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RecruitingNot ApplicableNCT07166848

Electrostimulation Study for Ocular Graft vs. Host Disease

Pilot Trial of Non-invasive Electrostimulation in Chronic Ocular Graft-vs-Host Disease

Sponsor

Zhonghui K. Luo, MD, PhD

Enrollment

15 participants

Start Date

Nov 30, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Ocular Graft-versus-host Disease

Summary

This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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 Criteria10

  • 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

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Interventions

DEVICEElectrodes with Currents

Electrodes will be placed on the cheeks and forehead, and treated with an amplitude of 300 µA for 30 mins

DEVICEElectrodes without Currents

Electrodes will be placed on the cheeks and forehead, and treated with an no amplitude for 30 mins

Locations(1)

Massachusetts Eye and Ear - Longwood Campus

Boston, Massachusetts, United States

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NCT07166848