Health policy regulations pertaining to advanced surgical devices-their socio-economic effects on ophthalmology practice.

The Israel Ministry of Health enacted regulations that aim to reduce private expenditure on healthcare services and mitigate social inequality. According to the modified rules, which went into effect in the second half of 2016, patients who undergo surgery in a private hospital and are covered by their healthcare provider's supplemental insurance (SI) make only a basic co-payment.The modified regulations limited the option of self-payment for advanced devices not covered by national health basket, meaning that patients for whom such devices are indicated had to pay privately for the entire procedure. These regulations applied to all medical and surgical devices not covered by national health insurance (NHI).Toric intraocular lenses (IOLs) are a case in point. These advanced lenses are implanted during cataract surgery to correct corneal astigmatism and, in indicated cases, obviate the need for complex eyeglasses postoperatively. Toric IOL implantation has been shown to be highly cost-effective in both economic and quality-of-life terms. Limitations of the use of these advanced IOLs threatened to increase social inequality.In 2017, further adjustments of the regulations were made which enabled supplemental charges for these advanced IOLs, performed through the SI programs of the healthcare medical organizations (HMOs). Allowing additional payment for these lenses at a fixed pre-set price made it possible to apply a supplemental part of the insurance package to the surgery itself. In mid 2018 these IOLs were included without budget in the national health basket, allowing for self-payment for the additional cost in addition to the basic coverage for all patients with NHI.This case study suggests that, in their efforts to enhance health care equity, policymakers may benefit if exercising due caution when limiting the extent to which SI programs can charge co-payments. This is because, when a service or product is not available via the basic NHI benefits package, limiting SI co-payments can sometimes result in a boomerang effect - leading to an increase in inequality rather than the sought-after decrease in inequality.

Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms. Final order.

The Food and Drug Administration (FDA or we) is classifying the intranasal electrostimulation device for dry eye symptoms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intranasal electrostimulation device for dry eye symptoms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Ophthalmic Devices; Classification of the Tear Electrostimulation Device. Final order.

The Food and Drug Administration (FDA or we) is classifying the tear electrostimulation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the tear electrostimulation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

A new system, the LipiFlow, for the treatment of meibomian gland dysfunction.

PURPOSE: To evaluate the safety and effectiveness of the LipiFlow System compared to the iHeat Warm Compress (WC) for adults with meibomian gland dysfunction (MGD). METHODS: This was a non-significant risk, prospective, open-label, randomized, crossover multicenter clinical trial. One hundred thirty-nine subjects were randomized between LipiFlow (n=69) and WC control (n=70). Subjects in the LipiFlow group received a 12-minute LipiFlow treatment and were reexamined at 1 day, 2 weeks and 4 weeks. Control subjects received a 5-minute iHeat treatment with instructions to perform the same treatment daily for 2 weeks. At 2 weeks, they crossed over (LipiFlow Crossover) and received the LipiFlow treatment. Effectiveness parameters: meibomian gland (MG) assessment, tear break-up time (TBUT) and dry eye symptoms. Safety parameters: adverse events, ocular health exam, ocular surface staining, intraocular pressure, visual acuity and discomfort. RESULTS: LipiFlow resulted in significant improvement (P < 0.05) in MG secretion at 2 and 4 weeks (mean ± standard deviation at baseline = 6.3 ± 3.5; 2 weeks = 14.3 ± 8.7; 4 weeks = 16.7 ± 8.7); and TBUT at 2 and 4 weeks: (at baseline = 5.5 ± 2.9; 2 weeks = 6.9 ± 5.0; 4 weeks = 7.4 ± 5.5). There was no significant change in MG secretion or TBUT in the control group. LipiFlow resulted in a greater significant reduction in dry eye symptoms than the iHeat WC. The crossover group demonstrated similar significant improvement 2 weeks post-treatment with the LipiFlow. There was no significant difference between groups in the incidence of non-serious, device-related adverse events. CONCLUSION: The LipiFlow System was significantly more effective than iHeat WC. These results support its safety and effectiveness in the treatment of MGD and dry eye symptoms.

Medical devices; ophthalmic devices; classification of the eyelid thermal pulsation system. Final rule.

The Food and Drug Administration (FDA) is classifying the eyelid thermal pulsation system into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

No loss of chance of diabetic retinopathy screening by endocrinologists with a digital fundus camera.

