Dry Eye Syndrome Clinical Trial
Official title:
Intense Pulsed Light (IPL) and Meibomian Gland Expression to Treat Ocular Rosacea Secondary to Inactive Chronic Ocular Graft Versus Host Disease (GVHD)
The purpose of this study was to see if Intense Pulsed Light (IPL) can be used safely and effectively to help treat dry eyes from ocular rosacea after chronic graft-versus-host disease (GVHD). Current treatment options for this disease are limited.
Ocular rosacea and meibomian gland disease are major contributors to keratoconjunctivitis
sicca after chronic GVHD. Rosacea exacerbates the aqueous deficiency caused by damage to
lacrimal and accessory lacrimal glands similar to cholestasis damage in the biliary system.
Subjects who had inactive chronic GVHD after allogeneic bone marrow transplantation and
severe dry eye symptoms related to ocular rosacea were recruited and treated with 4 monthly
sessions of IPL and meibomian gland expression. Their charts were reviewed prior to
treatment to confirm quiescence of active systemic disease. Symptom scores were quantified
with Ocular Surface Disease Index (OSDI) and Standard Patient Evaluation of Eye Dryness
questionnaire (SPEED2). Baseline complete eye exam was performed, and subjects received an
eyes assessment score based on the Chronic Graft-Versus-Host Disease (GVHD) Assessment and
Scoring Form.
Symptoms, exam, and diagnostic data were obtained at baseline (month 0, month 1, month 2,
month 3, month 4, month 5, month 6, month 9 and month 12). IPL treatment and meibomian gland
expression was performed at baseline (month 0), month 1, month 2, and month 3.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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