Safety, efficacy, and quality control of a photoelectric dye-based retinal prosthesis (Okayama University-type retinal prosthesis) as a medical device

Toshihiko Matsuo, Tetsuya Uchida, Kenichi Takarabe

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Patients with retinitis pigmentosa lose photore-ceptor cells as a result of genetic abnormalities and hence become blind. Neurons such as bipolar cells and ganglion cells remain alive even in the retina of these patients, and ganglion cells send axons to the brain as the optic nerve. The basic concept of retinal prostheses is to replace dead photoreceptor cells with artificial devices to stimulate the remaining neurons with electric currents or potentials. Pho-todiode arrays and digital camera-type electrode arrays are the two main approaches for retinal prostheses to stimulate retinal neurons, but these arrays have the problems of poor biocompatibility, low sensitivity, and low output of electric currents, and hence have a requirement for external electric sources (batteries). To overcome these problems, we are developing photoelectric dye-based retinal prostheses that absorb light and convert photon energy to generate electric potentials. The prototype, using a photoelectric dye-coupled polyethylene film, could induce intracellular calcium elevation in photoreceptor-lacking embryonic retinal tissues and cultured retinal neurons. The subretinal implantation of the prototype in the eyes of Royal College of Surgeons (RCS) rats led to vision recovery as proved by a behavior test. The photoelectric dye that was chosen for the prototype did not exhibit any cytotoxicity. The surface potentials of the photoelectric dye-coupled fi lm showed a rapid on-and-off response to illumination with a threshold for light intensity as measured by a Kelvin probe system. Photoelectric dye-based retinal prostheses are thin and soft, and therefore, a sheet of the fi lm of large size, corresponding to a large visual field, could be inserted into the vitreous and then to the subretinal space through a small opening by rolling up the film. Clinical studies of photoelectric dye-based retinal prostheses in patients with retinitis pigmentosa who lose sight will be planned after the manufacturing control and the quality control had been established for the medical device.

Original languageEnglish
Pages (from-to)213-225
Number of pages13
JournalJournal of Artificial Organs
Volume12
Issue number4
DOIs
Publication statusPublished - Dec 2009

Fingerprint

Visual Prosthesis
Quality Control
Quality control
Prosthetics
Coloring Agents
Dyes
Safety
Equipment and Supplies
Neurons
Retinal Neurons
Retinitis Pigmentosa
Electric currents
Ganglia
Light
Photoreceptor Cells
Digital cameras
Surface potential
Electric potential
Polyethylene
Cytotoxicity

Keywords

  • Electric potential
  • Kelvin probe
  • Photoelectric dye
  • Polyethylene film
  • Retinal prosthesis

ASJC Scopus subject areas

  • Biomaterials
  • Biomedical Engineering
  • Cardiology and Cardiovascular Medicine
  • Medicine (miscellaneous)
  • Medicine(all)

Cite this

@article{ccd01e134b284dc8a8a7cd0313c5f664,
title = "Safety, efficacy, and quality control of a photoelectric dye-based retinal prosthesis (Okayama University-type retinal prosthesis) as a medical device",
abstract = "Patients with retinitis pigmentosa lose photore-ceptor cells as a result of genetic abnormalities and hence become blind. Neurons such as bipolar cells and ganglion cells remain alive even in the retina of these patients, and ganglion cells send axons to the brain as the optic nerve. The basic concept of retinal prostheses is to replace dead photoreceptor cells with artificial devices to stimulate the remaining neurons with electric currents or potentials. Pho-todiode arrays and digital camera-type electrode arrays are the two main approaches for retinal prostheses to stimulate retinal neurons, but these arrays have the problems of poor biocompatibility, low sensitivity, and low output of electric currents, and hence have a requirement for external electric sources (batteries). To overcome these problems, we are developing photoelectric dye-based retinal prostheses that absorb light and convert photon energy to generate electric potentials. The prototype, using a photoelectric dye-coupled polyethylene film, could induce intracellular calcium elevation in photoreceptor-lacking embryonic retinal tissues and cultured retinal neurons. The subretinal implantation of the prototype in the eyes of Royal College of Surgeons (RCS) rats led to vision recovery as proved by a behavior test. The photoelectric dye that was chosen for the prototype did not exhibit any cytotoxicity. The surface potentials of the photoelectric dye-coupled fi lm showed a rapid on-and-off response to illumination with a threshold for light intensity as measured by a Kelvin probe system. Photoelectric dye-based retinal prostheses are thin and soft, and therefore, a sheet of the fi lm of large size, corresponding to a large visual field, could be inserted into the vitreous and then to the subretinal space through a small opening by rolling up the film. Clinical studies of photoelectric dye-based retinal prostheses in patients with retinitis pigmentosa who lose sight will be planned after the manufacturing control and the quality control had been established for the medical device.",
keywords = "Electric potential, Kelvin probe, Photoelectric dye, Polyethylene film, Retinal prosthesis",
author = "Toshihiko Matsuo and Tetsuya Uchida and Kenichi Takarabe",
year = "2009",
month = "12",
doi = "10.1007/s10047-009-0471-6",
language = "English",
volume = "12",
pages = "213--225",
journal = "Journal of Artificial Organs",
issn = "1434-7229",
publisher = "Springer Japan",
number = "4",

