Preliminary multi-site EyeCell™ data show 68.8% of evaluable treated eyes improved and 87.5% improved or remained stable; company builds on a growing body of published research in ocular electrical stimulation and microcurrent
Lionheart Health’s EyeCell™ research program is evaluating noninvasive bioelectric and microcurrent stimulation approaches designed to support retinal, optic-nerve and neurovisual function. The company’s broader research strategy is also evaluating combinations with photobiomodulation, exercise, systemic healthy-aging interventions and other investigational regenerative approaches.
Encouraging Preliminary EyeCell™ Clinical Findings
In Lionheart Health’s combined preliminary Virginia and Utah dataset, 16 treated eyes were evaluable.
Results included:
- 11 of 16 eyes improved — 68.8%
- 3 of 16 eyes remained stable — 18.8%
- 14 of 16 eyes improved or remained stable — 87.5%
- 2 of 16 eyes declined — 12.5%
- Selected responding eyes demonstrated visual-acuity gains ranging from several letters to approximately 10 letters
— Peter Wilcox, O.D., Principal Investigator, EyeCell™ Pilot Study and Virginia IRB Approved Site Investigator
The pilot program included EyeCell™ bioelectric signaling, frequency-specific transpalpebral microcurrent and, in some subjects, combinations of the approaches. Because of the small study population, mixed treatment exposure, site heterogeneity and limited control data, these results are considered preliminary and hypothesis-generating and should not be interpreted as establishing efficacy for treatment of macular degeneration or another eye disease.
“These early results are encouraging enough that we believe the appropriate next step is a larger, more standardized and controlled clinical investigation,” said Howard J. Leonhardt, Executive Chairman and Co-CEO of Lionheart Health, Inc. Lionheart Health currently identifies Leonhardt in that role. “Our objective is to determine through rigorous clinical testing which electrical signals, treatment combinations, patient populations and dosing schedules produce reproducible improvements and which do not.”
EyeCell™ Moving Into Next-Stage Macular Degeneration Clinical Development
Lionheart Health is preparing to advance the EyeCell™ program into a larger Phase II-stage clinical investigation focused on macular degeneration.
The planned program is expected to utilize standardized ophthalmic endpoints including:
- ETDRS best-corrected visual acuity
- Percentage of eyes gaining at least 5, 10 and 15 letters
- Contrast sensitivity
- Low-luminance visual acuity
- Microperimetry
- OCT retinal imaging
- OCT angiography
- Geographic-atrophy and drusen measurements when applicable
- Visual-field testing
- Patient-reported functional vision
- Ocular safety and adverse-event monitoring
Future studies are also expected to distinguish EyeCell™ bioelectric signaling from conventional microcurrent and other treatment components so the contribution of individual modalities can be determined.
Lionheart Health uses “Phase II” to describe this next stage of its clinical development program; it should not be interpreted as an FDA clearance, approval or authorization of EyeCell™ for treatment of macular degeneration.
Published Electrical-Stimulation Research Provides Supporting Scientific Rationale
A substantial body of independent preclinical and early clinical research supports continued investigation of electrical stimulation for retinal and visual-system disorders.
In animal models, transcorneal electrical stimulation has been reported to promote photoreceptor survival, preserve retinal function, protect retinal ganglion cells after optic-nerve injury, reduce light-induced photoreceptor degeneration and alter neurotrophic signaling involving factors such as BDNF and CNTF.[1–4] Animal studies have also demonstrated protective effects in inherited retinal degeneration and ischemic retinal injury.
