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

Implandata Ophthalmic Products GmbH13 enrolled

Overview

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.

(see above)

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Interventions

ARGOS-IO systemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE)

Number of patients experiencing a device-related SAE (SADE).

Time frame: Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.

Performance: Performance of the ARGOS-IO System Compared to Manometry

Consistency between manometric and telemetric IOP obtained by the ARGOS-IO system.

Time frame: Assessed at visits Week 4, Week 16, Week 28 and Week 52, final status at Week 52 reported.

Secondary Outcomes

Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.

Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events ("Frequency of Adverse Events"). \[Note that patients indicated for a BKPro surgery generally suffer from severe corneal disorders, reflected by the large number of AEs observed in this patient population.\]

Time frame: Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.

Performance: Correlation Between Finger Palpation and the ARGOS-IO System

Correlation between IOP estimation obtained by finger palpation and the telemetric IOP by the ARGOS-IO system.

Time frame: Assessed at visits from Day 1 through Week 52, final status at Week 52 reported.

Usability: User Acceptance at Home

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.

Time frame: Assessed at visit Week 52, final status at Week 52 reported.