| 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. |
- 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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| 4. |
- Behaegel, Josephine, et al.
(författare)
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Outcomes of Human Leukocyte Antigen-Matched Allogeneic Cultivated Limbal Epithelial Transplantation in Aniridia-Associated Keratopathy-A Single-Center Retrospective Analysis
- 2022
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Ingår i: Cornea. - : LIPPINCOTT WILLIAMS & WILKINS. - 0277-3740 .- 1536-4798. ; 41:1, s. 69-77
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To assess the efficacy and safety of human leukocyte antigen-matched allogeneic cultivated limbal epithelial stem cell grafts in the treatment of aniridia-associated keratopathy (AAK). Methods: Six eyes of 6 patients with severe AAK received an allogeneic stem cell graft between January 2010 and March 2017. Anatomical and functional results were assessed at 6 months, 1 year, 2 years, and the final follow-up visit available. Safety analysis was performed by considering all perioperative and postoperative adverse events and additional surgeries required during the follow-up period. Results: The mean follow-up was 53.6 months (range 24-104 months). In most patients (80%), there was an early improvement of the keratopathy postoperatively, which slowly regressed during longer follow-up. At the final follow-up, 4 of the eyes were graded as failure and 1 eye was graded as partial success. Grading the sixth eye was not possible because of an adverse event. None of the patients maintained a total anatomical success in the long-term. Only 1 patient maintained a modest improvement in best-corrected visual acuity from hand motion to counting fingers. Four serious adverse events were recorded in 2 patients. Conclusions: Severe AAK remains a challenging condition to manage. Transplantation of allogenic ex vivo cultivated limbal stem cells may provide a temporary improvement in ocular surface stability, but anatomical and functional results are poor in the long-term. The eyes are prone to adverse events, and any surgical treatment should take this into consideration.
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| 5. |
- Haagdorens, Michel, et al.
(författare)
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Plant Recombinant Human Collagen Type I Hydrogels for Corneal Regeneration
- 2022
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Ingår i: REGENERATIVE ENGINEERING AND TRANSLATIONAL MEDICINE. - : Springer Berlin/Heidelberg. - 2364-4133 .- 2364-4141. ; 8:2, s. 269-283
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Tidskriftsartikel (refereegranskat)abstract
- Purpose To determine feasibility of plant-derived recombinant human collagen type I (RHCI) for use in corneal regenerative implantsMethods RHCI was crosslinked with 1-ethyl-3-(3-dimethyl aminopropyl) carbodiimide (EDC) and N-hydroxysuccinimide (NHS) to form hydrogels. Application of shear force to liquid crystalline RHCI aligned the collagen fibrils. Both aligned and random hydrogels were evaluated for mechanical and optical properties, as well as in vitro biocompatibility. Further evaluation was performed in vivo by subcutaneous implantation in rats and corneal implantation in Gottingen minipigs.Results Spontaneous crosslinking of randomly aligned RHCI (rRHCI) formed robust, transparent hydrogels that were sufficient for implantation. Aligning the RHCI (aRHCI) resulted in thicker collagen fibrils forming an opaque hydrogel with insufficient transverse mechanical strength for surgical manipulation. rRHCI showed minimal inflammation when implanted subcutaneously in rats. The corneal implants in minipigs showed that rRHCI hydrogels promoted regeneration of corneal epithelium, stroma, and nerves; some myofibroblasts were seen in the regenerated neo-corneas.Conclusion Plant-derived RHCI was used to fabricate a hydrogel that is transparent, mechanically stable, and biocompatible when grafted as corneal implants in minipigs. Plant-derived collagen is determined to be a safe alternative to allografts, animal collagens, or yeast-derived recombinant human collagen for tissue engineering applications. The main advantage is that unlike donor corneas or yeast-produced collagen, the RHCI supply is potentially unlimited due to the high yields of this production method. Lay Summary A severe shortage of human-donor corneas for transplantation has led scientists to develop synthetic alternatives. Here, recombinant human collagen type I made of tobacco plants through genetic engineering was tested for use in making corneal implants. We made strong, transparent hydrogels that were tested by implanting subcutaneously in rats and in the corneas of minipigs. We showed that the plant collagen was biocompatible and was able to stably regenerate the corneas of minipigs comparable to yeast-produced recombinant collagen that we previously tested in clinical trials. The advantage of the plant collagen is that the supply is potentially limitless.
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| 6. |
- Labetoulle, Marc, et al.
