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A custom virtual reality training solution for ophthalmologic surgical clinical trials.

ABSTRACT: We present a summary of the development and clinical use of two custom designed high-fidelity virtual-reality simulator training platforms. This simulator development program began in 2016 to support the phase III clinical trial Archway (ClinicalTrials.gov identifier, NCT03677934) intended to evaluate the Port Delivery System (PDS) developed by Genentech Inc. and has also been used to support additional clinical trials. The two simulators address two specific ophthalmic surgical procedures required for the successful use of PDS and provide state-of-the-art physical simulation models and graphics. The simulators incorporate customized active haptic feedback input devices that approximate different hand pieces including a custom hand piece specifically designed for PDS implantation. We further describe the specific challenges of the procedure and the development of corresponding training strategies realized within the simulation platform.

SUBMITTER: Heimann F

PROVIDER: S-EPMC8052818 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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A custom virtual reality training solution for ophthalmologic surgical clinical trials.

Heimann Felix F Barteselli Giulio G Brand André A Dingeldey Andreas A Godard Laszlo L Hochstetter Hendrik H Schneider Michael M Rothkegel Alexander A Wagner Clemens C Horvath Joshua J Ranade Shrirang S

Advances in simulation (London, England) 20210416 1

We present a summary of the development and clinical use of two custom designed high-fidelity virtual-reality simulator training platforms. This simulator development program began in 2016 to support the phase III clinical trial Archway (ClinicalTrials.gov identifier, NCT03677934) intended to evaluate the Port Delivery System (PDS) developed by Genentech Inc. and has also been used to support additional clinical trials. The two simulators address two specific ophthalmic surgical procedures requi ...[more]

PMID: 33863399

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Project description:BackgroundVirtual reality (VR) surgery training has become a trend in clinical education. Many research papers validate the effectiveness of VR-based surgical simulators in training medical students. However, most existing articles employ subjective methods to study the residents' surgical skills improvement. Few of them investigate how to improve the surgery skills on specific dimensions substantially.MethodsOur paper resorts to physiological approaches to objectively study the quantitative influence and performance analysis of VR laparoscopic surgical training system for medical students. Fifty-one participants were recruited from a pool of medical students. They conducted four pre and post experiments in the training box. They were trained on VR-based laparoscopic surgery simulators (VRLS) in the middle of pre and post experiments. Their operation and physiological data (heart rate and electroencephalogram) are recorded during the pre and post experiments. The physiological data is used to compute cognitive load and flow experience quantitatively. Senior surgeons graded their performance using newly designed hybrid standards for fundamental tasks and Global operative assessment of laparoscopic skills (GOALS) standards for colon resection tasks. Finally, the participants were required to fill the questionnaires about their cognitive load and flow experience.ResultsAfter training on VRLS, the time of the experimental group to complete the same task could drop sharply (p < 0.01). The performance scores are enhanced significantly (p < 0.01). The performance and cognitive load computed from EEG are negatively correlated (p < 0.05).ConclusionThe results show that the VRLS could highly improve medical students' performance and enable the participants to obtain flow experience with a lower cognitive load. Participants' performance is negatively correlated with cognitive load through quantitative physiological analysis. This might provide a new way of assessing skill acquirement.

Project description:BackgroundSimulation training can improve the learning curve of surgical trainees. This research aimed to systematically review randomized clinical trials (RCT) evaluating the performance of junior surgical trainees following virtual reality training (VRT) and other training methods in laparoscopic cholecystectomy.MethodsMEDLINE (PubMed), Embase (Ovid SP), Web of Science, Scopus and LILACS were searched for trials randomizing participants to VRT or no additional training (NAT) or simulation training (ST). Outcomes of interest were the reported performance using global rating scores (GRS), the Objective Structured Assessment of Technical Skill (OSATS) and Global Operative Assessment of Laparoscopic Skills (GOALS), error counts and time to completion of task during laparoscopic cholecystectomy on either porcine models or humans. Study quality was assessed using the Cochrane Risk of Bias Tool. PROSPERO ID: CRD42020208499.ResultsA total of 351 titles/abstracts were screened and 96 full texts were reviewed. Eighteen RCT were included and 15 manuscripts had data available for meta-analysis. Thirteen studies compared VRT and NAT, and 4 studies compared VRT and ST. One study compared VRT with NAT and ST and reported GRS only. Meta-analysis showed OSATS score (mean difference (MD) 6.22, 95%CI 3.81 to 8.36, P < 0.001) and time to completion of task (MD -8.35 min, 95%CI 13.10 to 3.60, P = <0.001) significantly improved after VRT compared with NAT. No significant difference was found in GOALS score. No significant differences were found between VRT and ST groups. Intraoperative errors were reported as reduced in VRT groups compared with NAT but were not suitable for meta-analysis.ConclusionMeta-analysis suggests that performance measured by OSATS and time to completion of task is improved with VRT compared with NAT for junior trainee in laparoscopic cholecystectomy. However, conclusions are limited by methodological heterogeneity and more research is needed to quantify the potential benefit to surgical training.

Project description:BackgroundCOVID-19 pandemic has significantly impacted the field of medical training, necessitating innovative approaches to education and practice. During this period, the use of novel technologies like virtual reality (VR), augmented reality (AR), and mixed reality (MR) has become increasingly vital. These technologies offer the advantage of transcending the limitations of time and space, thus enabling medical professionals to access various personalized programs for both education and service delivery. This shift is particularly relevant in the realm of pediatric medicine, where traditional training and clinical methods face unique challenges.PurposeThe primary aim of this study is to explore the application of VR, AR, and MR technologies in pediatric medical settings, with a focus on both clinical applications and the training of pediatric medical professionals. We aim to comprehensively search and review studies that have utilized these technologies in the treatment of pediatric patients and the education of healthcare providers in this field.MethodsPeer-reviewed articles published in PubMed, the Cochrane Library, ScienceDirect, Google Scholar, and Scopus from January 1, 2018, to March 1, 2023, were comprehensively searched. The review was conducted according to the PRISMA (Preferred Reporting Items for Systematic review and Meta-Analyses) guidelines. Among the 89 studies, 63 investigated the clinical applications of VR (n=60) or AR (n=3) in pediatric patients, and 25 investigated the applications of VR (n=19), AR (n=5), or MR (n=1) for training medical professionals.ResultsA total of 36 randomized controlled trials (RCTs) for clinical application (n=31) and medical training (n=5) were retrieved. Among the RCTs, 21 reported significant improvements in clinical applications (n=17) and medical training (n=4).ConclusionDespite a few limitations in conducting research on innovative technology, such research has rapidly expanded, indicating that an increasing number of researchers are involved in pediatric research using these technologies.

Dataset Information

A custom virtual reality training solution for ophthalmologic surgical clinical trials.

Publications

A custom virtual reality training solution for ophthalmologic surgical clinical trials.

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