Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial aims to test the safety and feasibility of using a non-invasive ultrasound device to stimulate retinal nerve cells and restore vision in patients with age-related macular degeneration. Previous studies have shown that artificial stimulation, such as electric and optic stimulations, can partially restore vision, but these methods are invasive and pose surgical risks. The study aims to develop a non-invasive method for retinal stimulation. The investigators will follow the FDA guidelines to limit the ultrasound power and adhere to all clinical trial regulations to ensure all participants' safety.
The main questions the investigators aim to answer are:
Participants in this study will be asked to undergo Optical Coherence Tomography (OCT) scanning before and after the ultrasound stimulation to evaluate the device's safety. Then, they will receive five stimulation-rest cycles and complete a questionnaire to report what they see and how they feel during the device's operation.
This clinical trial aims to evaluate the efficacy and safety of a new non-invasive ultrasound retinal stimulation device for vision restoration in patients with age-related macular degeneration. The investigators will take the following measures:
Participants will receive stimulation from the non-invasive ultrasound device for five cycles and complete a questionnaire about their experiences. The researchers will analyze the results to determine the efficacy and safety of the device.
With these measures in place, The investigators believe that the study design and methodology are appropriate and will result in a low-risk study that meets the FDA's requirements for clinical trials.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Experimental | Stimulation of the ultrasound retinal stimulation Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive ultrasound retinal stimulation Device | Device | Record user feelings during the device is working |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual function-Assessed by Questionnaire | A questionnaire will be given to participants. The answers will be recorded as "No" or "Yes." If "Yes" is selected as the participant's answer, their descriptions according to the given questions will be recorded in detail. | 2 hours (average duration of procedure) |
| Adverse Event | The nature and number of Treatment-Related Adverse Events. | From time of procedure up to 2 hours after process completion |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort Level-Assessed by Questionnaire | A scale of 0 to 5 will be provided to the participants. 0 is no feeling, and 5 is very pain or uncomfortable | 2 hours (average duration of procedure) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qifa Zhou, PhD | Contact | (213) 821-2649 | qifazhou@usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Qifa Zhou, PhD | University of Southern California | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29916253 | Background | Ye J, Tang S, Meng L, Li X, Wen X, Chen S, Niu L, Li X, Qiu W, Hu H, Jiang M, Shang S, Shu Q, Zheng H, Duan S, Li Y. Ultrasonic Control of Neural Activity through Activation of the Mechanosensitive Channel MscL. Nano Lett. 2018 Jul 11;18(7):4148-4155. doi: 10.1021/acs.nanolett.8b00935. Epub 2018 Jun 19. | |
| 18550876 | Background |
| Label | URL |
|---|---|
| Noninvasive Ultrasound Retinal Stimulation for Vision Restoration at High Spatiotemporal Resolution | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
Not provided
Not provided
Tremendous development has been achieved in the matrix ultrasound transducer. The investigators build the signal element ultrasound transducer to provide a stable energy release to stimulate a particular area. The investigators can limit the ultrasound focus to a minor point. The neuron activities induced by the focused 3 Megahertz (MHz) transducers have shown a spatial resolution of 250±50 µm. According to previous study, the Intensity Spatial-Peak Pulse-Average (ISPPA.3) is 26 (Under FDA suggestion of 28).
