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This study aims to evaluate the safety and efficacy of applying pulse electrical stimulation around eyes of age-related macular patients.
Duration of study period(per participant): Screening period(0-4weeks), Intervention period(16weeks) Patient needs to visit site at least 5 times(Screening, V2, V3, V4, V5). V2 can be done with screening visit. Visit 3, 4, 5 is 2weeks, 6weeks, and 16weeks after visit 2(Baseline).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Pulsed Electrical Stimulation Treatment | Experimental | Patients wear our clinical trial device 30mins once a day for 16weeks. Device: Nu eyne M02 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02) | Drug | Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Safety Events | Check the safety issues(AE, SAE, etc.). | baseline ~ 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in contrast sensitivity | Check the change of contrast sensitivity in the baseline, 6, 16 weeks | baseline, 6, 16 weeks |
| Changes in score of VFQ-25(National Eye Institute) | Check the change of Changes in score of VFQ-25(National Eye Institute) in the baseline, 6, 16 weeks |
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Inclusion Criteria:
50 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
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
Exclusion Criteria:
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
Among female subjects who are likely to be pregnant, those who disagree to contraception in a medically permitted manner during this clinical trial period.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinho Jung, Ph.D candidate | Contact | +821083113509 | jinho.jung@nueyne.com | |
| Nayoung Kang | Contact | +821073734097 | nayoung.kang@nueyne.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Recruiting | Ansan | Gyeonggi-do | 15355 | South Korea |
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• Experimental: Transcutaneous Pulsed Electrical Stimulation Treatment Patients wear our clinical trial device 30mins once a day for 16weeks. Device: Nu eyne M02
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| baseline, 6, 16 weeks |
| Changes in best corrected visual acuity(Early Treatment Diabetic Retinopathy Study (ETDRS) Chart) | Check the change of best corrected visual acuity in the baseline, 6, 16 weeks | baseline, 6, 16 weeks |
| Changes in drusen area using optical coherence tomography(OCT) | Check the change of drusen area using optical coherence tomography(OCT) in the baseline, 6, 16 weeks | baseline, 6, 16 weeks |
| Changes in drusen volume using optical coherence tomography(OCT) | Check the change of drusen volume using optical coherence tomography(OCT) in the baseline, 6, 16 weeks | baseline, 6, 16 weeks |
| Progression to advanced Age-related Macular Degeneration (AMD) using fundus autofluorescence(FAF) | Check the Progression to advanced Age-related Macular Degeneration (AMD) using fundus autofluorescence(FAF) in the baseline, 6, 16 weeks | baseline, 6, 16 weeks |
| Progression to advanced Age-related Macular Degeneration (AMD) using fundus photography | Check the Progression to advanced Age-related Macular Degeneration (AMD) using fundus photography in the baseline, 6, 16 weeks | baseline, 6, 16 weeks |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
|
| Nune Eye Hospital | Not yet recruiting | Seoul | 06192 | South Korea |
|
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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