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Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Implandata Ophthalmic Products GmbH
ClinicalTrials.gov Identifier:
NCT02434692
First received: September 2, 2014
Last updated: August 16, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention
Primary Open Angle Glaucoma (POAG) Device: ARGOS-IO system

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Implandata Ophthalmic Products GmbH:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 22
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)
Arms Assigned Interventions
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mentally competent and willing to provide written informed consent
  2. Male or female aged ≥40 and ≤85 years. Female subjects of childbearing potential must be willing to use adequate contraception and must have a negative pregnancy test.
  3. Diagnosis of primary open-angle glaucoma (POAG) including high pressure glaucoma (HPG), normal pressure glaucoma (NPG) and ocular hypertension (OH), as defined by the European Glaucoma Society guideline (Heijl, Treverso, et al., 2008)
  4. Sufficiently controlled intraocular pressure (IOP)
  5. Study eye needs to be phakic
  6. Only one eye per patient may be implanted with the ARGOS-IO implant
  7. Cataract surgery indicated. The medical indication for a cataract operation must be given irrespective of the study participation. Potential study patients will be solicited for participation in the clinical trial only after the patient has given consent to the cataract operation.
  8. Pre-operative anterior chamber depth (ACD) ≥2.0 mm as measured from the corneal endothelium
  9. Axis length >22 mm
  10. Endothelial cell density of the cornea ≥2000 cells/mm²
  11. Subjects able and willing to attend all scheduled visits and comply with all study procedures

Exclusion Criteria:

  1. Any other type of glaucoma other than primary open-angle glaucoma as defined by inclusion criterion 3
  2. Severe POAG patients with a macular degeneration and visual field loss of -20 decibels (dB) or worse in both eyes. In case of a diverse developed visual field loss, the sensor can be implanted in the worse eye for protection the better eye.
  3. Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema
  4. Retinal detachment
  5. Corneal diseases, especially diseases affecting the corneal endothelium, e.g. Fuchs' Dystrophia
  6. Diabetes mellitus
  7. Existence of Marfan-Syndrome, Ehlers-Danlos-Syndrome or Weill-Marchesani-Syndrome
  8. 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
  9. Intraocular surgical procedure(s) within 6 months prior to ARGOS-IO implantation or any surgical procedure such as refractive eye surgery in the study eye that can affect the assessment of IOP by Goldmann applanation tonometry
  10. History of eye tumor
  11. Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP by Goldmann applanation tonometry (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy)
  12. Anterior chamber configuration that puts the subject at high risk to develop an angle closure glaucoma
  13. History of extensive keloid formation
  14. Severe dry eye syndrome
  15. Subjects who will need to undergo ancillary procedures in the study eye at the time of implantation or during the post-operative study period
  16. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, plaster or silicone (component of the device)
  17. Existence of other active medical eye implant and/or other active medical implants in the head/neck region
  18. Any contraindication for intraocular lens (IOL) implantation such as choroidal hemorrhage, concomitant severe eye disease, excessive vitreous loss, extremely shallow anterior chamber, microphthalmos, non-age-related cataract, posterior capsular rupture, severe corneal dystrophy, untraceable IOP, zonular separation, color vision deficiencies
  19. Severe generalized disease resulting in a life expectancy shorter than a year
  20. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
  21. Currently pregnant or breastfeeding
  22. Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device
  23. Patients who are not suitable for the study based on the surgeon's evaluation
  24. Patients unable or unwilling to understand or comply with required study procedures
  25. Patients with psychiatric disorders influencing their judgement or autonomy
  26. Subject and/or an immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the contract research organization.
  27. Enrollment of the fellow eye in this clinical study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02434692

Locations
Germany
Augenklinik Universitätsklinikum Aachen
Aachen, Germany, 52074
Augen-Zentrum-Nordwest
Ahaus, Germany, 48683
Universitäts-Augenklinik Bochum
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
Universitätsaugenklinik Magdeburg
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
Universitäts-Augenklinik
Tübingen, Germany, 72076
Sponsors and Collaborators
Implandata Ophthalmic Products GmbH
Investigators
Principal Investigator: Hagen Thieme, Prof. University Eye Clinic Magdeburg, Germany
  More Information

Responsible Party: Implandata Ophthalmic Products GmbH
ClinicalTrials.gov Identifier: NCT02434692     History of Changes
Other Study ID Numbers: ARGOS-02
CIV-13-11-011719 ( Other Identifier: EUDAMED )
Study First Received: September 2, 2014
Last Updated: August 16, 2017

Keywords provided by Implandata Ophthalmic Products GmbH:
Primary Open Angle Glaucoma
POAG
Glaucoma
Cataract
Surgery
Ocular Pressure

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 21, 2017