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

February 4, 2025 updated by: Implandata Ophthalmic Products GmbH

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

Intervention / Treatment

Detailed Description

(see above)

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 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).
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
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.
Assessed at visits Week 4, Week 16, Week 28 and Week 52, final status at Week 52 reported.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.]
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
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.
Assessed at visits from Day 1 through Week 52, final status at Week 52 reported.
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.
Assessed at visit Week 52, final status at Week 52 reported.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Implandata Ophthalmic Products GmbH

Investigators

  • Principal Investigator: Thomas Neuhann, Prof. MD, MVZ Prof. Neuhann

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGOS-KP01
  • CIV-14-09-012725 (Registry Identifier: EUDAMED)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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