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Trial record 10 of 23 for:    ologen

Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03506542
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
Aeon Astron Europe B.V.
Information provided by (Responsible Party):
Aleksandra Wlaz, Medical University of Lublin

Brief Summary:
  1. Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy.
  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.

Condition or disease Intervention/treatment Phase
Glaucoma Cataract Wound Heal Device: Ologen Procedure: Phacotrabeculectomy Drug: Mitomycin C Phase 2

Detailed Description:
  • Prospective randomized comparative study
  • Patients with cataract and:

primary open angle glaucoma (POAG) pseudoexfoliation (PEX) glaucoma (PEXG)

  • Phacotrabeculectomy augmented with OLO or MMC
  • Follow-up - 12 months

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized and have phacotrabeculectomy augmented with either OLO (Ologen) or MMC (Mitomycin C).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C Augmented Phacotrabeculectomy: Clinical Results of a Prospective Randomized Trial
Actual Study Start Date : June 2, 2014
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : March 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ologen (OLO)
Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy
Device: Ologen
Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C
Other Name: OLO

Procedure: Phacotrabeculectomy
Trabeculectomy with cataract extraction
Other Name: surgery

Active Comparator: Mitomycin C (MMC)
Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure)
Procedure: Phacotrabeculectomy
Trabeculectomy with cataract extraction
Other Name: surgery

Drug: Mitomycin C
Mitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure)
Other Name: MMC




Primary Outcome Measures :
  1. Mean intraocular pressure (IOP) after the surgery [ Time Frame: 12 months ]
    Decrease in IOP before and after the surgery


Secondary Outcome Measures :
  1. Mean best corrected visual acuity (BCVA) (LogMAR) [ Time Frame: 12 months ]
    Increase in best corrected visual acuity (BCVA) (LogMAR) before and after the surgery

  2. Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System) [ Time Frame: 12 months ]
    To compare filtrating blebs in two arms of the study

  3. Mean number of antiglaucoma medications [ Time Frame: 12 months ]
    To compare the number of antiglaucoma medications in two arms of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cataract
  • Primary open angle glaucoma or pseudoexfoliation glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication

Exclusion Criteria:

  • Difficulty in reading or speaking Polish
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506542


Sponsors and Collaborators
Medical University of Lublin
Aeon Astron Europe B.V.
Investigators
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Study Chair: Tomasz Żarnowski, MD PhD Prof Ophthalmology Clinic, Medical University in Lublin, Poland

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Responsible Party: Aleksandra Wlaz, PhD, ophthalmologist in Department of Diagnostics and Microsurgery of Glaucoma, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03506542     History of Changes
Other Study ID Numbers: not required
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors