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The goal of this study is to see whether repeated transcranial alternating current stimulation can activate impaired retinal ganglion cells and improve both structural and functional outcomes in patients with glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repetitive Transcranial Alternating Current Stimulation treatment | Experimental | Participants will receive 10 days of repeated transcranial alternating current stimulation in hospital. |
|
| Sham Repetitive Transcranial Alternating Current Stimulation | Sham Comparator | Participants will receive 10 days of repeated transcranial alternating current stimulation treatment (no active stimulation) in hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-Stimulator MC | Device | Experimental：Participants will receive 10 days of repeated transcranial alternating current stimulation treatment in hospital. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual field mean deviation (MD) from baseline to post-treatment | Visual field testing will be performed with the Humphrey field analyzer | From treatment initiation to 26 days after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual field mean deviation (MD) from baseline to post-treatment | Visual field testing will be performed with the Humphrey field analyzer | From treatment initiation to 12 days after treatment initiation |
| Change in visual field mean deviation (MD) from baseline to post-treatment |
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Inclusion Criteria:
Participant must be at least 18.
Clinical diagnosis of glaucoma, with Humphrey Visual Field 24-2 mean deviation (MD) between -22 dB and -5 dB, and Visual Field Index (VFI) between 10% and 90%. The visual field test at screening must meet the following reliability indices:
Best-corrected visual acuity (BCVA) ≥ 0.2 in the worse eye selected for stimulation treatment.
If a participant has two eyes meeting study criteria, one eye will be randomly selected by computer for study participation.
In the opinion of the investigator the participant's eye pressure must be clinically stable.
Participant must has the ability to comply with the requirements of the study and complete the schedule of events.
Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
Optical coherence tomography (OCT) imaging shows measurable changes in either peripapillary retinal nerve fiber layer (RNFL) thickness or macular ganglion cell-inner plexiform layer thickness.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chien-Chia Su | Contact | +886 972653340 | chienchiasu@ntu.edu.tw | |
| Yu-Cen Ma | Contact | s431075656@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Hawaii | 100 | Taiwan |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| DC-Stimulator MC | Device | Sham Comparator：Participants will receive 10 days of repeated transcranial alternating current stimulation treatment (no active stimulation) in hospital. |
|
Visual field testing will be performed with the Humphrey field analyzer |
| From treatment initiation to 19 days after treatment initiation |
| Change in visual field mean deviation (MD) from baseline to post-treatment | Visual field testing will be performed with the Humphrey field analyzer | From treatment initiation to 166 days after treatment initiation |
| Change in sensitivity at each of the 52 test points in the 24-2 visual field from baseline to post-treatment | From treatment initiation to 26 days after treatment initiation |
| Change in targeted mean deviation from baseline to post-treatment | From treatment initiation to 12 days after treatment initiation |
| Change in targeted mean deviation from baseline to post-treatment | From treatment initiation to 19 days after treatment initiation |
| Change in targeted mean deviation from baseline to post-treatment | From treatment initiation to 26 days after treatment initiation |
| Change in targeted mean deviation from baseline to post-treatment | From treatment initiation to 166 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Visual acuity measured by Landolt C Chart. | From treatment initiation to 5 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Contrast sensitivity measured by CSV-1000 | From treatment initiation to 5 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Contrast sensitivity measured by Pelli-Robson Contrast Sensitivity Chart | From treatment initiation to 5 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Contrast sensitivity measured by MARS Contrast Sensitivity Chart | From treatment initiation to 5 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Color vision measured by HRR pseudoisochromatic test | From treatment initiation to 5 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Continuous Chinese reading acuity measured by Paragraph Chinese Reading Acuity Test (P-CRAT) | From treatment initiation to 5 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Visual acuity measured by Landolt C Chart | From treatment initiation to 12 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Contrast sensitivity measured by CSV-1000 | From treatment initiation to 12 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Contrast sensitivity measured by Pelli-Robson Contrast Sensitivity Chart | From treatment initiation to 12 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Contrast sensitivity measured by MARS Contrast Sensitivity Chart | From treatment initiation to 12 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Color vision measured by HRR pseudoisochromatic test | From treatment initiation to 12 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Continuous Chinese reading acuity measured by Paragraph Chinese Reading Acuity Test (P-CRAT) | From treatment initiation to 12 days after treatment initiation] |
| Visual function analysis from baseline to post-treatment | Visual acuity measured by Landolt C Chart | From treatment initiation to 26 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Contrast sensitivity measured by CSV-1000 | From treatment initiation to 26 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Contrast sensitivity measured by Pelli-Robson Contrast Sensitivity Chart | From treatment initiation to 26 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Contrast sensitivity measured by MARS Contrast Sensitivity Chart | From treatment initiation to 26 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Color vision measured by HRR pseudoisochromatic test | From treatment initiation to 26 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Continuous Chinese reading acuity measured by Paragraph Chinese Reading Acuity Test (P-CRAT) | From treatment initiation to 26 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Visual acuity measured by Landolt C Chart | From treatment initiation to 166 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Contrast sensitivity measured by CSV-1000 | From treatment initiation to 166 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Contrast sensitivity measured by Pelli-Robson Contrast Sensitivity Chart | From treatment initiation to 166 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Contrast sensitivity measured by MARS Contrast Sensitivity Chart | From treatment initiation to 166 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Color vision measured by HRR pseudoisochromatic test | From treatment initiation to 166 days after treatment initiation |
