Chemical Burns, Congenital Aniridia, Congenital Glaucoma, Graft vs Host Disease, Stevens-Johnson Syndrome
Conditions
Keywords
Boston Keratoprosthesis
Brief summary
The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely. It is intended to be used together with the hand-held Mesograph reading device to telemetrically measure the intraocular pressure (IOP) of patients with a BKPro. The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients undergoing concomitant implantation of a BKPro and an ARGOS-IO sensor over the 12 month period beginning at implantation.
Detailed description
(see above)
Interventions
DEVICEARGOS-IO system
This study will enroll a minimum of 10 and a maximum of 15 patients. It is anticipated to be large enough to provide an initial estimate of common safety events and assessment of performance. Any adverse event (AE), serious adverse event (SAE), ADE (adverse device event) and SADE (serious adverse device event) will be listed. Incidence will be estimated with a 95% confidence interval (Pearson-Clopper, two-sided). The Bland-Altman method will be used to assess the limits of agreement between the IOP measurements ARGOS-IO and surgical manometry. When appropriate, two-sided 95% confidence intervals, for these limits will be calculated accounting for repeated measurements based on the method proposed by Zou (2011). Other secondary performance endpoints will be analyzed by descriptive and explorative statistical methods.
Sponsors
Implandata Ophthalmic Products GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female aged ≥ 18 and ≤ 80 years on the day of screening 2. Keratoprosthesis surgery indicated, defined as having a severely opaque and vascularized cornea AND either a verifiable history of two or more prior failed corneal transplant procedures or a medical condition such as alkali burns or autoimmune disease that makes the success of a traditional corneal transplant procedure unlikely. Potential study subjects will be solicited for participation in the clinical trial only after they have consented to the keratoprosthesis operation. 3. Axial length \> 21 mm 4. Ability and willingness to attend all scheduled visits and comply with all study procedures
Exclusion criteria
1. Reasonable chance of success with traditional keratoplasty 2. Current retinal detachment 3. Connective tissue diseases 4. 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 5. History of ocular or periocular malignancy 6. History of extensive keloid formation 7. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or silicone (component of the device) 8. Presence of another active medical eye implant and/or other active medical implants in the head/neck region 9. Signs of current infection, including fever and current treatment with antibiotics 10. Severe generalized disease that results in a life expectancy shorter than a year 11. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device 12. Currently pregnant or breastfeeding 13. 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 14. Intraoperative complication that would preclude implantation of the study device 15. 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. Previous or concurrent enrollment of the contralateral eye in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE) | Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported. | Number of patients experiencing a device-related SAE (SADE). |
| Performance: Performance of the ARGOS-IO System Compared to Manometry | Assessed at visits Week 4, Week 16, Week 28 and Week 52, final status at Week 52 reported. | Consistency between manometric and telemetric IOP obtained by the ARGOS-IO system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs. | Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported. | Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events (Frequency of Adverse Events). \[Note that patients indicated for a BKPro surgery generally suffer from severe corneal disorders, reflected by the large number of AEs observed in this patient population.\] |
| Performance: Correlation Between Finger Palpation and the ARGOS-IO System | Assessed at visits from Day 1 through Week 52, final status at Week 52 reported. | Correlation between IOP estimation obtained by finger palpation and the telemetric IOP by the ARGOS-IO system. |
| Usability: User Acceptance at Home | Assessed at visit Week 52, final status at Week 52 reported. | 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. |
Countries
Germany
Participant flow
Recruitment details
Recruitment from February 2015 to June 2016 in medical clinics.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Safety Set 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. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Safety Set |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 37.9 years STANDARD_DEVIATION 15.1 |
| Number of patients who successfully received the ARGOS-IO implant | 12 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 | 13 Participants |
| Region of Enrollment Germany | 13 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 13 / 13 |
| serious Total, serious adverse events | 9 / 13 |
Outcome results
Primary
Performance: Performance of the ARGOS-IO System Compared to Manometry
Consistency between manometric and telemetric IOP obtained by the ARGOS-IO system.
Time frame: 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).
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Safety Set | Performance: Performance of the ARGOS-IO System Compared to Manometry | Consistency between manometric and telemetric IOP results with a deviation <10% in # of events | 9 Comparisons |
| Safety Set | Performance: Performance of the ARGOS-IO System Compared to Manometry | Consistency between manometric and telemetric IOP results with a deviation <20% in # of events | 14 Comparisons |
Primary
Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE)
Number of patients experiencing a device-related SAE (SADE).
Time frame: 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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Safety Set | Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE) | Overall Number of Participants Analyzed | 13 Participants |
| Safety Set | Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE) | Number of Patients Experiencing a Device-related SAE (SADE) | 0 Participants |
Secondary
Performance: Correlation Between Finger Palpation and the ARGOS-IO System
Correlation between IOP estimation obtained by finger palpation and the telemetric IOP by the ARGOS-IO system.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Safety Set | Performance: Correlation Between Finger Palpation and the ARGOS-IO System | Category A (normal) | 18.2 mmHg | Standard Deviation 6.1 |
| Safety Set | Performance: Correlation Between Finger Palpation and the ARGOS-IO System | Category B (soft/hypertonic) | 8.9 mmHg | Standard Deviation 2.8 |
| Safety Set | Performance: Correlation Between Finger Palpation and the ARGOS-IO System | Category C (borderline) | 22.4 mmHg | Standard Deviation 4.9 |
| Safety Set | Performance: Correlation Between Finger Palpation and the ARGOS-IO System | Category D (hypertonic) | 34.3 mmHg | Standard Deviation 11 |
Secondary
Safety and Tolerability: 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 (Frequency of Adverse Events). \[Note that patients indicated for a BKPro surgery generally suffer from severe corneal disorders, reflected by the large number of AEs observed in this patient population.\]
Time frame: Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.
Population: All available adverse events.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Safety Set | Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs. | AEs with no relation to the IMD and/or | 61 A(D)Es |
| Safety Set | Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs. | AEs possibly related to the IMD | 15 A(D)Es |
| Safety Set | Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs. | Overall number of AEs/ADEs of which | 168 A(D)Es |
| Safety Set | Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs. | AEs related to the medical procedure and/or | 116 A(D)Es |
| Safety Set | Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs. | AEs unlikely related to the IMD and/or | 92 A(D)Es |
Secondary
Usability: User Acceptance at Home
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Safety Set | Usability: User Acceptance at Home | 5.9 score on a scale | Standard Deviation 3 |