RESUMEN
Purpose: The IC-8® Apthera™ (AcuFocus Inc.™, Irvine, California, USA) is the first small aperture intraocular lens (IOL) to receive FDA approval for presbyopia correction in the summer of 2022. It is a single-piece hydrophobic acrylic monofocal lens, which is placed in the capsular bag. In its center it carries a black circular mask (FilterRing™) with a diameter of 3.23 mm consisting of polyvinylidene fluoride and carbon black nanoparticles. In the center of this mask sits a 1.36 mm wide aperture. Thanks to this pinhole effect the IC-8® serves as an extended-depth-of-focus (EDOF) IOL and can be used in presbyopia correction.This report describes the case of a patient with an IC-8® implant who underwent Nd:YAG laser capsulotomy for posterior capsule opacification (PCO). The post laser checkup showed a dark central optical change within the IOL and the patient described optical phenomena as well as blurred central vision, which is why he received IOL exchange. The explanted IC-8® was sent to the Intermountain Ocular Research Center at the University of Utah for further analysis. Observations: A 56-year-old male underwent cataract surgery with implantation of a non-diffractive EDOF-IOL on the right and the IC-8® small aperture IOL on the left eye. On the left eye, the patient had received penetrating keratoplasty seven years prior to the cataract operation due to posttraumatic corneal scarring. The early checkups after cataract surgery showed a corrected distance visual acuity (CDVA) in the left eye of +0.1 logMAR in the first month. About 5 months after the operation, PCO was first described on the left eye leading to a decrease in visual acuity to +0.4 logMAR (CDVA). Due to PCO, Nd:YAG laser capsulotomy was conducted 5 months after the cataract operation on the left eye. 12 shots were applied at 2.7 mJ. The following appointments showed a continuously reduced visual acuity of +1.3 logMAR (uncorrected) on the left eye and the patient described blurry and 'swirled' central vision. By slightly tilting his head and thus not using the center of his optic axis, he would be able to see sharper. Slit lamp examination showed a small optical change inside the IC-8® IOL not resembling a pit but believed to be a small pocket of air. Due to the ongoing symptoms as well as the reduced VA, the seemingly damaged small aperture IOL was exchanged for a three-piece hydrophobic acrylic monofocal lens, which was also placed in the posterior chamber. The explanted IC-8® was sent to the Intermountain Ocular Research Center at the University of Utah for further analysis. Results from gross and light microscopic analysis showed that the change caused by the Nd:YAG laser application consisted of a localized optical area containing carbon black nanoparticles used for the circular mask within the IOL. Conclusions and importance: When dealing with PCO and performing Nd:YAG laser capsulotomy in eyes with an IC-8® IOL implant, the laser shots should be applied either inside the aperture or outside of the black circular mask of the IOL. Otherwise, the Nd:YAG laser can lead to bursts of carbon nanoparticles within the IOL which may cause optical phenomena as well as decreased visual acuity possibly resulting in an IOL exchange.
RESUMEN
PURPOSE: To evaluate whether the intraocular lens (IOL) calculation of the fellow eye (FE) can be used in eyes undergoing combined phacovitrectomy. METHODS: In this retrospective, consecutive case series, we enrolled patients who underwent combined phacovitrectomy with silicone oil removal and IOL implantation at the Goethe-University. Preoperative examinations included biometry (IOLMaster 700; Carl Zeiss). We used the IOL calculation of the FE (FE group) to calculate the prediction error compared with the IOL calculation using only the axial length (AL) of the FE (AL-FE group), as well as using the AL of the operated eye (OE group) in addition to the measurable biometric parameters. IOL calculation was performed using the Barrett Universal II formula. We compared the mean (MAE) and median absolute prediction error (MedAE) with each other. Furthermore, the number of eyes with ±0.50, ±1.00 and ±2.00 dioptres (D) deviation from the target refraction was compared. RESULTS: In total, 79 eyes of 79 patients were included. MedAE was lowest in the OE group (0.41 D), followed by FE group (1.00 D) and AL-FE group (1.02 D). Comparison between the AL-FE and FE groups showed no statistically significant difference (p = 0.712). Comparing eyes within ±0.50 D of the target refraction, the OE group (63.3%) performed best, followed by the AL-FE group (27.8%) and the FE group (26.6%). CONCLUSION: Our results indicate no clinically relevant difference between using the IOL calculation of the FE versus using only the AL of the FE in addition to the measurable parameters for the IOL calculation. A two-step procedure should always be strived for.
