Non-invasive Ultrasound Retinal Stimulation for Vision Restoration

NCT ID: NCT05914233

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-01-10
• Study Completion Date: 2028-07-15

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.

Detailed Description

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:

• The study population will consist of patients with age-related macular degeneration for whom traditional medical treatments have been ineffective and for whom there are no other viable treatment options.
• The investigators will follow the FDA guidelines and adhere to all regulations related to clinical trials to ensure the safety of all participants.
• The investigators will obtain informed consent from each participant and ensure that they fully understand the risks and benefits of the study before enrolling.
• The investigators will closely monitor each participant during the study and record any adverse events or complications.
• The investigators will use high-frequency ultrasound for localized stimulation, which is safe and effective in other studies.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single

Stimulation of the ultrasound retinal stimulation Device

Group Type: EXPERIMENTAL

Non-invasive ultrasound retinal stimulation Device

Intervention Type: DEVICE

Record user feelings during the device is working

Interventions

Non-invasive ultrasound retinal stimulation Device

Record user feelings during the device is working

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of AMD (regardless of stage and type) or RP. At least two volunteers should diagnose with RP.

2. Age 18 years or older

3. No other eye-related health conditions

4. No allergic history to commercial ultrasound gel

5. Must be willing and able to comply with the protocol testing

Exclusion Criteria

1. Declining to participate and inability to give informed consent.

2. Unable to comply with the process of the research

3. 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

4. Unable to fixate that hinders obtaining high-quality imaging

5. High myopia; refractive error of six diopters and above

6. Pregnancy

7. Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up, or testing of this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Qifa Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qifa Zhou, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Central Contacts

Qifa Zhou, PhD

Role: CONTACT

qifazhou@usc.edu

(213) 821-2649

References

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.

Reference Type: BACKGROUND

PMID: 29916253 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18550876 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28237413 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 5757022 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26934261 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 13315967 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 13129543 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20881025 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27453256 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33268865 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30166265 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27252349 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30157786 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36343006 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/37850175/

Noninvasive Ultrasound Retinal Stimulation for Vision Restoration at High Spatiotemporal Resolution

Other Identifiers

HS-23-00143

Identifier Type: -

Identifier Source: org_study_id