PEMF: an Adjunct Therapy for Anterior Uveitis (PEMF)

• ClinicalTrials.gov Identifier: NCT01154010
• Recruitment Status: Completed
• First Posted: June 30, 2010
• Results First Posted: May 4, 2017
• Last Update Posted: February 28, 2018
• Sponsor: Massachusetts Eye and Ear Infirmary
• Collaborator: BioElectronics Corporation
• Information provided by (Responsible Party): George Papaliodis, Massachusetts Eye and Ear Infirmary

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
• Conditions: Anterior Uveitis; Iritis
• Interventions: Device: PEMF; Device: PEMF Placebo
• Enrollment: 18

Participant Flow

Recruitment Details	Analysis in process as of December, 2016.
Pre-assignment Details	Analysis in process as of December, 2016.

Arm/Group Title	Active Device	Placebo Device
Arm/Group Description	ActiPatch, a device that emits a low frequency energy called "pulsed electromagnetic field" (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids. PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids. Analysis in process as of December, 2016.	Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids. PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids. Analysis in process as of December, 2016.
Period Title: Overall Study
Started	9	9
Completed	9	8
Not Completed	0	1
Reason Not Completed
Lost to Follow-up	0	1

Baseline Characteristics

Arm/Group Title		Active Device	Placebo Device	Total
Arm/Group Description		ActiPatch, a device that emits a low frequency energy called "pulsed electromagnetic field" (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids. PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.	Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids. PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.	Total of all reporting groups
Overall Number of Baseline Participants		9	9	18
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	9 participants	9 participants	18 participants
		42.33 (12.808)	40.22 (14.228)	41.275 (13.576)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants	9 participants	18 participants
	Female	3 33.3%	3 33.3%	6 33.3%
	Male	6 66.7%	6 66.7%	12 66.7%

Outcome Measures

1. Primary Outcome

Title	Inflammation Grade at Day 7
Description	Degree and grade of ocular inflammation based on Standard Uveitis Nomenclature will be assessed at initial visit, Day 3, and Day 7 of use of the PEMF device to assess if the PEMF device decreases the duration and severity of ocular inflammation when used as an adjunctive therapy for anterior uveitis. The results posted here are from day 7. The Standard Uveitis Nomenclature scale ranges from 0 to 4, with 0 indicating a minimal level of ocular inflammation and 4 indicating the maximal level of corneal inflammation.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Device	Placebo Device
Arm/Group Description:	ActiPatch, a device that emits a low frequency energy called "pulsed electromagnetic field" (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids. PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids. Analysis in process as of December, 2016.	Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids. PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids. Analysis in process as of December, 2016.
Overall Number of Participants Analyzed	9	8
Mean (Standard Deviation); Unit of Measure: units on a scale
	0.625 (0.876)	1.444 (1.130)

Adverse Events

Time Frame	7 days
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Active Device	Placebo Device
Arm/Group Description	ActiPatch, a device that emits a low frequency energy called "pulsed electromagnetic field" (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids. PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids. Analysis on-going as of December, 2016.	Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids. PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids. Analysis on-going as of December, 2016.
All-Cause Mortality
	Active Device	Placebo Device
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Active Device	Placebo Device
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/9 (0.00%)	0/9 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Active Device	Placebo Device
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/9 (0.00%)	0/9 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Director of the Ocular Immunology and Uveitis Service
• Organization: Massachusetts Eye and Ear Infirmary
• Phone: 617-573-5549
• EMail: George_Papaliodis@meei.harvard.edu

Publications:

McLeod KJ, Lee RC, Ehrlich HP. Frequency dependence of electric field modulation of fibroblast protein synthesis. Science. 1987 Jun 12;236(4807):1465-9.

Nicolle FV, Bentall RM. Use of radio-frequency pulsed energy in the control of postoperative reaction in blepharoplasty. Aesthetic Plast Surg. 1982;6(3):169-71.

Lee JH, McLeod KJ. Morphologic responses of osteoblast-like cells in monolayer culture to ELF electromagnetic fields. Bioelectromagnetics. 2000 Feb;21(2):129-36.

• Responsible Party: George Papaliodis, Massachusetts Eye and Ear Infirmary
• ClinicalTrials.gov Identifier: NCT01154010
• Other Study ID Numbers: 09-03-020
• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Results First Submitted: March 24, 2017
• Results First Posted: May 4, 2017
• Last Update Posted: February 28, 2018