Status:
COMPLETED
Performance and Safety of the ARGOS-SC Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery
Lead Sponsor:
Implandata Ophthalmic Products GmbH
Collaborating Sponsors:
CRO Dr. med Kottmann GmbH & Co. KG
Conditions:
Glaucoma
Open Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate both the safety and feasibility of the surgical implantation of the ARGOS-SC implant during non-penetrating glaucoma surgery and the safety and usability of th...
Detailed Description
This study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. Subjects will be followed up at regular intervals for one year following implantation to collect sa...
Eligibility Criteria
Inclusion
- Subjects able to understand the informed consent and willing to participate as evidenced by providing informed consent.
- Male or female aged ≥ 18 years on the day of screening Female subjects of childbearing potential (not surgically sterilized or more than one year post-menopausal) must be willing to use adequate contraception throughout the trial and must have a negative pregnancy test (urine beta-hCG) within 24 hours prior to ARGOS-SC pressure sensor implantation.
- Diagnosis of open angle glaucoma requiring a non-penetrating glaucoma surgery (NPGS). The medical indication for a non-penetrating glaucoma surgery 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 non-penetrating glaucoma operation.
- Subjects able and willing to attend all scheduled visits and comply with all study procedures
Exclusion
- Contraindications for a non-penetrating glaucoma surgery
- Neovascular glaucoma, primary and secondary angle closure glaucoma
- Condition after previous glaucoma incisional surgery
- IOP \> 40 mmHg
- Myopia (\> -6 dpt) or hypermetropia (\> +4 dpt)
- Axis length \< 22 mm or \> 26 mm
- Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema
- Acute retinal detachment
- Uncontrolled Diabetes Mellitus (DM) with manifestation of moderate to severe non-proliferative diabetic Retinopathy (DR) or proliferative DR.
- History or evidence of severe active inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to ARGOS-SC implantation
- Ocular surgery procedure(s) (excluding selective laser trabeculoplasty and peripheral iridotomy) within 6 months (cataract surgery within 3 months) prior to ARGOS-SC implantation in the study eye that can affect the assessment of IOP by Goldmann Applanation tonometry
- Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP by Goldmann Applanation tonometry/Pascal Dynamic Contour Tonometry (e.g. choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy)
- Existence of other active medical eye implant and/or other active medical implants in the head/neck region
- Difficulties or complications during NPGS procedure or implantation of ARGOS-SC sensor, as assessed by surgeon (e.g. perforation of trabeculo-descement's membrane; excessive aqueous filtration through TDM leading to shallow anterior chamber; excessive bleeding; choroidal detachment)
- Severe generalized disease resulting in a life expectancy shorter than a year
- Currently pregnant or breastfeeding
- 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
- Patients who are not suitable for the study based on the surgeon's evaluation
- Patients unable or unwilling to understand or comply with required study procedures
- Patients with psychiatric disorders influencing their judgement or autonomy
- 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.
- Enrollment of the fellow eye in this clinical study
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03756662
Start Date
November 19 2018
End Date
February 18 2021
Last Update
January 24 2025
Active Locations (5)
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1
Universitäts-Augenklinik
Bochum, Germany, 44892
2
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
Mainz, Germany, 55131
3
Augenklinik der LMU München
München, Germany, 80336
4
Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
Sulzbach, Germany, 66280