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

Phase 1

Completed

• Conditions: Nonexudative Age-related Macular Degeneration; Age-Related Macular Degeneration
• Interventions: Device: Active microcurrent therapy

• Registration Number: NCT05703867
• Lead Sponsor: Jarding, John, OD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-01
• Primary Completion: 1999-12
• Study Completion: 1999-12
• Status Verified: 2023-01
• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-20
• Last Update Submitted: 2023-01-28
• Study First Posted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active microcurrent therapy	Active microcurrent therapy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Proportion of improved, stable or worsened BCVA	Week 1	Proportion of eyes with improved, stable or worsened BCVA, and BCVA with both eyes open