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

Overview

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.

Interventions

• Device Non-invasive ultrasound retinal stimulation Device
  Record user feelings during the device is working

Primary outcome measures

• Visual function-Assessed by Questionnaire [Time frame: 2 hours (average duration of procedure)]
• Adverse Event [Time frame: From time of procedure up to 2 hours after process completion]

Secondary outcome measures (1)

• Comfort Level-Assessed by Questionnaire [Time frame: 2 hours (average duration of procedure)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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
• 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
• 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
• 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
• TASSICKER GE. Preliminary report on a retinal stimulator. Br J Physiol Opt. 1956 Apr;13(2):102-5. No abstract available. PMID 13315967
• 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
• 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

Identifiers

NCT: NCT05914233 · HS-23-00143

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