Eyeworld

Contact Name: by Title advantages have failed to translate to a measurable benefit with regard to complication rates and refractive outcomes. 6 Here we review the first prospective randomized trial comparing process measures and outcomes of FLACS versus CPS performed by ophthalmology residents, "Out- comes of resident-performed laser-assisted vs. traditional phacoemulsification" by Hansen et al. This study included post-graduate year-3 and -4 ophthalmology residents operating at a single site (Park- land Memorial Hospital System in Dallas, Texas) within a single residency program (University of Texas Southwest- ern Medical Center). All cataract surgeries by this group between October 2015 and June 2017 were eligible for the study, which ultimately enrolled 135 eyes of 96 subjects. Eyes were randomly assigned to FLACS or CPS, and sub- jects were offered premium IOLs as appropriate, though lens subgroups were not analyzed separately. Eyes were ex- cluded from consideration if they had prior ocular surgery, posterior polar cataract, phacodonesis, white or advanced cataract, anatomic conditions that precluded laser docking, pupil dilation <6 mm, or potential postoperative visual acuity worse than 20/30. The authors found no difference between the groups in the majority of measured variables. Specifically, there were no significant differences with regard to best cor- rected visual acuity (BCVA); cumulative dissipated energy; intraocular balanced salt solution irrigation fluid usage; postoperative endothelial cell density; endothelial cell loss after surgery; total intraoperative time (of note, for the FLACS group, this did not include time at the femtosec- ond laser prior to entering the operating room); duration of hydrodissection/hydrodelineation, nuclear disassembly, or wound sealing. Several operative steps did vary signifi- cantly in duration between the two groups; wound cre- ation, cortical cleanup, and IOL implantation were faster in the CPS group, and median time for capsulorhexis was faster in the FLACS group. The small size of the study rendered it underpowered to detect statistically significant differences in safety be- tween groups, but complications included one case of pos- terior capsule rent with vitreous prolapse per group; one case of posterior capsule rent without vitreous prolapse in the CPS group; and two cases of anterior capsule tears without vitreous prolapse in the CPS group. Postoperative cystoid macular edema was observed in one patient in the FLACS group. This study provides a useful contribution to the growing body of work on FLACS, especially with regard to its usage by novice surgeons still in training. Still, a number of limitations merit discussion. As the study is continued from page 12 ASCRS NEWS BRIEF SUMMARY: Please see the DEXTENZA Package Insert for full prescribing information for DEXTENZA (06/2019) 1 INDICATIONS AND USAGE DEXTENZA ® (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery. 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 four randomized, vehicle-controlled studies (n = 567). The mean age of the population was 68 years (range 35 to 87 years), 59% were female, and 83% were white. Forty-seven percent had brown iris color and 30% 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 (10%); intraocular pressure increased (6%); visual acuity reduced (2%); cystoid macular edema (1%); corneal edema (1%); eye pain (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-V2

• Blank Page
• Blank Page (1)