Phase
Condition
Vision Loss
Treatment
SAVIR Alpha Synch mobile (SASm)
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 2follow-up visits (2 days per visit).
Scheduling
Testing
A subject deemed incapable of performing the study intervention independently due tovisual impairment or any other condition that may prevent them from performing theintervention accurately require a family member or caregiver to assist in performingthe intervention.
Exclusion
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 implantsare 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 wouldaffect the subject's ability to perform all necessary study tasks
Any chronic unstable medical conditions (e.g., uncontrolled diabetes,) that maycause 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 forat least one year
Uncontrolled systemic hypertension (historical BP > 160/100 mmHg)
Pregnant or breast-feeding women or women that are planning to become pregnant, asthis device has not been tested on pregnant women and there is no data on usingrtACS for this particular group
Any severe skin condition (e.g., blisters, open wounds, cuts or irritation) or otherskin defect which compromise the integrity of the skin at or near stimulationlocations
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
Study Design
Connect with a study center
NYU Langone Health
New York, New York 10022
United StatesActive - Recruiting
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