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Virtual Reality Becomes a Reality for Ophthalmologic Surgical Clinical Trials.

ABSTRACT: The Port Delivery System with ranibizumab (PDS) is an innovative, investigational drug delivery system designed for continuous delivery of ranibizumab into the vitreous to maintain therapeutic drug concentrations for extended durations. The phase 2 Ladder trial (NCT02510794) tested the efficacy of three customized formulations of ranibizumab in patients with neovascular age-related macular degeneration, and the phase 3 Archway trial (NCT03677934) will further assess the safety and efficacy of PDS 100 mg/mL with fixed 24-week refills. The insertion of the PDS implant into the vitreous cavity and subsequent refill-exchange of the drug require procedural skills that are not directly transferable from everyday experience for most eye surgeons today. Preoperative practice for the PDS implant insertion and refill-exchange procedures is therefore critical for achieving optimal surgical outcomes. Virtual reality (VR) as a training tool has long been used by the aeronautic industry and more recently adapted for physician training in medicine and surgery, with encouraging results. Besides the primary use of traditional training tools, physicians participating in Archway have an option to practice in computer-simulated environments provided by VR simulators before performing their first PDS implant insertion and refill-exchange procedures on patients. This Perspective article describes the unique advantages and technologic challenges that practice on VR simulators has to offer, and the experience of Archway physicians with VR technology as a first in any ophthalmic clinical trial.

SUBMITTER: Pieramici DJ

PROVIDER: S-EPMC7414641 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Virtual Reality Becomes a Reality for Ophthalmologic Surgical Clinical Trials.

Pieramici Dante J DJ Heimann Felix F Brassard Raymond R Barteselli Giulio G Ranade Shrirang S

Translational vision science & technology 20200603 7

The Port Delivery System with ranibizumab (PDS) is an innovative, investigational drug delivery system designed for continuous delivery of ranibizumab into the vitreous to maintain therapeutic drug concentrations for extended durations. The phase 2 Ladder trial (NCT02510794) tested the efficacy of three customized formulations of ranibizumab in patients with neovascular age-related macular degeneration, and the phase 3 Archway trial (NCT03677934) will further assess the safety and efficacy of PD ...[more]

PMID: 32832208

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Project description:ImportanceVideo learning prior to surgery is common practice for trainees and surgeons, and immersive virtual reality (IVR) simulators are of increasing interest for surgical training. The training effectiveness of IVR compared with video training in complex skill acquisition should be studied.ObjectivesTo evaluate whether IVR improves learning effectiveness for surgical trainees and to validate a VR rating scale through correlation to real-world performance.Design, setting, and participantsThis block randomized, intervention-controlled clinical trial included senior (ie, postgraduate year 4 and 5) orthopedic surgery residents from multiple institutions in Canada during a single training course. An intention-to-treat analysis was performed. Data were collected from January 30 to February 1, 2020.InterventionAn IVR training platform providing a case-based module for reverse shoulder arthroplasty (RSA) for advanced rotator cuff tear arthropathy. Participants were permitted to repeat the module indefinitely.Main outcomes and measuresThe primary outcome measure was a validated performance metric for both the intervention and control groups (Objective Structured Assessment of Technical Skills [OSATS]). Secondary measures included transfer of training (ToT), transfer effectiveness ratio (TER), and cost-effectiveness (CER) ratios of IVR training compared with control. Additional secondary measures included IVR performance metrics measured on a novel rating scale compared with real-world performance.ResultsA total of 18 senior surgical residents participated; 9 (50%) were randomized to the IVR group and 9 (50%) to the control group. Participant demographic characteristics were not different for age (mean [SD] age: IVR group, 31.1 [2.8] years; control group, 31.0 [2.7] years), gender (IVR group, 8 [89%] men; control group, 6 [67%] men), surgical experience (mean [SD] experience with RSA: IVR group, 3.3 [0.9]; control group, 3.2 [0.4]), or prior simulator use (had experience: IVR group 6 [67%]; control group, 4 [44%]). The IVR group completed training 387% faster considering a single repetition (mean [SD] time for IVR group: 4.1 [2.5] minutes; mean [SD] time for control group: 16.1 [2.6] minutes; difference, 12.0 minutes; 95% CI, 8.8-14.0 minutes; P < .001). The IVR group had significantly better mean (SD) OSATS scores than the control group (15.9 [2.5] vs 9.4 [3.2]; difference, 6.9; 95% CI, 3.3-9.7; P < .001). The IVR group also demonstrated higher mean (SD) verbal questioning scores (4.1 [1.0] vs 2.2 [1.7]; difference, 1.9; 95% CI, 0.1-3.3; P = .03). The IVR score (ie, Precision Score) had a strong correlation to real-world OSATS scores (r = 0.74) and final implant position (r = 0.73). The ToT was 59.4%, based on the OSATS score. The TER was 0.79, and the system was 34 times more cost-effective than control, based on CER.Conclusions and relevanceIn this study, surgical training with IVR demonstrated superior learning efficiency, knowledge, and skill transfer. The TER of 0.79 substituted for 47.4 minutes of operating room time when IVR was used for 60 minutes.Trial registrationClinicalTrials.gov Identifier: NCT04404010.

