Optimization and Validation of a Virtual Reality Orientation and Mobility Test for Inherited Retinal Degenerations

Bennett, Jean; Aleman, Elena M; Maguire, Katherine H; Nadelmann, Jennifer; Weber, Mariejel L; Maguire, William; Maja, Ayodele; O’Neil, Erin; Maguire, Albert M.; Miller, Alexander J; Alemán, Tomás S.

doi:10.1167/tvst.12.1.28

Trans. Vis. Sci. Tech.

2023

DOI: 10.1167/tvst.12.1.28

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Optimization and Validation of a Virtual Reality Orientation and Mobility Test for Inherited Retinal Degenerations

Jean Bennett

Elena M Aleman

Katherine H Maguire

et al.

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2024

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Cited by 3 publications

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Report From the Second Global Scientific Conference on Clinical Trial Design and Outcome Measures for RDH12-Associated Inherited Retinal Degeneration

Cerolini,

Bennett,

Leroy

et al. 2024

Trans. Vis. Sci. Tech.

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Following the success of the first multi-stakeholder workshop to accelerate the development of treatments for patients with RDH12 -associated inherited retinal dystrophies in 2019, the patient organizations Eyes on the Future and the RDH12 Fund for Sight convened a second one day, multi-stakeholder workshop in November 2022, focusing on the challenges in clinical trial design and outcome measure selection for studies involving patients with RDH12 -associated inherited retinal disease (IRD). Face to face and virtual participants included representatives from patient organizations, academic and industry clinicians, and scientists, as well as representatives from multiple regulatory agencies. Key areas of discussion focused on RDH12 phenotypic heterogeneity, retinal structural-functional relationships, and the targeting of areas most likely to respond to gene therapies, the need for comprehensive natural history data to inform appropriate outcome measures, and the outcome measures most valued by the patient community including the lack of validated patient reported outcome measures. Learnings from recent IRD gene therapy trials and their relevance for RDH12 -associated IRDs were discussed. Innovative trial designs with outcome measures selected relevant for the RDH12 patient population, adaptive strategies, collaboration among scientists and clinicians, alignment among regulators, and close engagement with the patient community can enhance the future feasibility and success of clinical studies for RDH12 retinal dystrophy. Translational Relevance A multi-stakeholder, patient centric approach will be critical to the design of future successful clinical trials with outcome measures relevant to the RDH12 -IRD population .

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Report From the Second Global Scientific Conference on Clinical Trial Design and Outcome Measures for RDH12-Associated Inherited Retinal Degeneration

Cerolini,

Bennett,

Leroy

et al. 2024

Trans. Vis. Sci. Tech.

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Update on Clinical Trial Endpoints in Gene Therapy Trials for Inherited Retinal Diseases

Igoe,

Lam,

Gregori

2024

JCM

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Inherited retinal diseases (IRDs) encompass a wide spectrum of rare conditions characterized by diverse phenotypes associated with hundreds of genetic variations, often leading to progressive visual impairment and profound vision loss. Multiple natural history studies and clinical trials exploring gene therapy for various IRDs are ongoing. Outcomes for ophthalmic trials measure visual changes in three main categories—structural, functional, and patient-focused outcomes. Since IRDs may range from congenital with poor central vision from birth to affecting the peripheral retina initially and progressing insidiously with visual acuity affected late in the disease course, typical outcome measures such as central visual acuity and ocular coherence tomography (OCT) imaging of the macula may not provide adequate representation of therapeutic outcomes including alterations in disease course. Thus, alternative unique outcome measures are necessary to assess loss of peripheral vision, color vision, night vision, and contrast sensitivity in IRDs. These differences have complicated the assessment of clinical outcomes for IRD therapies, and the clinical trials for IRDs have had to design novel specialized endpoints to demonstrate treatment efficacy. As genetic engineering and gene therapy techniques continue to advance with growing investment from industry and accelerated approval tracks for orphan conditions, the clinical trials must continue to improve their assessments to demonstrate safety and efficacy of new gene therapies that aim to come to market. Here, we will provide an overview of the current gene therapy approaches, review various endpoints for measuring visual function, highlight those that are utilized in recent gene therapy trials, and provide an overview of stage 2 and 3 IRD trials through the second quarter of 2024.

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Virtual Reality With Eye Tracking for Pediatric Ophthalmology: A Systematic Review

Nikolaidou,

Sandali,

Chatzidimitriou

et al. 2024

J Pediatr Ophthalmol Strabismus

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Virtual reality presents an efficient and engaging approach to ophthalmological diagnosis and treatment in children. This systematic review investigates the current state of eye tracking technology integrated into virtual reality for the spectrum of pediatric ophthalmology. The search encompassed the MEDLINE database via PubMed, without imposing any time restrictions. A total of 20 relevant studies that met our inclusion criteria were incorporated and categorized into the following domains: diagnosis, examination, treatment, and rehabilitation use of virtual reality devices within the realm of pediatric ophthalmology. Strabismus examinations and postoperative monitoring, inherited retinal degeneration examination and visual function testing, therapy of amblyopia, glaucoma visual field testing, cerebral visual impairment rehabilitation, and neuro-ophthalmic disease examination were included in the final analysis. Pediatric ophthalmology offers a promising landscape for the integration of eye tracking technology within virtual reality, with accelerated, quantifiable, and objective examination and diagnosis, and precise, real-time measurements that are crucial in children. Virtual reality is an engaging experience, easily applied in a pediatric setting and facilitating compliance during examination and adherence to therapy. Although our systematic review provides insights into the current state of research, it is anticipated that further exploration is required for the widespread utilization of eye tracking in virtual reality within pediatric ophthalmology. [ J Pediatr Ophthalmol Strabismus . 20XX;X(X):XX–XX.]

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Optimization and Validation of a Virtual Reality Orientation and Mobility Test for Inherited Retinal Degenerations

Cited by 3 publications

References 22 publications

Report From the Second Global Scientific Conference on Clinical Trial Design and Outcome Measures for RDH12-Associated Inherited Retinal Degeneration

Report From the Second Global Scientific Conference on Clinical Trial Design and Outcome Measures for RDH12-Associated Inherited Retinal Degeneration

Update on Clinical Trial Endpoints in Gene Therapy Trials for Inherited Retinal Diseases

Virtual Reality With Eye Tracking for Pediatric Ophthalmology: A Systematic Review

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