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

NCT ID: NCT02540148

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2021-06-30

Brief 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)

Detailed 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.

Conditions

Age-Related (Dry) Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active Treatment

Patients will be fully consented before the start of the study. In the treatment group, subjects will undergo a treatment session to the enrolled eyes for three days during Week 1, followed by a single treatment session during Weeks 2, 14 and 26 with the Nova Oculus device. A treatment session is 15 minutes of treatment on each closed eye lid for a total of 30 minutes. ETDRS visual acuity will be performed on all subjects at enrollment (prior to the first treatment), prior to each treatment session, and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the visual acuity of subjects with dry AMD will be determined.e.

Group Type: EXPERIMENTAL

Nova Oculus™ Micro-current electrical stimulation

Intervention Type: DEVICE

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.

Non-active treatment

A second group of subjects will act as the control group. This group will undergo sham treatment to the enrolled eyes at the same intervals as the treatment group (Weeks 2, 14 and 26), but with a nonfunctional Nova Oculus device. A treatment session is 15 minutes of treatment on each closed eye lid for a total of 30 minutes. ETDRS visual acuity will be performed on all subjects at enrollment (prior to the first treatment), prior to each treatment session, and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the visual acuity of subjects with dry AMD will be determined.

Group Type: SHAM_COMPARATOR

Nova Oculus™ Micro-current electrical stimulation - Sham treatment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Eye Machine Canada Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Parkinson, MD

Role: PRINCIPAL_INVESTIGATOR

Independent

Locations

Dr. Kevin Parkinson

Coquitlam, British Columbia, Canada

Countries

Canada

References

Parkinson KM, Sayre EC, Tobe SW. Evaluation of visual acuity in dry AMD patients after microcurrent electrical stimulation. Int J Retina Vitreous. 2023 Jun 18;9(1):36. doi: 10.1186/s40942-023-00471-y.

Reference Type: DERIVED

PMID: 37331928 (View on PubMed)

Other Identifiers

NO001D

Identifier Type: -

Identifier Source: org_study_id