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PURPOSE: The AT LARA 829MP is a next-generation extended depth of focus (EDOF) intraocular lens (IOL) providing continuous vision over a range of distances. The aim of this prospective multi-centre randomised trial was to compare two EDOF IOLs and one monofocal IOL. METHODS: Cataract patients between 50 and 80 years were randomised for bilateral implantation with either the AT LARA 829MP (EDOF), the TECNIS Symfony (EDOF) or the CT ASPHINA 409MP (monofocal). Follow-up was at 1 to 2 weeks, 1 month and 4 to 6 months. RESULTS: A total of 211 patients were randomised and included in the final analysis. Monocular depth of focus was significantly better for AT LARA 829MP eyes compared with that for TECNIS Symfony at all thresholds (p = 0.024, 0.001 and 0.006, for 0.1, 0.2 and 0.3 logMAR respectively) with no significant difference for binocular depth of focus. LARA eyes had significantly better monocular depth of focus at all levels compared with ASPHINA eyes (all p < 0.0001), while there was no significant difference between Symfony and ASPHINA eyes at 0.1 logMAR and 0.2 logMAR. Both EDOF IOLs were significantly better than the monofocal ASPHINA at all levels for binocular depth of focus (LARA: all p < 0.0001; Symfony: all p = 0.002). Distance visual acuity was similar for all IOLs at 6 months; intermediate and near visual acuity were significantly better for the EDOF IOLs than for the monofocal (p < 0.0001). Refraction improved in all groups relative to baseline. Contrast sensitivity was higher with the CT ASPHINA 409MP but both EDOF lenses had a better spectacle independence rate. At 6 months, all IOLs were well centred with no cases of tilt. No general safety issues were raised for any of the groups. CONCLUSION: The two EDOF intraocular lenses investigated provided good visual outcomes with comparable visual acuity at all distances. The AT LARA 829MP provided the widest monocular depth of focus at 0.1 and 0.2 logMAR, with a clear superiority compared with the monofocal IOL. TECNIS Symfony was superior to the monofocal control at 0.3 logMAR. Spectacle independence and patient satisfaction were comparable. TRIAL REGISTRATION: Trial registered on https://clinicaltrials.gov/ under the identification NCT03172351 (date of registration 1 June May 2017).
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Lentes Intraoculares , Facoemulsificação , Percepção de Profundidade , Humanos , Implante de Lente Intraocular , Estudos Prospectivos , Desenho de Prótese , Pseudofacia , Refração OcularRESUMO
In this work we have analyzed the expression levels of the main aquaporins (AQPs) expressed in human lens epithelial cells (HLECs) using 112 samples from patients treated with cataract surgery and 36 samples from individuals treated with refractive surgery, with transparent lenses as controls. Aquaporin-1 (AQP1) is the main AQP, representing 64.1% of total AQPs in HLECs, with aquaporin-5 (AQP5) representing 35.9% in controls. A similar proportion of each AQP in cataract was found. Although no differences were found at the mRNA level compared to controls, a significant 1.65-fold increase (p=0.001) in AQP1protein expression was observed in HLECs from cataract patients, with the highest differences being found for nuclear cataracts (2.1-fold increase; p<0.001). A similar trend was found for AQP5 (1.47-fold increase), although the difference was not significant (p=0.161). Moreover we have shown increased membrane AQP5 protein expression in HLECs of patients with cataracts. No association of AQP1 or AQP5 expression levels with age or sex was observed in either group. Our results suggest regulation of AQP1 and AQP5 at the post-translational level and support previous observations on the implication of AQP1 and 5 in maintenance of lens transparency in animal models. Our results likely reflect a compensatory response of the crystalline lens to delay cataract formation by increasing the water removal rate.
