Primary Open Angle Glaucoma (POAG) Clinical Trial
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)
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.
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