Optic Neuropathy
Conditions
Brief summary
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).
Interventions
DEVICESAVIR Alpha Synch mobile (SASm)
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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age equal to or over 18 years old 2. Must have a permanent residence 3. Diagnosis of optic neuropathy 4. VF defects present in at least one eye (MD ≤ -3.00 dB) FL, FP, FN \<33% 5. Visual Field Index (VFI) 10-90% 6. Clear optical apparatus 7. Best-corrected VA of 20/400 or better in at least one eye 8. 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). 1. Scheduling 2. Testing 9. 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
1. High intraocular pressure (over 27 mmHg) 2. End-stage organ disease or medical condition with subsequent vision loss (e.g., diabetes, stroke) 3. Advanced or unstable retinal diseases 4. Pathological nystagmus 5. Acute conjunctivitis 6. Photosensitivity to flickering lights 7. Non-ocular/ocular surgery within the previous 2 months to enrollment date 8. Electric or electronic implants (e.g., cardiac pacemaker) 9. Metallic artifacts/implants in head and/or torso (titanium screw and dental implants are allowed) 10. Diagnosed epilepsy on medical treatment 11. Auto-immune disease, acute stage (e.g., rheumatoid arthritis) 12. Metastatic disease 13. Certain mental diseases/psychiatric conditions (e.g., schizophrenia) that would affect the subject's ability to perform all necessary study tasks 14. Any chronic unstable medical conditions (e.g., uncontrolled diabetes,) that may cause a subject to miss one or more of the interventions and visits 15. Addiction (e.g., drug/alcohol dependence) that has not been in abstinent control for at least one year 16. Uncontrolled systemic hypertension (historical BP \> 160/100 mmHg) 17. Pregnant or breast-feeding women or women that are planning to become pregnant, as this device has not been tested on pregnant women and there is no data on using rtACS for this particular group 18. Any severe skin condition (e.g., blisters, open wounds, cuts or irritation) or other skin defect which compromise the integrity of the skin at or near stimulation locations 19. IOP that the principal investigator determines that is not clinically stable 20. Complete blindness of both eyes 21. Non-resected brain tumors 22. Unstable diabetic retinopathy in the study eye 23. Optic neuropathies secondary to brain tumors 24. Subjects without the capacity to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm) | baseline, 1 week post-intervention | Outcome measure will be assessed using Optical coherence tomography (OCT). |
| Change in macular ganglion cell-inner plexiform layer thickness (µm) | baseline, 1 week post-intervention | Outcome measure will be assessed using Optical coherence tomography (OCT). |
| Change in optic nerve (ON) head cup-to-disc ratio (%) | baseline, 1 week post-intervention | Outcome measure will be assessed using Optical coherence tomography (OCT). |
| Change in Humphrey Visual Field Analyzer (HFA) score | baseline, 1 week post-intervention | 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. |
| Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score | baseline, 1 week post-intervention | 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. |
| Change in Pelli-Robson score | baseline, 1 week post-intervention | 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. |
| Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score | baseline, 1 week post-intervention | 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. |
Secondary
| Measure | 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 |
| 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 |
Countries
United States
Contacts
CONTACTAngeles Ramos, MD
CONTACTMaria de los Angeles Ramos, MD
PRINCIPAL_INVESTIGATORJonathan Williams, MD
NYU Langone Health
Outcome results
None listed