Effects of HFMH-EMS on Ocular Artery Circulation

NCT06861985 | Completed

• 1 other identifier: 202304EM005
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Investigated the effects of high-frequency multi-band harmonic electromagnetic stimulation on ophthalmic and central retinal artery circulation.

Conditions

Ocular Surface Disease; Central Retinal Artery Occlusion

Outcome Measures

Primary Outcomes (3)

• Peak Systolic Velocity (PSV)

  peak systolic velocity (PSV) of the ophthalmic artery (OA) were measured using color Doppler ultrasound of the eye arterial blood flow (EPIQ Elite ultrasound system, PHILIPS).

  At the first visit and after 90 minutes usage of device.

• End Diastolic Velocity (EDV)

  end diastolic velocity (EDV) of the ophthalmic artery (OA) were measured using color Doppler ultrasound of the eye arterial blood flow (EPIQ Elite ultrasound system, PHILIPS).

  At the first visit and after 90 minutes usage of device.

• Central Retinal Artery (CRA)

  Central Retinal Artery (CRA) were measured using color Doppler ultrasound of the eye arterial blood flow (EPIQ Elite ultrasound system, PHILIPS).

  At the first visit and after 90 minutes usage of device.

Study Arms (2)

experimental group

EXPERIMENTAL

high-frequency multi-band harmonic electromagnetic stimulation device group

Device: BOBY

control group

PLACEBO COMPARATOR

placebo device group

Other: Control

Interventions

BOBY DEVICE

high-frequency multi-band harmonic electromagnetic stimulation device

experimental group

Control OTHER

placebo group

control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old

You may not qualify if:

• hypertension
• diabetes
• heart disease
• eye-related diseases

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

National Central University

Hsinchu, Taiwan, 30013, Taiwan

Location

MeSH Terms

Conditions

Retinal Artery Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized double-blind controlled trial. All participants who meet the inclusion criteria are randomly assigned to either the "high-frequency multi-band harmonic electromagnetic stimulation device group" as the experimental group or the "placebo device group" as the control group.

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 6, 2025
• Study Start: September 20, 2023
• Primary Completion: September 20, 2023
• Study Completion: December 31, 2023
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)