OBJECTIVE: To compare the efficacy of the diabetic retinopathy (DR) screening with digital camera by endocrinologists with that by specialist and resident ophthalmologists in terms of sensitivity, specificity, and level of "loss of chance." RESEARCH DESIGN AND METHODS: In a cross-sectional study, 500 adult diabetic patients (1,000 eyes) underwent three-field retinal photography with a digital fundus camera following pupillary dilatation. Five endocrinologists and two ophthalmology residents underwent 40 h of training on screening and grading of DR and detection of associated retinal findings. A κ test compared the accuracy of endocrinologist and ophthalmology resident screening with that performed by experienced ophthalmologists. Screening efficiency of endocrinologists was evaluated in terms of "loss of chance," i.e., missed diagnoses that required ophthalmologist referrals. RESULTS: The mean weighted κ of DR screening performed by endocronologists was similar to that of ophthalmology residents (0.65 vs. 0.73). Out of 456 DR eyes, both endocrinologists and ophthalmology residents misdiagnosed only stage 1 DR (36 and 14, respectively), which did not require ophthalmologist referral. There were no significant differences between endocrinologists and ophthalmology residents in terms of diabetic maculopathy and incidental findings except for papillary cupping and choroidal lesions, which were not the main purpose of the study or of the training. CONCLUSIONS: The endocrinologist with specific training for DR detection using a three-field digital fundus camera with pupillary dilatation can perform a reliable DR screening without any loss of chance for the patients when compared with identical evaluation performed by experienced ophthalmologists.

[Development of the technology of the substance of davikol and standardization].

Among wide assortment of pharmaceutical remedies, that use modern medicine as a weapon against different diseases, special place belongs to the ophthalmic pharmaceutical forms, and their development presents independent branch of pharmaceutical technology. Recently, as a reason of various diseases and among them ophthalmic problems, is considered free radicals and reactions with their participation. Protection of the organism from such diseases presents a main goal of antioxidant system. Nowadays, special attention is paid to the natural antioxidants. On the basis of the natural honey technology of eye drops davikol with antioxidant activity have been developed. The objective of our study has been the development of the substance of prolonged pharmaceutical dosage form davikol - eye ophthalmic drops and its standardization. The qualitative and quantitative methods were developed. It is concluded that the optimal method of drying of davikol is sublimation. Dry powder (active substance) davikol was obtained; quality characteristics were identified.

Efficacy of a new warm moist air device on tear functions of patients with simple meibomian gland dysfunction.

PURPOSE: To evaluate the safety and efficacy of an original warm moist air device on tear functions and ocular surface of patients with simple meibomian gland dysfunction (MGD). METHODS: Fifteen patients with simple MGD and 20 healthy volunteers were recruited in an initial prospective interventional clinical trial to evaluate the safety and short-term effects of the warm moist air device. The device was applied to the eyes of the subjects for 10 minutes. Temperatures of the eye lids and corneas were measured with an infrared thermometer. Symptoms of ocular fatigue were scored using visual analog scales (VASs). Schirmer test, tear film break-up time (BUT), DR-1 tear film lipid layer interferometry, fluorescein staining, and rose bengal staining were also performed before and after the application of the eye steamer. After the initial study, another 2-week prospective clinical trial was carried out in 10 patients with MGD who received the warm moist air treatment. Ten other patients were also recruited and received warm compress treatment with hot towels for 2 weeks to evaluate the long-term effects of the warm moist air device and the warm compresses on tear film lipid layer thickness and ocular surface health. The warm moist air device and the warm compresses were applied for 10 minutes twice a day. The changes in VAS scores for symptoms, BUT values, fluorescein, and rose bengal staining scores were examined before and after each treatment during the second trial. RESULTS: VAS scores of ocular fatigue improved significantly with short- and long-term applications of the warm moist air device in both studies. The mean corneal surface and eye lid temperatures showed significant elevation within safe limits 10 minutes after the moist air application. The mean BUT prolonged significantly in the patients receiving warm moist air applications but did not change significantly in those treated with warm compresses. DR-1 tear film lipid layer interference showed evidence of lipid expression in the patients and controls, with thickening of the tear film lipid layer after 10 minutes of warm moist air device use. In the 2-week trial, tear film lipid layer thickness increased in both warm moist air device and warm compress groups, with a greater extent of increase in the warm moist air device group. CONCLUSION: Warm moist air device use provided symptomatic relief of ocular fatigue and improvement of tear stability in patients with MGD. The new warm moist air device seems to be a safe and promising alternative in the treatment of MGD.

Teleophthalmology link between a primary health care centre and a reference hospital.

