Clinical Trial of a Retinal Prosthesis System Using Suprachoroidal-Transretinal Stimulation (STS) for Advanced Outer Retinal Degeneration
Clinical Trial of a Retinal Prosthesis System Using Suprachoroidal-Transretinal Stimulation (STS) for Advanced Outer Retinal Degeneration
Fujikado Takashi
-
34-14 Maehama, Hiroishi-cho, Gamagori-shi, Aichi
+81-533-67-8904
clinical-trials@nidek.co.jp
Ichimura Tadakazu
NIDEK CO., LTD.
34-14 Maehama, Hiroishi-cho, Gamagori-shi, Aichi
+81-533-67-8904
clinical-trials@nidek.co.jp
Recruiting
Jan. 23, 2026
6
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
(1) Patients who have an eye meeting all of the following conditions
1.An eye diagnosed by the principal investigator and sub - investigator as having outer retinal degeneration (including hereditary retinal diseases such as retinitis pigmentosa and related disorders).
2.An eye in which the retinal potential is absent on electroretinogram (ERG).
3.An eye that perceives a phosphene at a current intensity of up to 1.5 mA during transcorneal electrical stimulation (TES) testing.
4.An eye that cannot distinguish a white target against a gray background during reach-to-grasp movement.
(2) Patients whose corrected visual acuity in both eyes is at the level of hand motion or worse.
(3) Patients who have no serious diseases other than ocular disorders and are not undergoing treatment for any other conditions.
(4) Patients who are able to perform daily indoor activities independently.
(5) Patients who can visit the hospital regularly for follow-up examinations after implantation surgery.
(6) Patients who have family members or others who can provide daily living support during participation in the study.
(7) Patients aged 25 years or older at the time of consent (gender not restricted).
(8) Patients who have provided written informed consent to participate in the study; a witness must be present at the time of consent.
(1) Patients who have an eye meeting any of the following conditions
1.An eye that is currently affected by or has a history of retinal or optic nerve diseases other than the present condition-such as glaucoma or retinal detachment-and is considered to significantly contribute to the current decline in visual function.
2.An eye diagnosed with cancer-associated retinopathy.
3.An eye considered to have active corneal or conjunctival disease (inflammation or infection).
(2) Patients in whom intracranial diseases such as cerebral aneurysm cerebral infarction or brain tumor have been confirmed by head MRI examination.
(3) Patients with active implantable medical devices in the body such as cochlear implants or pacemakers.
(4) Pregnant or breastfeeding women female patients who wish to become pregnant during the study period or female patients who cannot comply with the physicians instructions regarding contraception.
(5) Patients with epilepsy or a history of epilepsy.
(6) Patients with a history of hypersensitivity to metals (materials of the investigational device: gold platinum titanium etc.).
(7) Patients corresponding to contraindications for fluorescein injection solution.
(8) Patients who due to cognitive impairment intellectual disability or psychiatric disorders are judged by the principal investigator or sub-investigator to have difficulty in correctly understanding the significance of the study and complying with study requirements.
(9) Patients who are participating in clinical trials of other drugs medical devices or regenerative medical products.
(10) Any other patients deemed unsuitable for participation by the principal investigator or sub-investigator.
25age old over
No limit
Both
Patients with severe outer retinal degeneration
Implant an retinal prosthesisartificial retinal system in the eye and within the cranium
Reach-to-grasp movement: Accuracy of target position recognition
- Comparison between preoperative and postoperative Year 1 (Week 52) with the power switch ON: Non-operated eye covered with an eye mask.
Efficacy Endpoints
(1) Reach-to-grasp movement
- Comparison between preoperative and postoperative Year 1 (Week 52) with the power switch OFF: Non-operated eye covered with an eye mask
- Comparison at postoperative Year 1 (Week 52) between power switch ON and OFF: Both eyes covered with eye masks
(2) Walking test
- Comparison between preoperative and postoperative Year 1 (Week 52) with the power switch ON: Non-operated eye covered with an eye mask
- Comparison between preoperative and postoperative Year 1 (Week 52) with the power switch OFF: Non-operated eye covered with an eye mask
- Comparison at postoperative Year 1 (Week 52) between power switch ON and OFF: Both eyes covered with eye masks
(3) Grating acuity
- Comparison between preoperative and postoperative Year 1 (Week 52) with the power switch ON: Non-operated eye covered with an eye mask
- Comparison between preoperative and postoperative Year 1 (Week 52) with the power switch OFF: Non-operated eye covered with an eye mask
- Comparison at postoperative Year 1 (Week 52) between power switch ON and OFF: Both eyes covered with eye masks
(4) Daily living tasks
- Comparison between preoperative and postoperative Year 1 (Week 52) with the power switch ON: Non-operated eye covered with an eye mask
- Comparison between preoperative and postoperative Year 1 (Week 52) with the power switch OFF: Non-operated eye covered with an eye mask
(5) Questionnaire survey
- Comparison between preoperative and postoperative Year 1 (Week 52)
Safety Endpoint
- Incidence of adverse events
NIDEK CO., LTD.
The Institutional Review Board, The University of Osaka Hospital
2-2 Yamadaoka, Suita-shi, Osaka, Osaka
+81-6-6210-8290
jim-chiken@hp-crc.med.osaka-u.ac.jp
Approval
Nov. 11, 2025
The Institutional Review Board, Aichi Medical University Hospital
1-1 Yazakokarimata, Nagakute-shi, Aichi, Osaka
+81-561-62-3311
chiken@aichi-med-u.ac.jp
Approval
Nov. 11, 2025
The Institutional Review Board, Kyorin University Hospital
