N/A
N=12
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
Graft vs Host Disease · Congenital Aniridia · Chemical Burns · Stevens-Johnson Syndrome · Congenital Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT02945176 ↗Enrolled (actual)
12
Serious AEs
69.2%
Results posted
Feb 2025
Primary outcome: Primary: Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE) — 13; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ARGOS-IO system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Implandata Ophthalmic Products GmbH
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE) |
13; 0 | — |
| PRIMARY Performance: Performance of the ARGOS-IO System Compared to Manometry |
9; 14 | — |
| SECONDARY Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs. |
168; 116; 92; 61; 15 | — |
| SECONDARY Performance: Correlation Between Finger Palpation and the ARGOS-IO System |
18.2; 8.9; 22.4; 34.3 | — |
| SECONDARY Usability: User Acceptance at Home |
5.9 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02945176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.