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

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)

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 Overview

• Status: Completed
• Conditions: Congenital Glaucoma; Stevens-Johnson Syndrome; Graft vs Host Disease; Congenital Aniridia; Chemical Burns
• Intervention / Treatment: Device: ARGOS-IO system

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50924
    • Zentrum für Augenheilkunde der Universität zu Köln
  • Munich, Germany, 80637
    • MVZ Prof. Neuhann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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 Names: ARGOS-IO pressure sensor implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4, 16 and 28 weeks and 12 months following implantation
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.	4, 16 and 28 weeks and 12 months following implantation
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		4, 16, 28 and 52 weeks following implantation
User acceptance of the implantation procedure by means of evaluation of the implantation procedure questionnaire (investigators)		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)		4, 16, 28 and 52 weeks following implantation
Daily IOP self-measurement profiles (subjects)		4, 16, 28 and 52 weeks following implantation

Collaborators and Investigators

• Sponsor: Implandata Ophthalmic Products GmbH
• Investigators: Principal Investigator: Thomas Neuhann, Prof. MD, MVZ Prof. Neuhann

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ACTUAL): June 14, 2017
• Study Completion (ACTUAL): June 14, 2017

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (ESTIMATE): October 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Boston Keratoprosthesis
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Skin Diseases; Immune System Diseases; Eye Diseases; Wounds and Injuries; Congenital Abnormalities; Ocular Hypertension; Eye Abnormalities; Glaucoma, Open-Angle; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Uveal Diseases; Hypersensitivity; Eye Diseases, Hereditary; Erythema; Skin Diseases, Vesiculobullous; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Stomatitis; Drug Eruptions; Erythema Multiforme; Drug Hypersensitivity; Glaucoma; Burns; Iris Diseases; Hydrophthalmos; Stevens-Johnson Syndrome; Graft vs Host Disease; Aniridia; Burns, Chemical
• Other Study ID Numbers: ARGOS-KP01; CIV-14-09-012725 (REGISTRY: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED