OSLI Retina

December 2016

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The increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles (at the end of the 6 month period). USE IN SPECIFIC POPULATIONS Pregnancy Category C Risk Summary There are no adequate and well-controlled studies with OZURDEX ® in pregnant women. Animal reproduction studies using topical ocular administration of dexamethasone were conducted in mice and rabbits. Cleft palate and embryofetal death in mice and malformations of the intestines and kidneys in rabbits were observed. OZURDEX ® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data Topical ocular administration of 0.15% dexamethasone (0.375 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in mice. A dose of 0.375 mg/kg/day in the mouse is approximately 3 times an OZURDEX ® injection in humans (0.7 mg dexamethasone) on a mg/m2 basis. In rabbits, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.13 mg/kg/day, on gestational day 6 followed by 0.20 mg/kg/ day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys. A dose of 0.13 mg/kg/day in the rabbit is approximately 4 times an OZURDEX ® injection in humans (0.7 mg dexamethasone) on a mg/m2 basis. Nursing Mothers: Systemically administered corticosteroids are present in human milk and can suppress growth and interfere with endogenous corticosteroid production. The systemic concentration of dexamethasone following intravitreal treatment with OZURDEX ® is low. It is not known whether intravitreal treatment with OZURDEX ® could result in sufficient systemic absorption to produce detectable quantities in human milk. Exercise caution when OZURDEX ® is administered to a nursing woman. Pediatric Use: Safety and effectiveness of OZURDEX ® in pediatric patients have not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies in animals have been conducted to determine whether OZURDEX ® (dexamethasone intravitreal implant) has the potential for carcinogenesis. Although no adequate studies have been conducted to determine the mutagenic potential of OZURDEX ® , dexamethasone has been shown to have no mutagenic effects in bacterial and mammalian cells in vitro or in the in vivo mouse micronucleus test. Adequate fertility studies have not been conducted in animals. PATIENT COUNSELING INFORMATION Steroid-related Effects Advise patients that a cataract may occur after repeated treatment with OZURDEX ® . If this occurs, advise patients that their vision will decrease, and they will need an operation to remove the cataract and restore their vision. Advise patients that they may develop increased intraocular pressure with OZURDEX ® treatment, and the increased IOP will need to be managed with eye drops, and, rarely, with surgery. Intravitreal Injection-related Effects Advise patients that in the days following intravitreal injection of OZURDEX ® , patients are at risk for potential complications including in particular, but not limited to, the development of endophthalmitis or elevated intraocular pressure. When to Seek Physician Advice Advise patients that if the eye becomes red, sensitive to light, painful, or develops a change in vision, they should seek immediate care from an ophthalmologist. Driving and Using Machines Inform patients that they may experience temporary visual blurring after receiving an intravitreal injection. Advise patients not to drive or use machines until this has been resolved. ©2014 Allergan, Inc., Irvine, CA 92612, U.S.A. ® marks owned by Allergan, Inc. Patented. See: www.allergan.com/products/patent_notices Made in Ireland. Based on 72212US18 Re-order: APC02BN14 Rx only EXCLUSIVES COVER STORY Cover story continues on page 10 A SLACK Incorporated® publication NEWS ® SURGERY OCULAR Image: Robin A American operating rooms should look into what they can integrate from the Aravind method to reduce waste and the carbon footprint of cataract surgery, according to Alan L. Robin, MD. Surgical Maneuvers: Corneal collagen cross-linking available to stabilize and slow progression of keratoconus Avedro's cross-linking procedure was approved by the FDA in April. 6 European Glaucoma Society Congress June 19-22 EGS Congress BACK TO BASICS Pearls for residents, fellows as surgical training gets underway Reading, practicing basic techniques and following a mentor are the fi rst steps to take. 29 LINDSTROM'S PERSPECTIVE Ophthalmologists can try to lead by example to reduce carbon footprint 3 CEDARS/ASPENS DEBATES Offi ce-based cataract surgery: Pros and cons of a controversial idea Melissa Toyos, MD, FACS, explains why she thinks the time has come for offi ce- based cataract surgery. 