Trial Outcomes & Findings for PEMF: an Adjunct Therapy for Anterior Uveitis (NCT NCT01154010)
NCT ID: NCT01154010
Last Updated: 2018-02-28
Results Overview
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.
COMPLETED
NA
18 participants
7 days
2018-02-28
Participant Flow
Analysis in process as of December, 2016.
Analysis in process as of December, 2016.
Participant milestones
| Measure |
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.
Analysis in process as of December, 2016.
|
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.
Analysis in process as of December, 2016.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
Analysis in process as of December, 2016.
|
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.
Analysis in process as of December, 2016.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
PEMF: an Adjunct Therapy for Anterior Uveitis
Baseline characteristics by cohort
| Measure |
Active Device
n=9 Participants
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.
|
Placebo Device
n=9 Participants
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
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.33 years
STANDARD_DEVIATION 12.808 • n=99 Participants
|
40.22 years
STANDARD_DEVIATION 14.228 • n=107 Participants
|
41.275 years
STANDARD_DEVIATION 13.576 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 daysDegree 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.
Outcome measures
| Measure |
Active Device
n=9 Participants
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.
|
Placebo Device
n=8 Participants
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.
|
|---|---|---|
|
Inflammation Grade at Day 7
|
0.625 units on a scale
Standard Deviation 0.876
|
1.444 units on a scale
Standard Deviation 1.130
|
Adverse Events
Active Device
Placebo Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of the Ocular Immunology and Uveitis Service
Massachusetts Eye and Ear Infirmary
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place