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

NCT02434692 | Completed Results DMC

• 2 other identifiers: ARGOS-02CIV-13-11-011719
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Primary Open Angle Glaucoma (POAG)

Keywords

Primary Open Angle Glaucoma; POAG; Glaucoma; Cataract; Surgery; Ocular Pressure

Outcome Measures

Primary Outcomes (2)

• 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.

  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 \[Choritz et al., 2019 (Telemetric Measurement of … ARGOS-02 Trial) in the "References"-section\].

  Day 30 to Day 360 (V05 to V11)

Secondary Outcomes (1)

• Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.

  Day 0 to Day 360 (V01 [Implantation] to V11)

Study Arms (1)

Single-arm intervention ARGOS-IO system

EXPERIMENTAL

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

Interventions

ARGOS-IO system DEVICE

Implantation of ARGOS-IO pressure sensor after IOL placement within the cataract surgical procedure on day 0 (V01)

Single-arm intervention ARGOS-IO system

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mentally competent and willing to provide written informed consent
• 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.
• 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)
• Sufficiently controlled intraocular pressure (IOP)
• Study eye needs to be phakic
• Only one eye per patient may be implanted with the ARGOS-IO implant
• 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.
• Pre-operative anterior chamber depth (ACD) ≥2.0 mm as measured from the corneal endothelium
• Axis length \>22 mm
• Endothelial cell density of the cornea ≥2000 cells/mm²
• Subjects able and willing to attend all scheduled visits and comply with all study procedures

You may not qualify if:

• 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.
• Retinal detachment
• Corneal diseases, especially diseases affecting the corneal endothelium, e.g. Fuchs' Dystrophia
• Diabetes mellitus
• Existence of Marfan-Syndrome, Ehlers-Danlos-Syndrome or Weill-Marchesani-Syndrome
• 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
• 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
• History of eye tumor
• 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)
• Anterior chamber configuration that puts the subject at high risk to develop an angle closure glaucoma
• History of extensive keloid formation
• Severe dry eye syndrome
• Subjects who will need to undergo ancillary procedures in the study eye at the time of implantation or during the post-operative study period
• Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, plaster or silicone (component of the device)
• Existence of other active medical eye implant and/or other active medical implants in the head/neck region

Sponsors & Collaborators

• Implandata Ophthalmic Products GmbH: lead

Study Sites (11)

Augenklinik Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

Augen-Zentrum-Nordwest

Ahaus, 48683, Germany

Location

Universitäts-Augenklinik Bochum

Bochum, 44892, Germany

Location

Internationale Innovative Ophthalmochirurgie Breyer-Kaymak-Klabe

Düsseldorf, 40212, Germany

Location

Augenklinik der SLK-Kliniken

Heilbronn, 74078, Germany

Location

nordBLICK Augenklinik Bellevue

Kiel, 24105, Germany

Location

Universitätsaugenklinik Magdeburg

Magdeburg, 39120, Germany

Location

Augenärztliches Augenchirurgisches Zentrum (AAZ)

Nuremberg, 90403, Germany

Location

Klinik und Poliklinik für Augenheilkunde der Universität Rostock

Rostock, 18057, Germany

Location

Knappschaftsklinikum Saar - Augenklinik

Sulzbach, 66280, Germany

Location

Universitäts-Augenklinik

Tübingen, 72076, Germany

Location

Related Publications (1)

• Mansouri K, Gillmann K, Rao HL, Weinreb RN; ARGOS-2 Study Group. Weekly and seasonal changes of intraocular pressure measured with an implanted intraocular telemetry sensor. Br J Ophthalmol. 2021 Mar;105(3):387-391. doi: 10.1136/bjophthalmol-2020-315970. Epub 2020 Jun 4.

  PMID: 32499329 DERIVED

Related Links

• Telemetric Measurement of Intraocular Pressure via an Implantable Pressure Sensor-12-Month Results from the ARGOS-02 Trial

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma; Cataract

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Results Point of Contact

• Title: Clinical Study Manager
• Organization: Implandata Ophthalmic Products

clinical@implandata.com

+49 (0) 511 - 2204 2580

Study Officials

• Hagen Thieme, Prof.

  University Eye Clinic Magdeburg, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: May 5, 2015
• Study Start: July 9, 2014
• Primary Completion: April 11, 2017
• Study Completion: April 11, 2017
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-10

Locations

DE (11)