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Aquaporina 1/biossíntese , Aquaporina 5/biossíntese , Catarata/metabolismo , Células Epiteliais/metabolismo , Regulação da Expressão Gênica , Cápsula do Cristalino/metabolismo , Adulto , Idoso , Idoso de 80 Anos ou mais , Catarata/patologia , Células Epiteliais/patologia , Feminino , Humanos , Cápsula do Cristalino/patologia , Masculino , Pessoa de Meia-Idade , RNA Mensageiro/metabolismoRESUMO
PURPOSE: To determine normative corneal densitometry values in relation to age, sex, refractive error, corneal thickness, and keratometry, measured using the Oculus Pentacam system. METHODS: Three hundred and thirty-eight healthy subjects (185 men; 153 women) with no corneal disease underwent an exhaustive ocular examination. Corneal densitometry was expressed in standardized grayscale units (GSU). RESULTS: The mean corneal densitometry over the total area was 16.46 ± 1.85 GSU. The Pearson correlation coefficient for total densitometry was r = 0.542 (p < 0.001). Statistically significant differences were found between men and women for the total area (p = 0.006), with readings of 16.22 ± 1.54 GSU and 16.60 ± 1.83 GSU, respectively. When the cornea was divided into layers of different depths, a significant correlation was found for all layers and age: r = 0.447 (p < 0.001), r = 0.563 (p < 0.001), and r = 0.520 (p < 0.001) for the anterior, central, and posterior layers, respectively. However, when the cornea was divided into concentric annuli starting from the center of the cornea, densitometry was strongly correlated only with age in the 6-10-mm annulus (p < 0.001). Neither mean keratometry nor spherical equivalent was correlated with corneal densitometry in any zone of the cornea (p > 0.05). CONCLUSIONS: This is the first report of normative corneal densitometry values in relation to keratometry, corneal thickness, and spherical equivalent measured with the latest Oculus Pentacam software. Corneal densitometry increases with age, but corneal keratometry and refractive parameters do not affect light scattering in the human cornea.
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Envelhecimento/fisiologia , Córnea/anatomia & histologia , Densitometria/métodos , Refração Ocular/fisiologia , Adulto , Paquimetria Corneana , Topografia da Córnea , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
PURPOSE: To describe and compare corneal densitometry, subjective refraction, visual acuity, and corneal higher order aberrations (HOA) after corneal refractive surgery using either alcohol-assisted photorefractive keratectomy (aaPRK) or single-step transepithelial PRK (tPRK). METHODS: We conducted a retrospective and observational study. We analyzed 120 right eyes from 120 healthy consecutive myopic patients who underwent aaPRK or tPRK to correct myopia of up to 6 diopters and astigmatism of up to 2 diopters. The WaveLight EX500 excimer laser (Alcon Laboratories, Inc.) was used in all cases. Visual acuity, subjective refraction, and Pentacam AXL® measurements were performed at the preoperative visit and at 6-months follow-up visit. Pentacam AXL® software was used to assess corneal optical density in various annuli for different corneal depths and anterior corneal HOA (6â mm area of analysis). RESULTS: Preoperative spherical equivalent values were similar between groups preoperatively (-3.07 ± 1.52 and -3.38 ± 1.46 in the aaPRK and tPRK groups, respectively). There were no statistically significant differences in visual acuity and postoperative refraction between groups. Postoperative corneal densitometry did not show statistically significant differences in any of the areas studied and both surgical procedures obtained similar results. However, analysis of HOA showed statistically significant differences between the techniques (1.42 ± 0.39 and 1.80 ± 0.62 for the aaPRK and tPRK groups, respectively; p = 0.000). CONCLUSIONS: Both aaPRK and single-step tPRK gave comparable visual, refractive, and corneal density outcomes. Some differences were observed in HOA but were not clinically relevant.
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PURPOSE: To describe the intraocular rotational stability and refractive results of the toric AT TORBI 709 M (former AT.Comfort 464 TLC) intraocular lens (IOL) (Carl Zeiss Meditec AG, Jena, Germany). METHODS: Forty-eight eyes of 32 consecutive patients with cataract and greater than 1 diopter of corneal astigmatism were included. Implantation of the toric IOL was performed after phacoemulsification. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), residual refractive sphere, residual keratometric and refractive cylinders, and toric IOL axis were measured before and 1, 3, and 6 months after surgery. RESULTS: Mean logMAR UDVA and CDVA improved significantly after surgery (P < .05). UDVA was 20/40 or better in 88.1% of eyes and 20/25 or better in 61.9%. CDVA was 20/40 or better in 100% of eyes and 20/25 or better in 90.2%. Mean refractive cylinder decreased significantly from -2.23 ± 1.72 before to -0.43 ± 0.53 after surgery (P < .05). Vector analysis of attempted versus achieved correction showed 100% of eyes within ± 1.00 D and 95.2% within ± 0.50 D for J and 100% of eyes were within ± 1.00 D and 95.2% within ± 0.50 D for J. Mean toric IOL axis rotation was 4.42 ± 4.31 degrees (range: 0 to 16 degrees) and 86% of the lenses rotated less than 10 degrees. CONCLUSIONS: The AT TORBI 709 M IOL has proved to be a predictable and effective device with good rotational stability for the correction of preexisting astigmatism during cataract surgery.
