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

NCT02945176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-02-27

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Implandata Ophthalmic Products GmbH

    lead INDUSTRY

Principal Investigators

  • Thomas Neuhann, Prof. MD · MVZ Prof. Neuhann

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-06-14
Completion
2017-06-14

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02945176 on ClinicalTrials.gov