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Trial record 1 of 1 for:    NCT02670980
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Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy (IRIS 2)

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ClinicalTrials.gov Identifier: NCT02670980
Recruitment Status : Active, not recruiting
First Posted : February 2, 2016
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pixium Vision SA

Tracking Information
First Submitted Date  ICMJE January 4, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date April 3, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
Number of participants with treatment-related adverse events according to ISO14155 [ Time Frame: up to 36 month ]
All subjects undergo ophthalmological examinations in predefined intervals after implantation. Adverse event are rated to be serious or non-serious according ISO14155
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02670980 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
  • Visual acuity [ Time Frame: up to 36 month ]
    Measure probable benefit with square wave grating test
  • Square localization [ Time Frame: up to 36 month ]
    Measure probable by measuring the error in localizing a white square on black background.
  • Functional Vision [ Time Frame: up to 36 month ]
    Measure probable benefit e.g. by Functional Picture Assessment. The number of errors subjects make in detecting objects or persons on standardized pictures is measures. Other test may be developed during the study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy
Official Title  ICMJE Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy
Brief Summary This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or Choroideremia are implanted with an Intelligent Retinal Implant Systeme. All subjects undergo ophthalmological examinations in predefined intervals after implantation. Ophthalmological examinations include funduscopy, slit lamp examination and OCT. All adverse events are recorded and analyzed. Efficacy is measured using functional vision and visual function tests before and after implantation as well as with the system on and system off.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Retinitis Pigmentosa
  • Cone Rod Dystrophy
  • Choroideremia
Intervention  ICMJE Device: Intelligent Retinal Implant System
Study Arms  ICMJE Experimental: Retina Implant
Intelligent Retinal Implant System
Intervention: Device: Intelligent Retinal Implant System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is 25 years or older at the date of enrolment
  • Has a confirmed diagnosis of retinitis pigmentosa, choroideremia or cone-rod dystrophy
  • Has a visual acuity of logMAR 2.3 or worse in both the eyes as determined by a Square Grating scale.
  • Has functional ganglion cells and optic nerve activity
  • Has a memory of former useful form vision
  • Understands and accepts the obligation to present for all schedule follow-up visits.

Exclusion Criteria:

  • Has a history of severe glaucoma, uveitis, optic neuropathy or any confirmed damage to the optic nerve and/or visual cortex related to the projected implanted eye,
  • Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, current or prior retinal detachment, infectious or inflammatory retinal disease, etc.),
  • Has any disease or condition that prevents adequate visualization of the retina of the study eye including, but not limited to, corneal degeneration that cannot be resolved prior to implantation,
  • Has any disease or condition of the anterior segment of the study eye that prevents adequate physical examination (e.g., ocular trauma, etc.),
  • Has severe nystagmus,
  • Has any ocular condition that leads him or her to eye rubbing,
  • Has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols (e.g., deafness , multiple sclerosis, amyotrophic lateral sclerosis, neuritis, etc),
  • Has a history of epileptic seizure,
  • Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study,
  • Has a known sensitivity to the contact materials of the implant (platinum and parylene),
  • Presents with hypotony in the study eye,
  • Presents with hypertony in the study eye,
  • Is pregnant or lactating,
  • Has another active implanted device (e.g. cochlear implant) or any form of metallic implant in the head (other than dental work) that may interfere with the device function,
  • Has a diagnosis requiring an active implant (e.g., cardiac pacemaker, vagus nerve implant, etc.),
  • Has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis,
  • Is an immune-suppressed subject (e.g., due to HIV positive diagnosis, etc.),
  • Is carrier of multi-resistant germs,
  • Requires the use of any of the following medications:

    • Antimetabolites,
    • Thrombocyte aggregation reducing therapies (10 days prior until 3 days after surgery),
    • Oral anticoagulants (5 days before until 3 days after surgery),
  • Is participating in another investigational drug or device study,
  • Has any health concern that makes general anaesthesia inadvisable; Patients with an ASA-Score (or equivalent) of 3 or higher are excluded from the study,
  • Is likely requiring MRI scans subsequent to implantation and prior to explantation,
  • Is likely requiring therapeutic ultrasound subsequent to implantation and prior to explantation of the Retinal Implant.
  • Patients with recurrent or chronic inflammations or infections are excluded from the study. Specifically patients with the following disorders are excluded:

    • Common inflammation - severe chronic and consuming diseases that frequently associated with infection (e.g. Crohn disease, Whipple's disease)
    • Chronic inflammation of the skin in the area of the eye (e.g. dermatitis, rosacea, infection of the skin, herpes zoster)
    • Chronic inflammation in the area of the eye (e.g. herpes of cornea and/or conjunctiva, recurrent blepharoconjunctivitis, hordeolum, chalazion)
  • Has a severe psychological disorder. When in any doubt, an expert assessment needs to be arranged to clarify whether the patient's psychological health is suitable for the trial.
  • Has severe renal, cardiac, hepatic etc. organ diseases.
  • Has eye AP dimension that are incompatible (less than 20.5 or larger than 25mm) with the implant or head dimension that are incompatible with the Visual Interface. Please make sure that the size of the eye socket allows an implantation of the extra ocular part which has a thickness of 5mm.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   France,   Germany,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02670980
Other Study ID Numbers  ICMJE CPP1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pixium Vision SA
Study Sponsor  ICMJE Pixium Vision SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pixium Vision SA
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP