Development of a Cortical Visual Neuroprosthesis for the Blind

Launched by UNIVERSIDAD MIGUEL HERNANDEZ DE ELCHE · Dec 1, 2016

Keywords

ClinConnect Summary

This clinical trial is exploring a new device called a cortical visual prosthesis, which is designed to help people who are profoundly blind gain a limited but useful sense of vision. The goal is to see how safe and effective this device is for individuals with severe visual impairment. The study is currently looking for participants aged 18 and older who have significant vision loss in both eyes and are in good overall health. It’s important that participants can understand the trial and provide informed consent.

If you join this study, you will be monitored for up to six months to see how well the device works and if there are any safety concerns. The researchers are particularly interested in individuals with detailed medical histories of their blindness and those who are at lower surgical risk. However, people with certain medical conditions or those under 18 years or over 70 years old will not be eligible to participate. This trial is an exciting opportunity to potentially improve the quality of life for those affected by blindness.

Gender

ALL

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.