Status:
RECRUITING
Electrostimulation Study for Ocular Graft vs. Host Disease
Lead Sponsor:
Zhonghui K. Luo, MD, PhD
Conditions:
Chronic Ocular Graft-versus-host Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease.
Detailed Description
The trial is to test whether transcutaneous electrical stimulation (TES) may be an effective new type of non-invasive treatment for patients who are diagnosed with chronic ocular Graft-vs-Host Disease...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Patient undergoing any ocular surgical procedure (including intravitreal injections) within the past 3 months.
- Patient undergoing any systemic surgical procedures within 2 months.
- Patient undergoing any non-surgical eyelid procedure such as punctal plugs or punctal cautery within 1 month of study initiation.
- Patients on cytotoxic agents, drugs that inhibit peripheral nerve regeneration (i.e. Gabapentin, Nicotine), radiation therapy, or any other therapy per PI's discretion.
- Patients undergoing immunosuppression regimen change within 1 month of study initiation and/or during the study period.
- Patient who wears contact lens of any kind
Key Trial Info
Start Date :
November 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2029
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07166848
Start Date
November 30 2025
End Date
November 30 2029
Last Update
December 17 2025
Active Locations (1)
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1
Massachusetts Eye and Ear - Longwood Campus
Boston, Massachusetts, United States, 02215