We have evaluated a teleophthalmology service linking a primary health care centre and an eye clinic at a reference hospital. General practitioners at the primary care centre serving a population of 15,000 and ophthalmologists at the reference hospital participated in this study. Eye fundus digital images were taken from 278 eye fundi of 139 consecutive patients with clinical conditions that could potentially produce fundus alterations. Fundus images were obtained with a non-mydriatic fundus camera (Canon CR6-45M) and were electronically sent reference hospital where ophthalmologist inspected the images and returned the diagnosis. In 18 patients (13%) the images did not have good enough quality to exclude eye fundus lesions. In 24 patients (17%) clear eye fundus alterations were found in at least one eye. In 14 patients (10%) there were image features suggesting retinal alterations that could not be confirmed by image inspection. Media opacity (13 eyes, 5%, seven patients, 5%) was the most common cause of poor image quality. The most difficult assessment was the evaluation of optic nerve head cupping. Retinal oedema was not observable in the digital images. In our experience teleopthalmology services seem to be an effective alternative for eye fundus diagnosis and patient follow-up.

Efficacy and safety of infrared warming of the eyelids.

PURPOSE: To evaluate our newly developed infrared heater (IRH) and compare it to a broad-spectrum heater (BSH) for warming the eyelids. MATERIALS AND METHODS: Ten normal subjects were enrolled in this study. All measurements were recorded in a room with temperature 23 degrees C, 40% humidity, and no wind. The IRH is composed of two hard eye patches that have light-emitting diodes (LEDs) emitting near-infrared radiation. We first compared the temperature rises in the cornea, lacrimal gland, and eyelids after warming through closed eyelids with the IRH for 5 and 10 min. Next, we compared warming with the IRH or BSH for 30 min. We then used the IRH for 5 min with the eyes open to confirm its safety. Finally, we determined subjective feeling after warming the eyes. RESULTS: Direct comparison of 5 versus 10 min of warming with the IRH showed no significant differences in temperature rises in the upper eyelid (p = 0.09). The IRH caused significantly more heating (p < 0.05) than did the BSH everywhere except the cornea. The temperatures never rose above 37.7 degrees C for either heater during 30 min or with the IRH with the eyes open for 5 min. The subjects' comfort level rose significantly (p < 0.05) after treatment with the IRH. CONCLUSIONS: Our study showed the efficacy and safety of warming the eyelids with a newly developed IRH. Only 5 min is necessary to increase ocular temperature and enhance comfort.

Impact resistance of ceramic brackets according to ophthalmic lenses standards.

The overall resistance to accidental blows of the many ceramic brackets that are sold today has not been explored. Facing a similar diversity, the eyeglasses industry has chosen to standardize the testing of lenses by subjecting them to the drop of a steel ball. By slightly modifying this test, 10 brands of ceramic brackets were examined. In most cases, the findings coincided with those found by other authors when duplicating debonding. Thus, polycrystalline ceramics with bulkier structures and glazed surfaces were found to be more resistant to impact than the monocrystalline brackets, the loftier real "twins," and the less dense attachments. Protruding tie wings and bases were liabilities, and domed configurations seemed to deflect the blows. Bulkier "single" designs alone did not offer a guarantee of impact resistance when not accompanied by an appropriate microstructure and a smooth surface. The ceramic brackets most resistant to impact were found to be 20/20 by American Orthodontics and Fascination by Dentaurum. Medium resistance was displayed by Lumina by Ormco, Allure III and Allure by GAC, Transcend 2000 and Transcend by Unitek/3M; the last was not as good as the other four. The least resistant were Illusion by Ortho-Organizers, Intrigue by Lancer Orthodontics, and Starfire TMB by "A"-Co. Probably because of its real twin design, the last bracket lends itself to the highest probability for accidental breakage. Although resistance to impact and accidental debonding is desirable from the point of view of treatment, the advantage should be weighted against the chance of enamel fracture. Indeed a weak bracket attached with a soft adhesive may be preferable when the chance of an increased exposure to accidental blows is probable. In such cases, the ceramic may take the brunt of the force, instead of the tooth.

"Professor" William C. Wilson and his Actina electric pocket battery for curing ocular disease.

PURPOSE: To investigate the activities of the firm that manufactured and sold the Actina, the leading example of ophthalmic quackery in the era of the founding of the American Academy of Ophthalmology. METHODS: Advertisements for the Actina in turn-of-the-century newspapers and magazines were studied, and additional related investigations were undertaken at leading historical societies in the United States and at the headquarters of the American Medical Association. RESULTS: The Actina was widely advertised as a cure for most of life's ills, particularly those of the eye and ear. Its manufacturers claimed that electrical properties were the mechanism of the Actina's alleged therapeutic effects. However, research has shown that the instrument had no electrical properties, its manufacturers had no medical training, and that the Actina was useless as a therapeutic agent. CONCLUSIONS: The firm that manufactured the Actina was located in Kansas City and was at the zenith of its success when the first meeting of the American Academy of Ophthalmology was held there in 1896. Its fraudulent activities sparked a continuing public outcry that contributed to the passage of the Pure Food and Drug Act of 1906. The American Medical Association's Investigative Bureau was a major factor in the firm being put out of business in 1915 by the federal government.

