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

Primary Purpose

Glaucoma, Cataract, Wound Heal

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ologen
Phacotrabeculectomy
Mitomycin C
Sponsored by
Medical University of Lublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ologen (OLO)

    Mitomycin C (MMC)

    Arm Description

    Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy

    Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure)

    Outcomes

    Primary Outcome Measures

    Mean intraocular pressure (IOP) after the surgery
    Decrease in IOP before and after the surgery

    Secondary Outcome Measures

    Mean best corrected visual acuity (BCVA) (LogMAR)
    Increase in best corrected visual acuity (BCVA) (LogMAR) before and after the surgery
    Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System)
    To compare filtrating blebs in two arms of the study
    Mean number of antiglaucoma medications
    To compare the number of antiglaucoma medications in two arms of the study

    Full Information

    First Posted
    April 14, 2018
    Last Updated
    April 23, 2018
    Sponsor
    Medical University of Lublin
    Collaborators
    Aeon Astron Europe B.V.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03506542
    Brief Title
    Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C
    Official Title
    Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C Augmented Phacotrabeculectomy: Clinical Results of a Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2, 2014 (Actual)
    Primary Completion Date
    March 1, 2016 (Actual)
    Study Completion Date
    March 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Lublin
    Collaborators
    Aeon Astron Europe B.V.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    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. 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. 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Cataract, Wound Heal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients are randomized and have phacotrabeculectomy augmented with either OLO (Ologen) or MMC (Mitomycin C).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    53 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ologen (OLO)
    Arm Type
    Experimental
    Arm Description
    Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy
    Arm Title
    Mitomycin C (MMC)
    Arm Type
    Active Comparator
    Arm Description
    Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure)
    Intervention Type
    Device
    Intervention Name(s)
    Ologen
    Other Intervention Name(s)
    OLO
    Intervention Description
    Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C
    Intervention Type
    Procedure
    Intervention Name(s)
    Phacotrabeculectomy
    Other Intervention Name(s)
    surgery
    Intervention Description
    Trabeculectomy with cataract extraction
    Intervention Type
    Drug
    Intervention Name(s)
    Mitomycin C
    Other Intervention Name(s)
    MMC
    Intervention Description
    Mitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure)
    Primary Outcome Measure Information:
    Title
    Mean intraocular pressure (IOP) after the surgery
    Description
    Decrease in IOP before and after the surgery
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Mean best corrected visual acuity (BCVA) (LogMAR)
    Description
    Increase in best corrected visual acuity (BCVA) (LogMAR) before and after the surgery
    Time Frame
    12 months
    Title
    Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System)
    Description
    To compare filtrating blebs in two arms of the study
    Time Frame
    12 months
    Title
    Mean number of antiglaucoma medications
    Description
    To compare the number of antiglaucoma medications in two arms of the study
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tomasz Żarnowski, MD PhD Prof
    Organizational Affiliation
    Ophthalmology Clinic, Medical University in Lublin, Poland
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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