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Astigmatismo/cirurgia , Implante de Lente Intraocular , Lentes Intraoculares , Facoemulsificação , Adulto , Idoso , Idoso de 80 Anos ou mais , Astigmatismo/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Pseudofacia/fisiopatologia , Refração Ocular/fisiologia , Resultado do Tratamento , Acuidade Visual/fisiologiaRESUMO
BACKGROUND: Given differences in the pathogenic mechanisms underlying primary retinal detachment (RD) as a function of the status of the lens, the objective was to explore differences between pseudophakic and phakic patients with primary RD. METHODS: A retrospective study including 821 patients who underwent surgery for RD [491 cases of phakic and 330 of pseudophakic RD (pRD and psRD, respectively)] in our hospital between 2012 and 2020. RESULTS: The mean age was 58.24 ± 12.76 years in the pRD group and 66.87 ± 11.18 years in the psRD group (p = 0.001). There were more men in both groups (70% and 64.23% of pseudophakic and phakic patients, respectively; p = 0.07). The most common location for the RD was superior in both groups (43.94% and 51.93% of pseudophakic and phakic patients, respectively), rates of inferior and total RD were somewhat higher in the psRD group (31.82% and 13.33% in pseudophakic vs 25.25% and 11.0% in phakic patients, p = 0.001). In pseudophakic and phakic patients respectively, macular involvement in 69.09% and 62.73% of cases (p = 0.067). Proliferative vitreoretinopathy was significantly more common in the psRD group (7.88% vs 3.6% in phakic patients, p = 0.01).The rate of final anatomic reattachment differed markedly between groups, with a higher rate in phakic (94.03%) than pseudophakic (87.27%) patients (p = 0.001). CONCLUSIONS: The specific pathogenic mechanism involved in psRD seems to be responsible for worse evolution characteristics which are associated with poorer final anatomic and functional outcomes in pseudophakic patients.
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PURPOSE: To assess astigmatic reduction and rotational stability of Rayner T-flex toric intraocular lenses (IOL) (573T and 623T; Rayner Intraocular Lenses Ltd) in a series of cataract surgery patients with corneal astigmatism >1.50 diopters (D). METHODS: This prospective, observational study included 27 eyes from 22 consecutive patients with pre-operative regular corneal astigmatism ≥1.50 D in which Rayner T-flex toric IOL implantation was performed after phacoemulsification. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), residual refractive sphere, residual keratometric and refractive cylinder, and deviation from attempted toric IOL axis were measured. RESULTS: Mean UDVA 3 months after surgery was 0.1042±0.1290 with 20/40 or better in 96% of eyes and 20/25 or better in 52% of eyes. Mean refractive postoperative sphere was 0.25±0.37 D and mean refractive postoperative cylinder was 0.52±0.63 D. Vector analysis of attempted versus achieved visual correction showed that 100% of eyes were within ±1.00 D and 87% of eyes were within ±0.50 D. Mean change in keratometric astigmatism was 0.54±1.33 for J(0) and -0.24±1.17 for J(45) (P>.05). Twenty-five (92.6%) eyes had IOL rotation <10°. CONCLUSIONS: Rayner T-flex toric IOL implantation is an effective and reliable option to correct preexisting astigmatism in cataract surgery.
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Migração do Implante de Lente Intraocular , Astigmatismo/terapia , Implante de Lente Intraocular , Facoemulsificação , Refração Ocular/fisiologia , Rotação , Acuidade Visual/fisiologia , Idoso , Idoso de 80 Anos ou mais , Astigmatismo/complicações , Astigmatismo/fisiopatologia , Catarata/complicações , Feminino , Humanos , Lentes Intraoculares , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
PURPOSE: To evaluate intraoperative intraocular lens (IOL) delivery time and total surgical case time using the UltraSert preloaded delivery system (System U) during routine cataract surgeries and to compare with the manually loaded Monarch delivery system (System M). Physician satisfaction with System U was also assessed. PATIENTS AND METHODS: In this prospective observational study, subjects ≥18 years old underwent cataract surgery in 1 eye and received the AcrySof IQ IOL via the manually loaded System M (n=103) or the AcrySof IQ IOL model AU00T0 via the preloaded System U (n=93). Procedures were digitally recorded by an external camera or by a camera within the operating microscope. Device preparation, IOL delivery, and IOL positioning times were evaluated by 2 independent graders. Pearson χ2 test or Fisher exact test was used for categorical variables and Student's t-test or Wilcoxon rank-sum test for continuous variables (all tests were 2-sided and performed at a 5% α-level). Physician satisfaction levels were assessed using questionnaires. RESULTS: Lens delivery time was similar for System U and System M (12.9±5.1 and 12.2±6.3 s; P=0.412). Mean device preparation time for System U was significantly shorter compared with System M (30.3±6.6 versus 59.8±31.0 s; P<0.05). This resulted in a significantly shorter total intraoperative time (device preparation + lens delivery) with System U versus System M (43.0±8.6 versus 72.0±32.5 s; P<0.05). Total surgical case time (device preparation + lens delivery + lens positioning and unfolding) was shorter for System U versus System M (56.6±12.6 versus 89.6±34.6 s; P<0.05). Physicians reported greater satisfaction levels with System U compared with other devices. CONCLUSION: Use of the preloaded delivery system (System U) resulted in faster device preparation and reduced total surgical time compared with the manually loaded system (System M). System U was intuitive to use, and physicians preferred it to other devices.
