Trial Outcomes & Findings for Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG) (NCT NCT02434692)
NCT ID: NCT02434692
Last Updated: 2024-12-12
Results Overview
Number of patients experiencing a device related SAE (SADE) and complications during the implantation of the ARGOS-IO device.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Day 0 to Day 360 (V01 [Implantation] to V11)
Results posted on
2024-12-12
Participant Flow
Recruitment from July 2014 to March 2016 in medical clinics.
Participant milestones
| Measure |
Single-arm Intervention ARGOS-IO System
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)
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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22
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)
Baseline characteristics by cohort
| Measure |
Safety Set
n=23 Participants
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.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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7 Participants
n=5 Participants
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Age, Categorical
>=65 years
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16 Participants
n=5 Participants
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Age, Continuous
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67.7 years
STANDARD_DEVIATION 6.7 • n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
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Sex: Female, Male
Male
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15 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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23 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Germany
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23 participants
n=5 Participants
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Number of patients who successfully received the ARGOS-IO implant
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22 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Safety Set
n=23 Participants
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.
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Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation
SADEs
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0 participants
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Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation
SAEs
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9 participants
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Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation
Surgical complications
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7 participants
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PRIMARY outcome
Timeframe: Day 30 to Day 360 (V05 to V11)Population: All available GAT and ARGOS-IO measurements.
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 \[Choritz et al., 2019 (Telemetric Measurement of … ARGOS-02 Trial) in the "References"-section\].
Outcome measures
| Measure |
Safety Set
n=435 comparisons
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.
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Performance: Intraclass Correlation Between Intraocular Pressure (IOP) Measurements by GAT and the ARGOS-IO System
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0.789 Intraclass correlation coefficient
Interval 0.743 to 0.8717
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SECONDARY outcome
Timeframe: 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.
Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
Outcome measures
| Measure |
Safety Set
n=23 Participants
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.
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Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
Overall number of AEs/ADEs
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168 A(D)Es
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Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
AEs related to medical device
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74 A(D)Es
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Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
AEs related to medical procedure
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90 A(D)Es
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Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
AEs related to other
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52 A(D)Es
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Adverse Events
Safety Set
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Set
n=23 participants at risk
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.
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Eye disorders
Abnormal visual field test
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4.3%
1/23 • Number of events 1 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Anterior chamber fibrin
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8.7%
2/23 • Number of events 2 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Intraocular pressure increased
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8.7%
2/23 • Number of events 2 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Amaurosis fugax
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4.3%
1/23 • Number of events 1 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Corneal decompensation
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4.3%
1/23 • Number of events 1 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Cataract operation in fellow eye
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4.3%
1/23 • Number of events 1 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Gastrointestinal disorders
Abdominal pain upper
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4.3%
1/23 • Number of events 1 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Immune system disorders
Arthritis
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4.3%
1/23 • Number of events 1 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Gastrointestinal disorders
Constipation
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4.3%
1/23 • Number of events 1 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Metabolism and nutrition disorders
Dehydration
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4.3%
1/23 • Number of events 1 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Gastrointestinal disorders
Large intestine perforation
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4.3%
1/23 • Number of events 1 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Other adverse events
| Measure |
Safety Set
n=23 participants at risk
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.
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Eye disorders
Intraocular pressure increased
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52.2%
12/23 • Number of events 20 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Anterior chamber inflammation
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39.1%
9/23 • Number of events 11 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Pigment dispersion
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34.8%
8/23 • Number of events 8 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Anterior chamber fibrin
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13.0%
3/23 • Number of events 3 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Corneal endothelial cell loss
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21.7%
5/23 • Number of events 5 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Visual acuity reduced
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21.7%
5/23 • Number of events 5 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Blepharitis
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17.4%
4/23 • Number of events 4 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Corneal pigmentation
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17.4%
4/23 • Number of events 5 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Dry eye
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17.4%
4/23 • Number of events 4 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Iris prolapse
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17.4%
4/23 • Number of events 4 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Iris transillumination defect
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17.4%
4/23 • Number of events 4 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Corneal edema
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13.0%
3/23 • Number of events 3 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Macular edema
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13.0%
3/23 • Number of events 3 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Posterior capsule opafication
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13.0%
3/23 • Number of events 3 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Visual field test abnormal
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8.7%
2/23 • Number of events 2 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Conjunctival edema
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8.7%
2/23 • Number of events 2 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Corneal erosion
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8.7%
2/23 • Number of events 2 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Eye Pain
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8.7%
2/23 • Number of events 2 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Foreign body sensation in eye
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8.7%
2/23 • Number of events 2 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Glare
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8.7%
2/23 • Number of events 2 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Pupils unequal
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8.7%
2/23 • Number of events 2 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Eye disorders
Vitreous floaters
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8.7%
2/23 • Number of events 2 • Evaluation over 12 months follow-up period.
SAE Definition 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
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Additional Information
Clinical Study Manager
Implandata Ophthalmic Products
Phone: +49 (0) 511 - 2204 2580
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place