Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesi… (NCT02945176) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
Germany13 participantsStarted 2015-03
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE)
Timeframe: Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.
2
Performance: Performance of the ARGOS-IO System Compared to Manometry
Timeframe: Assessed at visits Week 4, Week 16, Week 28 and Week 52, final status at Week 52 reported.