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Transcorneal electrical stimulation safely tolerated over 1 year in patients with retinitis pigmentosa
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Self-administered weekly transcorneal stimulation in patients with retinitis pigmentosa was found safe and tolerable over 1 year of treatment, but the study failed to meet its primary endpoint of enlarged visual field area. The secondary endpoint was achieved with a significant improvement of photopic ERG, according to researchers.
A total of 52 patients with retinitis pigmentosa applied transcorneal electrical stimulation (TES) for 30 minutes per week for one year. The primary outcomes measures were visual field area and secondary outcomes measures were development of ERG parameters.
Patients were randomly assigned to the groups: sham, 150%, or 200% of individual electrical phosphene threshold. There was no significant difference in age between the groups.
Researchers assessed visual acuity, visual field, rod and cone full-field stimulus threshold, electrical phosphene thresholds and IOP.
Patients conducted the stimulation at home after 4 training sessions in the hospital. No serious adverse events or study dropouts were observed. Dry eye symptoms in 31 of the 52 patients was the main adverse event.
The visual field area showed a trend for prevention of visual field loss in the 200% group. A significant improvement of light-adapted single flash b-wave was noted for the 200% and 150% groups, according to researchers.
Tendencies of improved function were observed for scotopic b-wave amplitude for the 200% group, researchers wrote.
The researchers were not able to reproduce the highly significant enlargement of visual field area from a previous study, so the primary endpoint was not reached. The secondary endpoint was met as a significant improvement of the photopic ERG in the 200% group demonstrated an effect of TES on cone function, according to researchers.
The researchers see a potential for TES in helping patients with retinitis pigmentosa, but more studies need to clarify optimal stimulation themes and prove the definitive role of TES in treating patients with retinal degenerations, they said. – by Abigail Sutton
Disclosure: The researchers reported no relevant financial disclosures.
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