Background/Aims To analyse patients with chronic ocular graft-versus-host disease (GvHD) under treatment with 100% autologous serum eye drops from a sealed manufacturing system.
Methods 17 patients with chronic ocular GvHD received 100% autologous serum eye drops from single use vials manufactured in a sealed system. Retrospective analysis included visual acuity, corneal staining, frequency of artificial tears, ocular symptoms by means of a questionnaire and information on subjective side effects and cost compensation.
Results Data of prior to autologous serum eye drops therapy and at a 6-month follow-up were obtained. They demonstrated a significant increase in visual acuity (logMAR oculus dexter/right eye (OD) 0.5±0.32 to 0.4±0.3; oculus sinister/left eye (OS) 0.6±0.35 to 0.3±0.35; p=0.177/0.003) and significant improvement in corneal staining (Oxford grading scheme: OD from 3±1.03 to 2±1.43, OS from 4±1.0 to 2±1.09, p=0.004/0.001) and ocular symptoms (ocular surface disease index: 88±20.59 to 63±22.77; p=0.02). Frequency of artificial tears was reduced and no side effects were reported. Patient satisfaction was 100%, and cost compensation by health insurance reached 80%.
Conclusions 100% autologous serum eye drops using a sealed manufacturing system were efficient in improving the ocular surface, patient symptoms and visual acuity without side effects. It seems to be safe to use 100% autologous serum despite earlier suspicions regarding immune complex accumulations and exacerbation of ocular surface inflammation. The potential effects of serum levels of systemic immunosuppressives through readministration onto the ocular surface need to be elucidated.
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Contributors All authors have contributed to the manuscript as follows: VT: data collection, writing of manuscript. UG: statistical analysis, writing of manuscript. LS: data collection, database management. UH: data collection, patient treatment, manuscript review. LE: data collection, design of study. SR and V-MP-J: establishment of sealed manufacturing process. CS and MH: patient treatment, study design, manuscript review. BG: establishment of sealed manufacturing process, manuscript review, data collection, study design. CC: manuscript writing, data collection. PS: study design, data collection, writing manuscript, database management.
Funding This work was supported by Helmut und Ruth Lingen Stiftung, Cologne, Germany and Deutsche Forschungsgemeinschaft (DFG): FOR2240 “(Lymph)Angiogenesis And Cellular Immunity In Inflammatory Diseases Of The Eye” (to CC and PS).
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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