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

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Brief Title

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

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.
    



Study Type

Interventional


Primary Outcome

Safety of the ARGOS-IO pressure sensor in the first 12 months following implantation

Secondary Outcome

 Safety of the ARGOS-IO pressure sensor use in the first 4, 16 and 28 weeks and 12 months following implantation

Condition

Graft vs Host Disease

Intervention

ARGOS-IO system

Study Arms / Comparison Groups

 ARGOS-IO system
Description:  The ARGOS-IO system is a non-European Community (CE) marked investigational medical device composed of the implant and its accessories.
Implant: ARGOS-IO pressure sensor implant for sulcus placement or transcleral fixation
Accessories: MESOGRAPH reading device, Implant Injector

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

12

Start Date

March 2015

Completion Date

June 14, 2017

Primary Completion Date

June 14, 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female aged ≥ 18 and ≤ 80 years on the day of screening

          2. Keratoprosthesis surgery indicated, defined as having a severely opaque and
             vascularized cornea AND either a verifiable history of two or more prior failed
             corneal transplant procedures or a medical condition such as alkali burns or
             autoimmune disease that makes the success of a traditional corneal transplant
             procedure unlikely. Potential study subjects will be solicited for participation in
             the clinical trial only after they have consented to the keratoprosthesis operation.

          3. Axial length > 21 mm

          4. Ability and willingness to attend all scheduled visits and comply with all study
             procedures

        Exclusion Criteria:

          1. Reasonable chance of success with traditional keratoplasty

          2. Current retinal detachment

          3. Connective tissue diseases

          4. History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis,
             scleritis) in one or both eyes within 6 months prior to ARGOS-IO implantation

          5. History of ocular or periocular malignancy

          6. History of extensive keloid formation

          7. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or
             silicone (component of the device)

          8. Presence of another active medical eye implant and/or other active medical implants in
             the head/neck region

          9. Signs of current infection, including fever and current treatment with antibiotics

         10. Severe generalized disease that results in a life expectancy shorter than a year

         11. Any clinical evidence that the investigator feels would place the subject at increased
             risk with the placement of the device

         12. Currently pregnant or breastfeeding

         13. Participation in any study involving an investigational drug or device within the past
             30 days or ongoing participation in a study with an investigational drug or device

         14. Intraoperative complication that would preclude implantation of the study device

         15. Subject and/or an immediate family member is an employee of the investigational site
             directly affiliated with this study, the sponsor or the contract research
             organization.

        Previous or concurrent enrollment of the contralateral eye in this clinical study.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Thomas Neuhann, Prof. MD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT02945176

Organization ID

ARGOS-KP01

Secondary IDs

CIV-14-09-012725

Responsible Party

Sponsor

Study Sponsor

Implandata Ophthalmic Products GmbH


Study Sponsor

Thomas Neuhann, Prof. MD, Principal Investigator, MVZ Prof. Neuhann


Verification Date

August 2017