The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients with POAG and indicated cataract surgery.
This prospective, open-label, multi center, single-arm clinical investigation will enroll 22 consecutive patients. Enrollment will be temporarily halted in case a serious adverse device effect (SADE) occurs, and Data and Safety Monitoring Board (DSMB) meeting will be conducted as soon as possible. The DSMB will then recommend whether to further continue the study as planned, or whether enrollment shall be stopped. In order to provide a complete overview of the study to the DSMB, an interim analysis will be performed after half of the study population (11-14 subjects) is enrolled with a minimum follow-up of 1 month. A conclusion for safety will be made if in total no more than 2 of the total of 22 patients experience a SADE. The primary aim of this study is to show "safety", which will be evaluated based on the percentage of subjects who experience a SADE (="non-safety"), as defined in the primary endpoints. The study will be declared a success if the final non-safety event rate is less than 6% (type II error rate of 0.20). The calculation is based on a design optimizing the minimum expected sample size with parameters alpha=0.05, beta=0.20, p0=0.75, p1=0.94.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
24
Implantation of ARGOS-IO pressure sensor after IOL placement within the cataract surgical procedure on day 0 (V01)
Augenklinik Universitätsklinikum Aachen
Aachen, Germany
Augen-Zentrum-Nordwest
Ahaus, Germany
Universitäts-Augenklinik Bochum
Bochum, Germany
Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation
Number of patients experiencing a device related SAE (SADE) and complications during the implantation of the ARGOS-IO device.
Time frame: Day 0 to Day 360 (V01 [Implantation] to V11)
Performance: Intraclass Correlation Between Intraocular Pressure (IOP) Measurements by GAT and the ARGOS-IO System
Intraclass correlation between intraocular pressure (IOP) measurements made by GAT and the ARGOS-IO system (IOP in mmHg; starting at visit V05 as specified by the protocol) following the ICC(3,k) concordance analysis method \[Choritz et al., 2019 (Telemetric Measurement of … ARGOS-02 Trial) in the "References"-section\].
Time frame: Day 30 to Day 360 (V05 to V11)
Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
Time frame: Day 0 to Day 360 (V01 [Implantation] to V11)
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Internationale Innovative Ophthalmochirurgie Breyer-Kaymak-Klabe
Düsseldorf, Germany
Augenklinik der SLK-Kliniken
Heilbronn, Germany
nordBLICK Augenklinik Bellevue
Kiel, Germany
Universitätsaugenklinik Magdeburg
Magdeburg, Germany
Augenärztliches Augenchirurgisches Zentrum (AAZ)
Nuremberg, Germany
Klinik und Poliklinik für Augenheilkunde der Universität Rostock
Rostock, Germany
Knappschaftsklinikum Saar - Augenklinik
Sulzbach, Germany
...and 1 more locations