A custom virtual reality training solution for ophthalmologic surgical clinical trials

Heimann, Felix; Barteselli, Giulio; Brand, André; Dingeldey, Andreas; Godard, Laszlo; Hochstetter, Hendrik; Schneider, Michael; Rothkegel, Alexander; Wagner, Clemens; Horvath, Joshua D.; Ranade, Shrirang

doi:10.1186/s41077-021-00167-z

Cited by 7 publications

(5 citation statements)

References 8 publications

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“…For clinicians, simulation-based virtual reality provides a safe training space. VRmagic GmbH and Genentech Inc. developed two virtual reality training systems for the training in implantation and refill of the PDS device for the ARCHWAY trial [ 57 , 58 ]. Results from other modalities like simulation-based cataract surgery and vitreoretinal surgery have been interesting.…”

Section: Discussionmentioning

confidence: 99%

Clinical Trials and Future Outlooks of the Port Delivery System with Ranibizumab: A Narrative Review

Lowater,

Grauslund,

Subhi

et al. 2023

Ophthalmol Ther

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The port delivery system (PDS) of anti-VEGF therapy provides continuous delivery of ranibizumab (RBZ). In October of 2021, the American Food and Drug Administration (FDA) approved the PDS with RBZ as a treatment option for neovascular age-related macular degeneration (nAMD). As the field of PDS with RBZ is progressing rapidly, this narrative review provides a much-needed overview of existing clinical trials as well as ongoing and upcoming trials investigating PDS with RBZ. The phase 2 LADDER trial reported that the mean time to first refill with RBZ PDS 100 mg/ml was 15.8 months (80% CI 12.1–20.6), and pharmacokinetic profiling revealed a sustained concentration of RBZ in serum and aqueous humor. Later, the phase 3 ARCHWAY trial reported that PDS with RBZ (100 mg/ml) refilled every 24 weeks was non-inferior to monthly intravitreal injection (IVI) with RBZ (0.5 mg) in patients with nAMD over 9 months and 2 years. However, patients with PDS had a higher rate of adverse events including vitreous hemorrhage and endophthalmitis. Patients indicate high treatment satisfaction with both PDS and IVI, but the lower number of treatments with PDS was reported as a preferred choice. Several ongoing and future clinical trials, of which details are discussed in this paper, are further exploring the potentials of PDS with RBZ. We conclude that the PDS provides continuous deliverance of RBZ and that clinical efficacy levels are non-inferior to IVI therapy for nAMD. Yet, a higher rate of adverse events remains a concerning detail for widespread implementation. Future studies are warranted to better understand which patients may benefit best from this treatment approach, if long-term efficacy can be sustained, and if safety of PDS can be further improved.

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Section: Discussionmentioning

confidence: 99%

Clinical Trials and Future Outlooks of the Port Delivery System with Ranibizumab: A Narrative Review

Lowater,

Grauslund,

Subhi

et al. 2023

Ophthalmol Ther

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“…However, any ocular adverse events related to the PDS procedures are well understood, manageable, and are continually being analyzed to optimize patient outcomes (Holekamp et al., 2022 ). PDS surgical procedures have evolved based on trial learnings (Campochiaro et al., 2019 ; Bantseev et al., 2020 ), with an emphasis on surgeon training to standardize surgical techniques, supported by a state-of-the-art virtual reality training platform (Heimann et al., 2021 ).…”

Section: Discussionmentioning

confidence: 99%

The Port Delivery System with ranibizumab: a new paradigm for long-acting retinal drug delivery

Ranade¹,

Wieland

Tam³

et al. 2022

Drug Delivery

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The Port Delivery System with ranibizumab (PDS) is an innovative intraocular drug delivery system designed for the continuous delivery of ranibizumab into the vitreous for 6 months and beyond. The PDS includes an ocular implant, a customized formulation of ranibizumab, and four dedicated ancillary devices for initial fill, surgical implantation, refill-exchange, and explantation, if clinically indicated. Ranibizumab is an ideal candidate for the PDS on account of its unique physicochemical stability and high solubility. Controlled release is achieved via passive diffusion through the porous release control element, which is tuned to specific drug characteristics to accomplish a therapeutic level of ranibizumab in the vitreous. To characterize drug release from the implant, release rate was measured in vitro with starting concentrations of ranibizumab 10, 40, and 100 mg/mL, with release of ranibizumab 40 and 100 mg/mL found to remain quantifiable after 6 months. Using a starting concentration of 100 mg/mL, active release rate at approximately 6 months was consistent after the initial fill and first, second, and third refills, demonstrating reproducibility between implants and between multiple refill-exchanges of the same implant. A refill-exchange performed with a single 100-µL stroke using the refill needle was shown to replace over 95% of the implant contents with fresh drug. In vitro data support the use of the PDS with fixed refill-exchange intervals of at least 6 months in clinical trials.

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“…This simulator has been reported to be both innovative and cost efficient. In order to replicate the force occurring during ophthalmic surgeries, an end effector is developed by using 2 Touch C interfaces (Heimann et al 2021) and then a virtual world is added to increase the immersion. The developed end effector mimicked the tools used in real-life ophthalmic surgical procedures.…”

Section: Haptics In Medicinementioning

confidence: 99%

A comprehensive study to learn the impact of augmented reality and haptic interaction in ultrasound-guided percutaneous liver biopsy training and education

Mangalote,

Aboumarzouk,

Al-Ansari

et al. 2024

Artif Intell Rev

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Simulation based training methods are gaining popularity as they could provide a platform for practitioners to gain hands-on experience without causing ethical issues. By combining augmented reality (AR) and haptics, a training method for percutaneous liver biopsy (PLB) could be developed providing realistic scenarios, and real-time visualization of the human anatomy and needle. Additionally, it could also provide real-time feedback to the practitioner. In this review, we describe the conventional PLB procedure, then discuss AR technology and its application in the field of medicine for image-guided therapies, especially, hepatic biopsy. Next, we summarize the associated devices, models and methods illustrating a few haptic simulators devised for training and gesture assessment. Lastly, we present a few potential approaches to integrate AR and haptic interaction to develop a PLB training simulator by accounting the existing challenges.

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A custom virtual reality training solution for ophthalmologic surgical clinical trials

Cited by 7 publications

References 8 publications

Clinical Trials and Future Outlooks of the Port Delivery System with Ranibizumab: A Narrative Review

Clinical Trials and Future Outlooks of the Port Delivery System with Ranibizumab: A Narrative Review

The Port Delivery System with ranibizumab: a new paradigm for long-acting retinal drug delivery

A comprehensive study to learn the impact of augmented reality and haptic interaction in ultrasound-guided percutaneous liver biopsy training and education

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