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

NCT ID: NCT05703867

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

1999-12-31

Brief Summary

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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

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Conditions

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Age-Related Macular Degeneration Nonexudative Age-related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active microcurrent therapy

Group Type EXPERIMENTAL

Active microcurrent therapy

Intervention Type DEVICE

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

Interventions

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Active microcurrent therapy

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Professor Timothy Jackson, King's College

UNKNOWN

Sponsor Role collaborator

i-Lumen Scientific, Inc.

INDUSTRY

Sponsor Role collaborator

Jarding, John, OD

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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OL101

Identifier Type: -

Identifier Source: org_study_id