Skip to main content
OpenTrials
Completed

NCT Number: NCT02945176

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Graft vs Host Disease Aniridia Burns Burns, Chemical Chemical Burns Chemically-Induced Disorders Congenital Abnormalities Congenital Aniridia Congenital Glaucoma Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Drug Eruptions Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Erythema Erythema Multiforme Eye Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Glaucoma Glaucoma, Open-Angle Hydrophthalmos Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Infant, Newborn, Diseases Iris Diseases Mouth Diseases Ocular Hypertension Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases Stevens-Johnson Syndrome Stomatitis Stomatognathic Diseases Uveal Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zentrum für Augenheilkunde der Universität zu Köln, Cologne, Germany

Loading trial locations.

About this study

(see above)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARGOS-IO system

Device

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

Primary outcomes

  1. Safety and Tolerability: 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.

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

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

    Time frame: 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 outcomes

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

    Time frame: 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.]

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

    Time frame: 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.

  3. Usability: User Acceptance at Home

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Implandata Ophthalmic Products GmbH

Industry

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 26, 2016
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.