Anterior Uveitis, Iritis
Conditions
Keywords
PEMF, iritis, anterior uveitis
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.
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.
Interventions
DEVICEPEMF
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.
DEVICEPEMF 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.
Sponsors
BioElectronics Corporation
Massachusetts Eye and Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Analysis in process as of December, 2016.
Pre-assignment details
Analysis in process as of December, 2016.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 9 |
| 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.
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. | 9 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Active Device | Placebo Device | Total |
|---|---|---|---|
| Age, Continuous | 42.33 years STANDARD_DEVIATION 12.808 | 40.22 years STANDARD_DEVIATION 14.228 | 41.275 years STANDARD_DEVIATION 13.576 |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Inflammation Grade at Day 7
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | Inflammation Grade at Day 7 | 0.625 units on a scale | Standard Deviation 0.876 |
| Placebo Device | Inflammation Grade at Day 7 | 1.444 units on a scale | Standard Deviation 1.13 |