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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
Intelligent Medical Implants GmbH
About
Eligibility
Locations
Outcomes
Full info

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

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 25, 2007
    Last Updated
    March 2, 2010
    Sponsor
    Intelligent Medical Implants GmbH
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    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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