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PURPOSE: To evaluate the in vivo biocompatibility of photopolymerized poly(ethylene glycol) diacrylate (PEGDA) intrastromal inlays in rabbit corneas. METHODS: Sixty-three eyes of 42 New Zealand rabbits were included. Manual intrastromal pockets were dissected in 42 eyes. PEGDA inlays were obtained using a specifically designed photomask and were inserted in the intrastromal pocket of 21 eyes (inlay group); the remaining 21 right eyes did not receive any implant (pocket-only group). Twenty-one eyes with no intervention were used as controls. In vivo confocal microscopy (IVCM) was performed at every visit. After 2 months, rabbits were sacrificed and corneas removed for histological analysis. RESULTS: Corneas remained clear in all but two animals, and five cases of corneal neovascularization were seen (P = 0.2). Inlays remained stable without evidence of lateral or anterior migration, and no other complications were observed. No changes in anterior and posterior keratocyte density (P = 0.3 and P = 0.1, respectively) or endothelial cell density (P = 0.23) were observed between groups during the study time by IVCM. On pathology samples, thinning of the epithelium over the inlay area and epithelial hyperplasia over the edges were observed. A polygonal empty space with no evidence of PEGDA hydrogel within the midstroma was seen in the inlay group. Keratocytes were normal in shape and number in the vicinity of the PEGDA implant area. CONCLUSIONS: Photopolymerized PEGDA intrastromal inlays have shown relatively good safety and stability in rabbit corneas. Inlays were biostable in the corneal environment and remained transparent during follow up. TRANSLATIONAL RELEVANCE: The investigated PEGDA is promising for the development of biocompatible intrastromal implants.
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PURPOSE: To evaluate the results of AcrySof toric intraocular lens (IOL) (Alcon) implantation to correct preexisting astigmatism in patients having cataract surgery. SETTING: Ophthalmology Service, Donostia Hospital, San Sebastián, Spain. METHODS: This prospective observational study included 30 eyes of 15 consecutive patients with more than 1.00 diopter (D) of preexisting corneal astigmatism having cataract surgery. Bilateral implantation of the AcrySof toric IOL was performed after phacoemulsification. The uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), residual refractive sphere, residual keratometric and refractive cylinders, and toric IOL axis were measured. RESULTS: The UCVA was 20/40 or better in 93.3% of eyes and 20/25 or better in 66.6%. All eyes achieved 20/25 or better BCVA. The mean refractive cylinder decreased significantly after surgery from -2.34 D +/- 1.28 (SD) to -0.72 +/- 0.43 D (P<.01). Vector analysis of attempted versus achieved correction showed that 100% of eyes were within +/-1.00 D and 80% and 93.9% were within +/-0.50 D for J(0) and J(45), respectively. The mean toric IOL axis rotation was 3.63 +/- 3.11 degrees, with rotation less than 10 degrees in 96.7% of eyes. CONCLUSIONS: The results indicate that phacoemulsification and posterior chamber AcrySof toric IOL implantation is an effective option to correct preexisting astigmatism in cataract surgery. The AcrySof toric IOL showed good rotational stability.
Assuntos
Astigmatismo/cirurgia , Implante de Lente Intraocular , Lentes Intraoculares , Facoemulsificação , Resinas Acrílicas , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Refração Ocular/fisiologia , Acuidade Visual/fisiologiaRESUMO
PURPOSE: To compare corneal incision size and intraocular lens (IOL) performance/behavior following implantation with the following delivery systems: system U (UltraSert®), system S (Hoya iSert® 250/251), system T (Tecnis® iTec), and a manual system (Monarch® III Delivery System). SETTING: Six study sites (four in Spain and two in France). DESIGN: Prospective, multicenter, parallel-group, randomized, subject-masked, postmarket clinical study. MATERIALS AND METHODS: Subjects were enrolled based on predetermined inclusion/exclusion criteria. The effectiveness end points compared corneal incision size and enlargement after IOL implantation (day of surgery) among all delivery systems. Exploratory end points included mean enlargement of corneal incision size, rates of trapped trailing haptic, IOL adherence to the plunger tip, nozzle tip splitting, and mean surgically induced astigmatism (SIA) at postoperative visit. RESULTS: One hundred and nine subjects participated in the study. The mean corneal incision size following IOL implantation was 2.35±0.019 mm for system U, 2.47±0.016 mm for system T, 2.54±0.019 mm for system S, and 2.49±0.011 mm for the manual system. There were five instances of trapped trailing haptic (all system T group, N=26), one instance of IOL adherence to the plunger tip (system S group, N=26), and six instances of nozzle tip splitting (all system S group, N=26). System U had the least SIA (postoperative Day 1) (SIA Centroid = 0.10 diopters [axis: 83.06°]). CONCLUSION: Preloaded delivery system U supported the completion of surgery with the smallest incision size, the least SIA (postoperative Day 1), and no trapped trailing haptics or nozzle tip splitting compared to two other preloaded systems and one manual system.