RESUMEN
BACKGROUND: To assess changes in ocular biometry of the phakic eye after pars-plana-vitrectomy (PPV) and silicone oil (SO) endotamponade in eyes with a retinal detachment. METHODS: This retrospective, consecutive case series included 72 eyes of 72 patients who underwent PPV with 5000-centistokes SO endotamponade between July 2018 and June 2023. Pseudophakic eyes and eyes with a combined phacovitrectomy were excluded. Primary endpoints were keratometry values, anterior chamber depth (ACD), lens thickness (LT), horizontal corneal diameter (HCD), and axial length (AL) measured by swept-source optical coherence tomography-based biometry (IOLMaster 700) preoperatively and six weeks postoperatively. A recently described formula was used to adjust the AL (aAL) in eyes with SO endotamponade and a theoretical intraocular lens (IOL) calculation was performed. RESULTS: The mean age was 62.1 ± 8.3 years (range: 37-85). After PPV with SO fill, there was an increase in Kmean (0.19 ± 0.51D), while ACD (0.05 ± 0.13 mm), LT (0.03 ± 0.14 mm), and HCD (0.02 ± 0.24 mm) decreased. Preoperatively, the mean AL was 25.22 ± 1.78 mm, while postoperatively the AL was overestimated by 0.12 ± 0.42 mm on average (p = 0.04). By adjusting the AL, the mean difference could be reduced to -0.002 ± 0.41 mm. The aAL resulted in a difference in the refractive outcome in eyes with an AL > 25 mm of 0.34 ± 0.10D in the IOL calculation. CONCLUSIONS: While changes in biometry after PPV with SO endotamponade in the anterior segment are clinically less relevant, a considerable overestimation of AL with IOLMaster 700 was found. We recommend the use of a recently introduced formula for adjusting AL in eyes with SO, allowing overestimation to be minimised considerably.
RESUMEN
BACKGROUND: To evaluate the repeatability and agreement of two different ocular biometers and Scheimpflug devices in keratoconus eyes. METHODS: This prospective, comparative trial took place at the University hospital, Goethe University, Frankfurt am Main, Germany. We included eyes with keratoconus, one eye per patient, randomly selected. Measurements were taken with Galilei G6 (Ziemer, Switzerland) and Pentacam AXL (Oculus, Germany), three consecutive measurements each. Repeatability and agreement were evaluated for simulated keratometry (simK), astigmatism (simA), maximum keratometry (KMax) and its axis, total keratometry (TCP), axial length (AL), anterior chamber depth (ACD), and thinnest pachymetry (TCT). RESULTS: Both devices showed an excellent repeatability with intra class correlation (ICC) of > 0.97 for all parameters. The 95% limits of repeatability (LoR95%) and agreement (LoA95%) were narrow for all parameters. The Galilei G6 had a narrower LoAR95% for TCT (2.1 µm vs. 4.6 µm), but a wider LoR95% for KMax (0.52D vs. 1.18D). No relevant difference was found for the other parameters. Agreement between the devices was good to moderate, especially for simK and TCP. CONCLUSIONS: Both devices show excellent repeatability with narrow LoR95% and high ICC for all parameters. The only relevant difference was found for KMax and TCT in favor of Pentacam AXL and Galilei G6, respectively. Agreement was good to moderate, and most parameters should not be considered interchangeable.
RESUMEN
PURPOSE: To evaluate formulas for intraocular lens (IOL) calculation in children undergoing lens extraction and IOL implantation. METHODS: Retrospective, consecutive case series at the Department of Ophthalmology, Goethe University Frankfurt, Germany. We included eyes that received lens extraction and IOL implantation (SN60AT, Alcon, Fort Worth, TX) due to congenital or juvenile cataract. Preoperative assessments included biometry (IOLMaster 500/700, Carl Zeiss Meditec, Germany). To evaluate the measurements, we compared the mean prediction error (MPE), mean and median absolute prediction error (MAE, MedAE) of six different formulas, and number of eyes within ± 0.5, ± 1.0, ± 2.0D of target refraction. Postoperative spherical equivalent was measured by retinoscopy 4-12 weeks after surgery. RESULTS: 66 eyes matched our inclusion criteria with a mean age of 6.3 years ± 3.2. MedAE was lowest in SRK/T (0.55D ± 1.08) followed by Holladay I (0.75D ± 1.00), EVO 2.0 (0.80D ± 0.89), Barrett Universal II (BUII, 0.86D ± 1.00), Hoffer Q (0.97 D ± 0.94), and Haigis (1.10D ± 0.95). Regarding eyes within ± 0.5D SRK/T (45.5.%, 30 eyes) performed best, followed by Holladay I (36.4%, 24 eyes), EVO 2.0 and BUII (each 34.8%, 23 eyes). There was a myopic shift seen in all formulas (MPE: -0.21 to -0.90D). CONCLUSION: Using modern formulas, or even AI formulas, for IOL calculation in children's eyes does barely improve predictability of the postoperative refraction. A myopic shift can be found for all formulas. However, specific formulas like SRK/T seem to better anticipate this.
