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

I

Implandata Ophthalmic Products

Status

Completed

Conditions

Primary Open Angle Glaucoma (POAG)

Treatments

Device: ARGOS-IO system

Study type

Interventional

Funder types

Industry

Identifiers

NCT02434692
CIV-13-11-011719 (Other Identifier)
ARGOS-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Single-arm intervention ARGOS-IO system
Experimental group
Description:
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.
Treatment:
Device: ARGOS-IO system

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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