IRIS PILOT - Extended Pilot Study With a Retinal Implant System
Primary Purpose
Retinitis Pigmentosa, Cone-Rod Dystrophy, Choroideremia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Retinal Implant System (IRIS)
Sponsored by
About this trial
This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Visual Perception, Retina, Light, Retinitis Pigmentosa, Visual acuity, Retinal Implant, Electrical stimulation
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- 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)
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Secondary goals of this study phase are: Further evaluation of stimulation parameters, Light localization with use of camera, Safety verification of stimulation parameters
Full Information
NCT ID
NCT00427180
First Posted
January 25, 2007
Last Updated
March 2, 2010
Sponsor
Intelligent Medical Implants GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00427180
Brief Title
IRIS PILOT - Extended Pilot Study With a Retinal Implant System
Official Title
Extended Pilot Study to Evaluate Pattern Recognition With a Chronic Retinal Implant System
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Intelligent Medical Implants GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa, Cone-Rod Dystrophy, Choroideremia
Keywords
Visual Perception, Retina, Light, Retinitis Pigmentosa, Visual acuity, Retinal Implant, Electrical stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Retinal Implant System (IRIS)
Other Intervention Name(s)
IRIS
Intervention Description
AIMD - Active Implantable Medical Device designed for artificial electrical neural stimulation of photoreceptor degenerated retina
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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
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
Exclusion Criteria
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisbert Richard, Prof.
Organizational Affiliation
Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
15876648
Citation
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.
Results Reference
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IRIS PILOT - Extended Pilot Study With a Retinal Implant System
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