A prospective, randomized clinical trial evaluating the effect of transcorneal electrical stimulation on visual function

Abstract

Purpose : Traumatic optic neuropathy (TON), non-arteritic anterior ischemic neuropathy (NAION), and optic neuritis associated with multiple sclerosis (MS) can lead to untreatable visual compromise. To improve visual outcomes for these populations, new therapies are needed. The purpose of this prospective, randomized, sham-controlled study is to investigate the technical feasibility and efficacy of transcorneal electrical stimulation (TES) to improve visual function in participants diagnosed with TON, NAION, and optic neuritis due to MS.

Methods : Eligible participants with visual acuity (VA) worse than 20/40 and with no other ophthalmic diseases were recruited from the Wills Eye Hospital Emergency Department and Neuro-Ophthalmology clinics and randomized into treatment or sham-treatment groups for TES. After baseline testing for visual function, quality of life, and cognitive function, participants received 30 minutes of treatment or sham-treatment per week for 6 weeks. Sham-treatment participants then received 6 weeks of treatment. Repeat visual function testing was performed 1-week, 3 months, and 6 months post-treatment. The primary outcome measure for this study was the mean change in LogMAR values for VA. This report describes the baseline data for those enrolled and evaluates rate of adverse events.

Results : A total of 96 participants enrolled in the study between 7/10/2013 and 9/9/2016 and baseline data are reported. Thirteen participants had TON, 69 had NAION, and 14 had optic neuritis associated with MS. Thirty-eight (39.6%) participants were female and the mean age was 58 years. The mean VA (LogMar) was 0.9 in the TON group, 1.2 in the NAION group, and 0.9 in the MS group. The mean National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) score was 62.5 in the TON group, 64.2 in the NAION group, and 66.9 in the MS group. Sixty-four (67%) were assigned to the TES treatment group and 32 (33%) received the initial sham treatment. No participants experienced any adverse events associated with TES.

Conclusions : This abstract presents baseline data for a 4-year prospective sham-controlled clinical trial. Although enrolling TON participants was challenging, it is feasible to enroll participants with NAION and MS in this study and enrollment is complete. Results of visual function improvement after TES are under analysis and will be reported in the future.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.