retinitis pigmentosa
Conditions
Interventions
transdermal electric stimulation
Sponsors
Chiba university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A case must satisfying all the following criteria. Evaluation Eye (1) Typical Retinal pigmented patients (over 20 years old and under 80 years old) (2) Static visual field examination (HFA) 10-2 with two reliabilities (less than 20% of fixation defect rate, less than 15% false positive rate, false negative rate less than 33%) executed within 6 months The difference in the average retinal sensitivity at the four central points is within 5 dB and both values are less than 30 dB (3) Patients with decimal visual acuity of 0.1 to 0.7 (4) Patients presenting afferent stenoses within 10 degrees in 1 / 4 of dynamic visual field examination (Gp) (5) Patients with Mean Deviation (MD) value of HFA 10-2 <-10 dB (6) After receiving sufficient explanation for the participation of this trial, patients who gained document consent by the patient's free will with sufficient understanding (7) Patients who can come to hospital for 3 months every 2 weeks
Exclusion criteria
Exclusion criteria: cases who conflict with any of the following must not include this study. (1) Patients complicated of macular lesions such as vitreous macular traction syndrome, macular edema, epiretinal membrane, and myopia with posterior staphyloma associated with myopia (2) Patients undergoing internal eye surgery within 3 months (3) Patients who changed the dose and usage of isopropyl unoprostone, calcium antagonist, dark adaptation improving drug within 31 days before screening (4) Patients who have a history of drug allergy to drugs to be used during the trial period (mydriatic drugs, eye drops anesthetics, etc.) (5) Patients complicated with diabetic retinopathy (6) Patients who are currently complaining of external eye inflammation, infection, or severe dry eye (7) Patients who may be pregnant or pregnant. Patient who is breastfeeding. Patients who want pregnancy during the trial period (8) Patients with a history of optic nerve disease (9) Evaluation of efficacy nuclear cataract with moderate degree (grade 3 in Emery classification) to the eyes, patients with complication of anterior subcapsular, subcapsular cataract, or late cataract which have a serious effect on vision (10) Patients whose Mean Deviation (MD) value of HFA 10-2 has deteriorated by 3 dB or more per year (11) Patients who have not seen any deterioration in visual acuity, OCT findings, dynamic visual field inspection (Gp) findings, and visual field sensitivities at HFA 10-2 in the last 3 years (12) Patients currently participating in other clinical trials (13) patients under investigational responsibility (shared) doctors judged inappropriate for participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| effectiveness | — |
Countries
Japan
Contacts
Public ContactGen Miura
Chiba university hospital Ophthalmology
Outcome results
None listed