The ethics committee approved this retrospective study at Keio University School of Medicine (#20,170,350). Informed consents were obtained from all the participants and their guardians through the website at Keio University School of Medicine by posting a detailed written guideline and ethical statement of the present study. This study followed the guidelines of the tenets of the Declaration of Helsinki. Ethical guidelines for clinical research from the Japanese Ministry of Health, Labor, and Welfare indicate the studies which do not involve biological tissue and include reviewing medical records retrospectively; researchers do not need to obtain written informed consent from patients and guardians. Following the guidelines of the ethics committees, we posted a detailed written guideline and ethical statement of the present study, including the background of the study, the purpose of the study, study design, privacy policy, freedom to withdraw, inclusion and exclusion criteria, the factors assessed in the medical records, advantage, and disadvantage of participating the study, disclosure of the data, presenting the data at a conference or in a journal, and contact information.
Since we considered patients equal to or older than 18 as adults, the medical records of consecutive patients less than 18 years of age who received allogeneic HSCT at Keio University Hospital from December 2004 to June 2017 were reviewed retrospectively. Ophthalmic examination for baseline screening is routinely performed before HSCT in our outpatient clinic. All patients underwent standardized clinical and ophthalmological evaluations as described below before HSCT and 3, 6, 9, 12, 18, 24, and 30 months after transplantation. Some patients had additional examinations as indicated according to our follow-up schedule. The inclusion criteria for the study were (1) cases with ophthalmic examinations before HSCT, (2) cases involving no ocular complications before HSCT, and (3) follow-up examinations during at least two years after HSCT. The exclusion criteria for all participants were as follows: (1) a history of previous treatment for ophthalmic diseases and (2) other types of severe DED, including Stevens-Johnson syndrome and ocular cicatricial pemphigoid. (3) Patients who had treatment for other inflammatory diseases, including Sjogren’s syndrome, systemic lupus erythematosus, systemic sclerosis, and juvenile rheumatoid arthritis, that require systemic immunosuppression.
In total, 28 patients met the inclusion criteria, and two patients were excluded according to the exclusion criteria. Twenty-six patients remained in our study, and 11 DED cases and 15 non-DED cases were ultimately included in the primary analysis. The patients were divided into these two groups based on the diagnosis of DED to describe the characteristics of pediatric GVHD-related DED.
Since we considered patients equal to or older than 18 as adults, the medical records of consecutive patients less than 18 years of age who received allogeneic HSCT at Keio University Hospital from December 2004 to June 2017 were reviewed retrospectively. Ophthalmic examination for baseline screening is routinely performed before HSCT in our outpatient clinic. All patients underwent standardized clinical and ophthalmological evaluations as described below before HSCT and 3, 6, 9, 12, 18, 24, and 30 months after transplantation. Some patients had additional examinations as indicated according to our follow-up schedule. The inclusion criteria for the study were (1) cases with ophthalmic examinations before HSCT, (2) cases involving no ocular complications before HSCT, and (3) follow-up examinations during at least two years after HSCT. The exclusion criteria for all participants were as follows: (1) a history of previous treatment for ophthalmic diseases and (2) other types of severe DED, including Stevens-Johnson syndrome and ocular cicatricial pemphigoid. (3) Patients who had treatment for other inflammatory diseases, including Sjogren’s syndrome, systemic lupus erythematosus, systemic sclerosis, and juvenile rheumatoid arthritis, that require systemic immunosuppression.
In total, 28 patients met the inclusion criteria, and two patients were excluded according to the exclusion criteria. Twenty-six patients remained in our study, and 11 DED cases and 15 non-DED cases were ultimately included in the primary analysis. The patients were divided into these two groups based on the diagnosis of DED to describe the characteristics of pediatric GVHD-related DED.
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