Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C
NCT ID: NCT03506542
Last Updated: 2018-04-25
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
PHASE2
53 participants
INTERVENTIONAL
2014-06-02
2017-03-30
Brief Summary
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2. Study Design: The study is designed as a prospective randomized trial. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study.
3. Follow-Up: This investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.
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Detailed Description
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* Patients with cataract and:
primary open angle glaucoma (POAG) pseudoexfoliation (PEX) glaucoma (PEXG)
* Phacotrabeculectomy augmented with OLO or MMC
* Follow-up - 12 months
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ologen (OLO)
Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy
Ologen
Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C
Phacotrabeculectomy
Trabeculectomy with cataract extraction
Mitomycin C (MMC)
Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure)
Phacotrabeculectomy
Trabeculectomy with cataract extraction
Mitomycin C
Mitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure)
Interventions
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Ologen
Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C
Phacotrabeculectomy
Trabeculectomy with cataract extraction
Mitomycin C
Mitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary open angle glaucoma or pseudoexfoliation glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication
Exclusion Criteria
* Previous ocular surgery
* Pregnant and breastfeeding women
* Angle closure glaucoma
* Secondary glaucoma except pseudoexfoliation glaucoma
* Ocular diseases with excessive scarring
* Allergy to collagen or Mitomycin C
18 Years
ALL
Yes
Sponsors
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Aeon Astron Europe B.V.
INDUSTRY
Medical University of Lublin
OTHER
Responsible Party
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Aleksandra Wlaz
PhD, ophthalmologist in Department of Diagnostics and Microsurgery of Glaucoma
Principal Investigators
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Tomasz Żarnowski, MD PhD Prof
Role: STUDY_CHAIR
Ophthalmology Clinic, Medical University in Lublin, Poland
Other Identifiers
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not required
Identifier Type: -
Identifier Source: org_study_id
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