RESUMEN
PURPOSE: To compare two different datasets, using Eyetemis, an online analytical tool designed for assessing the spherical equivalent prediction errors (SEQ-PE) of intraocular lens (IOL) power calculation formulas following cataract surgery. SETTING: Institutional. DESIGN: Retrospective case series. METHODS: The study was comprised of two distinct datasets of patients who had undergone successful cataract surgery. Dataset-1 includes standard eyes whereas Dataset-2 includes eyes with keratoconus. An online tool was used for SEQ-PE analysis across the 2 datasets, adhering to ISO standards for evaluating accuracy based upon trueness and precision. The tool incorporates robust t-tests for comparing the trimmed-mean of the data, adjusting for heteroscedasticity. IOL constants in Dataset-1 were optimized for the comparison of Hoffer Q, Holladay1, SRK/T, Haigis and Barrett Universal II (BUII) formulas. In Dataset-2, IOL constants from the IOLCon website, were used for the comparison of the BUII and its designated KCN-version: Barrett TrueK Keratoconus (TrueK [KCN]). RESULTS: For Dataset-1: the trimmed-mean SEQ-PE values of all formulas were not significantly different from zero. BUII had superior precision and accuracy compared to all other formulas except from Haigis (P≤ 0.04). For Dataset-2: BUII's trimmed-mean SEQ-PE was significantly different from zero (0.59D, P< 0.01), unlike the TrueK [KCN] (0.12D, P= 0.10). Additionally, TrueK [KCN] exhibited enhanced precision and accuracy relative to BUII (P< 0.01). CONCLUSIONS: The online analysis tool provides a streamlined approach for assessing the prediction accuracy of SEQ refraction following cataract surgery, effectively evaluating trueness, precision, and overall accuracy through the use of advanced statistical methods.
RESUMEN
Blue light-filtering (BLF) intraocular lenses (IOLs) are designed to mimic the healthy natural adult crystalline lens. Studies that evaluated the relative merit of ultraviolet-only IOL design (ie, blocking wavelengths <400 nm) versus BLF IOL design (ie, filtering wavelengths ~400-475 nm in addition to blocking wavelengths <400 nm) on protection and function of the visual system suggest that neither design had a deleterious impact on visual acuity or contrast sensitivity. A BLF design may reduce some aspects of glare, such as veiling and photostress. BLF has been shown in many contexts to improve visual performance under conditions that are stressed by blue light, such as distance vision impaired by short-wave dominant haze. Furthermore, some data (mostly inferential) support the notion that BLF IOLs reduce actinic stress. Biomimetic BLF IOLs represent a conservative approach to IOL design that provides no harm for visual acuity, contrast sensitivity, or color vision while improving vision under certain circumstances (eg, glare).
RESUMEN
RATIONALE: Meta-analyses of case series of non-arteritic central retinal artery occlusion (CRAO) indicate beneficial effects of intravenous thrombolysis when initiated early after symptom onset. Randomized data are lacking to address this question. AIMS: The REperfusion therapy with intravenous alteplase for recovery of VISION in acute central retinal artery occlusion (REVISION) investigates intravenous alteplase within 4.5 h of monocular vision loss due to acute CRAO. METHODS: This study is the randomized (1:1), double-blind, placebo-controlled, multicenter adaptive phase III trial. STUDY OUTCOMES: Primary outcome is functional recovery to normal or mildly impaired vision in the affected eye defined as best-corrected visual acuity of the Logarithm of the Minimum Angle of Resolution of 0.5 or less at 30 days (intention-to-treat analysis). Secondary efficacy outcomes include modified Rankin Score at 90 days and quality of life. Safety outcomes include symptomatic intracranial hemorrhage, major bleeding (International Society on Thrombosis and Haemostasis definition) and mortality. Exploratory analyses of optical coherence tomography/angiography, ultrasound and magnetic resonance imaging (MRI) biomarkers will be conducted. SAMPLE SIZE: Using an adaptive design with interim analysis at 120 patients, up to 422 participants (211 per arm) would be needed for 80% power (one-sided alpha = 0.025) to detect a difference of 15%, assuming functional recovery rates of 10% in the placebo arm and 25% in the alteplase arm. DISCUSSION: By enrolling patients within 4.5 h of CRAO onset, REVISION uses insights from meta-analyses of CRAO case series and randomized thrombolysis trials in acute ischemic stroke. Increased rates of early reperfusion and good neurological outcomes in stroke may translate to CRAO with its similar pathophysiology. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04965038; EU Trial Number: 2023-507388-21-00.
