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

Primary Purpose

Graft vs Host Disease, Congenital Aniridia, Chemical Burns

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ARGOS-IO system
Sponsored by
Implandata Ophthalmic Products GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Graft vs Host Disease focused on measuring Boston Keratoprosthesis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zentrum für Augenheilkunde der Universität zu Köln
  • MVZ Prof. Neuhann

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARGOS-IO system

Arm 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

Outcomes

Primary Outcome Measures

Safety of the ARGOS-IO pressure sensor in the first 12 months following implantation
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
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
Level of agreement between IOP measurements made using manometry (mmHg) and the ARGOS-IO system (mmHg) over the first 12 months following implantation

Secondary Outcome Measures

Safety of the ARGOS-IO pressure sensor use in the first 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
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
User acceptance of the implantation procedure by means of evaluation of the implantation procedure questionnaire (investigators)
User acceptance of the ARGOS-IO system at the investigational site by means of evaluation of the investigator acceptance questionnaire (investigators)
Daily IOP self-measurement profiles (subjects)

Full Information

First Posted
September 7, 2016
Last Updated
August 15, 2017
Sponsor
Implandata Ophthalmic Products GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02945176
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 14, 2017 (Actual)
Study Completion Date
June 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Implandata Ophthalmic Products GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome, Congenital Glaucoma
Keywords
Boston Keratoprosthesis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARGOS-IO system
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
ARGOS-IO system
Other Intervention Name(s)
ARGOS-IO pressure sensor implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of the ARGOS-IO pressure sensor in the first 12 months following implantation
Description
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.
Time Frame
12 months
Title
Tolerability of the ARGOS-IO pressure sensor in the first 12 months following implantation
Description
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.
Time Frame
12 months
Title
Performance of the ARGOS-IO system compared to manometry in the first 12 months following implantation
Description
Level of agreement between IOP measurements made using manometry (mmHg) and the ARGOS-IO system (mmHg) over the first 12 months following implantation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Safety of the ARGOS-IO pressure sensor use in the first 4, 16 and 28 weeks and 12 months following implantation
Description
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.
Time Frame
4, 16 and 28 weeks and 12 months following implantation
Title
Tolerability of the ARGOS-IO pressure sensor use in the first 4, 16 and 28 weeks and 12 months following implantation
Description
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.
Time Frame
4, 16 and 28 weeks and 12 months following implantation
Title
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
Title
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
Title
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
Title
Daily IOP self-measurement profiles (subjects)
Time Frame
4, 16, 28 and 52 weeks following implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged ≥ 18 and ≤ 80 years on the day of screening 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. Axial length > 21 mm Ability and willingness to attend all scheduled visits and comply with all study procedures Exclusion Criteria: Reasonable chance of success with traditional keratoplasty Current retinal detachment Connective tissue diseases 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 History of ocular or periocular malignancy History of extensive keloid formation Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or silicone (component of the device) Presence of another active medical eye implant and/or other active medical implants in the head/neck region Signs of current infection, including fever and current treatment with antibiotics Severe generalized disease that results in a life expectancy shorter than a year Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device Currently pregnant or breastfeeding 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 Intraoperative complication that would preclude implantation of the study device 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Neuhann, Prof. MD
Organizational Affiliation
MVZ Prof. Neuhann
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zentrum für Augenheilkunde der Universität zu Köln
City
Cologne
ZIP/Postal Code
50924
Country
Germany
Facility Name
MVZ Prof. Neuhann
City
Munich
ZIP/Postal Code
80637
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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