Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||A Prospective, Open-label, Multicenter Clinical Investigation to Assess the Safety and Performance of the ARGOS-IO System in Patients With Primary Open Angle Glaucoma (POAG)|
- Safety [ Time Frame: 12 months ]
Number of patients experiencing 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 meets any of the following criteria of a serious adverse event:
- Resulted in death, permanent damage or disability or a congenital anomaly
- Was life threatening
- Required hospitalization or intervention to prevent permanent impairment or damage
- Incidence of adverse events [ Time Frame: 12 months ]Incidence of observed adverse events and adverse device events during a period between 3 months and 12 months following implantation.
- Severity of adverse events [ Time Frame: 12 months ]Severity of observed adverse events and adverse device events during a period between 3 months and 12 months following implantation.
- Performance [ Time Frame: 12 months ]Limits of agreement between measurements made using GAT and the ARGOS-IO system from V05 (day 30) through V11 (day 360)
|Study Start Date:||May 2014|
|Study Completion Date:||April 11, 2017|
|Primary Completion Date:||April 11, 2017 (Final data collection date for primary outcome measure)|
Experimental: Single-arm intervention ARGOS-IO system
The ARGOS-IO Pressure sensor will be additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery.
Device: ARGOS-IO system
Implantation of ARGOS-IO pressure sensor after cataract surgery on day 0 (V01)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02434692
|Augenklinik Universitätsklinikum Aachen|
|Aachen, Germany, 52074|
|Ahaus, Germany, 48683|
|Bochum, Germany, 44892|
|Internationale Innovative Ophthalmochirurgie Breyer-Kaymak-Klabe|
|Düsseldorf, Germany, 40212|
|Augenklinik der SLK-Kliniken|
|Heilbronn, Germany, 74078|
|nordBLICK Augenklinik Bellevue|
|Kiel, Germany, 24105|
|Magdeburg, Germany, 39120|
|Augenärztliches Augenchirurgisches Zentrum (AAZ)|
|Nürnberg, Germany, 90403|
|Klinik und Poliklinik für Augenheilkunde der Universität Rostock|
|Rostock, Germany, 18057|
|Knappschaftsklinikum Saar - Augenklinik|
|Sulzbach, Germany, 66280|
|Tübingen, Germany, 72076|
|Principal Investigator:||Hagen Thieme, Prof.||University Eye Clinic Magdeburg, Germany|