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

NCT ID: NCT02945176

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-06-14

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.

Detailed Description

(see above)

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ARGOS-IO system

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ARGOS-IO pressure sensor implant

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Implandata Ophthalmic Products GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Neuhann, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

MVZ Prof. Neuhann

Locations

Zentrum für Augenheilkunde der Universität zu Köln

Cologne, , Germany

MVZ Prof. Neuhann

Munich, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://doi.org/10.1016/j.ajo.2019.02.025

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

Other Identifiers

CIV-14-09-012725

Identifier Type: REGISTRY

Identifier Source: secondary_id

ARGOS-KP01

Identifier Type: -

Identifier Source: org_study_id