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

Not Applicable

Completed

Conditions: Stevens-Johnson Syndrome
Congenital Glaucoma
Congenital Aniridia
Graft vs Host Disease
Chemical Burns

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
ARGOS-IO system	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

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE)	Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.	Number of patients experiencing a device-related SAE (SADE).
Performance: Performance of the ARGOS-IO System Compared to Manometry	Assessed at visits Week 4, Week 16, Week 28 and Week 52, final status at Week 52 reported.	Consistency between manometric and telemetric IOP obtained by the ARGOS-IO system.

Secondary Outcome Measures

Name	Time	Method
Performance: Correlation Between Finger Palpation and the ARGOS-IO System	Assessed at visits from Day 1 through Week 52, final status at Week 52 reported.	Correlation between IOP estimation obtained by finger palpation and the telemetric IOP by the ARGOS-IO system.
Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.	Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.	Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events ("Frequency of Adverse Events"). \[Note that patients indicated for a BKPro surgery generally suffer from severe corneal disorders, reflected by the large number of AEs observed in this patient population.\]
Usability: User Acceptance at Home	Assessed at visit Week 52, final status at Week 52 reported.	User acceptance of the ARGOS-IO system at home by means of evaluation of patient questionnaires on a score on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). The score 7 represents a greater user acceptance.