| 1. |
- Behndig, Anders, et al.
(författare)
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Endophthalmitis prophylaxis in cataract surgery : Overview of current practice patterns in 9 European countries
- 2013
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Ingår i: Journal of cataract and refractive surgery. - : Ovid Technologies (Wolters Kluwer Health). - 0886-3350 .- 1873-4502. ; 39:9, s. 1421-1431
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Forskningsöversikt (refereegranskat)abstract
- Data on practice patterns for prophylaxis against infectious postoperative endophthalmitis (IPOE) during cataract surgery in 9 European countries were searched in national registers and reviews of published surveys. Summary reports assessed each nation's IPOE rates, nonantibiotic prophylactic routines, topical and intracameral antibiotic use, and coherence to the European Society of Cataract & Refractive Surgeons (ESCRS) 2007 guidelines. Although the reliability and completeness of available data vary between countries, the results show that IPOE rates differ significantly. Asepsis routines with povidone iodine and postoperative topical antibiotics are generally adopted. Use of preoperative and perioperative topical antibiotics as well as intracameral cefuroxime varies widely between and within countries. Five years after publication of the ESCRS guidelines, there is no consensus on intracameral cefuroxime use. Major obstacles include legal barriers or persisting controversy about the scientific rationale for systematic intracameral cefuroxime use in some countries and, until recently, lack of a commercially available preparation.
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| 2. |
- 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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| 3. |
- Guell, Jose, et al.
(författare)
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Systemic exposure to intracameral vs topical mydriatic agents : in cataract surgery.
- 2019
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Ingår i: Clinical Ophthalmology. - : Dovepress. - 1177-5467 .- 1177-5483. ; 13, s. 811-819
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The objective of this study was to compare systemic exposure to tropicamide/phenylephrine following intracameral or topical administration before cataract surgery.Patients and methods: Mydriatics exposure was calculated in patients randomized to intracameral fixed combination of mydriatics and anesthetic ([ICMA]: tropicamide 0.02%, phenylephrine 0.31%, and lidocaine 1%, N=271) or mydriatic eye drops ([EDs]: tropicamide 0.5% and phenylephrine 10%, N=283). Additional doses were permitted if required. Mydriatic plasma levels were determined by mass spectrometric HPLC in 15 patients per group before and after administration.Results: Most ICMA patients (73.6%) received a single dose (200 µL) representing an exposure to tropicamide of 0.04 mg and phenylephrine of 0.62 mg. None of these patients received additional mydriatics. In the control group (three administrations), the exposure was 0.45 (11.3-fold higher than ICMA) and 10.2 (16.5-fold higher) mg. When additional ED was used in this group (9.2% of patients), it was 37.5-fold higher for tropicamide (10 drops, 1.5 mg) and 54.8-fold higher for phenylephrine (10 drops, 34 mg) than the recommended ICMA dose. Tropicamide plasma levels were not detectable at any time point in ICMA patients while it was detectable in all ED patients at 12 and 30 minutes. Phenylephrine was detectable in 14.3% of ICMA patients compared to all ED patients at least at one time point. More ED patients experienced a meaningful increase in blood pressure and/or heart rate (11.2% vs 6.0% of ICMA patients; P=0.03).Conclusion: Systemic exposure to tropicamide/phenylephrine was lower and cardiovascular (CV) effects were less frequent with ICMA. This could be of particular significance in patients at CV risk.
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| 4. |
- 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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| 5. |
- Nuijts, Rudy M. M. A., et al.
(författare)
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Ocular tolerance in rabbits after intracameral administration of a fixed combination of tropicamide, phenylephrine, and lidovaine with and without rinsing
- 2017
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Ingår i: Journal of cataract and refractive surgery. - : ELSEVIER SCIENCE INC. - 0886-3350 .- 1873-4502. ; 43:5, s. 673-679
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To evaluate the safety and tolerability of a single intracameral administration of a combined mydriatic (tropicamide and phenylephrine) and anesthetic (lidocaine) formulation (Mydrane) with or without rinsing. Setting: Iris Pharma, La Gaude, France. Design: Experimental study. Methods: Sixty pigmented rabbits received 100 mu L or 200 mu L of the combination product or a placebo (sodium chloride 0.9%) by intracameral injection. For the combination product, separate groups were included with and without rinsing after administration. From day 1 day to day 7, assessments included general clinical and ocular observations, pupil diameter measurements, corneal assessments, confocal microscopy, and electroretinography (ERG). Necropsy examinations were performed at study completion at day 8. Results: Rapid mydriasis, stable 24 minutes after injection and returning to baseline levels by day 1, was induced in all groups that received the combination mydriatic and anesthetic drug. Rinsing had no effect. The combination product induced no adverse effects on the anterior or posterior segment of the eye (ie, no increased corneal thickness and endothelial cell loss, no abnormalities in ERG). Slitlamp examination showed slightly increased anterior chamber inflammation with rinsing in both the study group and placebo group. This observation was not confirmed by aqueous flare examination. No toxic effects of the products were found on histological evaluation. Conclusion: The combination mydriatic and anesthetic drug administered to pigmented rabbits as a single intracameral injection at volumes of 100 mu L and 200 mu L was well tolerated with no ocular adverse effects and no effect on the corneal endothelium.
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| 6. |
- 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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