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Midfacial hypoplasia is a common maxillofacial deformity in patients with cleft lip and palate, which requires surgical treatment. However, trans-sutural distraction osteogenesis (TSDO) remains some disadvantages, including difficulty in accurate location of surgical path, prolonged operation time, and excess surgical bleeding. This study aimed to evaluate the application of an optical surgical navigation system (OSNS) developed for TSDO. Six consecutive patients with midfacial hypoplasia who required TSDO were included in the study. Preoperatively, a head computed tomography was performed, and the data were imported into Mimics software (version: 20.0.0.691, Materialise Inc, Belgium) to design a three-dimensional simulation of the surgical approach. TSDO was performed with the use of OSNS. The accuracy and results of the procedure were initially evaluated by comparing the preoperative and postoperative periods. The patients included five boys and one girl, with an average age of 10 years; five with postoperative cleft lip and palate, and one without combined cleft lip and palate. The surgical procedure was successful, with a postoperative follow-up of 4–5 months. All patients demonstrated good treatment results without complications. In conclusioin, OSNS-assisted TSDO can noninvasively correct midfacial dysplasia, improve surgical precision, reduce bleeding and obtain better clinical results. OSNS can guide the TSDO safely and effectively. [ABSTRACT FROM AUTHOR]