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

NCT02945176 | Completed Results DMC

• 2 other identifiers: ARGOS-KP01CIV-14-09-012725
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Boston Keratoprosthesis

Outcome Measures

Primary Outcomes (2)

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

  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

  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 Outcomes (3)

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

  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

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

• Usability: User Acceptance at Home

  Assessed at visit Week 52, final status at Week 52 reported.

Study Arms (1)

ARGOS-IO system

EXPERIMENTAL

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

Interventions

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.

Also known as: ARGOS-IO pressure sensor implant

ARGOS-IO system

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Implandata Ophthalmic Products GmbH: lead

Study Sites (2)

Zentrum für Augenheilkunde der Universität zu Köln

Cologne, 50924, Germany

Location

MVZ Prof. Neuhann

Munich, 80637, Germany

Location

Related Links

• Telemetric Intraocular Pressure Monitoring after Boston Keratoprosthesis Surgery Using the Eyemate-IO Sensor: Dynamics in the First Year

MeSH Terms

Conditions

Graft vs Host Disease; Aniridia; Burns, Chemical; Stevens-Johnson Syndrome; Hydrophthalmos

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Study Manager
• Organization: Implandata Ophthalmic Products

clinical@implandata.com

+49 (0) 511 - 2204 2580

Study Officials

• Thomas Neuhann, Prof. MD

  MVZ Prof. Neuhann

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: October 26, 2016
• Study Start: March 1, 2015
• Primary Completion: June 14, 2017
• Study Completion: June 14, 2017
• Last Updated: February 27, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)