Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy

NCT02670980 | Completed

• 1 other identifier: CPP1
• Study Type: interventional
• Target: 10
• Locations: 5 countries
• Sites: 9

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.

Conditions

Retinitis Pigmentosa; Cone Rod Dystrophy; Choroideremia

Keywords

Retina Implant; Visual Prosthesis

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events according to ISO14155

  All subjects undergo ophthalmological examinations in predefined intervals after implantation. Adverse event are rated to be serious or non-serious according ISO14155

  up to 36 month

Secondary Outcomes (3)

• Visual acuity

  up to 36 month

• Square localization

  up to 36 month

• Functional Vision

  up to 36 month

Study Arms (1)

Retina Implant

EXPERIMENTAL

Intelligent Retinal Implant System

Device: Intelligent Retinal Implant System

Interventions

Intelligent Retinal Implant System DEVICE

Retina Implant

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.),

Sponsors & Collaborators

• Science Corporation: lead

Study Sites (9)

Medical University of Graz

Graz, 8036, Austria

Location

Clinique Ophtalmologique du CHU de Nantes

Nantes, 44000, France

Location

CHU Nimes, Service Ophtalmologie (France)/ Hopital Gui de Chauliac, CHU Montpelier, (France)

Nîmes, 30029, France

Location

Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild

Paris, 75012, France

Location

Dept. of Ophthalmology, University of Bonn

Bonn, 53127, Germany

Location

Universitäts KlinikumKlinik für Augenheilkunde Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Klinik und Poliklinik für Augenheilkunde Hamburg -Eppendorf

Hamburg, 20246, Germany

Location

Instituto de Microcirugia Ocular

Barcelona, 08035, Spain

Location

Moorfields Eye Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Retinitis Pigmentosa; Cone-Rod Dystrophies; Choroideremia

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Choroid Diseases; Uveal Diseases; Genetic Diseases, X-Linked

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: February 2, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); DE (3); AU (1); GB (1); ES (1)