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Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03651336
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : July 12, 2022
Sponsor:
Information provided by (Responsible Party):
Implandata Ophthalmic Products GmbH

Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE August 29, 2018
Last Update Posted Date July 12, 2022
Actual Study Start Date  ICMJE August 15, 2018
Actual Primary Completion Date April 27, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • Safety measured by Incidence of medical-device related adverse events and serious adverse events [ Time Frame: 3 years ]
    The primary objective of this clinical trial is to evaluate the long-term safety and tolerability of the ARGOS-IO pressure sensor under consideration of incidence, nature, severity and seriousness of observed medical device related adverse and serious adverse events.An AE is considered to be device-related if there is at least a possible relationship to the medical device according to the rating of the investigator.
  • Limits of agreement between IOP measurements made using GAT and the ARGOS-IO system at each study visit. [ Time Frame: 3 years ]
    IOP measured in mmHg
  • Limits of agreement between IOP measurements made using DCT and the ARGOS-IO system at each study visit. [ Time Frame: 3 Years ]
    IOP measured in mmHg
  • Incidence of observed device malfunctions and nature of device malfunction [ Time Frame: 3 years ]
    A device malfunction is e.g. difference of more than 5 mmHg between ARGOS-IO and GAT, readout error of the Mesograph because of measurements outside -2 and +70mmHG.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • Patient's compliance in IOP self-monitoring [ Time Frame: 3 years ]
    Daily self-measurements with the ARGOS-IO sensor should be done at least 4 times daily (morning, noon, afternoon, evening)
  • Impact of IOP self-monitoring on glaucoma progression [ Time Frame: 3 years ]
    Visual field (db), cup/disc ratio, OCT of the optic nerve (µm) and the IOP (mmHg) has to be compared together to evaluate glaucoma progression
  • Incidence in glaucoma medication change [ Time Frame: 3 years ]
    Number of glaucoma medication
  • Number of unscheduled visits due to self-measured increased intraocular pressure [ Time Frame: 3 years ]
    The patients decide to come for a visit by their own due to any reason. This will be documented.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
Official Title  ICMJE A Prospective, Open-label, Multicenter Clinical Follow-up Investigation of the ARGOS-01 and ARGOS-02 Patients to Assess the Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
Brief Summary The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-IO system in patients with Primary Open Angle Glaucoma (POAG)
Detailed Description

This study is a prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients.

From the ARGOS-01 to the ARGOS-02 study, some modifications were made to the form of the ARGOS-IO implant in consequence of the outcomes of the ARGOS-01 study.

Maximal 5 patients of the ARGOS-01 study and maximal 21 patients of the ARGOS-02 study will take part in this study.

The sensor was always implanted in one eye only which will be the study eye.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Primary Open-angle Glaucoma
Intervention  ICMJE Device: ARGOS-IO Sensor Pressure System
The ARGOS-IO Pressure sensor have been additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery in previous studies ARGOS-01 and ARGOS-02
Other Name: EYEMATE-IO
Study Arms  ICMJE Single-arm longterm follow-up ARGOS-IO Sensor Pressure System
The ARGOS-IO sensor was already implanted in a previous study as ARGOS-01 or ARGOS-02.
Intervention: Device: ARGOS-IO Sensor Pressure System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2020)		 13
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)		 25
Actual Study Completion Date  ICMJE April 27, 2022
Actual Primary Completion Date April 27, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor.

Exclusion Criteria:

  • N/A
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03651336
Other Study ID Numbers  ICMJE ARGOS-03
CIV-18-13-023284 ( Other Identifier: EUDAMED )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Implandata Ophthalmic Products GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Implandata Ophthalmic Products GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hagen Thieme, Prof. Universitätsaugenklinik Magdeburg
PRS Account Implandata Ophthalmic Products GmbH
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP