This phase II clinical trial studies how well bandage lenses work in treating patients with ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and damage caused by eye graft versus host disease.
PRIMARY OBJECTIVES: I. To determine the symptom improvement after 2 weeks of therapy with bandage lenses. SECONDARY OBJECTIVES: I. To confirm short-term safety within 1 month after bandage lenses. II. To determine improvement in ophthalmologic examinations after bandage lenses. III. To explore the use of optical coherence tomography as an objective measure of corneal inflammation. OUTLINE: Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale
Lee eye subscale: sx6 dry eyes, sx7 need to use eye drops frequently, sx8 difficulty seeing clearly 0=not at all, 4=extremely bothered. If have at least one of (sx6,sx7,sx8), then sx\_eye=mean(sx6,sx7,sx8)\*25. Minimum possible score: 0 correlated with better outcome, maximum score possible: 100 correlated with worse outcome. Clinically meaningful change is half a standard deviation, which is a decrease of 11.8 of more for this scale.
Time frame: 3 months
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale
8-level change score is from 0 completely gone to 7 very much worse. Clinically meaningful improvement is defined as half a standard deviation (decreased score of 11.8 or greater).
Time frame: 3 months
Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index
OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.
Time frame: 3 months
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI
OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.
Time frame: 3 months
Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale
The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.
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Time frame: 3 months
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale
The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.
Time frame: 3 months
Number of Patients Who Experienced Serious Adverse Events
Safety of Bandage Contact Lenses at 1 month
Time frame: 1 month
Change in Comprehensive Ophthalmologic Evaluations
LogMAR visual acuity score of 0 is equivalent to 20/20 vision. Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.
Time frame: 2 weeks
Change in Optical Coherence Tomography
Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.
Time frame: 2 weeks