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Voluntary clinical trials to examine the safety and efficacy of 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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021887
Enrollment
6
Registered
2016-04-12
Start date
2016-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis Pigmentosa

Interventions

Sponsors

Chiba university Department of Ophthalmology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
1:visual acuity 2:Retinal sensitivity 3:electroretinogram 4:Optical coherence tomography 5:Visual field 6:Quality of vision

Countries

Japan

Contacts

Public ContactGen Miura

Chiba university Department of Ophthalmology

gmiura2@chiba-u.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026