Optic NeuropathyNCT06662448
Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
A study testing SAVIR Alpha Synch mobile (SASm) in people with Optic Neuropathy, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optic Neuropathy
- What is being tested?
- SAVIR Alpha Synch mobile (SASm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 18 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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).
- Scheduling
- Testing
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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
- Auto-immune disease, acute stage (e.g., rheumatoid arthritis)
- Metastatic disease
- Certain mental diseases/psychiatric conditions (e.g., schizophrenia) that would affect the subject's ability to perform all necessary study tasks
- Any chronic unstable medical conditions (e.g., uncontrolled diabetes,) that may cause a subject to miss one or more of the interventions and visits
- Addiction (e.g., drug/alcohol dependence) that has not been in abstinent control for at least one year
- Uncontrolled systemic hypertension (historical BP > 160/100 mmHg)
- 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
- 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
- IOP that the principal investigator determines that is not clinically stable
- Complete blindness of both eyes
- Non-resected brain tumors
- Unstable diabetic retinopathy in the study eye
- Optic neuropathies secondary to brain tumors
- Subjects without the capacity to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10022
About this study
Official title: An Open-Label Study to Evaluate the Efficacy and Feasibility of Home-Based Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
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).
- Conditions
- Optic Neuropathy
- Being tested
- SAVIR Alpha Synch mobile (SASm)
- Medical subject headings
- Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SAVIR Alpha Synch mobile (SASm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm)
Outcome measure will be assessed using Optical coherence tomography (OCT).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 6 months post-intervention
Secondary outcomes (5)
Number of scheduled clinical appointments reviewed
Measured: Month 6
Number of patients considered potentially eligible as determined during review of the clinical appointment schedule
Measured: Month 6
Number of patients who are potentially eligible but express no interest in participating in the study
Measured: Month 6
Number of patients who are determined ineligible following screening procedures
Measured: Month 6
Number of participants' who adhered to the study protocol regimen
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start18 Nov 2024
- Primary completion18 May 2029 (estimated)
- Study completion18 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuropathyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Williams, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662448
- Sponsor's protocol ID
- 24-01043
- Status last verified
- Feb 2026
- First submitted
- 25 Oct 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Efficacy and Feasibility of Home-Based Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
- ClinicalTrials.gov ID
- NCT06662448
- Acronym / sponsor ID
- 24-01043
- Conditions
- Optic Neuropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 18 May 2029 (estimated)
- Study completion
- 18 May 2029 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based Repetitive Transorbital Alternating Current Stimulation (rtACS) | Experimental | Device: SAVIR Alpha Synch mobile (SASm)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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%
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAVIR 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. | Device | Home-based Repetitive Transorbital Alternating Current Stimulation (rtACS) |
Primary outcome
Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm)
Time frame: baseline, 1 week post-intervention
Outcome measure will be assessed using Optical coherence tomography (OCT).
Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm)
Time frame: baseline, 3 months post-intervention
Outcome measure will be assessed using Optical coherence tomography (OCT).
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, 1 week 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, 3 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, 1 week 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, 3 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, 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 Humphrey Visual Field Analyzer (HFA) score
Time frame: baseline, 3 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 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, 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 Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score
Time frame: baseline, 3 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 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, 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 Pelli-Robson score
Time frame: baseline, 3 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 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, 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.
Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score
Time frame: baseline, 3 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.
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.
5 secondary outcomes
Number of scheduled clinical appointments reviewed
Time frame: Month 6
Number of patients considered potentially eligible as determined during review of the clinical appointment schedule
Time frame: Month 6
Number of patients who are potentially eligible but express no interest in participating in the study
Time frame: Month 6
Number of patients who are determined ineligible following screening procedures
Time frame: Month 6
Number of participants' who adhered to the study protocol regimen
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Williams, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAVIR Alpha Synch mobile (SASm) in people with Optic Neuropathy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angeles Ramos, MD (929-455-5047, angeles.ramos@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm) (time frame: baseline, 1 week post-intervention). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.