IRIS PILOT - Extended Pilot Study With a Retinal Implant System
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Retinitis Pigmentosa Cone-Rod Dystrophy Choroideremia |
Device: Retinal Implant System (IRIS) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Extended Pilot Study to Evaluate Pattern Recognition With a Chronic Retinal Implant System |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
-
Device: Retinal Implant System (IRIS)
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.
Eligibility| Ages Eligible for Study: | 30 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Intelligent Medical Implants GmbH, Medical device industry |
| ClinicalTrials.gov Identifier: | NCT00427180 History of Changes |
| Other Study ID Numbers: | SP-80-00-00-00-01-V01, SP-80-00-00-00-02-V01, SP-80-00-00-00-03-V01 |
| Study First Received: | January 25, 2007 |
| Last Updated: | March 2, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Switzerland: Swissmedic Austria: Federal Office for Safety in Health Care |
Keywords provided by Intelligent Medical Implants GmbH:
|
Visual Perception Retina Light Retinitis Pigmentosa |
Visual acuity Retinal Implant Electrical stimulation |
Additional relevant MeSH terms:
|
Choroideremia Retinitis Retinitis Pigmentosa Eye Diseases, Hereditary Eye Diseases Choroid Diseases |
Uveal Diseases Genetic Diseases, Inborn Genetic Diseases, X-Linked Retinal Diseases Retinal Dystrophies Retinal Degeneration |
ClinicalTrials.gov processed this record on June 18, 2013