Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8431305 | Biology of Blood and Marrow Transplantation | 2007 | 6 Pages |
Abstract
To examine safety and efficacy of bandage soft contact lenses (BSCLs) for ocular chronic graft-versus host disease (GVHD), we conducted a phase II clinical trial. Extended-wear BSCLs were applied under daily topical antibiotic prophylaxis. Patients completed standardized symptom questionnaires at enrollment and at 2Â weeks, 4Â weeks, and 3Â months afterward. Ophthalmologic assessment was performed at enrollment, at 2Â weeks, and afterward as medically needed. Assessments at follow-up were compared with baseline by paired t-test. Nineteen patients with ocular GVHD who remained symptomatic despite conventional treatments were studied. The mean Lee eye subscale score was 75.4 at enrollment and improved significantly to 63.2 at 2Â weeks (PÂ =Â .01), to 61.8 at 4Â weeks (PÂ =Â .005), and to 56.3 at 3Â months (PÂ =Â .02). The ocular surface disease index score and 11-point eye symptom ratings also improved significantly. According to the Lee eye subscale, clinically meaningful improvement was observed in 9 patients (47%) at 2Â weeks, in 11 patients (58%) at 4Â weeks, and in 9 patients (47%) at 3Â months. Visual acuity improved significantly at 2Â weeks compared with enrollment values. Based on slit lamp exam at 2Â weeks, punctate epithelial erosions improved in 58% of the patients, showed stability in 16%, and worsened in 5%. No corneal ulceration or ocular infection occurred. BSCLs are a widely available, safe, and effective treatment option that improves manifestations of ocular GVHD in approximately 50% of patients. This study was registered at www.clinicaltrials.gov as NCT01616056.
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Authors
Yoshihiro Inamoto, Yi-Chen Sun, Mary E.D. Flowers, Paul A. Carpenter, Paul J. Martin, Peng Li, Ruikang Wang, Xiaoyu Chai, Barry E. Storer, Tueng T. Shen, Stephanie J. Lee,