Cortical visual prosthesis development for the blind
Official title: Pilot Study for the Development of a Cortical Visual Neuroprosthesis for the Blind Based on Intracortical Microelectrodes
Run by Universidad Miguel Hernandez de Elche · NCT02983370 · Data updated 2026-11-12
This study is testing a new device that uses tiny electrodes to help people who are profoundly blind gain a limited sense of vision.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 5 (estimated) |
| Sponsor | Universidad Miguel Hernandez de Elche Academic / other |
| Locations | 2 sites (Elche, Alicante and 1 other locations) |
| Status | Recruiting |
| Started | October 1, 2019 |
| Main results expected | December 2027 |
| Study ends | October 2028 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT02983370 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with severe bilateral visual impairment and no significant health issues that could complicate the procedure.
✕Probably not a fit
Patients with intact visual pathways or those with psychiatric disorders may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of a cortical visual prosthesis using intracortical microelectrodes to provide a limited sense of vision to individuals who are profoundly blind. It focuses on patients with severe visual impairment where traditional treatments have failed, particularly those with conditions like glaucoma or optic nerve atrophy. The pilot study will assess both the safety and efficacy of this innovative approach, which leverages advances in neuroscience and technology to restore vision. Participants will undergo a minicraniotomy as part of the intervention.
Why it matters
Potential benefit: If successful, this could provide a new means of vision restoration for profoundly blind patients, significantly improving their quality of life.
How similar studies have gone: While there have been successful studies on retinal prostheses, the approach of using cortical visual prostheses is still largely novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is capable and willing to provide informed consent for participation in the trial. * Severe visual impairment with bilateral visual loss. * Greater than 18 years of age. * General health: excellent. * Following a general physical and neurological examination, patient must have normal serum electrolytes, C-reactive protein, complete blood count and PT and PTT. * No history of stroke, seizure, coagulopathy, cardiac arrhythmias or ischemia, pulmonary, hepatic or renal disease, nor transmissible viruses such as hepatitis or HIV. * Stable dose of current regular medication for at least four weeks prior to trial entry. * Able to perform the study during the full time period of up to 6 months. Special consideration will be given to patients with (1) detailed medical histories, including documentation of the onset, mechanism and evolution of the blindness; (2) lower risks associated with surgery; and (3) no psychiatric disorders or other mental disabilities. Exclusion Criteria: * Age \<18 or \>70. * Period of appropriate visual functions \< 12 years /lifetime. * For medical reasons: Individuals with a history of seizure disorders, coagulopathy, cardiac arrythmias or ischemia, pulmonary, hepatic or renal disease, and any other neurological disorder. Patients who carry a transmissible virus such as hepatitis and individuals with HIV-related neuropathies. * Vulnerable subject groups (e.g., pregnant women, prisoners, etc.). * Persons unable to give written informed consent prior to participation in the study. * Not able to perform the study during the full time period (at least 3 months). * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Where it's running
-
Hospital IMED Elche
Elche, Alicante, Spain Recruiting -
Universidad Miguel Hernandez de Elche
Elche, Alicante, Spain Recruiting
Study contacts
- Principal investigator: Eduardo Fernandez, MD and PhD — Universidad Miguel Hernandez de Elche
- Study coordinator: Eduardo Fernandez, MD and PhD
- Email: e.fernandez@umh.es
- Phone: +34 965222001
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.