Study of Application of Transcutaneous Pulsed Electrical Stimulation Around Eye in Age-related Macular Degeneration
A 16-Week, Multi-Center, Open-Label, Exploratory Study to Evaluate the Safety and Efficacy of the Application of Pulse Electrical Stimulation Around the Eye in Early to Moderate Dry Age-Related Macular Degeneration
1 other identifier
interventional
25
1 country
3
Brief Summary
This study aims to evaluate the safety and efficacy of applying pulse electrical stimulation around eyes of age-related macular patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedStudy Start
First participant enrolled
October 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedSeptember 11, 2023
September 1, 2023
1.7 years
February 11, 2022
September 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Safety Events
Check the safety issues(AE, SAE, etc.).
baseline ~ 16 weeks
Secondary Outcomes (7)
Changes in contrast sensitivity
baseline, 6, 16 weeks
Changes in score of VFQ-25(National Eye Institute)
baseline, 6, 16 weeks
Changes in best corrected visual acuity(Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)
baseline, 6, 16 weeks
Changes in drusen area using optical coherence tomography(OCT)
baseline, 6, 16 weeks
Changes in drusen volume using optical coherence tomography(OCT)
baseline, 6, 16 weeks
- +2 more secondary outcomes
Study Arms (1)
Transcutaneous Pulsed Electrical Stimulation Treatment
EXPERIMENTALPatients wear our clinical trial device 30mins once a day for 16weeks. Device: Nu eyne M02
Interventions
Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.
Eligibility Criteria
You may qualify if:
- years or older
- Has a confirmed diagnosis of early to moderate AMD
- According to Staging of age-related macular degeneration of Beckman Initiative for Macular Research Classification Committee
- early AMD: Medium drusen(\>63 μm; ≤125 μm) and No AMD pigmentary abnormalities
- moderate AMD: Large drusen(\>125 μm) and/or Any AMD pigmentary abnormalities
- Best Corrected Visual Acuity \[BCVA\] of 20/200 or better measured by Early Treatment Diabetic Retinopathy Study(ETDRS) Charts
- A person who voluntarily agreed to participate in this clinical trial
You may not qualify if:
- Subject who is observed to have a atrophy of 175 micrometers or more in diameter invading the fovea on fundus examination or fundus autofluorescent with more than one eye
- Subject who is observed to have exudative macular degeneration on fundus examination or optical coherence tomography(OCT) with more than one eye
- Has a history of intravitreal injection, laser treatment, etc.
- Has eye pathology other than early age-related macular degeneration that may affect the outcome of clinical trials.
- Has a history of vitrectomy due to macular disease or cataract surgery within 1 month
- Has a disease that is judged to be difficult to interpret an ophthalmic imaging examination due to ocular media opacity
- Has a history of uncontrollable systemic chronic disease(diabetes mellitus) or malignancy(cases that have not recurred for more than 5 years after complete recovery are excluded)
- Autoimmune disease(Sjögren's syndrome, Rheumatoid arthritis, systemic lupus erythematosus, Graves' disease, etc.)
- Has a severe hearing impairment
- A person who is sensitive to orbit nerve stimulation and cannot be treated.
- Has a history of substance and/or alcohol abuse
- Has a confirmed diagnosis of psychiatric disease(depression, schizophrenia, bipolar disorder, dementia, etc)
- Those who participated in other clinical trials within 30 days of the screening visit
- Those who are judged to have "other reasons for prohibition of use" of our clinical trial medical device: heart-related problems. seizure. Patients transplanted metal or electronic device in head \& neck including deep brain stimulation device. Patient suffering from unknown pain. Patients with implantable or wearable cardioverter defibrillator. Patients who are warned not to use out clinical trial device or is prohibited from using it. (Dental implants are accepted.)
- In the case of subjects judged by the researcher that it would be difficult to participate in clinical trials
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Nune Eye Hospital
Seoul, 06192, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2022
First Posted
February 28, 2022
Study Start
October 5, 2022
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
September 11, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share