| Visual function analysis from baseline to post-treatment | Continuous Chinese reading acuity measured by Paragraph Chinese Reading Acuity Test (P-CRAT) | From treatment initiation to 166 days after treatment initiation |
| Quality of life analysis from baseline to post-treatment | Vision-related quality of life assessed using the National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25). Scores are converted to a 0-100 scale, where higher scores indicate better vision-related quality of life. | From treatment initiation to 12 days after treatment initiation |
| Quality of life analysis from baseline to post-treatment | Health status assessed using the 36-Item Short Form Health Survey (SF-36). Scores for each domain and the overall score range from 0 to 100, where higher scores indicate better health status. | From treatment initiation to 12 days after treatment initiation |
| Quality of life analysis from baseline to post-treatment | Mobility in daily life assessed using the Mobility questionnaire. This questionnaire focuses on difficulties related to mobility and driving. Scores are reported on a 0-172 scale, where higher scores indicate greater difficulty with mobility and driving in daily life. | From treatment initiation to 12 days after treatment initiation |
| Quality of life analysis from baseline to post-treatment | Vision-related quality of life assessed using the National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25). Scores are converted to a 0-100 scale, where higher scores indicate better vision-related quality of life. | From treatment initiation to 166 days after treatment initiation |
| Quality of life analysis from baseline to post-treatment | Health status assessed using the 36-Item Short Form Health Survey (SF-36). Scores for each domain and the overall score range from 0 to 100, where higher scores indicate better health status. | From treatment initiation to 166 days after treatment initiation |
| Quality of life analysis from baseline to post-treatment | Mobility in daily life assessed using the Mobility questionnaire. This questionnaire focuses on difficulties related to mobility and driving. Scores are reported on a 0-172 scale, where higher scores indicate greater difficulty with mobility and driving in daily life. | From treatment initiation to 166 days after treatment initiation |
| Optical coherence tomography (OCT) analysis from baseline to post-treatment | Peripapillary retinal nerve fiber layer (RNFL) thickness (μm) | From treatment initiation to 12 days after treatment initiation |
| Optical coherence tomography (OCT) analysis from baseline to post-treatment | Macular ganglion cell-inner plexiform layer thickness (μm) | From treatment initiation to 12 days after treatment initiation |
| Optical coherence tomography (OCT) analysis from baseline to post-treatment | Optic nerve head cup-to-disc ratio (%) | From treatment initiation to 12 days after treatment initiation |
| Optical coherence tomography (OCT) analysis from baseline to post-treatment | Peripapillary retinal nerve fiber layer (RNFL) thickness (μm) | From treatment initiation to 26 days after treatment initiation |
| Optical coherence tomography (OCT) analysis from baseline to post-treatment | Macular ganglion cell-inner plexiform layer thickness (μm) | From treatment initiation to 26 days after treatment initiation |
| Optical coherence tomography (OCT) analysis from baseline to post-treatment | Optic nerve head cup-to-disc ratio (%) | From treatment initiation to 26 days after treatment initiation |
| Optical coherence tomography (OCT) analysis from baseline to post-treatment | Peripapillary retinal nerve fiber layer (RNFL) thickness (μm) | From treatment initiation to 166 days after treatment initiation |
| Optical coherence tomography (OCT) analysis from baseline to post-treatment | Macular ganglion cell-inner plexiform layer thickness (μm) | From treatment initiation to 166 days after treatment initiation |
| Optical coherence tomography (OCT) analysis from baseline to post-treatment | Optic nerve head cup-to-disc ratio (%) | From treatment initiation to 166 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | Peripapillary vessel density | From treatment initiation to 12 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | capillary density | From treatment initiation to 12 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | Superficial density | From treatment initiation to 12 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | deep density | From treatment initiation to 12 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | foveal vessel density | From treatment initiation to 12 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | parafoveal vessel density | From treatment initiation to 12 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | Foveal avascular zone (FAZ) | From treatment initiation to 12 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | Peripapillary vessel density | From treatment initiation to 26 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | capillary density | From treatment initiation to 26 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | Superficial density | From treatment initiation to 26 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | deep density | From treatment initiation to 26 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | foveal vessel density | From treatment initiation to 26 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | parafoveal vessel density | From treatment initiation to 26 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | Foveal avascular zone (FAZ) | From treatment initiation to 26 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | Peripapillary vessel density | From treatment initiation to 166 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | capillary density | From treatment initiation to 166 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | Superficial density | From treatment initiation to 166 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | deep density | From treatment initiation to 166 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | foveal vessel density | From treatment initiation to 166 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | parafoveal vessel density | From treatment initiation to 166 days after treatment initiation |
| Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment | Foveal avascular zone (FAZ) | From treatment initiation to 166 days after treatment initiation |