Trial Outcomes & Findings for Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation (NCT NCT02945176)
NCT ID: NCT02945176
Last Updated: 2025-02-27
Results Overview
Number of patients experiencing a device-related SAE (SADE).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.
Results posted on
2025-02-27
Participant Flow
Recruitment from February 2015 to June 2016 in medical clinics.
13 patients with an indication for a Boston Type I Keratoprosthesis (BI-KPro) were initially enrolled (13 = Safety Set (SS)\*), 12 of whom successfully received the ARGOS-IO implant (12 = "ARGOS-IO system"-Group = Per-Protocol-Set (PPS)\*) and were subjected to the follow-up visits. In one patient, the surgical preparation of the eye for implantation of the BI-KPro was so complex that the surgeon decided not to attempt implantation of the ARGOS-IO implant. \*= as specified by the protocol
Participant milestones
| Measure |
ARGOS-IO System
The ARGOS-IO Pressure sensor will be additionally implanted during local routine working procedures for Boston Keratoprosthesis (BKPro) surgery in patients undergoing implantation of a Boston Type I Keratoprosthesis (BI-KPro).
ARGOS-IO system: Implantation of ARGOS-IO pressure sensor prior to fixation of the BI-KPro.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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9
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
Baseline characteristics by cohort
| Measure |
Safety Set
n=13 Participants
A total of 13 patients with an indication for BI-KPro implantation were initially enrolled in this open-label clinical investigation ("Safety Set"-Group), 12 of whom successfully received the ARGOS-IO implant. In one patient, the surgical preparation of the eye for implantation of the BI-KPro was so complex that the surgeon decided not to attempt implantation of the ARGOS-IO implant.
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|---|---|
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Age, Categorical
<=18 years
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1 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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12 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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37.9 years
STANDARD_DEVIATION 15.1 • n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 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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13 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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13 participants
n=5 Participants
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Number of patients who successfully received the ARGOS-IO implant
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12 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.Population: Safety: Number of Patients Experiencing a Device-related SAE (SADE)
Number of patients experiencing a device-related SAE (SADE).
Outcome measures
| Measure |
Safety Set
n=13 Participants
A total of 13 patients with an indication for BI-KPro implantation were initially enrolled in this open-label clinical investigation ("Safety Set"-Group), 12 of whom successfully received the ARGOS-IO implant. In one patient, the surgical preparation of the eye for implantation of the BI-KPro was so complex that the surgeon decided not to attempt implantation of the ARGOS-IO implant.
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|---|---|
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Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE)
Number of Patients Experiencing a Device-related SAE (SADE)
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0 Participants
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Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE)
Overall Number of Participants Analyzed
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13 Participants
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PRIMARY outcome
Timeframe: Assessed at visits Week 4, Week 16, Week 28 and Week 52, final status at Week 52 reported.Population: IOP measurements with the ARGOS-IO system and by surgical manometry at given intervals (9 patients).
Consistency between manometric and telemetric IOP obtained by the ARGOS-IO system.
Outcome measures
| Measure |
Safety Set
n=24 Comparisons
A total of 13 patients with an indication for BI-KPro implantation were initially enrolled in this open-label clinical investigation ("Safety Set"-Group), 12 of whom successfully received the ARGOS-IO implant. In one patient, the surgical preparation of the eye for implantation of the BI-KPro was so complex that the surgeon decided not to attempt implantation of the ARGOS-IO implant.
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Performance: Performance of the ARGOS-IO System Compared to Manometry
Consistency between manometric and telemetric IOP results with a deviation <10% in # of events
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9 Comparisons
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Performance: Performance of the ARGOS-IO System Compared to Manometry
Consistency between manometric and telemetric IOP results with a deviation <20% in # of events
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14 Comparisons
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SECONDARY outcome
Timeframe: Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.Population: All available adverse events.
Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events ("Frequency of Adverse Events"). \[Note that patients indicated for a BKPro surgery generally suffer from severe corneal disorders, reflected by the large number of AEs observed in this patient population.\]
Outcome measures
| Measure |
Safety Set
n=168 A(D)Es
A total of 13 patients with an indication for BI-KPro implantation were initially enrolled in this open-label clinical investigation ("Safety Set"-Group), 12 of whom successfully received the ARGOS-IO implant. In one patient, the surgical preparation of the eye for implantation of the BI-KPro was so complex that the surgeon decided not to attempt implantation of the ARGOS-IO implant.
