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

Sponsor

Jarding, John, OD (Other)

Overall Status

Completed

CT.gov ID

NCT05703867

Collaborator

Professor Timothy Jackson, King's College (Other), i-Lumen Scientific, Inc. (Industry)

404

Enrollment

Arm

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration Nonexudative Age-related Macular Degeneration	Device: Active microcurrent therapy	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

404 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 1998

Actual Primary Completion Date :

Dec 1, 1999

Actual Study Completion Date :

Dec 1, 1999

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active microcurrent therapy	Device: Active microcurrent therapy Non-invasive transpalpebral microcurrent therapy delivery to the upper and lower eyelids

Arm

Intervention/Treatment

Experimental: Active microcurrent therapy

Device: Active microcurrent therapy

Non-invasive transpalpebral microcurrent therapy delivery to the upper and lower eyelids

Outcome Measures

Primary Outcome Measures

Mean logMAR BCVA [Week 1]
Mean logarithm of the minimum angle of resolution (logMAR) best-corrected visual acuity (BCVA) following the last treatment

Secondary Outcome Measures

Proportion of improved, stable or worsened BCVA [Week 1]
Proportion of eyes with improved, stable or worsened BCVA, and BCVA with both eyes open

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Jarding, John, OD
Professor Timothy Jackson, King's College
i-Lumen Scientific, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jarding, John, OD

ClinicalTrials.gov Identifier:

NCT05703867

Other Study ID Numbers:

OL101

First Posted:

Jan 30, 2023

Last Update Posted:

Jan 31, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Macular Degeneration

Study Results

No Results Posted as of Jan 31, 2023