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

Graft vs Host Disease Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945176
• Other study ID #: ARGOS-KP01
• Secondary ID: CIV-14-09-012725
• Status: Completed
• Phase: N/A
• First received: September 7, 2016
• Last updated: August 15, 2017
• Start date: March 2015
• Est. completion date: June 14, 2017

Study information

• Verified date: August 2017
• Source: Implandata Ophthalmic Products GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 14, 2017
• Est. primary completion date: June 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Germany	Zentrum für Augenheilkunde der Universität zu Köln	Cologne
Germany	MVZ Prof. Neuhann	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Implandata Ophthalmic Products GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the ARGOS-IO pressure sensor in the first 12 months following implantation	Number of subjects experiencing at any time during the first 12 months a device related serious adverse event (SAE) defined as any adverse event that both: is considered by the investigator to have a possible, probable or definite relationship to the device; AND that leads to any following; death; a serious deterioration in the health of the subject that results in a life-threatening illness or injury or a permanent impairment of a body structure or function, or that requires medical/surgical intervention to prevent such; hospitalization or prolongation of existing hospitalization; fetal distress or death or a congenital abnormality or birth defect.	12 months
Primary	Tolerability of the ARGOS-IO pressure sensor in the first 12 months following implantation	Number of subjects experiencing at any time during the first 12 months a device related SAE defined as any adverse event that both: is considered by the investigator to have a possible, probable or definite relationship to the device; AND that leads to any following; death; a serious deterioration in the health of the subject that results in a life-threatening illness or injury or a permanent impairment of a body structure or function, or that requires medical/surgical intervention to prevent such; hospitalization or prolongation of existing hospitalization; fetal distress or death or a congenital abnormality or birth defect.	12 months
Primary	Performance of the ARGOS-IO system compared to manometry in the first 12 months following implantation	Level of agreement between IOP measurements made using manometry (mmHg) and the ARGOS-IO system (mmHg) over the first 12 months following implantation	12 months
Secondary	Safety of the ARGOS-IO pressure sensor use in the first 4, 16 and 28 weeks and 12 months following implantation	Incidence, nature, seriousness, severity and duration of adverse events and adverse device events in the first 4, 16 and 28 weeks and 12 months following implantation of the ARGOS-IO pressure sensor.	4, 16 and 28 weeks and 12 months following implantation
Secondary	Tolerability of the ARGOS-IO pressure sensor use in the first 4, 16 and 28 weeks and 12 months following implantation	Incidence, nature, seriousness, severity and duration of adverse events and adverse device events in the first 4, 16 and 28 weeks and 12 months following implantation of the ARGOS-IO pressure sensor.	4, 16 and 28 weeks and 12 months following implantation
Secondary	Level of agreement between IOP measurements made using surgical manometry (mmHg) and the ARGOS-IO system (mmHg) at 4, 16, 28 and 52 weeks following implantation		4, 16, 28 and 52 weeks following implantation
Secondary	User acceptance of the implantation procedure by means of evaluation of the implantation procedure questionnaire (investigators)		4, 16, 28 and 52 weeks following implantation
Secondary	User acceptance of the ARGOS-IO system at the investigational site by means of evaluation of the investigator acceptance questionnaire (investigators)		4, 16, 28 and 52 weeks following implantation
Secondary	Daily IOP self-measurement profiles (subjects)		4, 16, 28 and 52 weeks following implantation