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Purpose: This work assesses the change in tear function after LASIK surgery. Methods: This prospective, observational study was conducted in the Refractive Clinic of a tertiary care rural hospital. Tear dysfunction symptoms and the tear function tests were assessed in 269 eyes of 134 patients, OSDI score was used to document the tear dysfunction symptoms. Tear function was assessed by tear meniscus height, tear film break?up time (TBUT), Lissamine green staining, corneal fluorescein staining, Schirmer test 1 without anesthesia before and at 4–6 weeks and 10–12 weeks after LASIK surgery. Results: Preoperatively OSDI score was 8.54 ± 7.71. It increased to 15.11 ± 9.18 postoperatively at 4–6 weeks after LASIK surgery and 13 ± 9.56 at 10–12 weeks after LASIK surgery Mean TBUT preoperatively was 7.82 ± 3.57 sec which decreased to 5.34 ± 2.56 sec at 4–6 weeks and to 4.53 ± 2.63 sec at 10–12 weeks postoperatively. The number of eyes with clear secretion decreased from 40.5% preoperatively to 23.4% at 4–6 weeks and to 22.3% at 10–12 weeks postoperatively, whereas the granular and cloudy secretions increased significantly in eyes after LASIK surgery. The prevalence of eyes with Lissamine green score >3 (dry eye) increased from 17.1% preoperatively to 27.9% at 4–6 weeks and to 30.5% at 10–12 weeks. Similarly, the number of eyes showing positive fluorescein corneal staining increased from 5.6% preoperatively to 19% postoperatively at 4–6 weeks. Mean Schirmer score was 28.83 ± 6.39 mm preoperatively, 22.47 ± 5.38 mm at 4–6 weeks, and 21.27 ± 4.99 mm at 10–12 weeks after LASIK surgery. Conclusion: The prevalence of dry eye increased after LASIK as was assessed by an increase in the tear dysfunction symptoms using OSDI score and the deranged values of various tear function tests after LASIK surgery
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Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for protection of the public health by assuring that foods are safe, wholesome, sanitary and properly labelled. Approved Novel drugs are often innovative products that serve unmet medical needs or otherwise help to advance patient care.Methods: FDA novel drug approvals were analysed from calendar year (CY) 2012 to 2016 on the basis of three criteria i.e., impact, access and predictability. Impact measured on the basis of: percentage of novel drug approvals (a) first in class (b) for rare diseases. Access measured on the basis of: percentage of novel drug approvals (a) first cycle approval (b) approval in the U.S. before other countries and (c) percentage of priority reviews. Predictability measured by: the percentage of novel drug approvals that met the PDUFA goal dates for the application review.Results: Total number of novel drugs approved from CY 2012 to 2016 was 176 (average 35 novel drugs/ year). Impact of novel drug approvals: 40% were first in class and 39% were for rare diseases. Access of novel drug approvals: 84% were first cycle approval, 60% were approval in US before other countries, 51% priority reviews among novel drug approvals. Predictability of novel drug approvals: 97% approvals able to meet PDUFA goal dates for application review.Conclusions: Novel drug approvals during CY 2012-2016 had a high quality which is very much evident by their high impact, good access and high predictability.