Leber hereditary optic neuropathy
Conditions
Interventions
Skin electrical stimulation (SES), The number of intervention is six times (single SES every two weeks for 10 weeks)
Sponsors
Department of Surgery, Devision of Ophthalmology, Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Subjects should fulfill all conditions as follows: 1. Patients with ages ranging from 16 and 80 years of age. 2. Patients who provide written informed consent. In cases under 20 years, informed consent must be obtained from both patients themselves and guardians. 3. Patients with the disease more than 8 months since onset without visual improvement. 4. Patients with a missense mutation of mtDNA at the positon 11778. 5. Patients who show best corrected decimal visual acuity less than 0.1.
Exclusion criteria
Exclusion criteria: Exclusion criteria Patients who have at least one condition as below will be excluded. 1. Patients who had smoked until the last half of year 2. Patients with implantable electronic devices such as cardiac pacemakers etc. 3. Patients with a history of intraocular surgery within the past a year 4. Patients with other eye diseases except for the eyes with incipient cataract or intraocular lens 5. Patients who use idebenone and have past history of administration of idebenone within 1 year 6. Patients who use either ethambutol, chloramphenicol, linezolid, erythromycin, streptomycin, antiretroviral drugs, amiodarone, infliximab, clioquinol, dapsone, quinine, pheniprazine, suramin sodium, or isoniazid. 7. Patients with a history of epilepsy 8. Pregnant individuals 9. Patients with severe allergic diseases including atopic dermatitis 10. Patients participating in other clinical studies 11. Patients judged inappropriate for other research responsible doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LogMAR visual acuity at 1 week after six consecutive skin electrical stimulation (once every two weeks for 10 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. LogMAR visual acuity at 4 and 8 week after six consecutive skin electrical stimulation (once a week for 6 weeks). 2. Mean deviation and pattern standard deviation in Humphrey static visual field test (center 30-2, stimulus size 3 or 5), Foveal threshold value, total, the number of 1% and 5% of probability plot with pattern deviation 3. The value of critical fusion frequency 4. Color vision test (standard Pseudoisochromatic Plates Part 2 for Aquired Color Vision Defects (SPP-2)) 5. Thickness of peripapillary retinal nerve fiber and macular retinal ganglion cell complex detected by optical coherence tomography 6. The sensitivity of central visual field detected by Micrometry (MP-3) 7. The amplitude of visual evoked potential (Multifocal VEP) | — |
Countries
Japan
Contacts
Public ContactTakuji Kurimoto
Kobe University Graduate School of Medicine Ophthalmology
Outcome results
None listed