(författare)
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Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery
- 2016
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Ingår i: British Journal of Ophthalmology. - : BMJ Publishing Group Ltd. - 0007-1161 .- 1468-2079. ; 100:7, s. 976-985
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND/AIMS: To compare the efficacy and safety of intracameral (IC) administration at the beginning of cataract surgery, of Mydrane, a standardised ophthalmic combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%, to a standard topical regimen.METHODS: In this international phase III, prospective, randomised study, the selected eye of 555 patients undergoing phacoemulsification with intraocular lens (IOL) implantation received 200 μL of Mydrane (Mydrane group) just after the first incision or a topical regimen of one drop each of tropicamide 0.5% and phenylephrine 10% repeated three times (reference group). The primary efficacy variable was achievement of capsulorhexis without additional mydriatics. The non-inferiority of Mydrane to the topical regimen was tested. The main outcome measures were pupil size, patient perception of ocular discomfort and safety.RESULTS: Capsulorhexis without additional mydriatics was performed in 98.9% of patients and 94.7% in the Mydrane and reference groups, respectively. Both groups achieved adequate mydriasis (>7 mm) during capsulorhexis, phacoemulsification and IOL insertion. IOL insertion was classified as 'routine' in a statistically greater number of eyes in the Mydrane group compared with the reference group (p=0.047). Patients in the Mydrane group reported statistically greater comfort than the reference group before IOL insertion (p=0.034). Safety data were similar between groups.CONCLUSIONS: Mydrane is an effective and safe alternative to standard eye drops for initiating and maintaining intraoperative mydriasis and analgesia. Patients who received IC Mydrane were significantly more comfortable before IOL insertion than the reference group. Surgeons found IOL insertion less technically challenging with IC Mydrane.TRIAL REGISTRATION NUMBER: NCT02101359; Results.
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| 7. |
- Lundström, Mats, et al.
(författare)
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Changing practice patterns in European cataract surgery as reflected in the European Registry of Quality Outcomes for Cataract and Refractive Surgery 2008 to 2017
- 2021
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Ingår i: Journal of cataract and refractive surgery. - : Wolters Kluwer. - 0886-3350 .- 1873-4502. ; 47:3, s. 373-378
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: To study practice patterns in European cataract surgery over a 10-year period.SETTING: European clinics affiliated to the European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO).DESIGN: Registry cohort study.METHODS: The EUREQUO contains preoperative, intraoperative, and postoperative parameters reported by surgeons in many European clinics. All data reported to the registry are anonymized. Preoperative parameters included age, sex, visual acuity, target refraction, ocular comorbidity, and surgical difficulties. Surgical data included anesthesia, surgical technique, intraocular lens optic biomaterial, and complications. Postoperative parameters included visual acuity, refraction, and short-term complications.RESULTS: During the study period (January 1, 2008, to December 31, 2017), a total of 2 714 108 cataract extractions were reported to the EUREQUO. Preoperative data changed over time, with decreases in mean age (74.5-73.0 years), proportion of women from 60.6% (100 373/165 628) to 57.2% (174 908/305 845), and proportion of coexisting eye diseases from 30.0% (49 638/165 650) to 27.0% (82 704/305 846) and with improvements in preoperative visual acuity (mean logarithm of minimum angle of resolution [logMAR] 0.46 to 0.37). The use of topical anesthesia increased over time from 28.1% (26 238/93 320) to 71.7% (130 525/182 083). Surgical complications showed a significant decrease from 2.5% (4107/165 650) to 1.2% (3573/305 846). The visual outcome improved over time (mean logMAR 0.08 to 0.05), as did the absolute median prediction error (0.38 diopter [D] to 0.28 D).CONCLUSIONS: Trends in European cataract surgery practice patterns from 2008 to 2017 have moved toward younger patients with better preoperative visual acuity, fewer surgical complications, and better predicted refractions and visual outcomes.
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| 8. |
- Lundström, Mats, et al.
(författare)
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Femtosecond laser–assisted cataract surgeries reported to the European Registry of Quality Outcomes for Cataract and Refractive Surgery : Baseline characteristics, surgical procedure, and outcomes
- 2017
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Ingår i: Journal of Cataract and Refractive Surgery. - : Ovid Technologies (Wolters Kluwer Health). - 0886-3350. ; 43:12, s. 1549-1556
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Tidskriftsartikel (refereegranskat)abstract
- Purpose To describe a large cohort of femtosecond laser–assisted cataract surgeries in terms of baseline characteristics and the related outcomes. Setting Eighteen cataract surgery clinics in 9 European countries and Australia. Design Prospective multicenter case series. Methods Data on consecutive eyes having femtosecond laser–assisted cataract surgery in the participating clinics were entered in the European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO). A trained registry manager in each clinic was responsible for valid reporting to the EUREQUO. Demographics, preoperative corrected distance visual acuity (CDVA), risk factors, type of surgery, type of intraocular lens, visual outcomes, refractive outcomes, and complications were reported. Results Complete data were available for 3379 cases. The mean age was 64.4 years ± 10.9 (SD) and 57.8% (95% confidence interval [CI], 56.1-59.5) of the patients were women. A surgical complication was reported in 2.9% of all cases (95% CI, 2.4-3.5). The mean postoperative CDVA was 0.04 ± 0.15. logarithm of the minimum angle of resolution. A biometry prediction error (spherical equivalent) was within ±0.5 diopter in 71.8% (95% CI, 70.3-73.3) of all surgeries. Postoperative complications were reported in 3.3% (95% CI, 2.7-4.0). Patients with good preoperative CDVA had the best visual and refractive outcomes; patients with poor preoperative visual acuity had poorer outcomes. Conclusions The visual and refractive outcomes of femtosecond laser–assisted cataract surgery were favorable compared with manual phacoemulsification. The outcomes were highly influenced by the preoperative visual acuity, but all preoperative CDVA groups had acceptable outcomes.