}

TY - JOUR

T1 - Safety, efficacy, and quality control of a photoelectric dye-based retinal prosthesis (Okayama University-type retinal prosthesis) as a medical device

AU - Matsuo, Toshihiko

AU - Uchida, Tetsuya

AU - Takarabe, Kenichi

PY - 2009/12

Y1 - 2009/12

N2 - Patients with retinitis pigmentosa lose photore-ceptor cells as a result of genetic abnormalities and hence become blind. Neurons such as bipolar cells and ganglion cells remain alive even in the retina of these patients, and ganglion cells send axons to the brain as the optic nerve. The basic concept of retinal prostheses is to replace dead photoreceptor cells with artificial devices to stimulate the remaining neurons with electric currents or potentials. Pho-todiode arrays and digital camera-type electrode arrays are the two main approaches for retinal prostheses to stimulate retinal neurons, but these arrays have the problems of poor biocompatibility, low sensitivity, and low output of electric currents, and hence have a requirement for external electric sources (batteries). To overcome these problems, we are developing photoelectric dye-based retinal prostheses that absorb light and convert photon energy to generate electric potentials. The prototype, using a photoelectric dye-coupled polyethylene film, could induce intracellular calcium elevation in photoreceptor-lacking embryonic retinal tissues and cultured retinal neurons. The subretinal implantation of the prototype in the eyes of Royal College of Surgeons (RCS) rats led to vision recovery as proved by a behavior test. The photoelectric dye that was chosen for the prototype did not exhibit any cytotoxicity. The surface potentials of the photoelectric dye-coupled fi lm showed a rapid on-and-off response to illumination with a threshold for light intensity as measured by a Kelvin probe system. Photoelectric dye-based retinal prostheses are thin and soft, and therefore, a sheet of the fi lm of large size, corresponding to a large visual field, could be inserted into the vitreous and then to the subretinal space through a small opening by rolling up the film. Clinical studies of photoelectric dye-based retinal prostheses in patients with retinitis pigmentosa who lose sight will be planned after the manufacturing control and the quality control had been established for the medical device.

AB - Patients with retinitis pigmentosa lose photore-ceptor cells as a result of genetic abnormalities and hence become blind. Neurons such as bipolar cells and ganglion cells remain alive even in the retina of these patients, and ganglion cells send axons to the brain as the optic nerve. The basic concept of retinal prostheses is to replace dead photoreceptor cells with artificial devices to stimulate the remaining neurons with electric currents or potentials. Pho-todiode arrays and digital camera-type electrode arrays are the two main approaches for retinal prostheses to stimulate retinal neurons, but these arrays have the problems of poor biocompatibility, low sensitivity, and low output of electric currents, and hence have a requirement for external electric sources (batteries). To overcome these problems, we are developing photoelectric dye-based retinal prostheses that absorb light and convert photon energy to generate electric potentials. The prototype, using a photoelectric dye-coupled polyethylene film, could induce intracellular calcium elevation in photoreceptor-lacking embryonic retinal tissues and cultured retinal neurons. The subretinal implantation of the prototype in the eyes of Royal College of Surgeons (RCS) rats led to vision recovery as proved by a behavior test. The photoelectric dye that was chosen for the prototype did not exhibit any cytotoxicity. The surface potentials of the photoelectric dye-coupled fi lm showed a rapid on-and-off response to illumination with a threshold for light intensity as measured by a Kelvin probe system. Photoelectric dye-based retinal prostheses are thin and soft, and therefore, a sheet of the fi lm of large size, corresponding to a large visual field, could be inserted into the vitreous and then to the subretinal space through a small opening by rolling up the film. Clinical studies of photoelectric dye-based retinal prostheses in patients with retinitis pigmentosa who lose sight will be planned after the manufacturing control and the quality control had been established for the medical device.

KW - Electric potential

KW - Kelvin probe

KW - Photoelectric dye

KW - Polyethylene film

KW - Retinal prosthesis

UR - http://www.scopus.com/inward/record.url?scp=77949899056&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77949899056&partnerID=8YFLogxK

U2 - 10.1007/s10047-009-0471-6

DO - 10.1007/s10047-009-0471-6

M3 - Article

VL - 12

SP - 213

EP - 225

JO - Journal of Artificial Organs

JF - Journal of Artificial Organs

SN - 1434-7229

IS - 4

ER -