Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration

Age-Related (Dry) Macular Degeneration Clinical Trial

Official title:

Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540148
• Other study ID #: NO001D
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: The Eye Machine Canada Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assess the effectiveness of externally applied micro current electrical stimulation on improving the ETDRS visual acuity in subjects with vision loss from dry age-related macular degeneration (AMD)

Description:

Micro-current electrical stimulation will be used to treat /each eye in a group of subjects with dry AMD. 60 subjects will be randomly divided into two groups. A ratio of 1:3 will be maintained between control and the experimental groups. In the treatment group, subjects will undergo a treatment session to the enrolled eyes daily for three days during week 1, followed by a single treatment session during weeks 2, 14 and 26 with the Nova Oculus device. A second group of subjects will act as the control group. This group will undergo sham treatment at the same treatment intervals with a non-functional Nova Oculus device. ETDRS visual acuity will be performed on all subjects at enrollment prior to each treatment and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the ETDRS visual acuity of subjects with dry AMD will be determined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Fifty years of age or older

• Male or female

• Best-corrected vision 20/50 to 20/200 for each enrolled eye

• Confirmed diagnosis of dry AMD

• Vision loss attributable to dry AMD

• Subjects must be highly motivated, alert, oriented, mentally competent and able to understand and comply with the requirements of the study, abide by the restrictions, return for all required visits, and provide voluntary informed consent

Exclusion Criteria:

• Any visually significant retinal pathology other than dry AMD

• Previous intravitreal injection

• Seizure disorders

• Previous vitreo-retinal surgery. (ERM, PPV, RD etc)

• Dense cataract

• Eyelid pathology at the treatment sites

• Glaucoma patients with a visual field mean defect of greater than 10dB on Humphrey visual field testing

• Glasses are up to date (prescription <1 year old)

• Any prior electrical micro-stimulation treatment to the eyes

• Poor general health

• Active cancer

• Life expectancy less than 12 months

• Non-ambulatory

• Not considered suitable for participation for any other reason

Related Conditions & MeSH terms

• Age-Related (Dry) Macular Degeneration
• Macular Degeneration

Intervention

Device:
• Nova Oculus™ Micro-current electrical stimulation
Active treatment with transpalpebral micro-current electrical stimulation device, 3 sessions within 5 days of the 1st treatment. 1 session during weeks 2, 14 and 26.
• Nova Oculus™ Micro-current electrical stimulation - Sham treatment
Non-active treatment with transpalpebral micro-current electrical stimulation SHAM device, 3 sessions within 5 days of the 1st treatment. 1 session during weeks 2, 14 and 26.

Locations

Country	Name	City	State
Canada	Dr. Kevin Parkinson	Coquitlam	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
The Eye Machine Canada Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the increase in ETDRS visual acuity for those treated with Nova Oculus™ device to control subjects who did not receive active treatment.		26 weeks