Transpalpebral Microcurrent Stimulation for the Improveme... | NCT05703867

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

NCT05703867

Sponsor

Jarding, John, OD

Status

Completed

Last Update Posted

Jan 31, 2023Actual

Enrollment

404Actual

Phase

Phase 1Phase 2

Conditions

Age-Related Macular Degeneration
Nonexudative Age-related Macular Degeneration

Interventions

Active microcurrent therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1998Actual

Primary Completion Date

Dec 1999Actual

Completion Date

Dec 1999Actual

First Submitted Date

Jan 20, 2023

First Submission Date that Met QC Criteria

Jan 20, 2023

First Posted Date

Jan 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2023

Last Update Posted Date

Jan 31, 2023Actual

Name	Class
Professor Timothy Jackson, King's College	UNKNOWN
i-Lumen Scientific, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

404Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active microcurrent therapy	Experimental		Device: Active microcurrent therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active microcurrent therapy	Device	Non-invasive transpalpebral microcurrent therapy delivery to the upper and lower eyelids	Active microcurrent therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean logMAR BCVA	Mean logarithm of the minimum angle of resolution (logMAR) best-corrected visual acuity (BCVA) following the last treatment	Week 1

Secondary Outcomes

Measure	Description	Time Frame
Proportion of improved, stable or worsened BCVA	Proportion of eyes with improved, stable or worsened BCVA, and BCVA with both eyes open	Week 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided