An Open-Label Study to Evaluate the Efficacy and Feasibility of Home-Based Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Optic Neuropathy
- Sponsor
- NYU Langone Health
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm)
- Status
- Recruiting
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
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
- •High intraocular pressure (over 27 mmHg)
- •End-stage organ disease or medical condition with subsequent vision loss (e.g., diabetes, stroke)
- •Advanced or unstable retinal diseases
- •Pathological nystagmus
- •Acute conjunctivitis
- •Photosensitivity to flickering lights
- •Non-ocular/ocular surgery within the previous 2 months to enrollment date
- •Electric or electronic implants (e.g., cardiac pacemaker)
- •Metallic artifacts/implants in head and/or torso (titanium screw and dental implants are allowed)
- •Diagnosed epilepsy on medical treatment
Outcomes
Primary Outcomes
Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm)
Time Frame: baseline, 6 months post-intervention
Outcome measure will be assessed using Optical coherence tomography (OCT).
Change in macular ganglion cell-inner plexiform layer thickness (µm)
Time Frame: baseline, 6 months post-intervention
Outcome measure will be assessed using Optical coherence tomography (OCT).
Change in optic nerve (ON) head cup-to-disc ratio (%)
Time Frame: baseline, 6 months post-intervention
Outcome measure will be assessed using Optical coherence tomography (OCT).
Change in Humphrey Visual Field Analyzer (HFA) score
Time Frame: baseline, 6 months 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
Time Frame: baseline, 6 months 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
Time Frame: baseline, 6 months 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
Time Frame: baseline, 6 months post-intervention
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.
Secondary Outcomes
- 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)