This trial is active, not recruiting.

Condition primary open angle glaucoma (poag)
Treatment argos-io system
Sponsor Implandata Ophthalmic Products GmbH
Start date May 2014
End date November 2016
Trial size 22 participants
Trial identifier NCT02434692, ARGOS-02, CIV-13-11-011719


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
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.
argos-io system
Implantation of ARGOS-IO pressure sensor after cataract surgery on day 0 (V01)

Primary Outcomes

time frame: 12 months

Secondary Outcomes

Incidence of adverse events
time frame: 12 months
Severity of adverse events
time frame: 12 months
time frame: 12 months

Eligibility Criteria

Male or female participants from 40 years up to 85 years old.

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) 4. Sufficiently controlled intraocular pressure (IOP) 5. Phakic eyes 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) ≥2.5 mm 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 3. Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema 4. Retinal detachment 5. Corneal diseases 6. Diabetes mellitus 7. Connective tissue diseases 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 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

Additional Information

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)
Principal investigator Hagen Thieme, Prof.
Description This clinical investigation prospective, open-label, multicenter, single-arm clinical investigation will be conducted in two stages using a Simon two-stage design. Subjects will be enrolled as follows: First stage: 11 patients Second stage: 11 patients An interim analysis will be performed when the 11 patients of the first stage have completed their 3 month follow-up visits. The trial will be stopped if 2 or more patients have experienced a serious adverse device events (SADE) at this time. Otherwise enrollment will be resumed and the trial continued until an additional 11 patients have been enrolled in stage 2 and received ARGOS-IO implants. A conclusion for safety will be made if in total no more than 2 of the total of 22 patients experience an SADE.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Implandata Ophthalmic Products GmbH.