Transdermal electrical stimulation in patients with retinitis pigmentosa

JRCT ID: jRCT2032210094

Registered date:17/05/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Retinitis pigmentosa
• Date of first enrollment: 01/06/2021
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Transdermal electrical stimulation of the retina is performed.
On the main body of the treatment device, the magnitude of the current energized by electrical stimulation, the energizing time are displayed.
Set the strength (current amount) and time (treatment time) of the current stimulation, and select the treatment eye (both eyes in this study).
The skin electrode contacts the skin on the surface with the gel-like adhesive substance, and the cable connecting the skin electrode and the main body is connected to the protrusion on the opposite surface.
Electrodes are attached to the lower eyelid ear side of both eyes and the center of the forehead to energize.

Outcome(s)

• Primary Outcome: The superiority of the logMAR visual acuity at week 24 to the sham group in the electrical stimulation treatment group in the amount of change from baseline.
• Secondary Outcome: Comparison of electrical stimulation treatment group and sham group at 24 weeks for logMAR visual acuity, ETDRS visual acuity, mean deviation (MD) value of HFA 10-2, monocular Humphrey Esterman visual field test score, ellipsoid zone length, central foveal thickness and the comp 9 of the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) score.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Criteria 2 to 4 are applied to an eligible eye.
1. Clinically diagnosed with typical retinal pigmentosa and age >/=20-years and <80-years.
2. HFA 10-2 performed with reliability fixation defective rate <20%, false positive rate <15%, false negative rate <33%.
3. Decimal visual acuity from 0.1 to 0.7.
4. HFA 10-2 MD values less than -10 dB.
5. Patients who signed consent document with sufficient understanding after receiving explanation for the responsibilities of participating in this trial.
6. Regular hospital visits every 2 weeks for 24 weeks and follow up at Weeks 36 and 48.
7. Patients who can take appropriate contraceptive measures during the trial period.

Exclude criteria

1. Patients who have received electrical stimulation treatment for ocular diseases in the past.
2. Patients who underwent intraocular surgery within 3 months of the beginning of this trial.
3. Patients who changed the dose and usage of isopropyl unoprostone, calcium antagonist, and helenien within 31 days before the screening examination.
4. History of allergy to mydriatic agents and ophthalmic surface anesthetic.
5. Presence of ocular diseases such as vitreous macular traction syndrome, macular edema, epiretinal membrane, myopia with posterior staphyloma, diabetic retinopathy, inflammation or infection of accessory visual structures, severe dry eye, central retinal vein occlusion, ischemic optic neuropathy, optic nerve disease, grade 3 or higher Emery-Little grade cataract or posterior capsular opacification.
6. Patients who had not experienced any deterioration in the visual acuity, OCT findings, Goldmann perimetry findings, and HFA 10-2 visual field sensitivities in the last 3 years.
7. Patients with a pacemaker or defibrillator
8. Patients with a history of malignant tumor. However, patients who have not relapsed for more than 5 years can be enrolled.
9. 9. Patients diagnosed and treated for psychosis, dementia or mental symptoms.
10. Diabetic patients with poor glycemic control (HbA1c (NGSP)> 10.0%).
11. Patients with hypertension (systole > 180 mmHg and / or diastole > 110 mmHg) who have difficulty controlling blood pressure by treatment.
12. Patients with hepatic or renal dysfunction that meets any of the following at the time of screening.
AST, ALT: More than 3 times the upper limit of the facility standard value
Creatinine: More than 1.5 times the upper limit of the facility standard value
13. Patients who were pregnant, breastfeeding, may be or planned to be pregnant during the trial period.
14. Patients participating in other clinical trials.
15. Patients under investigational responsibility principal or sub investigator judged inappropriate for participation in this trial.

Related Information

• Primary Sponsor: Miura Gen
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development