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AIM: To compare intraoperative phacoemulsification parameters and its effect on the corneal endothelium of eyes undergoing femtosecond laser-assisted cataract surgery (FLACS) versus conventional phacoemulsification (CP) cataract surgery. METHODS: Two hundred eyes from one hundred patients were included in a prospective, non-blinded, randomized, controlled, intraindividual clinical study. One hundred eyes underwent FLACS while their one hundred fellow eyes underwent CP. All surgeries were performed using the Victus® femtosecond laser platform and Infinity® Vision System phacoemulsification machine. Primary outcome measure was endothelial cell density 6mo after surgery. Secondary outcome measures included central corneal thickness (CCT), average cell area, standard deviation, coefficient of variation and hexagonality before surgery and 6mo after surgery and endothelial cell density loss during this period were also evaluated. Intraoperative efficiency parameters [cumulative dissipated energy (CDE), total intraocular surgery time, total ultrasound time, total phacoemulsification time, total torsional energy time, total aspiration time, ultrasound energy, torsional amplitude and fluid required during surgery] were also collated. RESULTS: Data from these patients was not considered for analysis. Data from 92 patients were analysed. Postoperative endothelial cell density (cells/mm2) between groups (2211.88±392.49 CP; 2246.31±403.48 FLACS) was not statistically significant (P=0.869). Total ultrasound time, torsional energy time, CDE and fluid requirements were significantly lower the FLACS group (P<0.05). Other parameters did not show statistically significant difference between FLACS and CP. CONCLUSION: FLACS displays significant improvements in phacoemulsification parameters in comparison to CP. There are no significant differences in corneal endothelium measures between FLACS and CP.
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AIM: To analyze and compare five different variables over one year follow-up (1wk, 1, 3, 6 and 12mo): anterior capsule (AC), and posterior capsule (PC) area densitometry values, AC and PC linear densitometry values, and AC opening area reduction ratio after femtosecond laser-assisted cataract surgery. METHODS: This was a prospective comparative study. Seventy-one patients underwent femtosecond laser-assisted cataract surgery on single eye between June 2014 and December 2015. A 5.0 mm diameter laser assisted anterior capsulotomy was performed on all eyes. In every post-surgery evaluation, AC opacificaction (ACO) and PC opacification (PCO) density levels were provided by Oculus Pentacam®HR using area and linear densitometry methods. Digital images were captured with a slit-lamp Topcon photographic camera and IMAGEnet® 5 software. The AC opening area on the digital images was measured using the Sketchandcalc area calculator and converted to reduction ratio levels. RESULTS: Using Pearson correlation coefficient (PCC), we found no correlation (r=-0.091, P=0.46) in the twelfth month assessment between the evolution of ACO area densitometry values and PCO area densitometry values considered as independent variables. We found no correlation, using PCC (r=-0.096, P=0.43) between the evolution of ACO linear densitometry values and PCO linear densitometry values, in the twelfth month visit, working both as independent variables. AC linear densitometry levels and AC area densitometry levels continued to grow strongly from sixth to twelfth months. Analysis of the values of AC opening area reduction ratio (1wk, 1, 3, 6, 12mo) revealed statistically significant differences between the values of successive examinations but the magnitude of the change decreased. In the final period of monitoring between six and twelve months the magnitude of change was low. CONCLUSION: Our results show strong increases of Scheimpflug ACO densitometry values from the sixth to the twelfth month while capsulorhexis area reduction ratio levels displayed a considerable decrease. We found no correlation between ACO area and linear densitometry values and PCO area and linear densitometry values, in the twelfth month examination, working as independent variables.
