Scientific Publications
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Evaluation of a self-imaging SD-OCT system designed for remote home monitoring
Kim, JE, Tomkins-Netzer, O., Elman, MJ et al. Evaluation of a self-imaging SD-OCT system designed for remote home monitoring. BMC Ophthalmol 22, 261 (2022). https://doi.org/10.1186/s12886...
Prospective, Longitudinal Study: Daily Self-Imaging with Home OCT for Neovascular Age-Related Macular Degeneration
Liu Y., Holekamp NM & Heier JS, Prospective, longitudinal study: daily self-imaging with home OCT in neovascular age-related macular degeneration, Ophthalmology Retina (2022), doi: https://www.ophthalmologyretin...
Impact of Macular Fluid Volume Fluctuations on Visual Acuity During anti-VEGF Therapy in Eyes with nAMD
Chakravarthy, U., Havilio, M., Syntosi, A. et al. Impact of macular fluid volume fluctuations on visual acuity during anti-VEGF therapy in eyes with nAMD. Eye 35, 2983–2990 (2021). https://www.nature.com/article...
Retinal Specialist Versus Artificial Intelligence Detection of Retinal Fluid from Optical Coherence Tomography
Keenan TD, Clemons TE, Domalpally A, Elman MJ, Havilio M, Agrón E, Benyamini G, Chew EY, Retinal specialist versus artificial intelligence detection of retinal fluid from optical coherence tomography: AREDS2 10-year Follow-On, Ophthalmology (2020), doi: https://www.aaojournal.org/art...
SCANLY Home OCT FDA Intended Use
SCANLY Home OCT has not been approved by FDA for use other than described in the following Intend Use: The Notal Vision Home Optical Coherence Tomography (OCT) System is an Artificial Intelligence (AI)-based Home Use device indicated for visualization of intraretinal and subretinal hypo-reflective spaces in a 10 by 10-degrees area centered on the point of fixation of eyes diagnosed with neovascular age-related macular degeneration (NV-AMD). In addition, it provides segmentation and an estimation of the volume of hypo-reflective spaces. The Notal Home OCT device is intended for imaging at home between regularly scheduled clinic assessments and not intended to be used to make treatment decisions or replace standard-of care regularly scheduled examinations and clinical testing as needed, including in-office imaging and assessments for changes in vision, by an ophthalmologist.
See also Warnings and Precautions.
ForeseeHome FDA Intended Use
ForeseeHome has not been approved by FDA for use other than described in the following Indication for Use: The ForeseeHome is intended for use in the detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration as an aid in monitoring progression of disease factors causing metamorphopsia including, but not limited to choroidal neovascularization (CNV). It is intended to be used at home for patients with stable fixation.