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Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
Overall number of AEs/ADEs of which
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168 A(D)Es
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Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
AEs related to the medical procedure and/or
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116 A(D)Es
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Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
AEs unlikely related to the IMD and/or
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92 A(D)Es
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Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
AEs with no relation to the IMD and/or
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61 A(D)Es
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Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
AEs possibly related to the IMD
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15 A(D)Es
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SECONDARY outcome
Timeframe: Assessed at visits from Day 1 through Week 52, final status at Week 52 reported.Population: Intraocular pressure (IOP) estimation by finger palpation was grouped in 4 IOP categories: normal (A), soft/hypotonic (B), borderline (C) and hypertonic (D). Comparison measurements between finger palpation (IOP categories A/B/C/D) and telemetric IOP (in mmHg) by the ARGOS-IO system was carried out for all 12 patients. All available Finger Palpation estimates and ARGOS-IO measurements were analyzed (113 comparisons analyzed).
Correlation between IOP estimation obtained by finger palpation and the telemetric IOP by the ARGOS-IO system.
Outcome measures
| Measure |
Safety Set
n=113 Comparisons
A total of 13 patients with an indication for BI-KPro implantation were initially enrolled in this open-label clinical investigation ("Safety Set"-Group), 12 of whom successfully received the ARGOS-IO implant. In one patient, the surgical preparation of the eye for implantation of the BI-KPro was so complex that the surgeon decided not to attempt implantation of the ARGOS-IO implant.
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Performance: Correlation Between Finger Palpation and the ARGOS-IO System
Category A (normal)
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18.2 mmHg
Standard Deviation 6.1
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Performance: Correlation Between Finger Palpation and the ARGOS-IO System
Category B (soft/hypertonic)
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8.9 mmHg
Standard Deviation 2.8
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Performance: Correlation Between Finger Palpation and the ARGOS-IO System
Category C (borderline)
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22.4 mmHg
Standard Deviation 4.9
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Performance: Correlation Between Finger Palpation and the ARGOS-IO System
Category D (hypertonic)
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34.3 mmHg
Standard Deviation 11.0
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SECONDARY outcome
Timeframe: Assessed at visit Week 52, final status at Week 52 reported.Population: Each patient was asked to provide feedback on the user acceptance of the ARGOS-IO system at home. A total of 6 patients provided feedback via a structured questionnaire.
User acceptance of the ARGOS-IO system at home by means of evaluation of patient questionnaires on a score on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). The score 7 represents a greater user acceptance.
Outcome measures
| Measure |
Safety Set
n=6 Participants
A total of 13 patients with an indication for BI-KPro implantation were initially enrolled in this open-label clinical investigation ("Safety Set"-Group), 12 of whom successfully received the ARGOS-IO implant. In one patient, the surgical preparation of the eye for implantation of the BI-KPro was so complex that the surgeon decided not to attempt implantation of the ARGOS-IO implant.
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Usability: User Acceptance at Home
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5.9 score on a scale
Standard Deviation 3.0
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Adverse Events
Safety Set
Serious events: 9 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Set
n=13 participants at risk
A total of 13 patients with an indication for BI-KPro implantation were initially enrolled in this open-label clinical investigation ("Safety Set"-Group), 12 of whom successfully received the ARGOS-IO implant. In one patient, the surgical preparation of the eye for implantation of the BI-KPro was so complex that the surgeon decided not to attempt implantation of the ARGOS-IO implant.
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|---|---|
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Eye disorders
Cystoid macular oedema
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15.4%
2/13 • 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
Retinal detachment
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15.4%
2/13 • 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
Retinopathy proliferative
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15.4%
2/13 • 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 infiltrates
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7.7%
1/13 • 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 perforation
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7.7%
1/13 • 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
Hypotony of eye
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7.7%
1/13 • 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
Iris adhesions
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7.7%
1/13 • 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
Vitritis
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7.7%
1/13 • 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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General disorders
Complication associated with BI-KPro
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7.7%
1/13 • 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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Injury, poisoning and procedural complications
Transplant failure
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7.7%
1/13 • 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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Investigations
Intraocular pressure increased
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15.4%
2/13 • 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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Product Issues
Device dislocation
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7.7%
1/13 • 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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Renal and urinary disorders
Renal failure
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7.7%
1/13 • 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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Surgical and medical procedures
Corneal transplant
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15.4%
2/13 • 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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Other adverse events
| Measure |
Safety Set
n=13 participants at risk
A total of 13 patients with an indication for BI-KPro implantation were initially enrolled in this open-label clinical investigation ("Safety Set"-Group), 12 of whom successfully received the ARGOS-IO implant. In one patient, the surgical preparation of the eye for implantation of the BI-KPro was so complex that the surgeon decided not to attempt implantation of the ARGOS-IO implant.
