Review Article

Effect of Electrical Stimulation on Ocular Cells: A Means for Improving Ocular Tissue Engineering and Treatments of Eye Diseases

Table 2

A list of clinical trials on the effect of ES on ocular diseases.

NCT numberConditions understudyInterventions (age)OutcomeStatusStart date

NCT01600300MDTwo period treatment with Tesmac device, twice/day for 5 days, with a two-day interval40 (≥50)NANACompleted2002

NCT01282827Visual impairmentRepeated tACS (2 to 9 pulses, <1000 μA)40 (18-75)(i) Significant improvement of a VF detection deficit
(ii) Significant improvement of VA
(iii) EEG: increased synchronization in posterior brain regions
(iv) Patients’ visual improvements were stable for almost two months
GermanyCompleted2006

NCT00804102RP, macula off, POAG, hereditary MD, treated retina detachment, retinal artery occlusion, retinal vein occlusion, nonarthritic-anterior-ischemic optic-neuropathy, hereditary autosomal dominant optic atrophy, dry AMD, ischemic METranscorneal ES (Dawson-Trick-Litzkow electrode attached to patient eye)80 (≥18)(i) Safety of TES for RP patients.
(ii) VF area and scotopic b-wave amplitude were reached statistically significant
(iii) A larger sample size was needed for further investigations
GermanyCompleted2008

NCT01280877Optic nerve diseases
Optic nerve injuries
Optic neuropathies
tACS (8 to 14 pulses, <1000 μA), 1 pulse per minute during 25-35 min90 (≥18)(i) VF improved in the rtACS-treated patients.
(ii) EEG: signs of neuromodulation (suggested as probable brain plasticity modulation)
(iii) rtACS was reported as a safe and effective therapy for restoring vision
GermanyCompleted2010

NCT01630291Dry eyeElectrode device for lacrimal gland stimulation4 (≥18)NAMexicoCompleted2012

NCT01835002RPWeekly ES using Okustim® device for a period of 30 min for 6 months105 (18-80)(i) Transient dry eye symptoms
(ii) No other serious adverse events post TES.
(iii) The safety profile of TES
Germany, UK, the Netherlands, Italy, Denmark, and NorwayCompleted2012

NCT01847365RPWeakly transcorneal ES using Okustim® device for a period of 30 min for 6 months14 (≥18)(i) Safety and well tolerance of TES application
(ii) No significant difference in visual function improvement
United KingdomCompleted2013

NCT02019927NAION, trauma, MSTranscorneal ES using the OkuVision device97 (≥18)NAUnited StatesCompleted2013

NCT04008589StrokeRepetitive transorbital AC stimulation combination of transcranial direct current stimulation and rtACS45 (18-75)NAGermanyCompleted2014

NCT02086890RPElectro-acupuncture
Laser acupuncture transcorneal ES
21 (≥18)(i) TES caused significant improvement in VA and VF
(ii) TES reduced RP visual dysfunctions
(iii) TES induced retinal blood flow.
(iv) TES improved visual function
(v) MVF regulated visual function
United StatesActive, not recruiting2014

NCT02405143Stroke, infarction; posterior cerebral artery, hemianopsiaActive tACS using DC-stimulator MC50 (18-75)NAFinlandUnknown status2015

NCT02495935AmblyopiaOkuStim®40 (≥18)NAUnited StatesRecruiting2015

NCT02699216Dry MDES of the retina0 (≥50)NANAWithdrawn2016

NCT03239418Blepharoptosis
Lagophthalmos
Neuromuscular ES60 (≥19)NAUnited StatesUnknown status2017

NCT02548572RPTranscorneal ES using Okustim device0 (22-80)NAUnited StatesWithdrawn2019

NCT04042363MS, optic neuritisTransorbital ES (eyetronic next wave 1.1)45 (18-60)NAFranceRecruiting2019

NCT04010994GlaucomaTransorbital ES50 (≥18)NAGermanyEnrolling by invitation2019

NCT04017234MyopiaFrequency following response, eye exercise, and transcutaneous27 (6-13)NATaiwanRecruiting2019

NCT02540148Dry AMDNova oculus™ microcurrent ES60 (≥50)NACanadaRecruiting2019

NCT04634383Ocular injury
Optic nerve diseases
Photoreceptor degeneration
Blindness, acquired
WFMA—wireless floating microelectrode array5 (18-65)NAUnited StatesRecruiting2020

NCT04648085Dry eye
Neuropathic pain
Eye pain
Transcutaneous ES42 (>18)NAMexicoRecruiting2021

AMD: age-related macular degeneration; EEG: electroencephalogram; ES: electrical stimulation; : location; MD: macular degeneration; ME: macula edema; MS: multiple sclerosis; : number of patients; NAION: nonarteritic anterior ischemic optic neuropathy; NA: not available; POAG: primary open angle glaucoma; RP: retinitis pigmentosa; rtACS: repeated transcranial alternating current stimulation; VA: visual acuity; VF: visual field.