NCT02540148

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

Completed NA Last updated 17 August 2021

What this trial tests

NA trial testing Nova Oculus™ Micro-current electrical stimulation in Age-Related (Dry) Macular Degeneration in 60 participants. Completed in 30 June 2021.

Timeline

15 November 2019

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	The Eye Machine Canada Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	15 November 2019
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across Canada

Drugs / interventions tested

• Nova Oculus™ Micro-current electrical stimulation
• Nova Oculus™ Micro-current electrical stimulation - Sham treatment

Conditions studied

• Age-Related (Dry) Macular Degeneration — all drugs for Age-Related (Dry) Macular Degeneration →

Sponsor

The Eye Machine Canada Inc.

Who can join

50 and older, any sex, with Age-Related (Dry) Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Electrical Stimulation on Ocular Cells: A Means for Improving Ocular Tissue Engineering and Treatments of Eye Diseases.
   Sanie-Jahromi F, Azizi A, Shariat S, Johari M. · · 2021 · cited 9× · PMID 34840978 · DOI 10.1155/2021/6548554
2. Treating patients with geographic atrophy: are we there yet?
   Antonio-Aguirre B, Arevalo JF. · · 2023 · cited 6× · PMID 37986170 · DOI 10.1186/s40942-023-00493-6
3. Evaluation of visual acuity in dry AMD patients after microcurrent electrical stimulation.
   Parkinson KM, Sayre EC, Tobe SW. · · 2023 · cited 6× · PMID 37331928 · DOI 10.1186/s40942-023-00471-y
4. Gene therapy for geographic atrophy in age-related macular degeneration: current insights.
   Jamil MU, Waheed NK. · · 2025 · cited 5× · PMID 39578546 · DOI 10.1038/s41433-024-03463-w
5. Effectiveness and Safety of Non-Invasive Neuromodulation for Vision Restoration: A Systematic Review and Meta-Analysis.
   Navarro PA, Contreras-Lopez WO, Tello A, Cardenas PL, et al · · 2024 · cited 2× · PMID 38487361 · DOI 10.1080/01658107.2023.2279092