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The purpose of this study is to test the efficacy and feasibility of an intervention protocol for home-based repetitive transorbital alternating current stimulation (rtACS) for the treatment of visual impairment in people with optic neuropathy. The primary aims are to evaluate the effectiveness of home-based rtACS to ameliorate the progressive effects of vision loss functionally in the eye and the visual pathway, and in regard to people's independence (i.e., functional ability).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based Repetitive Transorbital Alternating Current Stimulation (rtACS) | Experimental | Participants will undergo 30 stimulation sessions. The first two sessions will be administered in the office, the first one the day after the subjects' baseline visit and the second one 48 hours after the first intervention. Then subjects will conduct 28 at-home intervention sessions taking place every other day over the course of 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAVIR Alpha Synch mobile (SASm) | Device | The SAVIR Alpha Synch mobile is a device first used in office and then intended to be used for the home therapy of the visual system with non-invasive electrical stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm) | Outcome measure will be assessed using Optical coherence tomography (OCT). | baseline, 1 week post-intervention |
| Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm) | Outcome measure will be assessed using Optical coherence tomography (OCT). | baseline, 3 months post-intervention |
| Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm) | Outcome measure will be assessed using Optical coherence tomography (OCT). | baseline, 6 months post-intervention |
| Change in macular ganglion cell-inner plexiform layer thickness (µm) | Outcome measure will be assessed using Optical coherence tomography (OCT). | baseline, 1 week post-intervention |
| Change in macular ganglion cell-inner plexiform layer thickness (µm) | Outcome measure will be assessed using Optical coherence tomography (OCT). | baseline, 3 months post-intervention |
| Change in macular ganglion cell-inner plexiform layer thickness (µm) | Outcome measure will be assessed using Optical coherence tomography (OCT). | baseline, 6 months post-intervention |
| Change in optic nerve (ON) head cup-to-disc ratio (%) | Outcome measure will be assessed using Optical coherence tomography (OCT). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of scheduled clinical appointments reviewed | Month 6 | |
| Number of patients considered potentially eligible as determined during review of the clinical appointment schedule | Month 6 | |
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Inclusion Criteria:
Age equal to or over 18 years old
Must have a permanent residence
Diagnosis of optic neuropathy
VF defects present in at least one eye (MD ≤ -3.00 dB) FL, FP, FN <33%
Visual Field Index (VFI) 10-90%
Clear optical apparatus
Best-corrected VA of 20/400 or better in at least one eye
Commitment to comply with study procedures: 8-week period of intervention sessions (30 sessions every other day), baseline visit, post-intervention visit, and 2 follow-up visits (2 days per visit).
A subject deemed incapable of performing the study intervention independently due to visual impairment or any other condition that may prevent them from performing the intervention accurately require a family member or caregiver to assist in performing the intervention.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angeles Ramos, MD | Contact | 929-455-5047 | angeles.ramos@nyulangone.org | |
| Maria de los Angeles Ramos, MD | Contact | 929-455-5047 | Angeles.Ramos@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Williams, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10022 | United States |
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Joseph.Panarelli@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Joseph.Panarelli@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| baseline, 1 week post-intervention |
| Change in optic nerve (ON) head cup-to-disc ratio (%) | Outcome measure will be assessed using Optical coherence tomography (OCT). | baseline, 3 months post-intervention |
| Change in optic nerve (ON) head cup-to-disc ratio (%) | Outcome measure will be assessed using Optical coherence tomography (OCT). | baseline, 6 months post-intervention |
| Change in Humphrey Visual Field Analyzer (HFA) score | The Humphrey Visual Field Analyzer (HFA) score is a numerical value that represents a patient's retinal sensitivity at specific points in the retina. The score is measured in decibels (dB), with higher numbers indicating higher sensitivity. A normal reading is around 30 dB, and values below this range may indicate a visual field defect. The dBs tested by the Humphrey analyzer range between 0 and 50 dB (0 is the brightest and 50 is the dimmest). A value of 0 means the patient could not see the brightest target, and a 50 means the dimmest target was seen. | baseline, 1 week post-intervention |
| Change in Humphrey Visual Field Analyzer (HFA) score | The Humphrey Visual Field Analyzer (HFA) score is a numerical value that represents a patient's retinal sensitivity at specific points in the retina. The score is measured in decibels (dB), with higher numbers indicating higher sensitivity. A normal reading is around 30 dB, and values below this range may indicate a visual field defect. The dBs tested by the Humphrey analyzer range between 0 and 50 dB (0 is the brightest and 50 is the dimmest). A value of 0 means the patient could not see the brightest target, and a 50 means the dimmest target was seen. | baseline, 3 months post-intervention |
| Change in Humphrey Visual Field Analyzer (HFA) score | The Humphrey Visual Field Analyzer (HFA) score is a numerical value that represents a patient's retinal sensitivity at specific points in the retina. The score is measured in decibels (dB), with higher numbers indicating higher sensitivity. A normal reading is around 30 dB, and values below this range may indicate a visual field defect. The dBs tested by the Humphrey analyzer range between 0 and 50 dB (0 is the brightest and 50 is the dimmest). A value of 0 means the patient could not see the brightest target, and a 50 means the dimmest target was seen. | baseline, 6 months post-intervention |
| Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score | The ETDRS VA score is based on the number of letters a patient can correctly read on an ETDRS chart from a distance of 4 meters. The final score is calculated by adding 30 to the total number of letters read correctly at 4 meters.Good VA is 20/20 to 20/50; intermediate VA is <20/50 to 20/200; poor VA is <20/200. | baseline, 1 week post-intervention |
| Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score | The ETDRS VA score is based on the number of letters a patient can correctly read on an ETDRS chart from a distance of 4 meters. The final score is calculated by adding 30 to the total number of letters read correctly at 4 meters.Good VA is 20/20 to 20/50; intermediate VA is <20/50 to 20/200; poor VA is <20/200. | baseline, 3 months post-intervention |
| Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score | The ETDRS VA score is based on the number of letters a patient can correctly read on an ETDRS chart from a distance of 4 meters. The final score is calculated by adding 30 to the total number of letters read correctly at 4 meters.Good VA is 20/20 to 20/50; intermediate VA is <20/50 to 20/200; poor VA is <20/200. | baseline, 6 months post-intervention |
| Change in Pelli-Robson score | The Pelli-Robson test is a wall-mounted chart with large letters arranged in triplets. The contrast decreases by 0.15 log units for each triplet. Patients are given credit for a contrast level if they answer two of the three letters in a triplet correctly. Each letter correctly identified is scored as 0.05 log units. The Pelli-Robson contrast sensitivity chart score range is 0.00-2.25 log contrast sensitivity. A score of 2.0 indicates normal contrast sensitivity, less than 1.5 indicates moderate reduction in contrast sensitivity, indicating some level of visual impairment, and less than 1.0 indicates visual disability. | baseline, 1 week post-intervention |
| Change in Pelli-Robson score | The Pelli-Robson test is a wall-mounted chart with large letters arranged in triplets. The contrast decreases by 0.15 log units for each triplet. Patients are given credit for a contrast level if they answer two of the three letters in a triplet correctly. Each letter correctly identified is scored as 0.05 log units. The Pelli-Robson contrast sensitivity chart score range is 0.00-2.25 log contrast sensitivity. A score of 2.0 indicates normal contrast sensitivity, less than 1.5 indicates moderate reduction in contrast sensitivity, indicating some level of visual impairment, and less than 1.0 indicates visual disability. | baseline, 3 months post-intervention |
| Change in Pelli-Robson score | The Pelli-Robson test is a wall-mounted chart with large letters arranged in triplets. The contrast decreases by 0.15 log units for each triplet. Patients are given credit for a contrast level if they answer two of the three letters in a triplet correctly. Each letter correctly identified is scored as 0.05 log units. The Pelli-Robson contrast sensitivity chart score range is 0.00-2.25 log contrast sensitivity. A score of 2.0 indicates normal contrast sensitivity, less than 1.5 indicates moderate reduction in contrast sensitivity, indicating some level of visual impairment, and less than 1.0 indicates visual disability. | baseline, 6 months post-intervention |
| Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score | The 39-item VFQ is designed to measure vision-related quality of life (VRQoL). It is a frequently used measure of VRQoL in vision science research. The VFQ-39 is divided into 12 subscales: general health, general vision, ocular pain, near vision, distant vision, vision specific social functioning, vision-specific role difficulties, vision-specific mental health, vision-specific dependency, driving, peripheral vision, and color vision. Responses are rated on either Likert or dichotomous (yes/no) scales. The questionnaire is scored by converting the original numeric values from the survey to a 0 to 100 scale, with 100 being the best score and 0 being the worst. | baseline, 1 week post-intervention |
| Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score | The 39-item VFQ is designed to measure VRQoL. It is a frequently used measure of VRQoL in vision science research. The VFQ-39 is divided into 12 subscales: general health, general vision, ocular pain, near vision, distant vision, vision specific social functioning, vision-specific role difficulties, vision-specific mental health, vision-specific dependency, driving, peripheral vision, and color vision. Responses are rated on either Likert or dichotomous (yes/no) scales. The questionnaire is scored by converting the original numeric values from the survey to a 0 to 100 scale, with 100 being the best score and 0 being the worst. | baseline, 3 months post-intervention |
| Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score | The 39-item VFQ is designed to measure VRQoL. It is a frequently used measure of VRQoL in vision science research. The VFQ-39 is divided into 12 subscales: general health, general vision, ocular pain, near vision, distant vision, vision specific social functioning, vision-specific role difficulties, vision-specific mental health, vision-specific dependency, driving, peripheral vision, and color vision. Responses are rated on either Likert or dichotomous (yes/no) scales. The questionnaire is scored by converting the original numeric values from the survey to a 0 to 100 scale, with 100 being the best score and 0 being the worst. | baseline, 6 months post-intervention |
| Number of patients who are potentially eligible but express no interest in participating in the study |
| Month 6 |
| Number of patients who are determined ineligible following screening procedures | Month 6 |
| Number of participants' who adhered to the study protocol regimen | Month 6 |