Clinical Trial: Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Prospective Open-label, Multicenter Clinical Investigation to Assess the Safety and Performance of ARGOS-IO System in Patients Undergoing Implantation of a Boston Keratoprosthesis (BKPro)

Brief Summary:

The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely. It is intended to be used together with the hand-held Mesograph reading device to telemetrically measure the intraocular pressure (IOP) of patients with a BKPro.

The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients undergoing concomitant implantation of a BKPro and an ARGOS-IO sensor over the 12 month period beginning at implantation.


Detailed Summary:
Sponsor: Implandata Ophthalmic Products GmbH

Current Primary Outcome:

  • Safety of the ARGOS-IO pressure sensor in the first 12 months following implantation [ Time Frame: 12 months ]

    Number of subjects experiencing at any time during the first 12 months a device related serious adverse event (SAE) defined as any adverse event that both:

    is considered by the investigator to have a possible, probable or definite relationship to the device

    AND that leads to any following

    • death
    • a serious deterioration in the health of the subject that results in a life-threatening illness or injury or a permanent impairment of a body structure or function, or that requires medical/surgical intervention to prevent such
    • hospitalization or prolongation of existing hospitalization
    • fetal distress or death or a congenital abnormality or birth defect.
  • Tolerability of the ARGOS-IO pressure sensor in the first 12 months following implantation [ Time Frame: 12 months ]

    Number of subjects experiencing at any time during the first 12 months a device related SAE defined as any adverse event that both:

    is considered by the investigator to have a possible, probable or definite relationship to the device

    AND that leads to any following

    • death
    • Same as current

      Current Secondary Outcome:

      • Safety of the ARGOS-IO pressure sensor use in the first 4, 16 and 28 weeks and 12 months following implantation [ Time Frame: 4, 16 and 28 weeks and 12 months following implantation ]
        Incidence, nature, seriousness, severity and duration of adverse events and adverse device events in the first 4, 16 and 28 weeks and 12 months following implantation of the ARGOS-IO pressure sensor.
      • Tolerability of the ARGOS-IO pressure sensor use in the first 4, 16 and 28 weeks and 12 months following implantation [ Time Frame: 4, 16 and 28 weeks and 12 months following implantation ]
        Incidence, nature, seriousness, severity and duration of adverse events and adverse device events in the first 4, 16 and 28 weeks and 12 months following implantation of the ARGOS-IO pressure sensor.
      • Level of agreement between IOP measurements made using surgical manometry (mmHg) and the ARGOS-IO system (mmHg) at 4, 16, 28 and 52 weeks following implantation [ Time Frame: 4, 16, 28 and 52 weeks following implantation ]
      • User acceptance of the implantation procedure by means of evaluation of the implantation procedure questionnaire (investigators) [ Time Frame: 4, 16, 28 and 52 weeks following implantation ]
      • User acceptance of the ARGOS-IO system at the investigational site by means of evaluation of the investigator acceptance questionnaire (investigators) [ Time Frame: 4, 16, 28 and 52 weeks following implantation ]
      • Daily IOP self-measurement profiles (subjects) [ Time Frame: 4, 16, 28 and 52 weeks following implantation ]


      Original Secondary Outcome: Same as current

      Information By: Implandata Ophthalmic Products GmbH

      Dates:
      Date Received: September 7, 2016
      Date Started: March 2015
      Date Completion: June 2017
      Last Updated: October 24, 2016
      Last Verified: October 2016