Status:

RECRUITING

Development of a Cortical Visual Neuroprosthesis for the Blind

Lead Sponsor:

Universidad Miguel Hernandez de Elche

Collaborating Sponsors:

Hospital IMED Elche

Conditions:

Blindness

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

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. Th...

Detailed Description

Visual impairment is one of the ten most prevalent disabilities and poses extraordinary challenges to individuals in our society, which is heavily dependent on sight. Drug development and genetic engi...

Eligibility 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.

Key Trial Info

Start Date :

October 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT02983370

Start Date

October 1 2019

End Date

December 1 2025

Last Update

May 8 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Hospital IMED Elche

Elche, Alicante, Spain, 03202

2

Universidad Miguel Hernandez de Elche

Elche, Alicante, Spain, 03202