Primary Open Angle Glaucoma (POAG)
Conditions
Keywords
Primary Open Angle Glaucoma, POAG, Glaucoma, Cataract, Surgery, Ocular Pressure
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.
Detailed 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.
Interventions
DEVICEARGOS-IO system
Implantation of ARGOS-IO pressure sensor after IOL placement within the cataract surgical procedure on day 0 (V01)
Sponsors
Implandata Ophthalmic Products GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation | Day 0 to Day 360 (V01 [Implantation] to V11) | Number of patients experiencing a device related SAE (SADE) and complications during the implantation of the ARGOS-IO device. |
| Performance: Intraclass Correlation Between Intraocular Pressure (IOP) Measurements by GAT and the ARGOS-IO System | Day 30 to Day 360 (V05 to V11) | 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 \[Choritz et al., 2019 (Telemetric Measurement of … ARGOS-02 Trial) in the References-section\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs. | Day 0 to Day 360 (V01 [Implantation] to V11) | Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events. |
Countries
Germany
Participant flow
Recruitment details
Recruitment from July 2014 to March 2016 in medical clinics.
Participants by arm
| Arm | Count |
|---|---|
| Safety Set In this multicenter, open-label, single-arm, interventional clinical trial a total of 24 patients with primary open angle glaucoma were initially enrolled, 22 of whom successfully received the ARGOS-IO implant. Of the two patients, initially enrolled but not implanted with the ARGOS-IO implant, one patient was included due to a misunderstanding of the inclusion and exclusion criteria, which was noticed before the procedure. 23 patients were thus included in the safety evaluation set (Safety Set-Group). Due to surgical complications during cataract surgery, an implantation of the ARGOS-IO pressure sensor was not attempted in the second patient.
Goldmann applanation tonometry (GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V11) through 12 months. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Safety Set |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 67.7 years STANDARD_DEVIATION 6.7 |
| Number of patients who successfully received the ARGOS-IO implant | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment Germany | 23 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 23 / 23 |
| serious Total, serious adverse events | 9 / 23 |
Outcome results
Primary
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 \[Choritz et al., 2019 (Telemetric Measurement of … ARGOS-02 Trial) in the References-section\].
Time frame: Day 30 to Day 360 (V05 to V11)
Population: All available GAT and ARGOS-IO measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Safety Set | Performance: Intraclass Correlation Between Intraocular Pressure (IOP) Measurements by GAT and the ARGOS-IO System | 0.789 Intraclass correlation coefficient |
Primary
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.
Time frame: Day 0 to Day 360 (V01 [Implantation] to V11)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Safety Set | Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation | SADEs | 0 participants |
| Safety Set | Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation | SAEs | 9 participants |
| Safety Set | Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation | Surgical complications | 7 participants |
Secondary
Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
Time frame: Day 0 to Day 360 (V01 [Implantation] to V11)
Population: 168 AEs were reported, 74 AEs in 18 patients (p) were related to the ARGOS-IO device, 90 AEs in 21 p had a relationship to the medical procedure \& 52 AEs in 17 p were related to other. Most common but as well expected AEs even after a standard cataract surgery were increased IOP (2 x in 14 p), anterior chamber inflammation (11x in 9 p) \& anterior chamber fibrin (5 p). Pigment dispersion was described in 8 p.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Safety Set | Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs. | Overall number of AEs/ADEs | 168 A(D)Es |
| Safety Set | Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs. | AEs related to medical device | 74 A(D)Es |
| Safety Set | Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs. | AEs related to medical procedure | 90 A(D)Es |
| Safety Set | Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs. | AEs related to other | 52 A(D)Es |