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PURPOSE: To compare the clinical classification of anterior capsule opacification (ACO) after femtosecond laser-assisted cataract surgery with the mean density values of ACO provided by rotating Scheimpflug device (Pentacam HR) densitometry software and to determine which densitometry method correlates best with the clinical classification. SETTING: Ophthalmology Department, Donostia University Hospital, Donostia-San Sebastian, Spain. DESIGN: Prospective comparative study. METHODS: Femtosecond laser-assisted cataract surgery was performed using the Victus platform between June 2014 and March 2015. Inclusion criteria were age between 55 years and 85 years, a pupil diameter larger than 6.0 mm in full mydriasis, no intraoperative complications, a curvilinear anterior capsulotomy without tears, and an intraocular lens in the correct intracapsular position at the end surgery. The ACO was measured by a clinical classification ranging from 0 to 4. In addition, ACO density was measured with the Scheimpflug device using 3 densitometry methods (area, linear, and peak). RESULTS: The study comprised 32 eyes of 32 patients. Area and linear densitometry values provided by the Scheimpflug device had a strong correlation with the values obtained by clinical classification, whereas peak densitometry values had a very weak correlation at 6 months (area densitometry: Spearman ρ = 0.78; P < .0005; linear densitometry: ρ = 0.73; P < .0005; peak densitometry ρ = 0.21; P = .2). CONCLUSION: The Scheimpflug device provided an objective measurement of ACO after cataract surgery. FINANCIAL DISCLOSURE: None of the authors has a financial or proprietary interest in any material or method mentioned.
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Opacificação da Cápsula , Extração de Catarata , Densitometria , Idoso , Idoso de 80 Anos ou mais , Catarata , Feminino , Humanos , Implante de Lente Intraocular , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Software , EspanhaRESUMO
PURPOSE: To assess the clinical visual outcomes of bilateral implantation of Restor +2.5 diopter (D) multifocal intraocular lenses (IOLs) and contralateral implantation of a Restor +2.5 D multifocal IOL in the dominant eye and Restor +3.0 D multifocal IOL in the fellow eye. SETTING: Multicenter study at 8 investigative sites. DESIGN: Prospective randomized parallel-group patient-masked 2-arm study. METHODS: This study comprised adults requiring bilateral cataract extraction followed by multifocal IOL implantation. The primary endpoint was corrected intermediate visual acuity (CIVA) at 60 cm, and the secondary endpoint was corrected near visual acuity (CNVA) at 40 cm. Both endpoints were measured 3 months after implantation with a noninferiority margin of Δ = 0.1 logMAR. RESULTS: In total, 103 patients completed the study (53 bilateral, 50 contralateral). At 3 months, the mean CIVA at 60 cm was 0.13 logMAR and 0.10 logMAR in the bilateral group and contralateral group, respectively (difference 0.04 logMAR), achieving noninferiority. Noninferiority was not attained for CNVA at 40 cm; mean values at 3 months for bilateral and contralateral implantation were 0.26 logMAR and 0.11 logMAR, respectively (difference 0.15 logMAR). Binocular defocus curves suggested similar performance in distance vision between the 2 groups. Treatment-emergent ocular adverse events rates were similar between the groups. CONCLUSION: Bilateral implantation of the +2.5 D multifocal IOL resulted in similar distance as contralateral implantation of the +2.5 D multifocal IOL and +3.0 D multifocal IOL for intermediate vision (60 cm), while noninferiority was not achieved for near distances (40 cm).
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Implante de Lente Intraocular , Miopia/cirurgia , Facoemulsificação , Adulto , Idoso , Idoso de 80 Anos ou mais , Sensibilidades de Contraste/fisiologia , Método Duplo-Cego , Feminino , Humanos , Lentes Intraoculares , Masculino , Pessoa de Meia-Idade , Miopia/fisiopatologia , Satisfação do Paciente , Estudos Prospectivos , Desenho de Prótese , Pseudofacia/fisiopatologia , Inquéritos e Questionários , Acuidade Visual/fisiologiaRESUMO
PURPOSE: To evaluate clinical outcomes after the implantation of a diffractive trifocal intraocular lens (IOL). SETTING: Nine European ophthalmology centers. DESIGN: Prospective noncomparative interventional multicenter study. METHODS: The trifocal diffractive AT LISA tri 839MP IOL was implanted in eyes with bilateral cataract. Monocular and binocular visual performance was assessed as was the level of perceived photic phenomena, patient satisfaction, and spectacle dependence 1 month and 3 months postoperatively. RESULTS: The IOL was implanted in 208 eyes of 104 patients. The mean binocular uncorrected distance visual acuity improved from 0.44 logMAR ± 0.30 (SD) to 0.02 ± 0.10 logMAR and 0.03 ± 0.09 logMAR at 1 month and 3 months, respectively (P < .01). The mean binocular uncorrected intermediate visual acuity (80 cm) improved from 0.51 ± 0.30 logMAR to 0.09 ± 0.13 logMAR and 0.10 ± 0.15 logMAR at 1 month and 3 months, respectively (P < .01). The mean binocular uncorrected near visual acuity improved from 0.67 ± 0.31 logMAR to 0.16 ± 0.14 logMAR and 0.15 ± 0.14 logMAR, respectively (P < .01). Among the more frequently perceived photic phenomena were halos; however, approximately 75% of patients were not bothered by them. More than 90% of patients were satisfied with the outcome. Spectacle independence at all distances was higher than 90%. CONCLUSION: This IOL provided excellent visual outcomes and high refractive predictability at all distances, including intermediate, leading to high levels of patient satisfaction and spectacle independence. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.