Human studies have produced several encouraging signals:
- In a 2011 prospective randomized sham-controlled study of 24 patients with retinitis pigmentosa, Schatz and colleagues reported that the highest electrical-stimulation dose was associated with approximately 17% expansion/change in visual-field area, compared with declines in lower-dose and sham groups, together with favorable electrophysiologic findings.[5]
- A subsequent one-year randomized study involving 52 patients with retinitis pigmentosa evaluated weekly transcorneal electrical stimulation. The prespecified primary endpoint was not definitively met, but favorable electrophysiologic and dose-related signals supported continued investigation.[6]
- A later dose-response analysis of these data reported annual visual-field-area loss of approximately 2.1% in electrically stimulated eyes, compared with 5.8% in untreated fellow eyes and 7.5% in the sham group, suggesting a potential retinal-preservation effect that requires prospective confirmation.[7]
- The multicenter TESOLA/OkuStim safety study involving 105 patients with retinitis pigmentosa found no serious treatment-related adverse events; transient dry-eye symptoms were the most frequently reported adverse event. Secondary efficacy outcomes did not show clinically significant group-level changes, supporting safety more strongly than efficacy.[8]
- In age-related macular degeneration, Chaikin and colleagues evaluated 31 eyes in 17 patients using transpalpebral frequency-specific microcurrent. Among 25 dry-AMD eyes, 52% showed a positive visual-acuity trend, while 5 of 6 wet-AMD eyes improved and one remained unchanged. The study had no control arm and therefore requires cautious interpretation.[9]
- A 2023 randomized pilot involving 62 patients with dry AMD compared transpalpebral microcurrent with sham treatment. The treatment group increased from a mean of 19.6 ETDRS letters at baseline to 27.8 letters at 30 weeks, while the sham group declined from 24.2 to 22.1 letters. The estimated between-group difference in change from baseline was 10.4 letters at 30 weeks, although the investigators emphasized the need for replication in larger studies.[10]
- In patients with chronic optic neuropathy, Fujikado and colleagues reported clinically meaningful visual-acuity improvement after transcorneal electrical stimulation in 2 of 3 eyes with nonarteritic ischemic optic neuropathy and 4 of 5 eyes with traumatic optic neuropathy in a small uncontrolled study.[11]
- Transcorneal electrical stimulation has also produced encouraging visual-function or electrophysiologic signals in small studies involving retinal artery occlusion, although randomized studies have produced mixed results and have not established efficacy.[12,13]
- In a separate randomized sham-controlled approach targeting the visual system rather than the retina alone, Gall and colleagues reported a mean 24.0% visual-field improvement following repetitive transorbital alternating-current stimulation versus 2.5% after sham in patients with optic-nerve damage. The trial did not demonstrate a corresponding significant visual-acuity improvement.[14]
- Kondrot reported outcomes from 152 patients representing 290 eyes treated in a three-day multimodality program incorporating microcurrent, nutrition, oxidative therapy and syntonic light. Across the entire mixed-treatment population, 69% of eyes gained at least five visual-acuity letters, including 15% gaining at least 10 letters. Because four therapies were administered together without a control group, these findings cannot determine the independent effect of microcurrent.[15]
Taken collectively, these studies do not establish electrical stimulation as a proven treatment for macular degeneration or retinal disease, but they provide a substantial scientific rationale for larger, controlled clinical trials designed to identify reproducible treatment effects, optimal stimulation parameters and appropriate patient populations.
EyeCell™ Skaphor™ Released for Eye-Fatigue and Wellness Use
Separate from Lionheart Health’s investigational medical research program, the company has released the EyeCell™ Skaphor™ Model through the Lionheart Health eStore for general eye-health and wellness applications.
The commercial wellness positioning is focused on:
- Tired eyes
- Digital eye fatigue
- Eye-area relaxation
- General visual wellness
- Noninvasive microcurrent and micropulse optical stimulation
Lionheart currently describes the system as an advanced microcurrent and micropulse optical-light wellness platform for tired and aging eyes and explicitly states that it is not cleared for medical treatment of eye disease outside appropriately conducted clinical research.
Patients with diagnosed or suspected eye disease should remain under the care of a qualified ophthalmologist and should not discontinue, delay or substitute prescribed standard-of-care therapies.
Building a Multimodality EyeCell™ Research Platform
Lionheart Health’s longer-term research strategy is to evaluate EyeCell™ bioelectric stimulation alongside complementary modalities that have independent scientific rationales, potentially including:
- Transpalpebral microcurrent
- Retinal photobiomodulation
- PEMF as an investigational adjunct
- BodStim™ exercise and systemic metabolic conditioning
- Klotho-focused nutrition and healthy-aging programs
- Evidence-based retinal nutritional support
- Investigational neuroprotective and regenerative signaling programs
Each component will require prospective testing to determine whether combining modalities produces additive or synergistic benefit.
New EyeCell™ Multimodal Vision Study
About Lionheart Health
Lionheart Health, Inc. is a regenerative health, longevity and bioelectric technology company focused on translating advanced diagnostics, bioelectric stimulation and precision health protocols into clinically measurable improvements in human function and healthy aging. The company operates clinical research, wellness, product-development and licensing programs across multiple health applications.