5 THE DRY EYE Unsung heroes of dry eye care: Technicians make or break a dry eye clinic Techs are the fi rst to educate patients about dry eye and are invested in helping them get better. 9 Measures needed to reduce impact of cataract surgery's high carbon footprint Health care procedures are a large contributor to carbon emissions throughout the world. Presently, surgeons and health care organizations are analyzing the eff ects of carbon emissions from cataract surger- ies and how to decrease the carbon footprint of these procedures. In 2013, researchers from the United Kingdom published a benchmark component analysis study on the carbon emissions per cataract surgery. Daniel S. Morris, FRCSEd(Ophth), a consultant ophthalmol- ogist at the University Hospital of Wales, U.K., and lead author of the study, noted one cataract surgery had a carbon footprint of 181.1 kg carbon dioxide equivalent (CO 2 eq). Cataract surgery carbon footprint ‡ e study included 2,230 patients treated for cata- racts in Cardiff . ‡ e procedures had a total carbon footprint of 405.4 tons of CO 2 eq. Putting this into context, the average carbon footprint for one U.K. resident per year is generally estimated at 10 tons of CO 2 eq, according to the study. "‡ ere is a lot of waste with every cataract surgery. Ocular Surgery News posed the following question: How do you see Brexit impacting ophthalmology in Europe and the U.K.? I think it is much too early to judge. In the short term, there will be no changes. ‡ e so-called bonus for the NHS of £350 million that someone said would appear by leaving the EU will never materialize. ‡ is has now been admitted by one of the senior Brexit politicians. We do not know whether the U.K. will be able to access the single market and avoid tariff s for British ophthalmic products going to Europe. As for the medical personnel who come from the EU or outside and are essential for the functioning of the NHS, again nothing is yet clear. ‡ ings may revert to how they were before the U.K. entered the European Economic Community, with large numbers of doctors and nurses com- ing from ex-colonies such as India. With the pound having lost value, all capital equipment and items such as IOLs, if they come from the USA, will be much more expensive. On the other hand, items produced in the U.K. will be- come much cheaper if exported to the USA. We are in for an extended period of uncertainty. Richard B. Packard, MD, FRCS, FRCOphth Director of Arnott Eye Associates, London OSN Europe Edition Board Member In my opinion, we should not be overly alarmed by Brexit. ‡ e U.K. is an island and was not in the Eurozone nor in the Schengen Area. It has always been hal¤ earted about EU integration, refl ect- ing a historically ambivalent attitude to Europe. Volume 34 • Number 14 JULY 25, 2016 Web Watch Meeting coverage starts on page 13 Meeting News Coverage Brexit: What are the consequences? May 20-21 OSN Italy Read John A. Hovanesian, MD, FACS's, blog, "Going green starts with surgeon demand" 21 Richard B. Packard Brexit continues on page 19 OSNUS07B16pgs1,10-12.indd 1 7/7/2016 11:46:29 AM Image: Robin A American operating rooms should look into what they can integrate from the Aravind method to reduce waste and the carbon footprint of cataract surgery, according to Alan L. Robin, MD. Surgical Maneuvers: Corneal collagen cross-linking available to stabilize and slow progression of keratoconus Avedro's cross-linking procedure was approved by the FDA in April. 6 one of the senior Brexit politicians. We do not know whether the U.K. will be able to access the single market and avoid tariff s for British the single market and avoid tariff s for British the single market and avoid tariff ophthalmic products going to Europe. As for the medical personnel who come from the EU or outside and are essential for the functioning of the NHS, again nothing is yet clear. ‡ ings of the NHS, again nothing is yet clear. ‡ ings of the NHS, again nothing is yet clear. ‡ may revert to how they were before the U.K. entered the European Economic Community, with large numbers of doctors and nurses com- ing from ex-colonies such as India. With the pound having lost value, all capital equipment and items such as IOLs, if they come from the USA, will be much more expensive. On the other hand, items produced in the U.K. will be- come