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NCT05703867 Clinical Trial

Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

Age-Related Macular Degeneration Clinical Trial

Official title:
Interventional Study of Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05703867
Other study ID # OL101
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 1998
Est. completion date December 1999

Study information
Verified date January 2023
Source Jarding, John, OD
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the effectiveness of transpalpebral microcurrent stimulation as a therapy for dry age-related macular degeneration. Participants are assessed at baseline for visual acuity and treated for 4 consecutive days for a total of 8 sessions (2 per day) with microcurrent stimulation. A follow-up visit is conducted to evaluate the participant and collect follow-up visual acuity.

Recruitment information / eligibility
Status Completed
Enrollment 404
Est. completion date December 1999
Est. primary completion date December 1999
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Adults aged at least 50 years with dry AMD in at least one eye Exclusion Criteria: - Eye diseases other than dry AMD - Implanted electrical devices - Seizure disorders

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Active microcurrent therapy
Non-invasive transpalpebral microcurrent therapy delivery to the upper and lower eyelids

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Jarding, John, OD i-Lumen Scientific, Inc., Professor Timothy Jackson, King's College

Outcome
Type Measure Description Time frame Safety issue
Primary Mean logMAR BCVA Mean logarithm of the minimum angle of resolution (logMAR) best-corrected visual acuity (BCVA) following the last treatment Week 1
Secondary Proportion of improved, stable or worsened BCVA Proportion of eyes with improved, stable or worsened BCVA, and BCVA with both eyes open Week 1
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