Project description:ImportancePlanning complex operations such as robotic-assisted partial nephrectomy requires surgeons to review 2-dimensional computed tomography or magnetic resonance images to understand 3-dimensional (3-D), patient-specific anatomy.ObjectiveTo determine surgical outcomes for robotic-assisted partial nephrectomy when surgeons reviewed 3-D virtual reality (VR) models during operative planning.Design, setting, and participantsA single-blind randomized clinical trial was performed. Ninety-two patients undergoing robotic-assisted partial nephrectomy performed by 1 of 11 surgeons at 6 large teaching hospitals were prospectively enrolled and randomized. Enrollment and data collection occurred from October 2017 through December 2018, and data analysis was performed from December 2018 through March 2019.InterventionsPatients were assigned to either a control group undergoing usual preoperative planning with computed tomography and/or magnetic resonance imaging only or an intervention group where imaging was supplemented with a 3-D VR model. This model was viewed on the surgeon's smartphone in regular 3-D format and in VR using a VR headset.Main outcomes and measuresThe primary outcome measure was operative time. It was hypothesized that the operations performed using the 3-D VR models would have shorter operative time than those performed without the models. Secondary outcomes included clamp time, estimated blood loss, and length of hospital stay.ResultsNinety-two patients (58 men [63%]) with a mean (SD) age of 60.9 (11.6) years were analyzed. The analysis included 48 patients randomized to the control group and 44 randomized to the intervention group. When controlling for case complexity and other covariates, patients whose surgical planning involved 3-D VR models showed differences in operative time (odds ratio [OR], 1.00; 95% CI, 0.37-2.70; estimated OR, 2.47), estimated blood loss (OR, 1.98; 95% CI, 1.04-3.78; estimated OR, 4.56), clamp time (OR, 1.60; 95% CI, 0.79-3.23; estimated OR, 11.22), and length of hospital stay (OR, 2.86; 95% CI, 1.59-5.14; estimated OR, 5.43). Estimated ORs were calculated using the parameter estimates from the generalized estimating equation model. Referent group values for each covariate and the corresponding nephrometry score were summed across the covariates and nephrometry score, and the sum was exponentiated to obtain the OR. A mean of the estimated OR weighted by sample size for each nephrometry score strata was then calculated.Conclusions and relevanceThis large, randomized clinical trial demonstrated that patients whose surgical planning involved 3-D VR models had reduced operative time, estimated blood loss, clamp time, and length of hospital stay.Trial registrationClinicalTrials.gov identifiers (1 registration per site): NCT03334344, NCT03421418, NCT03534206, NCT03542565, NCT03556943, and NCT03666104.