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|---|---|
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Eye disorders
Eye pain
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46.2%
6/13 • Number of events 7 • 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
Hypotony of eye
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38.5%
5/13 • Number of events 7 • 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
Vitritis
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23.1%
3/13 • 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
Keratitis
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15.4%
2/13 • 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
Choroidal detachment
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15.4%
2/13 • 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
Retinopathy proliferative
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15.4%
2/13 • 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
Visual acuity reduced
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15.4%
2/13 • 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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Injury, poisoning and procedural complications
Procedural Pain
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23.1%
3/13 • 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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Investigations
Intraocular pressure increased
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46.2%
6/13 • Number of events 28 • 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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Investigations
Intraocular pressure decreased
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23.1%
3/13 • 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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Product Issues
Retroprosthetic membrane
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46.2%
6/13 • Number of events 7 • 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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Product Issues
Device material opacification (BKPro and IOL)
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23.1%
3/13 • 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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Surgical and medical procedures
Corneal sutures removal
|
38.5%
5/13 • 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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Ear and labyrinth disorders
Tinnitus
|
7.7%
1/13 • 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
Cystoid macular edema
|
7.7%
1/13 • 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 epithelium defect
|
7.7%
1/13 • 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
Iris adhesion
|
7.7%
1/13 • 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
Ocular discomfort
|
7.7%
1/13 • 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
Trichiasis
|
7.7%
1/13 • 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
Anterior chamber cell
|
7.7%
1/13 • 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
|
7.7%
1/13 • 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
|
|
Eye disorders
Blepharitis
|
7.7%
1/13 • 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
|
|
Eye disorders
Choroidal haemorrhage
|
7.7%
1/13 • 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
|
|
Eye disorders
Conjunctival disorder
|
7.7%
1/13 • 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
|
|
Eye disorders
Conjunctival haemorrhage
|
7.7%
1/13 • 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
Conjunctival hyperaemia
|
7.7%
1/13 • 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
|
|
Eye disorders
Corneal infiltrates
|
7.7%
1/13 • 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
|
|
Eye disorders
Corneal neovascualrisation
|
7.7%
1/13 • 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
|
|
Eye disorders
Erythema of eyelid
|
7.7%
1/13 • 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
|
|
Eye disorders
Eye inflammation
|
7.7%
1/13 • 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
|
|
Eye disorders
Eye pruritus
|
7.7%
1/13 • 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
|
|
Eye disorders
Keratic precipitates
|
7.7%
1/13 • 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
|
|
Eye disorders
Lacrimation increased
|
7.7%
1/13 • 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
|
|
Eye disorders
Lens disorder
|
7.7%
1/13 • 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
|
|
Eye disorders
Pigment dispersion
|
7.7%
1/13 • 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
|
|
Eye disorders
Retinal detachment
|
7.7%
1/13 • 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
|
|
Eye disorders
Retinal disorder
|
7.7%
1/13 • 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
|
|
Eye disorders
Retinal haemorrhage
|
7.7%
1/13 • 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
|
|
Eye disorders
Retinal scar
|
7.7%
1/13 • 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
|
|
Eye disorders
Retinal tear
|
7.7%
1/13 • 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
|
|
Eye disorders
Retinal thickening
|
7.7%
1/13 • 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
|
|
Eye disorders
Subretinal fibrosis
|
7.7%
1/13 • 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
|
|
Eye disorders
Visual impairment
|
7.7%
1/13 • 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
|
|
Eye disorders
Vitreous haemorrhage
|
7.7%
1/13 • 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
|
|
Eye disorders
Vitreous opacities
|
7.7%
1/13 • 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
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • 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
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • 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
|
|
General disorders
Atrophy of the donor cornea
|
7.7%
1/13 • 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
|
|
General disorders
Subjectively worse impression
|
7.7%
1/13 • 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
|
|
General disorders
Drug intolerance
|
7.7%
1/13 • 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
|
|
Infections and infestations
Bacterial disease carrier
|
7.7%
1/13 • 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
|
|
Infections and infestations
Gastroenteritis
|
7.7%
1/13 • 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
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • 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
|
|
Injury, poisoning and procedural complications
Hyphaema
|
7.7%
1/13 • 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
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
7.7%
1/13 • 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
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
7.7%
1/13 • 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
|
|
Injury, poisoning and procedural complications
Suture related complication
|
7.7%
1/13 • 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
|
|
Investigations
Seidel Test positive
|
7.7%
1/13 • 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
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • 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
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • 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
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
7.7%
1/13 • 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
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • 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
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • 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
|
|
Nervous system disorders
Paraesthesia
|
7.7%
1/13 • 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
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • 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
|
|
Psychiatric disorders
Panic attack
|
7.7%
1/13 • 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
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • 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
|
|
Renal and urinary disorders
Renal failure
|
7.7%
1/13 • 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
|
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