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| 9. |
- Lundström, Mats, et al.
(författare)
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Risk factors for dropped nucleus in cataract surgery as reflected by the European Registry of Quality Outcomes for Cataract and Refractive Surgery
- 2020
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Ingår i: Journal of Cataract and Refractive Surgery. - : Ovid Technologies (Wolters Kluwer Health). - 1873-4502 .- 0886-3350. ; 46:2, s. 287-292
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: To analyze the incidence, risk factors, and outcomes of cataract surgery complicated by a dropped nucleus. SETTING: Patients who have received cataract surgery in 18 European countries. DESIGN: Retrospective cross-sectional register-based study. METHODS: Data from the European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO) were analyzed. The EUREQUO contains preoperative baseline, intraoperative, and follow-up data. Intraoperative data include dropped nucleus as a complication. Baseline data such as demographic data, ocular comorbidities, surgical difficulties, and visual and refractive outcomes were tested for association with a dropped nucleus for the study period from January 1, 2008, to December 31, 2018. RESULTS: The number of reported patients with complete data was 1 715 348. Dropped nucleus was reported in 1221 eyes (0.071%) during the study period. White cataract, previous vitrectomy, poor preoperative visual acuity, small pupil, pseudoexfoliation, diabetic retinopathy, and male sex were significantly related to dropped nucleus. Year of surgery showed a significant trend of decreasing occurrence of dropped nucleus over time. Eyes with the complication of a dropped nucleus also had a poorer visual and refractive outcome compared with eyes with existing risk factors but no such complication. CONCLUSIONS: Many risk factors for dropped nucleus complications were identified. A significant trend of decreasing occurrence of dropped nucleus was found for the study period. The visual and refractive outcome was poorer for eyes with a dropped nucleus.
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| 10. |
- Lundström, Mats, et al.
(författare)
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Risk factors for refractive error after cataract surgery : Analysis of 282 811 cataract extractions reported to the European Registry of Quality Outcomes for cataract and refractive surgery
- 2018
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Ingår i: Journal of Cataract and Refractive Surgery. - : Ovid Technologies (Wolters Kluwer Health). - 0886-3350. ; 44:4, s. 447-452
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To analyze risk factors for refractive error after cataract surgery and provide a benchmark for refractive outcomes after standard cataract surgery. setting: One hundred cataract surgery clinics from 12 European countries. Design: Multicenter database study. Methods: Data on consecutive cataract extractions reported to the European Registry of Quality Outcomes for Cataract and Refractive Surgery between January 1, 2014 and December 31, 2015 were analyzed in terms of demographics, preoperative corrected distance visual acuity (CDVA), target refraction, coexisting eye diseases, surgical difficulties including previous ophthalmic interventions, type of surgery, intraocular lens (IOL), and surgical complications. For clinics committed to reporting follow-up data within 7 to 60 days after surgery, postoperative CDVA and refraction were analyzed. Results: Of the 548 392 cases analyzed, follow-up data were available for 282 811 cases. The absolute mean biometry prediction error in spherical equivalent was 0.42 diopters (D). A biometry prediction error within ±0.50 D was achieved for 205 675 eyes (72.7%). A biometry prediction error within ±1.0 D was achieved for 263 015 eyes (93.0%). Poor preoperative CDVA, target refraction, coexisting eye diseases, surgical difficulties including previous ophthalmic interventions, and surgical complications were in varying degrees related to a postoperative refractive error. Conclusions: Several risk factors (poor preoperative CDVA, ocular comorbidity, and previous eye surgery) were related to poor refractive outcomes after cataract extraction. When these risk factors are present, care should be taken with the preoperative examination and choice of IOL to avoid a refractive surprise. The average outcomes can be used as a refractive outcome benchmark.
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