Removal of epithelium and scraping the underlying stroma as treatment for photorefractive keratectomy overcorrection or undercorrection of myopia.

BACKGROUND AND OBJECTIVE: A minority of patients who undergo excimer laser photorefractive keratectomy are overcorrected to the extent that they are symptomatic; they tend to be "poor healers" with little post-excimer subepithelial haze and a thinned epithelial layer. The reverse situation can also occur where "aggressive healing" results in undercorrection, excessive haze and a thickened epithelial layer. PATIENTS AND METHODS: Overcorrection was treated in 19 eyes by removal of the corneal epithelium overlying the treated cornea with a disposable number 15 scalpel blade under topical anesthesia at the slit lamp. The exposed stroma was gently abraded with the blade in order to create inflammation and the laying down of tissue to partially resteepen the cornea. Eight eyes with undercorrection had "hyperplastic epithelium" removed with the number 15 blade. The intention was to abrade underlying subepithelial haze only if it was felt that a plaque of "haze" could be removed by so doing; in fact, no plaques were removed and it was difficult to remove the epithelium without associated trauma to the superficial stroma. RESULTS: The mean refraction of the overcorrected eyes was +2.77 diopters (D) compared with +0.68 D at 12 months post-scraping. This can be contrasted with -3.11 D prior to scraping, and -4.67 D at 12 months for the undercorrected eyes. The only difference that could be detected between the overcorrected and undercorrected eyes was that the mean pre-excimer refraction of the overcorrected patients was -5.68 D, whereas that of the undercorrected patients was -8.22 D. It was not possible to predict which overcorrected eyes would do well after scraping. CONCLUSION: Scraping is a very effective treatment of overcorrection after photorefractive keratectomy. Scraping as a treatment of undercorrection should not be undertaken.

[A comprehensive approach to designing of magnetotherapy techniques based on the Atos device]. / Kompleksnyi podkhod k razrabotke magnitoterapevticheskoi tekhniki na primera apparata "ATOS".

The paper determines how to apply a comprehensive approach to designing magnetic therapeutical techniques based on concomitant exposures to two or more physical factors. It shows the advantages of the running pattern of a magnetic field and photostimuli in terms of optimization of physiotherapeutical exposures. An Atos apparatus with an Amblio-1 attachment is used as an example to demonstrate how to apply the comprehensive approach for ophthalmology.

Ophthalmologic procedures in the emergency department--Part II: Routine evaluation procedures.

The emergency physician (EP) must be familiar with performance of ophthalmologic procedures for evaluation and treatment of a multitude of eye complaints. This article is the second of three articles addressing ophthalmologic procedures potentially of use by the EP. This article reviews the indications and the techniques for the following routine procedures: visual acuity testing, pupil dilatation, topical anesthesia use, and tonometry. Criteria for consultation also are addressed.

Comparison of two needle lengths in regional ophthalmic anesthesia with etidocaine and hyaluronidase.

The effect of needle length on the efficacy of regional ophthalmic anesthesia in conjunction with cataract surgery was studied in 97 patients using a two-site injection technique. The local anesthetic used was etidocaine 1.5% with hyaluronidase. In 48 patients, the anesthetic was administered inferolaterally with a 22-millimeter needle, and in the other 49 patients, with a 31-millimeter needle. Every patient had a medial injection with a 12-millimeter needle to achieve lid akinesia and to complete the globe akinesia. At 5 minutes, lid akinesia was considered better in the 22-millimeter needle group (P < .005). After one supplemental dose, when necessary, complete globe akinesia was achieved at 15 minutes significantly more often (94% vs 79%) in the 31-millimeter needle group (P < .05). Lid akinesia in the two groups was identical at that time. Eight patients in the short-needle group and three in the long-needle group experienced some pain during surgery. Throughout the study, the required intraorbital anesthetic volumes were smaller in the 31-millimeter needle group. We recommend the use of a 31-millimeter needle inferolaterally in combination with a 12-millimeter needle medially to achieve satisfactory regional anesthesia for cataract surgery.