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Implante de Lente Intraocular , Satisfação do Paciente/estatística & dados numéricos , Facoemulsificação , Acuidade Visual/fisiologia , Idoso , Idoso de 80 Anos ou mais , Catarata/fisiopatologia , Sensibilidades de Contraste , Feminino , Humanos , Lentes Intraoculares , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Pseudofacia/fisiopatologia , Visão Binocular/fisiologiaRESUMO
PURPOSE: To compare the cost-effectiveness of different intra-ocular lens (IOL) materials (Hydrophobic acrylic, Polymethylmethacrylate (PMMA), Hydrophilic acrylic and Silicone) implanted after cataract surgery with reference to Nd:YAG laser capsulotomy and Nd:YAG-related complications in four European countries (France, Italy, Germany and Spain). SETTING: A retrospective review of 1,525 patients (eyes), aged 50 to 80 years, operated with phacoemulsification for cataract in 1996 or 1997 in 16 surgical centres (4 per country). METHODS: The study was conducted using a cost-effectiveness approach. Medical charts were reviewed to collect retrospective information during the 3-year period following cataract surgery in order to identify patients who underwent Nd:YAG laser capsulotomy post-operatively. Clinical data were combined with unit costs assessed by experts for Nd:YAG laser capsulotomy and their complications. A cost-effectiveness ratio (cost per patient without Nd:YAG laser capsulotomy intervention) was estimated in relation to each IOL material used in each of the four European countries. RESULTS: Hydrophobic acrylic, specifically Acrysof, was the most cost-effective IOL material in all the countries except Germany where it was second. PMMA had the best ratio in Germany, was second in Spain and only third in Italy and France. Silicone was second in France and ranked third in the other countries, while hydrophilic acrylic had the worst ratio overall in all countries. CONCLUSIONS: Cost-effectiveness ratios of hydrophobic acrylic (Acrysof) were better than those of other types of IOL materials used in most of the countries. Sensitivity analyses were performed to vary the base case analysis to demonstrate the economic importance of the assumptions. In all cases, hydrophobic acrylic IOL material was shown to be a highly cost-effective option.
Assuntos
Resinas Acrílicas/economia , Extração de Catarata/economia , Lentes Intraoculares/economia , Polimetil Metacrilato/economia , Elastômeros de Silicone/economia , Idoso , Catarata/terapia , Análise Custo-Benefício , Europa (Continente) , Feminino , Humanos , Terapia a Laser , Cápsula do Cristalino/cirurgia , Implante de Lente Intraocular/economia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Estudos RetrospectivosRESUMO
PURPOSE: To analyze objective optical quality changes after pterygium surgical excision using the Optical Quality Analysis System. METHODS: Forty eyes with primary pterygium suitable for surgical treatment were included. Uncorrected distance visual acuity, corrected distance visual acuity (CDVA), objective scattering index (OSI), and cutoff frequency of the modulation transfer function (MTFcutoff) were recorded preoperatively and at 1 and 6 months postoperatively. Slit-lamp measurement of pterygium size was performed to classify them: small in group 1 and medium size/large in group 2. A paired comparative study of all data that included preoperative with 1-month results (comparison A), preoperative with 6-month results (comparison B), and 1 month with sixth-month results (comparison C) was performed. RESULTS: In global analysis, uncorrected distance visual acuity and OSI showed significant changes in comparison A, all parameters in comparison B, and CDVA, OSI, and MTFcutoff in comparison C. When subdividing into groups, in group 1, there was significant improvement between preoperative uncorrected distance visual acuity value and those at 1 and 6 months. Significant improvement in CDVA, OSI, and MTFcutoff values were observed in comparisons B and C. In group 2, MTFcutoff values significantly improved in comparisons B and C. The comparison of mean values between each group at each evaluation showed a lower value for MTFcutoff at 1 month after surgery. A comparative analysis of the evolution between both groups based on pterygium size did not reveal significant differences. CONCLUSIONS: Pterygium can undermine visual quality, and its excision provides significant improvement even at 6 months after surgery. Optical Quality Analysis System proved useful for postoperative outcomes.
