Eyeworld

18 March 2019 EW NEWS & OPINION confidence in young surgeons stems from the fact that not all refractive cataract surgeons are well versed in corneal excimer ablation surgery," he said. "We should do a better job of training our non-LASIK surgeons about excimer candidacy, as that will allow the young cataract surgeon to be more confident in recommending corneal ablation as a backup plan for unhappy patients." Additionally, Dr. Zavodni said there are newer technologies that can be used to help cataract sur- geons nail their refractive outcomes, including intraoperative aberrome- try and postop IOL modifications. Dr. Lee finds that a majority of people who have a successful toric or presbyopia-correcting IOL are happy, so dealing with complications may be rare. But it could be infrequent enough that physicians may not get enough experience managing such patients, he said. Since patients may be unhappy for a variety of reasons, Dr. Lee said actions like managing dry eye/ocular surface issues, making sure the measurements are accurate, and knowing how to do laser refrac- tive surgery enhancement can all be important. In addressing the need to manage patients postoperatively, Dr. Kim stressed that "prevention is key." Preparing for every potential outcome and correcting for that pri- or to surgery is essential and worth taking the extra time to help prevent postoperative issues, she said. To build confidence, she recom- mended choosing straightforward cases. Dr. Kim also said to make sure patients are out of contact lenses for a period of time prior to measure- ments and to use multiple methods to confirm the axis and amount of astigmatism. "Optimization of the ocular surface cannot be stressed enough," she said. For torics, consider the type of lens material, as some studies have shown a higher rate of rotation with one type over others. She also suggested getting a macula OCT to rule out any subtle retinal pathology that may contribute to symptoms postoperatively. EW Editors' note: Drs. Kim, Lee, and Zavodni have no financial interests related to their comments. Contact information Kim: joankim93@gmail.com Lee: samuel.lee.md@gmail.com Zavodni: zacharyzavodni@gmail.com not performed surgery with these types of lenses (with an average of one case performed); in the fellow group, 36% had not performed surgery with multifocal/EDOF lenses (with an average of eight cases); and for those young physicians in prac- tice less than 5 years, 29% had not performed any of these cases (with an average of 17 cases). Dr. Zavodni said that he is not surprised by the overall use of multifocal and EDOF lenses. "About a third of young surgeons in the first 5 years of practice are not using these lenses," he said. "I think this is in large part because most surgeons in this demographic were train- ing during a time when high-add multifocals were leading to a large number of patient complaints." He added that there has been a recent shift to low-add multifocals and EDOFs, which result in overall higher patient satisfaction. "I think surgeon use of these lenses will consequently expand slowly with time," he said. "Residents in training today are seeing a higher percentage of happy multifocal patients in their attending clinics, and I expect that will lead to higher adoption rates moving forward." Dr. Kim said that training is a great time to start using this tech- nology since the attending surgeon can help guide decision making and avoid any pitfalls. "In addition, companies are willing to provide free trial lenses for patients so that residents and fellows can become more confident using this technolo- gy," she said. "It takes more time, thought, and energy during preoperative and intraoperative planning, though, which might also contribute to the lower rates of implantation," Dr. Kim said, adding that she finds that residents and fellows can be so consumed with getting their surgical volume that they don't take the time to consider the potential benefits from offering these other options. Unhappy patients When asked about confidence in managing unhappy patients (toric and presbyopia-correcting IOL pa- tients), the majority of respondents in the three groups (physicians with 1–3 years of training, fellows, and those in practice less than 5 years) seemed to be neutral or unconfident in their abilities. For physicians in practice less than 5 years, 55% were confident or very confident with managing the unhappy toric IOL patient, but the percentage of confi- dence in the other groups fell below 40%, as did confidence in handling the unhappy presbyopia-correcting IOL patient in all three groups. Dr. Zavodni said that he found this data most concerning. "Only 55% and 37% of providers were confident in managing unhappy toric and presbyopia-correcting lens patients, respectively," he said, adding that he thinks this would be a good area of focus in educational programming. "The two biggest challenges facing the premium IOL cataract sur- geon are managing residual postop- erative refractive error and aligning patient expectations with clinical outcomes," Dr. Zavodni said. He added that it's difficult to manage the unhappy premium IOL patient whose expectations are not met. "With regard to something as simple as residual refractive er- ror, I suspect that part of the poor ASCRS continued from page 16 BRIEF SUMMARY: Please see the DEXTENZA Package Insert for full prescribing information for DEXTENZA (11/2018) 1 INDICATIONS AND USAGE DEXTENZA ® (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular pain following ophthalmic surgery (1). 4 CONTRAINDICATIONS DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis. 5 WARNINGS AND PRECAUTIONS 5.1 Intraocular Pressure Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during the course of the treatment. 5.2 Bacterial Infection Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection [see Contraindications (4)]. 5.3 Viral Infections Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex) [see Contraindications (4)]. 5.4 Fungal Infections Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate [see Contraindications (4)]. 5.5 Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. 6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Intraocular Pressure Increase [see Warnings and Precautions (5.1)] • Bacterial Infection [see Warnings and Precautions (5.2)] • Viral Infection [see Warnings and Precautions (5.3)] • Fungal Infection [see Warnings and Precautions (5.4)] • Delayed Healing [see Warnings and Precautions (5.5)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation; delayed wound healing; secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera [see Warnings and Precautions (5)]. DEXTENZA was studied in three randomized, vehicle-controlled studies (n = 351). The mean age of the population was 68 years (range 43 to 87 years), 62% were female, and 85% were white. Forty-six percent had brown iris color and 31% had blue iris color. The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (9%); intraocular pressure increased (5%); visual acuity reduced (2%); eye pain (1%); cystoid macular edema (1%); corneal edema (1%); and conjunctival hyperemia (1%). The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%). 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies with DEXTENZA in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, administration of topical ocular dexamethasone to pregnant mice and rabbits during organogenesis produced embryofetal lethality, cleft palate and multiple visceral malformations [see Animal Data]. Data Animal Data Topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in a mouse study. A daily dose of 0.75 mg/kg/day in the mouse is approximately 5 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m 2 basis. In a rabbit study, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.36 mg /day, on gestational day 6 followed by 0.24 mg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys. A daily dose of 0.24 mg/day is approximately 6 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m 2 basis. 8.2 Lactation Systemically administered corticosteroids appear in human milk and could suppress growth and interfere with endogenous corticosteroid production; however the systemic concentration of dexamethasone following administration of DEXTENZA is low [see Clinical Pharmacology (12.3)]. There is no information regarding the presence of DEXTENZA in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production to inform risk of DEXTENZA to an infant during lactation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DEXTENZA and any potential adverse effects on the breastfed child from DEXTENZA. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients. 17 PATIENT COUNSELING INFORMATION Advise patients to consult their surgeon if pain, redness, or itching develops. MANUFACTURED FOR: Ocular Therapeutix, Inc. Bedford, MA 01730 USA PP-US-DX-0072

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