PEMF: an Adjunct Therapy for Anterior Uveitis
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if a medical device (ActiPatch) that emits a low frequency pulsed electromagnetic field (PEMF) will benefit patients with anterior uveitis. Anterior uveitis (aka iritis) is an inflammatory disease involving the front segment of the eye. This is a common cause of a painful red eye, and ActiPatch has been shown to be effective in treating tissue inflammation. The conventional treatment of iritis typically involves frequent administration of topical steroids which have their own inherent risks (development of cataracts and/or glaucoma). The purpose of this study is to determine if ActiPatch therapy can be used to shorten the length of time and/or quantity of steroids administered.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Iritis is an inflammatory disease focused in the anterior chamber of the eye. The inflammation inside the eye can lead to a number of conditions that ultimately effect vision. These can include glaucoma, posterior synechiae, cystoid macular edema, and cataract. The standard treatment for the disease is drug therapy centered around the administration of corticosteroids. These are administered in the form of eye drops, and if necessary periocular/intraocular injections, or/and by systemic oral/IV administration. Unfortunately, the treatment with corticosteroids can similarly induce severe side effects including glaucoma and cataract formation. ActiPatch is a medical device that emits a low frequency pulsed electromagnetic field. This device has been shown to reduce inflammation and pain in a number of conditions, eg blepharoplasty (eyelid surgery). ActiPatch is FDA approved for use after blepharoplasty to reduce swelling, inflammation and pain. The treatment is not invasive, does not require additional medication, and side effects from ActiPatch and other PEMF devices have not been reported. The potential benefit of treating uveitis with ActiPatch is the potential to reduce the time and/or amount of steroid administration. This would benefit patients by reducing the risk of unwanted side effects of the corticosteroid treatment.
The benefit to society would be an improved treatment for anterior uveitis.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active Device 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. |
Device: 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.
|
| Placebo Comparator: Placebo Device 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. |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Inflammation Grade at Day 7 [7 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Human subjects who have been clinically diagnosed with anterior uveitis (iritis) but are in otherwise in good health will be recruited for the study. The age requirement will be a minimum of 18 yrs. We will recruit 24 patient for this study. Subjects will only be included who have been clinically diagnosed with anterior uveitis (noninfectious). Eligibility will be determined by the treating Ophthalmologist (principal investigator) for inclusion in the study.
Exclusion Criteria:
-
Vulnerable subjects, as defined by the Institutional Review Board (IRB), will not be recruited for participation (This includes individuals under 18, pregnant women, prisoners, fetuses, patients mentally or physically unable to provide written informed consent).
-
Other groups excluded include: patients with pacemakers and patients with ferromagnetic metal implants since these devices may be effected by the pulsed electromagnetic field.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts Eye and Ear Infirmary
- BioElectronics Corporation
Investigators
- Principal Investigator: George Papaliodis, MD, Massachusetts Eye and Ear Infirmary
Study Documents (Full-Text)
None provided.More Information
Publications
- Lee JH, McLeod KJ. Morphologic responses of osteoblast-like cells in monolayer culture to ELF electromagnetic fields. Bioelectromagnetics. 2000 Feb;21(2):129-36.
- 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.
- 09-03-020
Study Results
Participant Flow
| Recruitment Details | Analysis in process as of December, 2016. |
|---|---|
| Pre-assignment Detail | 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 |
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 Participants | 9 | 9 | 18 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
42.33
(12.808)
|
40.22
(14.228)
|
41.275
(13.576)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
3
33.3%
|
3
33.3%
|
6
33.3%
|
| Male |
6
66.7%
|
6
66.7%
|
12
66.7%
|
Outcome Measures
| 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. |
| Measure Participants | 9 | 8 |
| Mean (Standard Deviation) [units on a scale] |
0.625
(0.876)
|
1.444
(1.130)
|
Adverse Events
| Time Frame | 7 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Active Device | Placebo Device | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/9 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Active Device | Placebo Device | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/9 (0%) | ||
Limitations/Caveats
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 |
| George_Papaliodis@meei.harvard.edu |
- 09-03-020