Status:
UNKNOWN
IRIS PILOT - Extended Pilot Study With a Retinal Implant System
Lead Sponsor:
Intelligent Medical Implants GmbH
Conditions:
Retinitis Pigmentosa
Cone-Rod Dystrophy
Eligibility:
All Genders
30-79 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00427180
Start Date
December 1 2006
End Date
December 1 2010
Last Update
March 3 2010
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