Scientific References
1. Morimoto T, Fujikado T, Choi JS, et al. Transcorneal electrical stimulation promotes the survival of photoreceptors and preserves retinal function in Royal College of Surgeons rats. Investigative Ophthalmology & Visual Science.2007;48:4725–4732.
2. Miyake K, Yoshida M, Inoue Y, Hata Y. Neuroprotective effect of transcorneal electrical stimulation on the acute phase of optic nerve injury. Investigative Ophthalmology & Visual Science. 2007.
3. Ni YQ, Gan DK, Xu HD, Xu GZ, Da CD. Neuroprotective effect of transcorneal electrical stimulation on light-induced photoreceptor degeneration. Experimental Neurology. 2009;219:439–452. doi:10.1016/j.expneurol.2009.
4. Tao Y, Chen T, Liu ZY, et al. Topographic Quantification of the Transcorneal Electrical Stimulation-Induced Protective Effects on N-Methyl-N-Nitrosourea-Treated Retinas. Investigative Ophthalmology & Visual Science. 2016;57:4614–4624. doi:10.1167/iovs.16-19305.
5. Schatz A, Röck T, Naycheva L, et al. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Investigative Ophthalmology & Visual Science.2011;52:4485–4496. doi:10.1167/iovs.10-6932.
6. Schatz A, Pach J, Gosheva M, et al. Transcorneal Electrical Stimulation for Patients With Retinitis Pigmentosa: A Prospective, Randomized, Sham-Controlled Follow-up Study Over 1 Year. Investigative Ophthalmology & Visual Science. 2017;58:257–269. doi:10.1167/iovs.16-19906.
7. Stett A, Schatz A, Gekeler F, Franklin J. Transcorneal Electrical Stimulation Dose-Dependently Slows the Visual Field Loss in Retinitis Pigmentosa. Translational Vision Science & Technology. 2023;12:29. doi:10.1167/tvst.12.2.29.
8. Jolly JK, Wagner SK, Martus P, et al. Transcorneal electrical stimulation for the treatment of retinitis pigmentosa: a multicenter safety study of the OkuStim System—TESOLA Study. Ophthalmic Research. 2020;63:234–243. doi:10.1159/000505001.
9. Chaikin L, Kashiwa K, Bennet M, Papastergiou G, Gregory W. Microcurrent stimulation in the treatment of dry and wet macular degeneration. Clinical Ophthalmology. 2015;9:2345–
10. Parkinson KM, et al. Evaluation of visual acuity in dry AMD patients after microcurrent electrical stimulation.International Journal of Retina and Vitreous. 2023. doi:10.1186/s40942-023-00471-
11. Fujikado T, Morimoto T, Matsushita K, et al. Effect of transcorneal electrical stimulation in patients with nonarteritic ischemic optic neuropathy or traumatic optic neuropathy. Japanese Journal of Ophthalmology. 2006;50:266–
12. Oono S, Kurimoto T, Kashimoto R, Tagami Y, Okamoto N, Mimura O. Transcorneal electrical stimulation improves visual function in eyes with branch retinal artery occlusion. Clinical Ophthalmology. 2011;5:397–402. doi:10.2147/OPTH.S17751.
13. Naycheva L, Schatz A, Willmann G, et al. Transcorneal electrical stimulation in patients with retinal artery occlusion: a prospective, randomized, sham-controlled pilot study. Ophthalmology and Therapy. 2013;2:25–39. doi:10.1007/s40123-013-0012-5.
14. Gall C, Schmidt S, Schittkowski MP, et al. Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial. PLoS ONE. 2016;11.
15. Kondrot EC. Improvement in Vision Parameters for Participants Treated With Alternative Therapies in a 3-day Program. Alternative Therapies in Health and Medicine. 2015;21(6):22–35.
Important Regulatory and Research Notice
The EyeCell™ macular-degeneration program and any use of EyeCell™, bioelectric signaling, microcurrent, photobiomodulation, PEMF or other Lionheart technologies for treatment of retinal or ophthalmic disease remain investigational unless and until specifically cleared or approved by the appropriate regulatory authority. Investigational studies should be conducted under applicable IRB oversight, informed patient consent, appropriate ophthalmology supervision and required regulatory authorization.