Not provided
Not provided
Not provided
Not provided
| Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N Engl J Med. 2008 Jun 12;358(24):2606-17. doi: 10.1056/NEJMra0801537. No abstract available. |
| 28237413 | Background | Chaumet-Riffaud AE, Chaumet-Riffaud P, Cariou A, Devisme C, Audo I, Sahel JA, Mohand-Said S. Impact of Retinitis Pigmentosa on Quality of Life, Mental Health, and Employment Among Young Adults. Am J Ophthalmol. 2017 May;177:169-174. doi: 10.1016/j.ajo.2017.02.016. Epub 2017 Feb 22. |
| 5757022 | Background | Brandolin P, Martinelli G, Zanoni A. [Possibilities of use of neuroleptoanalgesic drugs of type II (dehydrobenzoperidol and fentanyl) in emergency abdominal surgery in aged patients]. Acta Anaesthesiol. 1968;19:Suppl 4:93+. No abstract available. Italian. |
| 26934261 | Background | Chou R, Dana T, Bougatsos C, Grusing S, Blazina I. Screening for Impaired Visual Acuity in Older Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2016 Mar 1;315(9):915-33. doi: 10.1001/jama.2016.0783. |
| 13315967 | Background | TASSICKER GE. Preliminary report on a retinal stimulator. Br J Physiol Opt. 1956 Apr;13(2):102-5. No abstract available. |
| 13129543 | Background | Humayun MS, Weiland JD, Fujii GY, Greenberg R, Williamson R, Little J, Mech B, Cimmarusti V, Van Boemel G, Dagnelie G, de Juan E. Visual perception in a blind subject with a chronic microelectronic retinal prosthesis. Vision Res. 2003 Nov;43(24):2573-81. doi: 10.1016/s0042-6989(03)00457-7. |
| 20881025 | Background | Ahuja AK, Dorn JD, Caspi A, McMahon MJ, Dagnelie G, Dacruz L, Stanga P, Humayun MS, Greenberg RJ; Argus II Study Group. Blind subjects implanted with the Argus II retinal prosthesis are able to improve performance in a spatial-motor task. Br J Ophthalmol. 2011 Apr;95(4):539-43. doi: 10.1136/bjo.2010.179622. Epub 2010 Sep 29. |
| 27453256 | Background | da Cruz L, Dorn JD, Humayun MS, Dagnelie G, Handa J, Barale PO, Sahel JA, Stanga PE, Hafezi F, Safran AB, Salzmann J, Santos A, Birch D, Spencer R, Cideciyan AV, de Juan E, Duncan JL, Eliott D, Fawzi A, Olmos de Koo LC, Ho AC, Brown G, Haller J, Regillo C, Del Priore LV, Arditi A, Greenberg RJ; Argus II Study Group. Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial. Ophthalmology. 2016 Oct;123(10):2248-54. doi: 10.1016/j.ophtha.2016.06.049. Epub 2016 Jul 21. |
| 33268865 | Background | Lu Y, Brommer B, Tian X, Krishnan A, Meer M, Wang C, Vera DL, Zeng Q, Yu D, Bonkowski MS, Yang JH, Zhou S, Hoffmann EM, Karg MM, Schultz MB, Kane AE, Davidsohn N, Korobkina E, Chwalek K, Rajman LA, Church GM, Hochedlinger K, Gladyshev VN, Horvath S, Levine ME, Gregory-Ksander MS, Ksander BR, He Z, Sinclair DA. Reprogramming to recover youthful epigenetic information and restore vision. Nature. 2020 Dec;588(7836):124-129. doi: 10.1038/s41586-020-2975-4. Epub 2020 Dec 2. |
| 30166265 | Background | Fomenko A, Neudorfer C, Dallapiazza RF, Kalia SK, Lozano AM. Low-intensity ultrasound neuromodulation: An overview of mechanisms and emerging human applications. Brain Stimul. 2018 Nov-Dec;11(6):1209-1217. doi: 10.1016/j.brs.2018.08.013. Epub 2018 Aug 23. |
| 27252349 | Background | Liu SH, Lai YL, Chen BL, Yang FY. Ultrasound Enhances the Expression of Brain-Derived Neurotrophic Factor in Astrocyte Through Activation of TrkB-Akt and Calcium-CaMK Signaling Pathways. Cereb Cortex. 2017 Jun 1;27(6):3152-3160. doi: 10.1093/cercor/bhw169. |
| 30157786 | Background | Chen Y, Shi Z, Shen Y. Eye damage due to cosmetic ultrasound treatment: a case report. BMC Ophthalmol. 2018 Aug 29;18(1):214. doi: 10.1186/s12886-018-0891-2. |
| 36343006 | Result | Lu G, Qian X, Gong C, Ji J, Thomas BB, Humayun MS, Zhou Q. Ultrasound Retinal Stimulation: A Mini-Review of Recent Developments. IEEE Trans Ultrason Ferroelectr Freq Control. 2022 Dec;69(12):3224-3231. doi: 10.1109/TUFFC.2022.3220568. Epub 2022 Nov 24. |
| D058499 |
| Retinal Dystrophies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |