We performed optical radiation safety evaluations of LED flashlights to determine if they pose potential ocular hazards. Six commercially available flashlight samples were randomly selected from various vendors online. They were evaluated in accordance with specifications provided in the American National Standards Institute/Illuminating Engineering Society of North America (ANSI/IESNA) Standards RP 27.1 and RP 27.3. Four of the flashlights were found to have relatively high blue-light-weighted radiance values with short times (40 to 50 s) to reach the exposure limit specified in RP 27.1. These flashlights are in Risk Group 2 and present a moderate risk for retinal damage. Two of the flashlights are in Risk Group 1 and present a low risk for retinal damage. None of the flashlights present an ultraviolet (UV) radiation hazard or a retinal thermal hazard. Cautionary labeling on the packaging as required by RP 27.3 and on the flashlight handle is recommended for flashlights and on other handheld light sources that are in Risk Group 2 or Risk Group 3.

We present a fiber-optic dual-confocal laser caliper method for noncontact high-precision sensing and measuring thickness and refractive index of intraocular lens (IOL) implants. The principle of the method is based on sensing and measuring the confocal intensity response of the laser beam reflection from the opposite object surfaces, which provides the advanced feature of having no limitations on the object shape, thickness, and transparency. Using single-mode optical fibers and a 658-nm laser source, the thickness measurement accuracy was assessed to be as high as 5 pm. In addition, refractive index of a transparent object with thickness smaller than the working distance of the focusing lenses can be measured. The thickness and refractive index of a planoconvex IOL were measured with a high accuracy. (C) The Authors. Published by SPIE under a Creative Commons Attribution 3.0 Unported License.

The authors evaluated the potential for ocular damage from optical radiation emitted by Light Emitting Diode (LED) based lamps used for general illumination. Ten LED lamps were randomly selected off the shelf from a local home improvement store. The LEDs were behind diffusers in half of these lamps, while in the other half, the LEDs were clearly visible. In addition, a battery powered LED lantern having a LED source behind a diffuser was measured. The optical radiation emissions from two common incandescent lamps were also measured to compare the relative hazards of LED and incandescent lamps. All lamp samples were evaluated in accordance with procedures specified in the American National Standards Institute/Illuminating Engineering Society of North America (ANSI/IESNA) Standard RP-27.3. For comparison purposes, the lantern and 100 W incandescent lamps were also evaluated according to ANSI RP-27.1. These measurements indicate that no lamp evaluated poses any photobiological hazard, and therefore, all lamps fall in the RP-27.3 category of Exempt Group. However, when evaluated in accordance with RP-27.1, the 100 W incandescent lamp would be classified in Risk Group 1 (low risk), while the LED lantern would be classified in Risk Group 2 (moderate risk).

The scanning light scattering profiler (SLSP) methodology has been developed for the full-angle quantitative evaluation of forward and backward light scattering from intraocular lenses (IOLs) using goniophotometer principles. This protocol describes the SLSP platform and how it employs a 360° rotational photodetector sensor that is scanned around an IOL sample while recording the intensity and location of scattered light as it passes through the IOL medium. The SLSP platform can be used to predict, non-clinically, the propensity for current and novel IOL designs and materials to induce light scatter. Non-clinical evaluation of light scattering properties of IOLs can significantly reduce the number of patient complaints related to unwanted glare, glistening, optical defects, poor image quality, and other phenomena associated with the unintended light scattering. Future studies should be conducted to correlate SLSP data with clinical results to help identify which measured light scatter is most problematic for patients that have undergone cataract surgery subsequent to IOL implantation.

A novel test methodology was developed for quantitative evaluation of critical radiant power characteristics as a function of time for diode pumped solid state (DPSS) laser pointers. It is based on a simultaneous measurement of time-dependent radiant power characteristics of multi-wavelength spectral components emitted by DPSS laser pointers. The authors tested green DPSS laser pointers, which emit three spectral components at the fundamental near-infrared (1064-nm), pumping near-infrared (808-nm), and second-harmonic green (532-nm) wavelengths. The obtained experimental results are employed for performing eye hazard evaluation according to U. S. and International laser safety standards. All tested green laser pointers demonstrated significant variability of radiant power as a function of time and wavelength. Thus, the severity of the potential eye hazard from DPSS laser pointers for a given exposure time depends on when a person was exposed after the pointer was turned on. Most laser pointers emitted radiation in excess of their classification limits, including unwanted infrared radiation that is not necessary for their intended use as laser pointers.

There have been many recent reports regarding the potential risks of UV emissions from compact fluorescent lamps (CFLs). In some of these reports, the robustness of the measurements was difficult to discern. We conducted round-robin measurements, involving three lamp manufacturers and two government research laboratories to gather reliable data on the UV emissions from commercially available CFLs. The initial sample of lamps consisted of 71 spiral-shaped CFLs purchased from local retailers. From the initial sample, 14 high UV emitting CFLs were chosen for further evaluation. We compared the UV emissions at a distance of 20cm with the UV exposure limits (ELs) published by the International Commission on Non-ionizing Radiation Protection (ICNIRP). We found that the allowable exposure time for measured lamps ranged from 21 to 415h. This indicates that the emissions would not exceed the short-term ELs that have been established by the ICNIRP for healthy individuals. We also evaluated the potential long-term risk and found it to be insignificant. There was a large variation in the UV emissions found, even for lamps from a single package, indicating that it is impossible to predict the UV output of a CFL based on its physical appearance and model designation.

PURPOSE: To present a proof-of-concept study on the development and implementation of an innovative confocal laser method platform for precise quantitative evaluation of critical optical properties unique to toric intraocular lenses (IOLs).SETTING: U.S. Food and Drug Administration, Optical Therapeutics and Medical Nanophotonics Laboratory, Silver Spring, Maryland, USA.DESIGN: Experimental study.METHODS: The optical properties of hydrophobic toric IOLs were evaluated with a confocal laser method that was modified to isolate the 2 planes of focus that are observed with toric IOLs.RESULTS: The results show the confocal laser method has the potential to measure the orthogonally separated optical powers and then calculate them to the commonly referenced spherical equivalent and cylinder powers of toric IOLs with high accuracy (<= 1 mu m of focal length measurement). Furthermore, the proposed confocal laser method design includes a new component for precise differentiation of the 2 focal planes and isolation of the 2 focal points, and thus for accurate measurement of the anterior cylinder axis of toric IOLs.CONCLUSION: The modifications to the confocal laser method platform enabled the quantitative evaluation of optical properties attributed to toric IOLs. Published by Elsevier Inc. on behalf of ASCRS and ESCRS.

Glare, glistenings, optical defects, dysphotopsia, and poor image quality are a few of the known deficiencies of intraocular lenses (IOLs). All of these optical phenomena are related to light scatter. However, the specific direction that light scatters makes a critical difference between debilitating glare and a slightly noticeable decrease in image quality. Consequently, quantifying the magnitude and direction of scattered light is essential to appropriately evaluate the safety and efficacy of IOLs. In this study, we introduce a full-angle scanning light scattering profiler (SLSP) as a novel approach capable of quantitatively evaluating the light scattering from IOLs with a nearly 360° view. The SLSP method can simulate in situ conditions by controlling the parameters of the light source including angle of incidence. This testing strategy will provide a more effective nonclinical approach for the evaluation of IOL light scatter.

Improving technology and high demand has prompted a rapidly evolving intraocular lens (IOL) industry. To keep up with the improved designs, optical property evaluation techniques need to be adapted quickly to ensure IOL safety and efficacy. Identifying critical parameters are essential in evaluating IOL optical properties, which include temperature, medium, and test light characteristics. Here, we present a novel preclinical quantitative study of the dispersion effect that the wavelength of exposed test light has on IOL optical properties, specifically dioptric power. Dioptric power levels of IOLs were measured using a confocal laser method (CLM) when exposed to various wavelengths throughout the visible spectrum. Results showed statistically significant yet minimal focal point shift and, therefore, dioptric power changes ( $\sim$0.15D) due to the effect of test light wavelength, similar to known wavelength-dependent relationships associated with changes in refractive index. Further evaluation of critical parameters can lead to an improvement of IOL product designs and overall public health.

Optical power properties of lenses and materials in general can be influenced by thermal changes of the material and surrounding medium. In the case of an intraocular lens (IOL) implant, the spherical power (SP), cylinder power, (CP), astigmatism, and spherical aberration are the critical fundamental properties that can significantly impact its efficacy. Directly evaluating how changes in temperature can affect these optical properties may show the importance of considering temperature when evaluating IOL optical characteristics. In this paper, we present a quantitative study on evaluating the impact of environmental temperature changes on IOL fundamental optical properties by testing IOL samples with different materials (e.g., hydrophobic and hydrophilic) and designs (e.g., monofocal and toric) to better encompass types of IOLs in conventional use today. The results from this study demonstrate that significant changes are observed as temperatures are changed from room temperature (20°C) to slightly above body temperature (40°C). Findings indicate that evaluating optical properties at arbitrary temperatures could significantly affect the characterization of IOLs that are already near the tolerance thresholds.

The design and manufacture of intraocular lenses (IOLs) depend upon the identification and quantitative preclinical evaluation of key optical properties and environmental parameters. The confocal laser method (CLM) is a new technique for measuring IOL optical properties, such as dioptric power, optical quality, refractive index, and geometrical parameters. In comparison to competing systems, the CLM utilizes a fiber-optic confocal laser design that significantly improves the resolution, accuracy, and repeatability of optical measurements. Here, we investigate the impact of changing the beam diameter on the CLM platform for the evaluation of IOL dioptric powers. Due to the Gaussian intensity profile of the CLM laser beam, the changes in focal length and dioptric power associated with changes in beam diameter are well within the tolerances specified in the ISO IOL standard. These results demonstrate some of the advanced potentials of the CLM toward more effectively and quantitatively evaluating IOL optical properties.

We propose a novel common-path Fourier domain optical coherence tomography (CP-FD-OCT) method for noncontact, accurate, and objective in vitro measurement of the dioptric power of intraocular lenses (IOLs) implants. The CP-FD-OCT method principle of operation is based on simple two-dimensional scanning common-path Fourier domain optical coherence tomography. By reconstructing the anterior and posterior IOL surfaces, the radii of the two surfaces, and thus the IOL dioptric power are determined. The CP-FD-OCT design provides high accuracy of IOL surface reconstruction. The axial position detection accuracy is calibrated at 1.22 μm in balanced saline solution used for simulation of in situ conditions. The lateral sampling rate is controlled by the step size of linear scanning systems. IOL samples with labeled dioptric power in the low-power (5D), mid-power (20D and 22D), and high-power (36D) ranges under in situ conditions are tested. We obtained a mean power of 4.95/20.11/22.09/36.25 D with high levels of repeatability estimated by a standard deviation of 0.10/0.18/0.2/0.58 D and a relative error of 2/0.9/0.9/1.6%, based on five measurements for each IOL respectively. The new CP-FD-OCT method provides an independent source of IOL power measurement data as well as information for evaluating other optical properties of IOLs such as refractive index, central thickness, and aberrations.

An alternative method for quantification of glistenings in intraocular lenses (IOLs) using an integrating sphere with an adjustable back aperture to remove ballistic photons is presented. Glistenings in soft IOLs have been known for more than a decade; however, their severity and visual impact are still under investigation. A number of studies have been made to quantitatively describe glistenings in IOLs. Quantization and precise grading of IOLs will provide needed information to evaluate the severity and visual impact of glistenings in patients. We investigated the use of a simple modification of an integrating-sphere method to eliminate ballistic photons to quantitatively measure scattered light from glistenings in IOLs. The method described in this paper provides a simple and effective way to quantitatively characterize glistenings in vitro. It may be especially useful to quantify scattering associated with low-grade glistenings where the density of the scattering centers is low. Finally, the modified integrating-sphere method may also be generally applicable to quantitatively characterize scattering from other optical media.

Cutaneous transilluminators are light-emitting devices used to localize blood vessels for various medical procedures. They are often used in populations that may be at increased risk for skin burns, such as neonates and the elderly. While there is a known potential for skin burns, little is known about the ophthalmic risk from the use of these devices. This paper will report on the laboratory evaluation of the potential ocular hazards from transilluminators (TIs). Our results indicate that transilluminators which incorporate white-light LEDs have emissions that have the potential for producing injury to the retina, especially in patients who may have a reduced aversion response.

