Ocular Surface DiseaseNCT06861985
Effects of HFMH-EMS on Ocular Artery Circulation
A study testing BOBY in people with Ocular Surface Disease and Central Retinal Artery Occlusion, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
Investigated the effects of high-frequency multi-band harmonic electromagnetic stimulation on ophthalmic and central retinal artery circulation. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Surface Disease, Central Retinal Artery Occlusion
- What is being tested?
- BOBY
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Sep 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 to 65 years old
Who cannot join
- hypertension
- diabetes
- heart disease
- eye-related diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of High-Frequency Multiband Harmonic Electromagnetic Stimulation (HFMH-EMS) on Ocular Artery Circulation After Prolonged Smartphone Usage
Investigated the effects of high-frequency multi-band harmonic electromagnetic stimulation on ophthalmic and central retinal artery circulation.
Read the detailed description
This study investigated the effects of prolonged smartphone usage for over 90 minutes on ophthalmic and central retinal artery circulation before and after smartphone use and compared the effects with versus without intervention by high-frequency multi-band harmonic electromagnetic stimulation.
- Being tested
- BOBY, Control
- Medical subject headings
- Retinal Artery Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOBYDevice
high-frequency multi-band harmonic electromagnetic stimulation device
ControlOther
placebo group
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | high-frequency multi-band harmonic electromagnetic stimulation device group Receives: Device: BOBY |
| control group | Placebo comparator | placebo device group Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: At the first visit and after 90 minutes usage of device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start20 Sep 2023
- Primary completion20 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861985
- Sponsor's protocol ID
- 202304EM005
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-Frequency Multiband Harmonic Electromagnetic Stimulation (HFMH-EMS) on Ocular Artery Circulation After Prolonged Smartphone Usage
- ClinicalTrials.gov ID
- NCT06861985
- Acronym / sponsor ID
- 202304EM005
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigated the effects of high-frequency multi-band harmonic electromagnetic stimulation on ophthalmic and central retinal artery circulation.
Detailed description
This study investigated the effects of prolonged smartphone usage for over 90 minutes on ophthalmic and central retinal artery circulation before and after smartphone use and compared the effects with versus without intervention by high-frequency multi-band harmonic electromagnetic stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: BOBYhigh-frequency multi-band harmonic electromagnetic stimulation device group |
| control group | Placebo comparator | Other: Controlplacebo device group |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20 to 65 years old
Key exclusion criteria (4 listed)
- hypertension
- diabetes
- heart disease
- eye-related diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOBYhigh-frequency multi-band harmonic electromagnetic stimulation device | Device | experimental group |
| Controlplacebo group | Other | control group |
Primary outcome
Peak Systolic Velocity (PSV)
Time frame: At the first visit and after 90 minutes usage of device.
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).
End Diastolic Velocity (EDV)
Time frame: At the first visit and after 90 minutes usage of device.
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).
Central Retinal Artery (CRA)
Time frame: At the first visit and after 90 minutes usage of device.
Central Retinal Artery (CRA) were measured using color Doppler ultrasound of the eye arterial blood flow (EPIQ Elite ultrasound system, PHILIPS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOBY in people with Ocular Surface Disease and Central Retinal Artery Occlusion, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Systolic Velocity (PSV) (time frame: At the first visit and after 90 minutes usage of device.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.