Non-invasive Ultrasound Retinal Stimulation for Vision Restoration

NCT05914233 | Not Yet Recruiting

• 1 other identifier: HS-23-00143
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

• Is using high-frequency ultrasound safe using a wearable device for localized retinal neural activity stimulation?
• Does the stimulation through the device restore vision in patients with age-related macular degeneration? 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.

Conditions

Retinitis Pigmentosa; Ultrasound Therapy; Complications; Age-Related Macular Degeneration

Keywords

Ultrasound Stimulation; Retinal; Retinitis pigmentosa; Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Comfort Level-Assessed by Questionnaire

  2 hours (average duration of procedure)

Study Arms (1)

Single

EXPERIMENTAL

Stimulation of the ultrasound retinal stimulation Device

Device: Non-invasive ultrasound retinal stimulation Device

Interventions

Non-invasive ultrasound retinal stimulation Device DEVICE

Record user feelings during the device is working

Single

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of AMD (regardless of stage and type) or RP. At least two volunteers should diagnose with RP.
• Age 18 years or older
• No other eye-related health conditions
• No allergic history to commercial ultrasound gel
• Must be willing and able to comply with the protocol testing

You may not qualify if:

• Declining to participate and inability to give informed consent.
• Unable to comply with the process of the research
• If the volunteer has optic nerve disease, including the history of glaucoma, optic neuropathy, or other confirmed damage to optic nerve or visual cortex damage
• Unable to fixate that hinders obtaining high-quality imaging
• High myopia; refractive error of six diopters and above
• Pregnancy
• Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up, or testing of this study

Sponsors & Collaborators

• University of Southern California: lead

Related Publications (14)

• 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.

  PMID: 29916253 BACKGROUND

• 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.

  PMID: 18550876 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.

  PMID: 28237413 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.

  PMID: 5757022 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.

  PMID: 26934261 BACKGROUND

• TASSICKER GE. Preliminary report on a retinal stimulator. Br J Physiol Opt. 1956 Apr;13(2):102-5. No abstract available.

  PMID: 13315967 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.

  PMID: 13129543 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.

  PMID: 20881025 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.

  PMID: 27453256 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.

  PMID: 33268865 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.

  PMID: 30166265 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.

  PMID: 27252349 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.

  PMID: 30157786 BACKGROUND

• 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.

  PMID: 36343006 RESULT

Related Links

• Noninvasive Ultrasound Retinal Stimulation for Vision Restoration at High Spatiotemporal Resolution

MeSH Terms

Conditions

Macular Degeneration; Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Eye Diseases, Hereditary; Retinal Dystrophies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Qifa Zhou, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qifa Zhou, PhD

CONTACT

(213) 821-2649; qifazhou@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 22, 2023
• Study Start (Estimated): January 10, 2027
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): July 15, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share