In recent years, there has been an increase in the popularity of light-emitting diode (LED)-based, battery-powered transilluminators (BPTs) for facilitating transdermal vascular access in adults and neonates. BPTs are believed to have lower potential for inducing skin burns than prior devices based on high-power broadband lamps; however, the optical and thermal outputs of BPTs are not well documented and safety limits for these devices are not well established. In this study, we characterize and assess the optical and thermal outputs of six BPTs that incorporate red, orange and white LEDs. Optical measurements included spectral irradiance and peak local irradiance. Thermal measurements included transient temperature readings for an exposure time of 4 min in ambient air and ex vivo tissue pre-heated to physiological temperatures. The greatest mean temperature rise produced in tissue by a non-white-light diode BPT was 2.5 °C, whereas a mean temperature rise of 9.1 °C was measured in a BPT that incorporated white-light diodes with relatively high irradiance levels. The dominant cause of temperature rise was most likely heat generation within the devices. Thermal damage analyses based on temperature limits and the Arrhenius equation indicate that although some of the devices studied approach the threshold for damage, none appear to exceed it under normal operating conditions. The results demonstrated that ambient air measurements may be suitable for identifying worst-case BPT temperatures. This study highlights the potential risk of LED-based medical devices as well as the need for additional research on related issues such as neonatal thermal injury thresholds.

We present a novel confocal laser method (CLM) for precise testing of the dioptric power of both positive and negative intraocular lens (IOL) implants. The CLM principle is based on a simple fiber-optic confocal laser design including a single-mode fiber coupler that serves simultaneously as a point light source used for formation of a collimated Gaussian laser beam, and as a highly sensitive confocal point receiver. The CLM approach provides an accurate, repeatable, objective, and fast method for IOL dioptric power measurement over the range from 0 D to greater than +-30 D under both dry and in-situ simulated conditions.

The optical radiation emitted from eight indirect ophthalmoscopes was measured. The levels were compared with the threshold limit values (TLVs) published by the American Conference of Governmental Industrial Hygienists. Many tested instruments were found to emit unnecessarily high levels ofultraviolet and infrared radiation in addition to visible light. The levels of optical radiation emitted from most of the ophthalmoscopes were below the applicable TLVs. Nevertheless, suitable blocking filters can reduce the emission of ultraviolet and infrared radiation. Use of the ophthalmoscopes at the lowest possible power setting and the shortest possible exposure time would further minimize patient exposure.

We examined the effects of ultraviolet (UV) radiation in combination with high levels of infrared (IR) radiation on the spectral transmittance of plastic filters. The biological action spectrum for damage to the human eye and skin changes dramatically in the 300-400 nm wavelength range. Cut-off filters used in this region to shape the spectrum of exposure sources are thus critical to the design of experiments which use broadband light sources. The changes in transmittance of three types of plastic filters were observed over an exposure period of 1000 h. One set of three filters was exposed mainly to UV radiation, while the other set was exposed to UV radiation plus IR radiation. Filters exposed to both UV and IR radiation showed spectral changes in their transmittance, while the filters exposed to UV only showed no measurable changes.

The spectral irradiance was measured from twenty handheld ophthalmoscopes. The optical radiation emitted from each ophthalmoscope was compared to the threshold limit values (TLVs) for acute effects published by the American Conference of Governmental Industrial Hygienists. All ophthalmoscopes tested were found to emit unnecessary ultraviolet and infrared radiation in addition to visible light. The levels of optical radiation emitted from most of the ophthalmoscopes were below the applicable TLVs. Nevertheless, suitable blocking filters can reduce the emission of ultraviolet and infrared radiation. Use of the ophthalmoscopes at the lowest possible power would further minimize patient exposure.

Measurement scales for laser power and energy measurements using the C-series calorimeters, an electrically calibrated pyroelectric null radiometer, and a commercially available self-calibrating twin calorimeter system were compared at the 3-mW and 30-mW levels at 488 nm and 647.1 nm. Results show agreement in absolute measurements by these devices to within estimated uncertainties. A similar comparison at the 9-mW level of the argon UV laser lines (351.1 nm and 363.8 nm) showed agreement between measurements made by the C-series calorimeter and the electrically calibrated pyroelectric radiometer to within measurement uncertainties. A discrepancy of about 10% between these and the twin calorimeter measurements may be due to an uncorrected window transmission error in the latter.