_study_id