Assuntos
Procedimentos Cirúrgicos Oftalmológicos , Pterígio/fisiopatologia , Pterígio/cirurgia , Testes Visuais/instrumentação , Acuidade Visual/fisiologia , Feminino , Humanos , Luz , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Espalhamento de RadiaçãoRESUMO
PURPOSE: To determine astigmatic changes by vector analysis and postoperative refractive and visual outcomes after implantation of the monofocal aspheric bitoric AT Torbi 709M toric intraocular lens (IOL). SETTING: Three centers in Salzburg, Austria, and Alicante and San Sebastián, Spain. DESIGN: Prospective interventional case series. METHODS: Preoperative and postoperative visual acuity, subjective and objective refractions, and corneal radii using a topographer were examined in all patients. All patients had postoperative examinations within the first week and at 6 to 12 weeks. Astigmatic changes were evaluated using the Alpins vector method based on 3 fundamental vectors as follows: target induced astigmatism (TIA), surgically induced astigmatism (SIA), and difference vector. The various relationships between these 3 vectors were calculated, providing an extensive description of the astigmatic correction achieved. RESULTS: Eighty-eight eyes (71 patients) were included. Postoperatively, refractive cylinder was reduced significantly (P < .001), concurrent with visual improvement. The mean magnitude of the SIA vector (2.54 diopters [D] ± 1.21 [SD]) was slightly higher than the mean magnitude of the TIA vector (2.37 ± 1.15 D) at the last follow-up. The mean difference vector was 0.46 ± 0.46 D, the mean magnitude of error was 0.16 ± 0.46 D, and the mean correction index was 1.09 ± 0.21, all indicating minimal overcorrection at 3 months that remained stable during the follow-up. CONCLUSION: Implantation of the toric IOL was safe and effective for the treatment of eyes with cataract in combination with preexisting regular corneal astigmatism over a short-term follow-up. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.
Assuntos
Astigmatismo/fisiopatologia , Astigmatismo/cirurgia , Implante de Lente Intraocular , Facoemulsificação , Adulto , Idoso , Idoso de 80 Anos ou mais , Catarata/fisiopatologia , Topografia da Córnea , Feminino , Humanos , Lentes Intraoculares , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Pseudofacia/fisiopatologia , Refração Ocular/fisiologia , Acuidade Visual/fisiologiaRESUMO
PURPOSE: The aim of this study was to compare the incidence of Nd : YAG laser capsulotomy after cataract surgery according to the type of intra-ocular lens material (PMMA, silicone, hydrophilic acrylic, hydrophobic acrylic) implanted in four European countries (France, Italy, Germany, Spain). DESIGN: A retrospective record review. PARTICIPANTS: A review of 1525 patients (first operated eye), aged 50 to 80 years, operated on for cataract in 1996 or 1997 in 16 surgical centers (4 per country). METHODS: The study employed a retrospective cohort design. Charts were reviewed to collect information during at least a three-year period following cataract surgery to identify patients who underwent Nd : YAG laser capsulotomy postoperatively. MAIN OUTCOME MEASURES: Data on the type of intra-ocular lens implanted was extracted from the patient notes, as was the date and outcome of the Nd : YAG laser intervention. Kaplan-Meier survival curve analysis with the time to Nd : YAG laser was performed on the data. RESULTS A total of 1525 patients (first operated eye) were available for the study (n = 294 for hydrophilic acrylic, n = 384 for PMMA, n = 421 for hydrophobic acrylic, n = 426 for silicone). There was a highly statistically significant difference between the IOL groups for the incidence of posterior capsule opacification (p < 0.001) and for Nd : YAG laser treatment (p < 0.001). The mean delay of Nd : YAG laser treatment from the date of cataract operation was 2.48 years (+/-1.70, ranging from 0 to 5.88 years). The rate of Nd : YAG laser capsulotomy over the follow-up period was lowest in the hydrophobic acrylic group (7.1%), followed by silicone (16.2%), PMMA (19.3%) and hydrophilic acrylic (31.1%), respectively. CONCLUSIONS: A low incidence of posterior capsular opacification (PCO) and Nd : YAG laser treatment was detected in hydrophobic acrylic IOLs in comparison to three other types of IOLs implanted in a large cohort of persons with age-related cataract. Choice of IOL type may reduce the need for Nd : YAG laser treatment, although further research on the reasons for this is needed.