Electrostimulation Study for Ocular Graft vs. Host Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhonghui K. Luo, MD, PhD
About this trial
This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of chronic ocular graft vs. host disease (oGVHD) (ICCGVHD criteria probable or definite)
OSDI score of 22 or higher
NEI corneal staining score (or modified NEI score) of 2 or higher.
Disqualifiers
Patients with any open wound on the eyelid.
Patient with any active cornea ulcer, dacryocystitis, hordeolum, filamentary keratitis, uveitis, retinal detachment, uncontrolled glaucoma or other active pathology per PI's discretion.
Patient with a pacemaker or ICD.
Patient currently pregnant or with a potential to be pregnant during the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Electrodes with Currents
DeviceElectrodes will be placed on the cheeks and forehead, and treated with an amplitude of 300 µA for 30 mins
Electrodes without Currents
DeviceElectrodes will be placed on the cheeks and forehead, and treated with an no amplitude for 30 mins
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: ElectrostimulationExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of Electrostimulation (ES) Treatment.
To evaluate whether the use of electrostimulation (ES) over a course of 10 treatments (in 8 weeks) will ameliorate symptoms and signs of chronic ocular Graft-vs-Host Disease (oGVHD) and the effect on sub-basal corneal nerve regeneration.
Time frame
8 WeeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhonghui K. Luo, MD, PhD
Lead sponsor
Massachusetts Eye and Ear Infirmary
Sponsor institution
Source ClinicalTrials.gov