Graft vs Host DiseaseNCT02945176
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
A study testing ARGOS-IO system in people with Graft vs Host Disease and Congenital Aniridia, run by Implandata Ophthalmic Products GmbH at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns
- What is being tested?
- ARGOS-IO system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2015to 14 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 and ≤ 80 years on the day of screening
- 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.
- Axial length > 21 mm
- Ability and willingness to attend all scheduled visits and comply with all study procedures
Who cannot join
- Reasonable chance of success with traditional keratoplasty
- Current retinal detachment
- Connective tissue diseases
- 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
- History of ocular or periocular malignancy
- History of extensive keloid formation
Show all 16Show fewer
- Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or silicone (component of the device)
- Presence of another active medical eye implant and/or other active medical implants in the head/neck region
- Signs of current infection, including fever and current treatment with antibiotics
- Severe generalized disease that results in a life expectancy shorter than a year
- Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
- Currently pregnant or breastfeeding
- Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device
- Intraoperative complication that would preclude implantation of the study device
- 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.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Zentrum für Augenheilkunde der Universität zu Köln
Cologne, 50924
MVZ Prof. Neuhann
Munich, 80637
About this study
Official title: A Prospective Open-label, Multicenter Clinical Investigation to Assess the Safety and Performance of ARGOS-IO System in Patients Undergoing Implantation of a Boston Keratoprosthesis (BKPro)
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.
Read the detailed description
(see above)
- Conditions
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome, Congenital Glaucoma
- Being tested
- ARGOS-IO system
- Keywords
- Boston Keratoprosthesis
- Medical subject headings
- Graft vs Host Disease, Aniridia, Burns, Chemical, Stevens-Johnson Syndrome, Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGOS-IO systemDevice
Also called ARGOS-IO pressure sensor implant
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.
| Study group | Role | What they receive |
|---|---|---|
| ARGOS-IO system | Experimental | The ARGOS-IO system is a non-European Community (CE) marked investigational medical device composed of the implant and its accessories.
Implant: ARGOS-IO pressure sensor implant for sulcus placement or transcleral fixation
Accessories: MESOGRAPH reading device, Implant Injector Receives: Device: ARGOS-IO system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE)
Number of patients experiencing a device-related SAE (SADE).
Measured: Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.
Performance: Performance of the ARGOS-IO System Compared to Manometry
Consistency between manometric and telemetric IOP obtained by the ARGOS-IO system.
Measured: Assessed at visits Week 4, Week 16, Week 28 and Week 52, final status at Week 52 reported.
Secondary outcomes (3)
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.]
Measured: Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.
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.
Measured: Assessed at visits from Day 1 through Week 52, final status at Week 52 reported.
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.
Measured: Assessed at visit Week 52, final status at Week 52 reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startMar 2015
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Implandata Ophthalmic Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Neuhann, Prof. MD, Principal investigator, MVZ Prof. Neuhann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945176
- Sponsor's protocol ID
- ARGOS-KP01
- Other IDs
- CIV-14-09-012725
- Status last verified
- Feb 2025
- First submitted
- 7 Sep 2016
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open-label, Multicenter Clinical Investigation to Assess the Safety and Performance of ARGOS-IO System in Patients Undergoing Implantation of a Boston Keratoprosthesis (BKPro)
- ClinicalTrials.gov ID
- NCT02945176
- Acronym / sponsor ID
- ARGOS-KP01
- Conditions
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome, Congenital Glaucoma
- Keywords
- Boston Keratoprosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Implandata Ophthalmic Products GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Posted 27 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARGOS-IO system | Experimental | Device: ARGOS-IO systemThe ARGOS-IO system is a non-European Community (CE) marked investigational medical device composed of the implant and its accessories. Implant: ARGOS-IO pressure sensor implant for sulcus placement or transcleral fixation Accessories: MESOGRAPH reading device, Implant Injector |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged ≥ 18 and ≤ 80 years on the day of screening
- 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.
- Axial length > 21 mm
- Ability and willingness to attend all scheduled visits and comply with all study procedures
Key exclusion criteria (16 listed)
- Reasonable chance of success with traditional keratoplasty
- Current retinal detachment
- Connective tissue diseases
- 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
- History of ocular or periocular malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARGOS-IO systemAlso: ARGOS-IO pressure sensor implantThis 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. | Device | ARGOS-IO system |
Primary outcome
Safety and Tolerability: 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.
Number of patients experiencing a device-related SAE (SADE).
Performance: Performance of the ARGOS-IO System Compared to Manometry
Time frame: 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.
3 secondary outcomes
Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
Time frame: Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.
Performance: Correlation Between Finger Palpation and the ARGOS-IO System
Time frame: Assessed at visits from Day 1 through Week 52, final status at Week 52 reported.
Usability: User Acceptance at Home
Time frame: Assessed at visit Week 52, final status at Week 52 reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Telemetric Intraocular Pressure Monitoring after Boston Keratoprosthesis Surgery Using the Eyemate-IO Sensor: Dynamics in the First YearLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Neuhann, Prof. MD principal investigator
MVZ Prof. Neuhann
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARGOS-IO system in people with Graft vs Host Disease and Congenital Aniridia, run by Implandata Ophthalmic Products GmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.