Safety of an Intracameral Fixed Combination for Mydriasis and Intraocular Anaesthesia During Cataract Surgery.

Purpose: To compare the safety of a standardized, commercially available intracameral combination of mydriatics and anesthetic (ICMA) with a reference topical mydriatic regimen for cataract surgery. Patients and Methods: The safety results from two international, randomized, controlled clinical studies were combined to compare ICMA at the beginning of cataract surgery (ICMA group) to the reference topical mydriatic regimen (reference group). Data were collected on ocular and systemic adverse events, corneal and anterior chamber examination, endothelial cell density, retinal thickness and visual acuity. Analysis was performed on a pooled safety set from both studies, preoperatively and up to 1 month postoperatively. Results: 342 patients received ICMA and 318 the reference topical regimen. Ocular adverse events were reported in 17.0% of patients in the ICMA group and 18.6% in the reference group. No difference was shown between groups in endothelial cell density (2208 ± 498 cells/mm2 for ICMA group versus 2241 ± 513 cells/mm2 for the reference group; p=0.547) and retinal thickness (change from baseline less than 50 µm in 94.7% versus 95.0% of patients, respectively) at 1 month postoperatively. At 1-day post-surgery, less patients in the ICMA group had moderate or severe (Grades 2 and 3) superficial punctate corneal staining (3.9% versus 7.0% for the reference group; p=0.064). Postoperatively, some ocular symptoms were also less frequently reported in the ICMA group. Best-corrected visual acuity increased in 96.0% of patients in the ICMA group and 95.8% in the reference group at 1 month. Conclusion: ICMA injection at the beginning of cataract surgery was demonstrated to be safe and may also provide perioperative and postoperative advantages over the standard topical mydriatic regimen.

Decision taking in corneal refractive surgery.

A 27-year-old woman who wants to get rid of contact lenses and spectacles was seen at our clinic. She had strabismus surgery as a child and was patched for the right eye but now shows mild nondisturbing exophoria. Infrequently, she likes to box in the sports school. Her corrected distance visual acuity at presentation in the right eye was 20/16 with -3.75 -0.75 × 50 and in the left eye 20/16 with -3.75 -1.25 × 142. Her cycloplegic refraction in the right eye was -3.75 -0.75 × 44 and in the left eye was -3.25 -1.25 × 147. The left eye is the dominant eye. The tear break-up time was 8 seconds in both eyes, and the Schirmer tear test was 7 to 10 mm in right and left eyes, respectively. Pupil sizes under mesopic conditions were 6.62 mm and 6.68 mm. The anterior chamber depth (ACD) (measured from the epithelium) in the right eye was 3.89 mm and in the left eye was 3.87 mm. The corneal thickness was 503 µm and 493 µm of the right and left eye, respectively. Corneal endothelial cell density was on average 2700 cells/mm2 for both eyes. Slitlamp biomicroscopy showed clear corneas and a normal flat iris configuration. Supplemental Figures 1 to 4 (available at http://links.lww.com/JRS/A818, http://links.lww.com/JRS/A819, http://links.lww.com/JRS/A820, and http://links.lww.com/JRS/A821) show the corneal topography and Belin-Ambrósio deviation (BAD) maps at presentation of the right eye and left eye, respectively. Would you consider this patient a candidate for corneal refractive surgery (eg, laser-assisted subepithelial keratectomy, laser in situ keratomileusis [LASIK], or small-incision lenticule extraction [SMILE] procedure)? Has your opinion changed given the recent opinion of the U.S. Food and Drug Administration (FDA) regarding LASIK?1 The patient herself is slightly favoring an implantation of a phakic intraocular lens (pIOL), as she prefers something reversible. Would you implant a pIOL, and which type of IOL, for this level of myopia? What is your diagnosis or are additional diagnostic methodologies needed to establish a diagnosis? What is your treatment advice for this patient? REFERENCES 1. U.S. Food and Drug Administration, HHS. Laser-assisted in situ keratomileusis (LASIK) lasers-patient labeling recommendations; draft guidance for industry and food and drug administration staff; availability. July 28, 2022, Federal Register; 87 FR 45334. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/laser-assisted-situ-keratomileusis-lasik-lasers-patient-labeling-recommendations Accessed January 25, 2023.

ESCRS Clinical Trends Survey 2016-2021: 6-year assessment of practice patterns among society delegates.

PURPOSE: To evaluate clinical opinions and practice patterns of delegates to the ESCRS. SETTING: Clinical Trends Surveys were administered during annual ESCRS congresses held between 2016 and 2021, and data collected online and in-person. DESIGN: Survey questions addressed several specialty areas, including cataract surgery, presbyopia-correcting and toric intraocular lenses (IOLs), ocular surface disease, and glaucoma. METHODS: Survey results were compared and analyzed across 6 years. 4 main profile questions were used for cross-tabulation analyses of questions pertaining to refractive surgery-practice location, years in practice, primary surgery setting, and average annual volume of cataract surgery. RESULTS: The highest number of responses (3019) was collected in 2019, with the lowest (569) received in 2020. The use of presbyopia-correcting and toric IOLs has increased significantly from 2016 to 2021, with certain respondent segments using them more frequently than others. Although optical biometry remains the preferred method for obtaining preoperative measurements, the use of tomography (Scheimpflug) has significantly increased. In 2021, 61.1% and 44.9% of respondents always performed preoperative checks of the ocular surface before refractive and cataract surgery, respectively. The number of respondents who perform glaucoma surgery has significantly decreased over the years, with an increasing number of delegates reporting having only a medical glaucoma practice. On average, 5.4% of patients with cataract and glaucoma underwent combined minimally invasive glaucoma surgery and cataract procedures in 2021. CONCLUSIONS: Evaluation of the Clinical Trends Survey data provides valuable insights into the shifting practice patterns and clinical opinions of ESCRS delegates.

Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients.

BACKGROUND: Cataract surgery in diabetics is more technically challenging due to a number of factors including poor intraoperative pupil dilation and a higher risk of vision threatening complications. This study evaluates the safety and efficacy of an intracameral combination of 2 mydriatics and 1 anesthetic (ICMA, Mydrane) for cataract surgery in patients with well-controlled type-2 diabetes. METHODS: Post-hoc subgroup analysis of a phase 3 randomized study, comparing ICMA to a conventional topical regimen. Data were collected from 68 centers in Europe and Algeria. Only well-controlled type-2 diabetics, free of pre-proliferative retinopathy, were included. The results for non-diabetics are also reported. The primary efficacy variable was successful capsulorhexis without additional mydriatic treatment. Postoperative safety included adverse events, endothelial cell density and vision. RESULTS: Among 591 randomized patients, 57 (9.6%) had controlled type 2 diabetes [24 (42.1%) in the ICMA Group and 33 (57.9%) in the Topical Group; intention-to-treat (ITT) set]. Among diabetics, capsulorhexis was successfully performed without additional mydriatics in 24 (96.0%; modified-ITT set) patients in the ICMA Group and 26 (89.7%) in the Topical Group. These proportions were similar in non-diabetics. No diabetic patient [1 (0.5%) non-diabetics] in the ICMA Group had a significant decrease in pupil size (≥3 mm) intraoperatively compared to 4 (16.0%; modified-ITT set) diabetics [16 (7.3%) non-diabetics] in the Topical group. Ocular AE among diabetics occurred in 2 (8.0%; Safety set) patients in the ICMA Group and 5 (16.7%) in the Topical Group. Endothelial cell density at 1 month postoperatively was similar between groups in diabetics (P = 0.627) and non-diabetics (P = 0.368). CONCLUSIONS: ICMA is effective and can be safely used in patients with well-controlled diabetes, with potential advantages compared to a topical regimen including reduced systemic risk, better corneal integrity and reduced risk of ocular complications. TRIAL REGISTRATION: The trial was registered at (reference # NCT02101359) on April 2, 2014.

Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program.

PURPOSE: The objective of this study was to report the evaluation of efficacy and safety of cyclosporine A cationic emulsion (CsA CE) 0.1% for the treatment of severe keratitis in adults with dry eye disease (DED) in a French early-access program. METHODS: Patients with DED and severe keratitis (corneal fluorescein staining [CFS] score of 3-5 on the Oxford scale and/or the presence of corneal lesions [filaments or ulcers]) were enrolled in a compassionate use program (Authorization for Temporary Use [ATU]) for once-daily CsA CE, which was approved by French health authorities prior to its registration. Efficacy and safety at 1, 3, 6, and 12-month follow-up visits were evaluated. RESULTS: The ATU cohort (n=1,212; mean age =60.5 years; 79.5% female; 98.1% with severe keratitis; 74.5% with corneal lesions) consisted of 601 CsA-naïve patients and 611 patients treated previously with other CsA formulations. The primary DED etiology was Sjögren's syndrome (48.7%). Clinical benefit could be discerned among 548 evaluable patients from months 1 to 12: keratitis improvement, 44.8% at month 1 and 42.1% at month 12; keratitis stabilization, 47.2% and 45.7%, respectively; symptom improvement, 47.2% and 48.6%; and symptom stabilization, 44.8% and 45.0%. Corneal clearing (CFS score =0) increased from 4.8% (month 1) to 11.4% (month 12). No unexpected safety concerns were identified; instillation site pain (10.2%) and eye irritation (7.8%) were the most common adverse events. CONCLUSION: The French ATU cohort provides supportive data on the clinical benefit of CsA CE in improving/stabilizing symptoms and corneal damage in DED patients with severe keratitis in real-world clinical practice.

Surgical, antiseptic, and antibiotic practice in cataract surgery: Results from the European Observatory in 2013.

PURPOSE: To report the results from the first iteration of the European Observatory of Cataract Surgery, which was initiated to track changes in surgical, antiseptic, and antibiotic practices in cataract surgery over the coming years. SETTING: Practicing European cataract surgeons (n = 479). DESIGN: Internet-based declarative questionnaire or telephone questionnaire. METHODS: The questionnaire comprised 37 questions divided into 8 categories as follows: screening, surgeon profile, surgical procedure used, product use before arrival at the operating room, techniques for mydriasis and anesthesia, product use during the surgery, product use after the patient leaves the operating room, and surgeon's attitude to guidelines. RESULTS: Cataract surgeons (n = 2700) were initially contacted, of whom 479 (17.7%) were included in the survey. The current baseline survey revealed considerable variation between countries in their implementation of infectious postoperative endophthalmitis (IPOE) prophylaxis. In some countries, adoption of intracameral cefuroxime is almost universal, whereas in others, the use of such prophylaxis is below one half. When intracameral cefuroxime is used, it is generally cefuroxime powder designed for parenteral use. A preparation specifically registered for intracameral use is now available, and this formulation is more commonly used in countries in which intracameral cefuroxime was most widely adopted. CONCLUSION: The baseline results from this ongoing survey suggest a considerable level of heterogeneity between European countries in IPOE prophylaxis. Further iterations of this survey will monitor whether a consensus begins to emerge. FINANCIAL DISCLOSURES: This work was supported by Laboratoires Théa, under the supervision of the expert group. Members of the expert group were remunerated by Laboratoires Théa. J.F. Stolz, MD, PhD, provided editorial assistance in manuscript preparation, for which he was remunerated by Laboratoires Théa. Anders Behndig, Rita Mencucci, and Jacek P. Szaflik report no relevant conflicts of interest.