The study evaluates the efficacy and safety of allogeneic platelet lysate eye drops in patients with severe ocular graft versus host disease refractory to conventional systemic and local treatments. The corneal staining, conjunctival hyperemia, tear film break up time,Schirmer test and ocular surface disease index will be evaluated before and after allogeneic platelet lysate treatment. The safety of allogeneic platelet lysate treatment will be also assessed.
The corneal staining with fluorescein will be assessed using Oxford grading scale. Tear film break up time is the time in seconds taken to appear first dry sport after complete blinking. Fluorescein is instilled into the patient tear film, the tear film is observed under cobalt blue illumination.Schirmer test will be performed without anesthesia. Conjunctival hyperemia will be graded from 0 to 2. The OSDI questinnaire will assess the impact of treatment on the quality of life.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Eye drops
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, Russia
Response of ocular chronic GVHD
Measured by 2015 NIH response criteria
Time frame: 2 years
Ocular adverse events
Local ocular adverse events measured by CTCAE v5.0.
Time frame: 2 years
Tear film breakup time
Measured by fluorescein staining of the tear film
Time frame: 2 years
Area of epithelial damage
Measured by fluorescein staining of the ocular surface by the Oxford grading scale (grades 0-5 with increasing severity with higher grades)
Time frame: 2 years
Patient reported outcomes: severity of dry eye syndrome in patients with chronic ocular graft-versus-host and its impact on the quality of life based on 12 questions, score from 0 to 4.
Ocular Surface Disease Index (OSDI) questionnaire.
Time frame: 2 years
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