Scientific Publications
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Prevalence of Undiagnosed Age-Related Macular Degeneration in Primary Eye Care
Neely DC, Bray KJ, Huisingh CE, Clark ME, McGwin G Jr, Owsley C. Prevalence of Undiagnosed Age-Related Macular Degeneration in Primary Eye Care. JAMA Ophthalmol. 2017 Jun 1;135(6):570-575.
Economic Evaluation of a Home-Based Age-Related Macular Degeneration Monitoring System
Wittenborn JS, Clemons T, Regillo C, et al. Economic Evaluation of a Home-Based Age-Related Macular Degeneration Monitoring System. JAMA Ophthalmol. 2017 May 1;135(5):452-459.
Determining the Value of Home Monitoring of Patients With Age-Related Macular Degeneration
Pershing S, Stein JD. Determining the Value of Home Monitoring of Patients With Age-Related Macular Degeneration. JAMA Ophthalmol. 2017 May 1;135(5):459-460.
The Potential Importance of Detection of Neovascular Age-Related Macular Degeneration When Visual Acuity Is Relatively Good.
Ho AC, Albini TA, Brown DM, Boyer DS, Regillo CD, Heier JS. The Potential Importance of Detection of Neovascular Age-Related Macular Degeneration When Visual Acuity Is Relatively Good. JAMA Ophthalmology. 2017 Mar 1;135(3):268-273.
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.
