Electrostimulation for chronic ocular graft-versus-host disease
Pilot Trial of Non-invasive Electrostimulation in Chronic Ocular Graft-vs-Host Disease
This study will see if gentle electrical stimulation on the skin near the eyes can reduce symptoms and the need for eye drops for people with chronic ocular graft-versus-host disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07166848 on ClinicalTrials.gov |
What this trial studies
This is a non-invasive trial applying transcutaneous electrical stimulation (TES) near the eyes and comparing active electrodes to electrodes without current (sham). Participants who meet symptom and corneal staining thresholds will receive repeated TES sessions and be monitored over time for symptom scores and corneal surface changes. Key outcome measures include patient-reported symptom scores (OSDI), corneal staining (NEI score), and changes in topical medication use. Standard exclusions include active ocular infection, recent ocular surgery, implanted electrical devices, and pregnancy.
Who should consider this trial
Good fit: Adults with chronic ocular graft-versus-host disease who have moderate to worse dry eye symptoms (OSDI ≥22) and measurable corneal staining (NEI score ≥2) are the intended candidates.
Not a fit: Patients with active ocular ulcers or infections, recent eye surgery or procedures, implanted pacemakers/ICDs, or who are pregnant would be excluded and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this non-invasive treatment could reduce corneal surface damage, improve eye comfort, and decrease the need for frequent lubricating eye drops.
How similar studies have performed: Electrical stimulation has shown mixed early results in other ocular surface and neuropathic eye conditions, and its application specifically to ocular GVHD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Boston, Massachusetts
- Massachusetts Eye and Ear - Longwood Campus — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Zhonghui Luo, MD, PhD — Massachusetts Eye and Ear Infirmary
- Study coordinator: Michael Cheung, MSc, CCRP
- Email: mcheung0@meei.harvard.edu
- Phone: 6175736060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.