| 1. |
- Behndig, Anders, et al.
(författare)
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Surgical, antiseptic, and antibiotic practice in cataract surgery : results from the European Observatory in 2013
- 2015
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Ingår i: Journal of cataract and refractive surgery. - : Elsevier. - 0886-3350 .- 1873-4502. ; 41:12, s. 2635-2643
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Tidskriftsartikel (refereegranskat)abstract
- 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 Thea, under the supervision of the expert group. Members of the expert group were remunerated by Laboratoires Thea J.F. Stolz, MD, PhD, provided editorial assistance in manuscript preparation, for which he was remunerated by Laboratoires Thea Anders Behndig, Rita Mencucci, and Jacek P. Szaflik report no relevant conflicts of interest.
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| 2. |
- Labetoulle, Marc, et al.
(författare)
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Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients
- 2020
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Ingår i: BMC Ophthalmology. - : BioMed Central (BMC). - 1471-2415. ; 20:1
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 3. |
- Nuijts, Rudy MMA, et al.
(författare)
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Safety of an intracameral fixed combination for mydriasis and intraocular anaesthesia during cataract surgery
- 2024
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Ingår i: Clinical Ophthalmology. - : Dove Medical Press. - 1177-5467 .- 1177-5483. ; 18, s. 1103-1115
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Tidskriftsartikel (refereegranskat)abstract
- 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/mmfor ICMA group versus 2241 ± 513 cells/mmfor 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.
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