Project description:Precision medicine just witnessed two breakthroughs in oncology in 2017. Pembrolizumab (Keytruda), Merck's anti-programmed cell death-1 (PD-1) monoclonal antibody (mAb), received accelerated approval in May 2017 by the US Food and Drug Administration for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having microsatellite instability-high (MSI-H) or deficient DNA mismatch repair (dMMR). Shortly after, nivolumab (Opdivo), Bristol-Myers Squibb's anti-PD-1 mAb, gained an accelerated approval in August 2017 for adult and pediatric patients with MSI-H or dMMR metastatic colorectal cancer that has progressed after standard chemotherapy. These regulatory approvals marked an important milestone that a cancer treatment may be approved based on a common biomarker rather than the anatomic location in the body where the tumor originated, and therefore established a precedent for tumor type-agnostic therapy. In the 2017 American Society for Clinical Oncology annual meeting, larotrectinib (LOXO-101), Loxooncology's oral, potent, and selective inhibitor of tropomyosin receptor kinases (TRK), demonstrated unprecedented efficacy on unresectable or metastatic solid tumors with neurotrophic tropomyosin receptor kinase (NTRK)-fusion proteins in adult and pediatric patients. Both the anti-PD-1 mAbs and the TRK-targeting therapies share some basic features: (a) biomarker-based, well-defined rare patient population; (b) exceptionally high clinical efficacy, e.g., near 40% overall response rate (ORR) for pembrolizumab across 15 tumor types with MSI-H/dMMR and 75% ORR for larotrectinib across more than 12 tumor types with NTRK-fusion proteins; (c) durable responses lasting at least 6 months with complete responses observed; and (d) parallel development in adult and pediatric populations. With increasing accessibility to genetic analysis tools such as next-generation sequencing, tumor type-agnostic therapy has become a reality, both during clinical development and in clinical practice. Adjustments in our approaches to developing new anti-cancer drugs and to adopting these new cancer treatments in clinical practice need to occur in order to prepare ourselves for the new era of precision medicine.

Project description:BackgroundVirtual reality (VR) has proven effective in the treatment of specific phobias and trauma particularly when in-vivo exposure therapy might be costly (e.g. fear of flying, combat scenes). Similarly, VR has been associated with improvement of chronic pain and of acute pain during medical procedures. Despite its effectiveness as a healthcare tool, VR technology is not well-integrated into common practice. This qualitative study aims to explore the provider perception of the value of VR and identify barriers to VR implementation among healthcare providers.MethodsA 66-item self-report survey was created to examine application of VR to clinical practice, perceived value of this treatment, ease of learning the technology, billing considerations, and other obstacles. 128 providers (MDs and PhDs) who were located in the United States and had used VR as a therapeutic tool in the past year were identified through research papers, as well as user lists and news articles from VR application websites. Of the 128 providers contacted, 17% (22) completed our online self-report measure. Of these, 13% of respondents (N = 17) completed greater than 75% of the questionnaire and were considered completers. Provider responses were collected over a one-month period and qualitatively analyzed.ResultsThe majority of providers were from an academic institution (n = 12, 70.6%), and all providers practiced in the outpatient setting. Providers most commonly reported using VR for the treatment of acute pain and/or anxiety related to medical procedures (n = 11, 64.7%), followed by specific phobia (n = 6, 35.3%) and social phobia (n = 6, 35.3%). All providers agreed VR is a valuable tool they would recommend to colleagues. The majority (n = 15, 93.8%) believed VR helped their patients progress in treatment, compared with other methods. Providers cited the ability to individualize treatment (n = 14, 87.5%) and increase patient engagement (n = 15, 93.8%) as main benefits of VR. A minority reported negative feedback from patients about content (n = 4, 25%) or about the technology in general (n = 6, 37.5%), whereas all reported some form of positive feedback. The slight majority (n = 10, 58.8%) of providers did not find transitioning to VR difficult. Of those who did, cost was the most commonly cited barrier (n = 6). Regarding reimbursement, only 17.6% (n = 3) of providers reported the ability to bill for VR sessions. Most providers (n = 15, 88.2%) received training on their VR platform which they found beneficial. Comparing the trained and untrained groups found no significant difference in VR comfort level (p = 0.5058), the value of VR in practice (p = 0.551) or whether providers would recommend VR to others (p = 0.551), though sample sizes were small.ConclusionsIn corroboration with previous research, this study demonstrates that VR is well-received by patients and providers, allowing increased patient engagement and treatment individualization. However, associated costs, including an inability to bill for this service, can present a barrier to further implementation. These findings will guide further development of virtual reality as a standardized tool in psychiatry and pain management.

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.

Dataset Information

Virtual Reality Becomes a Reality for Ophthalmologic Surgical Clinical Trials.

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Virtual Reality Becomes a Reality for Ophthalmologic Surgical Clinical Trials.

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