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)
Verified date | August 2017 |
Source | Implandata Ophthalmic Products GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | April 11, 2017 |
Est. primary completion date | April 11, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Augenklinik Universitätsklinikum Aachen | Aachen | |
Germany | Augen-Zentrum-Nordwest | Ahaus | |
Germany | Universitäts-Augenklinik Bochum | Bochum | |
Germany | Internationale Innovative Ophthalmochirurgie Breyer-Kaymak-Klabe | Düsseldorf | |
Germany | Augenklinik der SLK-Kliniken | Heilbronn | |
Germany | nordBLICK Augenklinik Bellevue | Kiel | |
Germany | Universitätsaugenklinik Magdeburg | Magdeburg | |
Germany | Augenärztliches Augenchirurgisches Zentrum (AAZ) | Nürnberg | |
Germany | Klinik und Poliklinik für Augenheilkunde der Universität Rostock | Rostock | |
Germany | Knappschaftsklinikum Saar - Augenklinik | Sulzbach | |
Germany | Universitäts-Augenklinik | Tübingen |
Lead Sponsor | Collaborator |
---|---|
Implandata Ophthalmic Products GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | 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 |
12 months | |
Secondary | Incidence of adverse events | Incidence of observed adverse events and adverse device events during a period between 3 months and 12 months following implantation. | 12 months | |
Secondary | Severity of adverse events | Severity of observed adverse events and adverse device events during a period between 3 months and 12 months following implantation. | 12 months | |
Secondary | Performance | Limits of agreement between measurements made using GAT and the ARGOS-IO system from V05 (day 30) through V11 (day 360) | 12 months |
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