NCT02699216

BioCurrent Electrical Stimulation for the Treatment of Dry ARMD

BioCurrent Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: DuBois Vision Clinic · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the treatment of Dry Macular Degeneration and the resulting change in vision with a very, very low current that is similar to what occurs in the body naturally. In Phase 1, 16 participants will be treated, with half receiving treatment and half a sham (no treatment). After the treatment period of one week, those not treated will be treated. In Phase 2, all participants will be treated.

Detailed description

The study will assess the effectiveness of transpalpebral micro-current electrical stimulation on improving the visual acuity in subjects with vision loss from Dry Macular Degeneration. The BioCurrent electrical stimulation will be applied by a device with the intended use of treating Dry Macular Degeneration. The device delivers a micro-current, an electrical current in the one millionth of an ampere range, to the retina in frequencies changing in a pre-defined pattern from 5Hz to 80Hz during each spot (40 sec). The device also incorporates a voltage limiter (a maximum of 245 micro A is possible) and a current level indicator. 200 micro A will be used. Very low electrical micro-current is delivered to the subject through the goggle probe.

Conditions

• Dry Macular Degeneration

Interventions

Type	Name	Description
DEVICE	Electrical Stimulation of the Retina	Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2016-03-04
• Last updated: 2018-06-06