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Non-invasive Ultrasound Retinal Stimulation for Vision Restoration

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-invasive ultrasound retinal stimulation Device
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Ultrasound Stimulation, Retinal, Retinitis pigmentosa, Age-Related Macular Degeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single

    Arm Description

    Stimulation of the ultrasound retinal stimulation Device

    Outcomes

    Primary Outcome Measures

    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.
    Adverse Event
    The nature and number of Treatment-Related Adverse Events.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    May 8, 2023
    Last Updated
    June 19, 2023
    Sponsor
    University of Southern California
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05914233
    Brief Title
    Non-invasive Ultrasound Retinal Stimulation for Vision Restoration
    Official Title
    Revolutionary Non-Invasive Ultrasound Technology for Vision Restoration in Age-Related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP) Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 15, 2023 (Anticipated)
    Primary Completion Date
    July 15, 2024 (Anticipated)
    Study Completion Date
    July 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Southern California

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Age-Related Macular Degeneration, Retinitis Pigmentosa, Ultrasound Therapy; Complications
    Keywords
    Ultrasound Stimulation, Retinal, Retinitis pigmentosa, Age-Related Macular Degeneration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    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).
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single
    Arm Type
    Experimental
    Arm Description
    Stimulation of the ultrasound retinal stimulation Device
    Intervention Type
    Device
    Intervention Name(s)
    Non-invasive ultrasound retinal stimulation Device
    Intervention Description
    Record user feelings during the device is working
    Primary Outcome Measure Information:
    Title
    Visual function-Assessed by Questionnaire
    Description
    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.
    Time Frame
    2 hours (average duration of procedure)
    Title
    Adverse Event
    Description
    The nature and number of Treatment-Related Adverse Events.
    Time Frame
    From time of procedure up to 2 hours after process completion
    Secondary Outcome Measure Information:
    Title
    Comfort Level-Assessed by Questionnaire
    Description
    A scale of 0 to 5 will be provided to the participants. 0 is no feeling, and 5 is very pain or uncomfortable
    Time Frame
    2 hours (average duration of procedure)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qifa Zhou, PhD
    Phone
    (213) 821-2649
    Email
    qifazhou@usc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Qifa Zhou, PhD
    Organizational Affiliation
    University of Southern California
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29916253
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18550876
    Citation
    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. Erratum In: N Engl J Med. 2008 Oct 16;359(16): 1736.
    Results Reference
    background
    PubMed Identifier
    28237413
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    5757022
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26934261
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    13315967
    Citation
    TASSICKER GE. Preliminary report on a retinal stimulator. Br J Physiol Opt. 1956 Apr;13(2):102-5. No abstract available.
    Results Reference
    background
    PubMed Identifier
    13129543
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20881025
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27453256
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33268865
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30166265
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27252349
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30157786
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    36343006
    Citation
    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.
    Results Reference
    result

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    Non-invasive Ultrasound Retinal Stimulation for Vision Restoration

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