An exploratory clinical trial on the effectiveness and safety of skin electrical stimulation for Leber hereditary optic neuropathy
- Conditions
- eber hereditary optic neuropathy
- Registration Number
- JPRN-UMIN000031057
- Lead Sponsor
- Department of Surgery, Devision of Ophthalmology, Kobe University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 11
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ogMAR visual acuity at 1 week after six consecutive skin electrical stimulation (once every two weeks for 10 weeks).
- Secondary Outcome Measures
Name Time Method 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)