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)
Verified date | August 2017 |
Source | Implandata Ophthalmic Products GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Zentrum für Augenheilkunde der Universität zu Köln | Cologne | |
Germany | MVZ Prof. Neuhann | Munich |
Lead Sponsor | Collaborator |
---|---|
Implandata Ophthalmic Products GmbH |
Germany,
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 |
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