Virtual Reality Becomes a Reality for Ophthalmologic Surgical Clinical Trials

Pieramici, Dante J.; Heimann, Felix; Brassard, Raymond; Barteselli, Giulio; Ranade, Shrirang

doi:10.1167/tvst.9.7.1

Cited by 10 publications

(6 citation statements)

References 14 publications

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“…Virtual reality has also been used in visual rehabilitation of patients with hemianopia who underwent telerehabilitation that showed improved visual performance 41 . VR-based training has also demonstrated benefits in sports medicine, traumatic brain injury, and for eye-hand coordination in trainee surgeons 42 .…”

Section: Discussionmentioning

confidence: 99%

Measuring visual information gathering in individuals with ultra low vision using virtual reality

Kartha

Sadeghi

Bradley

et al. 2023

Sci Rep

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People with ULV (visual acuity ≤ 20/1600 or 1.9 logMAR) lack form vision but have rudimentary levels of vision that can be used for a range of activities in daily life. However, current clinical tests are designed to assess form vision and do not provide information about the range of visually guided activities that can be performed in daily life using ULV. This is important to know given the growing number of clinical trials that recruit individuals with ULV (e.g., gene therapy, stem cell therapy) or restore vision to the ULV range in the blind (visual prosthesis). In this study, we develop a set of 19 activities (items) in virtual reality involving spatial localization/detection, motion detection, and direction of motion that can be used to assess visual performance in people with ULV. We estimated measures of item difficulty and person ability on a relative d prime (d′) axis using a signal detection theory based analysis for latent variables. The items represented a range of difficulty levels (− 1.09 to 0.39 in relative d′) in a heterogeneous group of individuals with ULV (− 0.74 to 2.2 in relative d′) showing the instrument’s utility as an outcome measure in clinical trials.

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Section: Discussionmentioning

confidence: 99%

Measuring visual information gathering in individuals with ultra low vision using virtual reality

Kartha

Sadeghi

Bradley

et al. 2023

Sci Rep

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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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“…Therefore, updated guidelines and suggestions have been supplied for the PDS implant insertion process, refill and exchange method, appropriate conjunctiva care, and Tenon’s capsule handling practices. Additionally, physicians undergoing PDS surgical training have access to cutting-edge virtual reality teaching technology that was specifically developed for the PDS [ 40 , 41 ].…”

Section: Adverse Eventsmentioning

confidence: 99%

Ranibizumab Port Delivery System in Neovascular Age-Related Macular Degeneration: Where Do We Stand? Overview of Pharmacokinetics, Clinical Results, and Future Directions

Carlà,

Savastano,

Boselli

et al. 2024

Pharmaceutics

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The ranibizumab (RBZ) port delivery system (PDS) is a device designed to continuously deliver RBZ in the vitreous chamber for the treatment of neovascular age-related macular degeneration (nAMD). It is implanted during a surgical procedure and can provide sustained release of the medication for several months. This review, updated to January 2024, focuses on past clinical studies as well as current and forthcoming trials looking into a PDS with RBZ. In the phase 2 LADDER trial, the mean time to first refill of a PDS with RBZ 100 mg/mL was 15.8 months, with the pharmacokinetic (PK) profile showing a sustained concentration of RBZ in the blood and aqueous humor. More recently, a PDS with RBZ (100 mg/mL) refilled every 24 weeks was shown to be non-inferior to a monthly intravitreal injection (IVI) with RBZ (0.5 mg) over 40 and 92 weeks in the phase 3 ARCHWAY trial. The refill every 24 weeks allowed for a RBZ vitreous exposure within the concentration range of monthly intravitreal injections (IVIs), and the expected half-life (106 days) was comparable with the in vitro results. Nonetheless, vitreous hemorrhage and endophthalmitis were more common side effects in PDS patients. In conclusion, a PDS continuously delivering RBZ has a clinical effectiveness level comparable with IVI treatment. However, a greater frequency of unfavorable occurrences highlights the need for procedure optimization for a wider adoption. Ongoing trials and possible future approaches need to be addressed.

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Virtual Reality Becomes a Reality for Ophthalmologic Surgical Clinical Trials

Cited by 10 publications

References 14 publications

Measuring visual information gathering in individuals with ultra low vision using virtual reality

Measuring visual information gathering in individuals with ultra low vision using virtual reality

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

Ranibizumab Port Delivery System in Neovascular Age-Related Macular Degeneration: Where Do We Stand? Overview of Pharmacokinetics, Clinical Results, and Future Directions

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