Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT02983370

Development of a Cortical Visual Neuroprosthesis for the Blind

Led by Universidad Miguel Hernandez de Elche · Updated on 2026-05-05

5

Participants Needed

2

Research Sites

469 weeks

Total Duration

On this page

Sponsors

U

Universidad Miguel Hernandez de Elche

Lead Sponsor

H

Hospital IMED Elche

Collaborating Sponsor

AI-Summary

What this Trial Is About

The objective of this study is to evaluate the usefulness of a cortical visual prosthesis based on intracortical microelectrodes to provide a limited but useful sense of vision to profoundly blind. This pilot study will provide important information on safety and efficacy for the development of an useful cortical visual neuroprosthesis for the blind.

CONDITIONS

Official Title

Development of a Cortical Visual Neuroprosthesis for the Blind

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Age less than 18 or greater than 70.
  • Period of appropriate visual functions less than 12 years during lifetime.
  • History of seizure disorders, coagulopathy, cardiac arrhythmias 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 such as pregnant women and prisoners.
  • Persons unable to give written informed consent prior to participation.
  • Not able to perform the study during the full time period (at least 3 months).
  • Any other significant disease or disorder which may put the participant at risk, influence study results, or limit participation.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Hospital IMED Elche

Elche, Alicante, Spain, 03202

Actively Recruiting

2

Universidad Miguel Hernandez de Elche

Elche, Alicante, Spain, 03202

Actively Recruiting

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Research Team

E

Eduardo Fernandez, MD and PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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