Unique ID issued by UMIN | UMIN000021887 |
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Receipt number | R000025232 |
Scientific Title | Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for retinitis pigmentosa |
Date of disclosure of the study information | 2016/04/12 |
Last modified on | 2017/07/11 22:06:18 |
Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for retinitis pigmentosa
Transdermal electrical stimulation intended for retinitis pigmentosa
Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for retinitis pigmentosa
Transdermal electrical stimulation intended for retinitis pigmentosa
Japan |
Retinitis Pigmentosa
Ophthalmology |
Others
NO
To examine the safety and efficacy of transdermal electrical stimulation treatment with the skin electrode for retinitis pigmentosa patients
Efficacy
Exploratory
Phase II
Safety (adverse events such as decrease of visual function, skin disorders)
Evaluated at the time of 1 hour, 1 week, 2 weeks, and 4 weeks after the end of the treatment
1:visual acuity
2:Retinal sensitivity
3:electroretinogram
4:Optical coherence tomography
5:Visual field
6:Quality of vision
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Total of three times through the skin electrical stimulation to every two weeks
20 | years-old | <= |
80 | years-old | > |
Male and Female
Patients who meet all of the following criteria at least one eye
1)typical retinitis pigmentosa patients (less than 20 years of age or 80 years of age)
2)2 times of reliability that was performed within 31 days (fixation failure rate of less than 20%, the false positive rate of less than 15%, false-negative rate of less than 33%) static perimetry (HFA) 10-2 center four points with the average difference in the retina sensitivity is within 3dB, and also less than 30dB any of the value
3)Patient decimal vision of 0.01-0.4
4)Patients with afferent visual field constriction of 10 degrees or less in the 1 / 4 of the Goldman visual field examination (Gp)
5)Patient HFA10-2 of Mean Deviation (MD) value is less than -15dB
6)Patients after receiving a sufficient explanation Upon participation in the present study, after an adequate understanding, the document agreed by the free will of the patient himself was obtained
Patients conflict with one of the following:
1)Patients with vitreous macular traction syndrome, macular edema, epiretinal membrane, macular lesions such as high myopia with posterior staphyloma
2)Patients undergoing eye surgery within three months
3)Patients who use isopropyl unoprostone, calcium antagonist, dark adaptation improving agent within 31 days
4)Patient with a history of drug allergy for mydriatic, such as eye drops anesthetic that we plan to use during the trial period
5)Patients who are complicated by diabetic retinopathy
6)patients with merging inflammation external eye, infections, or severe dry eye
7)Patients likely to have been pregnant or pregnant. Patients during breast-feeding. Patients who wish to become pregnant during the study period
8)Patients with a history of optic nerve disease
9)Patients with merger moderate (grade3 of Emery classification) or more of nuclear cataract, serious affect such pre subcapsular cataract, posterior subcapsular cataract or secondary cataract in vision
6
1st name | |
Middle name | |
Last name | Takayuki Baba |
Chiba university
Department of Ophthalmology
1-8-1 Inohana Chuo-ku Chiba-shi Chiba
043-222-7171
babatakayuki@nifty.com
1st name | |
Middle name | |
Last name | Gen Miura |
Chiba university
Department of Ophthalmology
1-8-1 Inohana Chuo-ku Chiba-shi Chiba
043-222-7171
gmiura2@chiba-u.jp
Chiba university
Department of Ophthalmology
Chiba university
Department of Ophthalmology
Other
YES
UH2016012C
ACReSS
千葉大学病院(千葉県)
2016 | Year | 04 | Month | 12 | Day |
Unpublished
Terminated
2015 | Year | 11 | Month | 16 | Day |
2016 | Year | 06 | Month | 01 | Day |
2016 | Year | 04 | Month | 12 | Day |
2017 | Year | 07 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025232
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