much cheaper if exported to the USA. We are in for an extended period of uncertainty. Richard B. Packard, MD, FRCS, FRCOphth Director of Arnott Eye Associates, London OSN Europe Edition Board Member In my opinion, we should not be overly alarmed by Brexit. ‡ e U.K. is an island and was not in the by Brexit. ‡ e U.K. is an island and was not in the by Brexit. ‡ Eurozone nor in the Schengen Area. It has always been hal¤ earted about EU integration, refl been hal¤ earted about EU integration, refl been hal¤ ect- earted about EU integration, refl ect- earted about EU integration, refl ing a historically ambivalent attitude to Europe. Brexit: What are the consequences? Brexit continues on page 19 Brexit continues on page 19 Brexit Like us! Cover story continues on page 10 Cover story continues on page 10 Cover story European Glaucoma Society Congress June 19-22 EGS Congress Ophthalmologists can try to lead by example to reduce carbon footprint 3 CEDARS/ASPENS DEBATES Offi ce-based cataract Offi ce-based cataract Offi surgery: Pros and cons of a controversial idea Melissa Toyos, MD, FACS, explains why she thinks the time has come for offi ce- time has come for offi ce- time has come for offi based cataract surgery. 5 THE DRY EYE Unsung heroes of dry eye care: Technicians make or break a dry eye clinic Techs are the fi rst to Techs are the fi rst to Techs are the fi educate patients about dry eye and are invested in helping them get better. 9 ogist at the University Hospital of Wales, U.K., and lead author of the study, noted one cataract surgery had a carbon footprint of 181.1 kg carbon dioxide equivalent (CO 2 eq). Cataract surgery carbon footprint ‡ e study included 2,230 patients treated for cata- ‡ e study included 2,230 patients treated for cata- ‡ racts in Cardiff . ‡ racts in Cardiff . ‡ racts in Cardiff e procedures had a total carbon . ‡ e procedures had a total carbon . ‡ footprint of 405.4 tons of CO 2 eq. Putting this into context, the average carbon footprint for one U.K. resident per year is generally estimated at 10 tons of CO 2 eq, according to the study. "‡ ere is a lot of waste with every cataract surgery. "‡ ere is a lot of waste with every cataract surgery. "‡ Ocular Surgery News posed the following question: How do you see Brexit impacting ophthalmology in Europe and the U.K.? I think it is much too early to judge. In the short term, there will be no changes. ‡ e so-called bonus for ‡ e so-called bonus for ‡ the NHS of £350 million that someone said would appear by leaving the EU will never materialize. ‡ is will never materialize. ‡ is will never materialize. ‡ has now been admitted by one of the senior Brexit politicians. We do not know whether the U.K. will be able to access the single market and avoid tariff ophthalmic products going to Europe. As for the medical personnel who come from the EU or outside and are essential for the functioning of the NHS, again nothing is yet clear. ‡ may revert to how they were before the U.K. entered the European Economic Community, with large numbers of doctors and nurses com- ing from ex-colonies such as India. With the pound having lost value, all capital equipment and items such as IOLs, if they come from the Meeting coverage starts on page 13 Meeting News Coverage Brexit: What are the consequences? May 20-21 OSN Italy Richard B. Packard continues on page 10 eq. Putting this into context, the average carbon footprint for one U.K. resident per year is generally estimated at 10 tons of ere is a lot of waste with every cataract surgery. one of the senior Brexit politicians. We do not know whether the U.K. will be able to access the single market and avoid tariff ophthalmic products going to Europe. As for the medical personnel who come from the EU or outside and are essential for the functioning of the NHS, again nothing is yet clear. ‡ may revert to how they were before the U.K. entered the European Economic Community, with large numbers of doctors and nurses com- ing from ex-colonies such as India. With the pound having lost value, all capital equipment and items such as IOLs, if they come from the Brexit: What are the consequences? Follow us! FOLLOW US ON TWITTER Offering the latest news and perspectives in your specialty. Twitter.com/Healio_OSN LIKE US ON FACEBOOK Featuring breaking news, videos and expert commentaries. Facebook.com/ocularsurgerynews Join the discussion STAY IN TOUCH with your ophthalmology community

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