Safety and effectiveness of transdermal electrical stimulation for non-arteritic anterior ischemic optic neuropathy

JRCT ID: jRCT2032190198

Registered date:03/02/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-arteritic anterior ischemic optic neuropathy
• Date of first enrollment: 11/10/2019
• Target sample size: 5
• Study type: Interventional
• Intervention(s): retinal electrical stimulation

Outcome(s)

• Primary Outcome: logMAR visual acuity change

Secondary Outcome

<Secondary endpoints>
1. logMAR visual acuity change from 0 week at each visits.
2. ETDRS visual acuity change from 0 week at Week 12.
3. Change of mean Deviation measured by Static perimetry (HFA) with 10-2 program from baseline at Week 12.
4. Change of Esterman test score (100) measured by Static perimetry from baseline at Week 12.
<Survey of adverse events (type, incident, severity, so on)>

Key inclusion & exclusion criteria

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

Include criteria

1. Clinically diagnosed with central retinal artery occlusion and age >20-years and <80-years.
2. Patients who have a definitive diagnosis of Non-Arteritic Anterior Ischemic Optic Neuropathy and have been older than 6 months since their estimated onset.
3. Patients with decimal visual acuity less than 0.7 above hand motion.
4. Patients who have obtained informed consent from the person's free will, after receiving sufficient explanation for participating in this clinical trial.
5. Patients who can visit hospital for 12 weeks every 2 weeks.

Exclude criteria

1. Patients with ESR>20 mm/h and CRP>10 mg/L in blood tests.
2. Patients who have been confirmed with nonarteritic ischemic optic neuropathy and who have an eye disease other than ischemic optic neuropathy by contrast-enhanced MRI.
3. Patients who have a history of drug allergy to drugs (mydriatics and anesthetics eye drops) to be used during the trial period.
4. Patients with complications that have a significant affect on visual function.
5. Patients with a history of or complications of malignancy. However, patients who have a history but have not relapsed for more than 5 years can be registered.
6. Patients diagnosed and treated for dementia and mental illness.
7. Patients complicated with poor control diabetes (HbA1c (NGSP)> 10.0%).
8. Patients with uncontrollable hypertension (systolic > 180 mmHg and / or diastolic 110 mmHg).
9. Patients with liver / renal dysfunction that falls under any of the following at clinical screening.
AST, ALT: more than 3 times the upper limit of (facility) standard value.
Serum creatinine: more than 1.5 times the upper limit of (institutional) standard value
10. Patients taking ethambutol hydrochloride and / or amiodarone hydrochloride.
11. Patients who are pregnant, breastfeeding, may be or planned to be pregnant during the trial period.
12. Patients participating in other clinical trials.
13. Patients under investigational responsibility (shared) doctors judged inappropriate for participation in this trial.

Related Information

• Primary Sponsor: Yamamoto Shuichi
• Source(s) of Monetary Support: Mayo Corporation
• Secondary ID(s): UMIN000036220