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

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: NCT02945176
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Implandata Ophthalmic Products GmbH

Tracking Information
First Submitted Date  ICMJE September 7, 2016
First Posted Date  ICMJE October 26, 2016
Last Update Posted Date August 18, 2017
Study Start Date  ICMJE March 2015
Actual Primary Completion Date June 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • 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
    • 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.
  • Performance of the ARGOS-IO system compared to manometry in the first 12 months following implantation [ Time Frame: 12 months ]
    Level of agreement between IOP measurements made using manometry (mmHg) and the ARGOS-IO system (mmHg) over the first 12 months following implantation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02945176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Graft vs Host Disease
  • Congenital Aniridia
  • Chemical Burns
  • Stevens-Johnson Syndrome
  • Congenital Glaucoma
Intervention  ICMJE Device: ARGOS-IO system
This study will enroll a minimum of 10 and a maximum of 15 patients. It is anticipated to be large enough to provide an initial estimate of common safety events and assessment of performance. Any adverse event (AE), serious adverse event (SAE), ADE (adverse device event) and SADE (serious adverse device event) will be listed. Incidence will be estimated with a 95% confidence interval (Pearson-Clopper, two-sided). The Bland-Altman method will be used to assess the limits of agreement between the IOP measurements ARGOS-IO and surgical manometry. When appropriate, two-sided 95% confidence intervals, for these limits will be calculated accounting for repeated measurements based on the method proposed by Zou (2011). Other secondary performance endpoints will be analyzed by descriptive and explorative statistical methods.
Other Name: ARGOS-IO pressure sensor implant
Study Arms  ICMJE Experimental: ARGOS-IO system

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

Intervention: Device: ARGOS-IO system
Publications * Enders P, Hall J, Bornhauser M, Mansouri K, Altay L, Schrader S, Dietlein TS, Bachmann BO, Neuhann T, Cursiefen C. Telemetric Intraocular Pressure Monitoring after Boston Keratoprosthesis surgery with the Eyemate-IO Sensor: Dynamics in the first year. Am J Ophthalmol. 2019 Mar 5. pii: S0002-9394(19)30084-4. doi: 10.1016/j.ajo.2019.02.025. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2016)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 14, 2017
Actual Primary Completion Date June 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02945176
Other Study ID Numbers  ICMJE ARGOS-KP01
CIV-14-09-012725 ( Registry Identifier: EUDAMED )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Implandata Ophthalmic Products GmbH
Study Sponsor  ICMJE Implandata Ophthalmic Products GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Neuhann, Prof. MD MVZ Prof. Neuhann
PRS Account Implandata Ophthalmic Products GmbH
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP