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About
This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V1)
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Inclusion criteria
Exclusion criteria
Has a history of severe glaucoma, uveitis, optic neuropathy or any confirmed damage to the optic nerve and/or visual cortex,
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, amyotrophc 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,
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:
Is participating in another investigational drug or device study that may interfere with the proposed treatment or the ensuring follow-up schedule, (in Germany: Is participating in another investigational drug or device study)
Has any health concern that makes general anaesthesia inadvisable, (in Germany: Patients with an ASA-Score 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
In Germany: - Patients with recurrent or chronic inflammations or infections are excluded from the study. Specifically patients with the following disorders are excluded:
In Germany: - Has severe renal, cardiac, hepatic etc. organ diseases
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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