IRIS PILOT - Extended Pilot Study With a Retinal Implant System

March 2, 2010 updated by: Intelligent Medical Implants GmbH

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intelligent Medical Implants GmbH

Investigators

  • Principal Investigator: Gisbert Richard, Prof., Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 25, 2007

First Posted (Estimate)

January 26, 2007

Study Record Updates

Last Update Posted (Estimate)

March 3, 2010

Last Update Submitted That Met QC Criteria

March 2, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP-80-00-00-00-01-V01
  • SP-80-00-00-00-02-V01 (Other Identifier: IMI Intelligent Medical Implants GmbH)
  • SP-80-00-00-00-03-V01 (Other Identifier: IMI Intelligent Medical Implants GmbH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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