Retinitis PigmentosaNCT00427180
IRIS PILOT - Extended Pilot Study With a Retinal Implant System
A study testing Retinal Implant System (IRIS) in people with Retinitis Pigmentosa and Cone-Rod Dystrophy, run by Intelligent Medical Implants GmbH.
Trial summary
Investigate whether blind subjects that fulfil the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Retinitis Pigmentosa, Cone-Rod Dystrophy, Choroideremia
- What is being tested?
- Retinal Implant System (IRIS)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 79 years at the date of enrollment
- Normal hearing and linguistic understanding (with hearing aids if - necessary and in the language of the hospital or in English)
- Ability to understand the study and procedures involved
- Willingness to participate and comply with follow-up procedures
- Good general health based on investigator's opinion
- Ability to undergo surgery using general anaesthesia
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- Signed informed consent
- RP, choroideremia, or rod cone dystrophy
- Visual field less than 40 ° (if measurable)
- Visual acuity not better than (1/50), (logMAR≥1.7)
- Visual function stable for a duration of at least one year (according to subject statement)
- Normal eye pressure (9-21 mmHg)
- Bulbus length (AP) between 21 and 25 mm
Who cannot join
- Allergic response to multiple antibiotics
- Known allergies to materials of the implant
- Known carrier of multi-resistant organisms
- Pregnancy or lactating
- History of epileptic seizures
- Having active implantable devices (or need within the next 3 years)
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- Patients with cancer or patients received cancer therapy within the last 2 years
- Currently undergoing psychiatric treatment without expert opinion approving participation on the study
- Patients having insufficient mental capacity
- Neurological diseases, in particular those affecting nerve conduction velocities
- Patients currently taking medications affecting brain function
- Immunosuppressive subjects
About this study
Official title: Extended Pilot Study to Evaluate Pattern Recognition With a Chronic Retinal Implant System
Investigate whether blind subjects that fulfil the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross.
Read the detailed description
The Retinal Implant System consists of three main components, the Retinal Stimulator, which is the component actually implanted into the eye, the visual interface, and the Pocket Processor The Retinal Stimulator will be implanted into the eye of a blind subject during a surgical operation. However, the external components are activated only during the test sessions under the control of the investigator team. In a first step of the investigation a software controlled system on a PC which is connected to the Pocket Processor via Ethernet interface, will generate the defined stimulation patterns (bars, crosses, cubes). During the test session, the blind subject is exposed to a series of these stimulation patterns and he / she has to describe the visual perceptions. Based on his descriptions and in an interactive way, the stimulation signal is subsequently be modulated by changing parameters like amplitude, duration of impulse, polarity, number of repetitions or pulse frequency on the PC.
In a second step the visual interface is equipped with a camera which presents realtime images to the subject. Data obtained from the investigation with computer generated patterns in the first step are used in the second step to improve the fitting software for the use in the camera supported system.
Finally the system should enable the subject to recognize simple images supported from the camera.
- Conditions
- Retinitis Pigmentosa, Cone-Rod Dystrophy, Choroideremia
- Being tested
- Retinal Implant System (IRIS)
- Keywords
- Visual Perception, Retina, Light, Retinitis Pigmentosa, Visual acuity, Retinal Implant, Electrical stimulation
- Medical subject headings
- Retinitis Pigmentosa, Cone-Rod Dystrophies, Choroideremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal Implant System (IRIS)Device
Also called IRIS
AIMD - Active Implantable Medical Device designed for artificial electrical neural stimulation of photoreceptor degenerated retina
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate whether blind subjects that fulfill the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross.
