Development, Validation, and Innovation in Ophthalmic Laser-Based Imaging: Report From a US Food and Drug Administration-Cosponsored Forum.

In April 2019, the US Food and Drug Administration, in conjunction with 11 professional ophthalmic, vision science, and optometric societies, convened a forum on laser-based imaging. The forum brought together the Food and Drug Administration, clinicians, researchers, industry members, and other stakeholders to stimulate innovation and ensure that patients in the US are the first in the world to have access to high-quality, safe, and effective medical devices. This conference focused on the technology, clinical applications, regulatory issues, and reimbursement issues surrounding innovative ocular imaging modalities. Furthermore, the emerging role of artificial intelligence in ophthalmic imaging was reviewed. This article summarizes the presentations, discussion, and future directions.

Mobile Laser Indirect Ophthalmoscope: For the Induction of Choroidal Neovascularization in a Mouse Model.

PURPOSE: This study aims to evaluate and standardize the reliability of a mobile laser indirect ophthalmoscope in the induction of choroidal neovascularization (CNV) in a mouse model. MATERIALS & METHODS: A diode laser indirect ophthalmoscope was used to induce CNV in pigmented male C57BL/6J mice. Standardization of spot size and laser intensity was determined using different aspheric lenses with increasing laser intensities applied around the optic disc. Development of CNV was evaluated 1, 5, and 14 days post laser application using fluorescein angiography (FA), histology, and choroidal flat mounts stained for the endothelial marker CD31 and FITC-dextran. Correlation between the number of laser hits to the number and size of developed CNV lesions was determined using flat mount choroid staining. The ability of intravitreally injected anti-human and anti-mouse VEGF antibodies to inhibit CNV induced by the mobile laser was evaluated. RESULTS: Laser parameters were standardized on 350 mW for 100 msec, using the 90 diopter lens to accomplish the highest incidence of Bruch's membrane rupture. CNV lesions' formation was validated on days 5 and 14 post laser injury, though FA showed leakage on as early as day 1. The number of laser hits was significantly correlated with the CNV area. CNV growth was successfully inhibited by both anti-human and mouse VEGF antibodies. CONCLUSION: The mobile laser indirect ophthalmoscope can serve as a feasible and a reliable alternative method for the CNV induction in a mouse model.

Multimedia interactiva para el desarrollo de habilidades en el uso del oftalmoscopio indirecto / Interactive Multimedia development skills in the use of indirect ophthalmoscope

El oftalmoscopio indirecto es un medio diagnóstico y terapéutico muy necesario y con una amplia utilidad para todos los oftalmólogos, pues este contribuye al desarrollo del proceso de enseñanza-aprendizaje de la asignatura Oftalmología y en especial del segmento posterior del ojo. El objetivo es presentar una multimedia interactiva "Oftalmoscopio indirecto" para el desarrollo de las habilidades profesionales en el uso correcto de este medio diagnóstico en los residentes del Servicio Oftalmológico del Hospital Militar Central "Dr. Carlos J. Finlay". La multimedia contiene diferentes acápites relacionados con el examen oftalmológico, historia, videos, simuladores, posturas y ventajas del oftalmoscopio indirecto. La implementación de esta herramienta de trabajo, a partir del cumplimiento de las acciones que se establecen en la guía elaborada al efecto, permitirá a los residentes que se encuentran en ejercicio o en formación autoprepararse y contribuir a resolver los problemas que detecten a través del oftalmoscopio indirecto en el diagnóstico y tratamiento oportuno de afecciones oftalmológicas que constituyen un problema de salud en Cuba.

The indirect ophthalmoscope is a very necessary diagnostic and therapeutic tool, widely used by all ophthalmologists, as this contributes to the development of teaching and learning Ophthalmology in general and particularly the posterior segment of the eye. Our purpose was to present the interactive multimedia "Indirect Ophthalmoscope" for the development of professional skills in residents of the ophthalmology Service at the Central Military Hospital concerning the proper use of this diagnostic tool. The multimedia contains different headings related to eye exam, history, videos, simulators, positions and advantages of indirect ophthalmoscope. From the fulfillment of the actions set out in the guide produced for this purpose, the implementation of this tool will allow residents to prepare themselves and help to solve problems detected through the indirect ophthalmoscope when diagnosing and treating eye conditions that constitute a health problem in Cuba.

Concentric ring scanning laser ophthalmoscope artifacts and dysphotopsia in diffractive multifocal pseudophakia.

A 67-year-old woman had decreased visual acuity in her left eye and disturbing concentric ring dysphotopsias after bilateral implantation of ReSTOR (SN60D3; Alcon Laboratories, Inc., Fort Worth, TX) diffractive multifocal intraocular lenses (IOLs). Monochromatic (820-nm infrared and 488-nm red-free) scanning laser ophthalmoscopy (SLO) documented central retinal concentric ring patterns resembling the patient's drawings of her dysphotopsia, prompting investigation of the relationship of these phenomena. Similar SLO findings were present in four eyes of three additional ReSTOR pseudophakes without dysphotopsia, but absent in monofocal pseudophakes or phakic individuals. Optical analysis shows that concentric ring SLO imaging artifacts can be caused by coherent reflection of monochromatic laser radiation off the diffractive optical element on the IOL's anterior surface, whereas concentric ring dysphotopsias are due to diffraction or projection of broad spectrum light sources in ordinary environments. Thus, the IOL's diffractive optics is the origin of both concentric ring dysphotopsia and SLO artifacts, but diffraction or projection causes the visual phenomenon, whereas coherent reflection produces the imaging anomaly.

Adjustment of guidelines for exposure of the eye to optical radiation from ocular instruments: statement from a task group of the International Commission on Non-Ionizing Radiation Protection (ICNIRP).

A variety of optical and electro-optical instruments are used for both diagnostic and therapeutic applications to the human eye. These generally expose ocular structures to either coherent or incoherent optical radiation (ultraviolet, visible, or infrared radiation) under unique conditions. We convert both laser and incoherent exposure guidelines derived for normal exposure conditions to the application of ophthalmic sources.

Study of the effect of involuntary user movement on the potential light hazards from some ophthalmic instruments.

A study was undertaken to determine whether involuntary user movement provides a basis for relaxing the measurement conditions for evaluating the potential optical radiation hazards to the eye from slit lamps and indirect ophthalmoscopes. This was accomplished by assessment of the extent to which light from these devices can be maintained in focus on a 1-mm-diameter fiber-optic cable for 45 s. The results suggest that, although involuntary user movements can be significant, they do not provide a basis for relaxing the measurement conditions for evaluating the potential optical radiation hazards to the cornea and lens from slit lamps and indirect ophthalmoscopes.