NCT00427180

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 3, 2010

Status Verified

March 1, 2010

Enrollment Period

3.9 years

First QC Date

January 25, 2007

Last Update Submit

March 2, 2010

Conditions

Retinitis PigmentosaCone-Rod DystrophyChoroideremia

Keywords

Visual PerceptionRetinaLightRetinitis PigmentosaVisual acuityRetinal ImplantElectrical stimulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    18 months

Secondary Outcomes (1)

  • Secondary goals of this study phase are: Further evaluation of stimulation parameters, Light localization with use of camera, Safety verification of stimulation parameters

    18 months

Interventions

Retinal Implant System (IRIS)DEVICE

AIMD - Active Implantable Medical Device designed for artificial electrical neural stimulation of photoreceptor degenerated retina

Also known as: IRIS

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 15876648BACKGROUND

MeSH Terms

Conditions

Retinitis PigmentosaCone-Rod DystrophiesChoroideremia

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChoroid DiseasesUveal DiseasesGenetic Diseases, X-Linked

Study Officials

  • Gisbert Richard, Prof.

    Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 26, 2007

Study Start

December 1, 2006

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

March 3, 2010

Record last verified: 2010-03