Measured: 18 months
Secondary outcomes (1)
Secondary goals of this study phase are: Further evaluation of stimulation parameters, Light localization with use of camera, Safety verification of stimulation parameters
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionNov 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intelligent Medical Implants GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gisbert Richard, Prof., Principal investigator, Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427180
- Sponsor's protocol ID
- SP-80-00-00-00-01-V01
- Other IDs
- SP-80-00-00-00-02-V01, SP-80-00-00-00-03-V01
- Status last verified
- Mar 2010
- First submitted
- 25 Jan 2007
- Last updated
- 3 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hornig R, Laube T, Walter P, Velikay-Parel M, Bornfeld N, Feucht M, Akguel H, Rossler G, Alteheld N, Lutke Notarp D, Wyatt J, Richard G. A method and technical equipment for an acute human trial to evaluate retinal implant technology. J Neural Eng. 2005 Mar;2(1):S129-34. doi: 10.1088/1741-2560/2/1/014. Epub 2005 Feb 22.
PubMed 15876648
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Pilot Study to Evaluate Pattern Recognition With a Chronic Retinal Implant System
- ClinicalTrials.gov ID
- NCT00427180
- Acronym / sponsor ID
- SP-80-00-00-00-01-V01
- Conditions
- Retinitis Pigmentosa, Cone-Rod Dystrophy, Choroideremia
- Keywords
- Visual Perception, Retina, Light, Retinitis Pigmentosa, Visual acuity, Retinal Implant, Electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Intelligent Medical Implants GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 26 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate whether blind subjects that fulfil the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross.
Detailed description
The Retinal Implant System consists of three main components, the Retinal Stimulator, which is the component actually implanted into the eye, the visual interface, and the Pocket Processor The Retinal Stimulator will be implanted into the eye of a blind subject during a surgical operation. However, the external components are activated only during the test sessions under the control of the investigator team. In a first step of the investigation a software controlled system on a PC which is connected to the Pocket Processor via Ethernet interface, will generate the defined stimulation patterns (bars, crosses, cubes). During the test session, the blind subject is exposed to a series of these stimulation patterns and he / she has to describe the visual perceptions. Based on his descriptions and in an interactive way, the stimulation signal is subsequently be modulated by changing parameters like amplitude, duration of impulse, polarity, number of repetitions or pulse frequency on the PC.
In a second step the visual interface is equipped with a camera which presents realtime images to the subject. Data obtained from the investigation with computer generated patterns in the first step are used in the second step to improve the fitting software for the use in the camera supported system.
Finally the system should enable the subject to recognize simple images supported from the camera.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age between 30 and 79 years at the date of enrollment
- Normal hearing and linguistic understanding (with hearing aids if - necessary and in the language of the hospital or in English)
- Ability to understand the study and procedures involved
- Willingness to participate and comply with follow-up procedures
- Good general health based on investigator's opinion
Key exclusion criteria (12 listed)
- Allergic response to multiple antibiotics
- Known allergies to materials of the implant
- Known carrier of multi-resistant organisms
- Pregnancy or lactating
- History of epileptic seizures
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 |
|---|---|---|
| Retinal Implant System (IRIS)Also: IRISAIMD - Active Implantable Medical Device designed for artificial electrical neural stimulation of photoreceptor degenerated retina | Device | – |
Primary outcome
Investigate whether blind subjects that fulfill the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross.
Time frame: 18 months
1 secondary outcome
Secondary goals of this study phase are: Further evaluation of stimulation parameters, Light localization with use of camera, Safety verification of stimulation parameters
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2010.
- Background: PubMed 15876648Hornig R, Laube T, Walter P, Velikay-Parel M, Bornfeld N, Feucht M, Akguel H, Rossler G, Alteheld N, Lutke Notarp D, Wyatt J, Richard G. A method and technical equipment for an acute human trial to evaluate retinal implant technology. J Neural Eng. 2005 Mar;2(1):S129-34. doi: 10.1088/1741-2560/2/1/014. Epub 2005 Feb 22.
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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.
Gisbert Richard, Prof. principal investigator
Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf
Questions about this trial
What is this clinical trial studying?
A study testing Retinal Implant System (IRIS) in people with Retinitis Pigmentosa and Cone-Rod Dystrophy, run by Intelligent Medical Implants GmbH.
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 13 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 3 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Investigate whether blind subjects that fulfill the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00427180, which also lists 1 linked publication.
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 3 Mar 2010.