Asunto(s)
Fibrinolíticos , Recuperación de la Función , Oclusión de la Arteria Retiniana , Activador de Tejido Plasminógeno , Humanos , Oclusión de la Arteria Retiniana/tratamiento farmacológico , Activador de Tejido Plasminógeno/uso terapéutico , Activador de Tejido Plasminógeno/administración & dosificación , Fibrinolíticos/uso terapéutico , Fibrinolíticos/administración & dosificación , Método Doble Ciego , Recuperación de la Función/efectos de los fármacos , Reperfusión/métodos , Resultado del Tratamiento , Administración Intravenosa , Agudeza Visual/efectos de los fármacos , Agudeza Visual/fisiología , Masculino , Ensayos Clínicos Fase III como Asunto , Femenino , Terapia Trombolítica/métodos , Persona de Mediana EdadRESUMEN
A 28-year-old nurse had an aberration-free femto-laser in situ keratomileusis (LASIK) performed for her myopia of -6.25 -0.50 × 096 and -6.75 -0.50 × 175 in the right and left eye, respectively. Corrected distance visual acuity (CDVA) preoperatively was 20/16. Preoperatively, there were no abnormalities on Scheimpflug imaging, and a pachymetry of 585 µm was measured in both eyes. Flap thickness was 115 µm. The patient was quite nervous during the surgery. Since the surgery, her uncorrected distance visual acuity (UDVA) and CDVA are suboptimal at 20/30 and 20/20 in the right eye, and 20/20 and 20/16 in the left eye. 3 months postoperatively, there is a stable manifest refraction of +0.25 -1.25 × 030 and +0.25 -0.00 × 0. The keratometric astigmatism in the Scheimpflug imaging is 1.2 diopter (D) × 114 and 0.4 D × 78 in the right and left eyes, respectively (FIgures 1 and 2). Thinnest pachymetry is 505 µm and 464 µm in the right and left eye, respectively. Her wavefront analysis shows refraction in a 6 mm zone of -0.99 -1.22 × 32 and -0.91 -0.36 × 136. The cycloplegic refraction is 1.25 -1.00 × 023 and +1.00 -0.25 × 006 (Figures 3 and 4). What is the cause of the suboptimal visual outcome in this case? What would be your treatment strategy to improve visual outcome?
Asunto(s)
Astigmatismo , Aberración de Frente de Onda Corneal , Queratomileusis por Láser In Situ , Miopía , Humanos , Femenino , Adulto , Queratomileusis por Láser In Situ/métodos , Aberración de Frente de Onda Corneal/cirugía , Resultado del Tratamiento , Agudeza Visual , Refracción Ocular , Miopía/cirugía , Miopía/complicaciones , Astigmatismo/cirugía , Astigmatismo/complicaciones , Láseres de Excímeros/uso terapéuticoRESUMEN
PURPOSE: To compare precision of pupil size measurements of a multifunctional device (Pentacam AXL Wave [Pentacam]) and 2 infrared-based pupillometers (PupilX, Colvard) and to compare repeatability of Pentacam and PupilX. SETTING: Department of Ophthalmology, Goethe-University, Frankfurt am Main, Germany. DESIGN: Prospective, comparative trial. METHODS: Pupil diameter of healthy eyes was measured with Colvard once and Pentacam without glare (WO) and with glare (WG), PupilX in 0, 1, and 16 lux 3 times each. In a second series, measurements with Pentacam WO and PupilX in 0.06 and 0.12 lux were assessed. RESULTS: 36 eyes of participants aged 21 to 63 years were included. Mean pupil diameter was 6.05 mm with Colvard, 5.79 mm (first series), 5.50 mm (second series) with Pentacam WO, 3.42 mm WG, 7.26 mm PupilX in 0, 4.67 mm 1, 3.66 mm 16, 6.82 mm in 0.06, and 6.39 mm in 0.12 lux. Measurements with Pentacam WO were significantly different to PupilX in 0, 0.06, 0.12, and 1 lux (all P < .001), but not to Colvard ( P = .086). Pupil size measured with Pentacam WG and PupilX in 16 lux was not significantly different ( P = .647). Consecutive measurements with Pentacam WO and WG had mean SD of 0.23 mm and 0.20 mm, respectively, and with PupilX 0.11 in 0, 0.24 mm 1, and 0.20 mm in 16 lux. CONCLUSIONS: Pentacam provided good assessment of pupil size but was not equivalent to PupilX in low lighting conditions. Repeatability was more favorable for Pentacam.
Asunto(s)
Interferometría , Pupila , Humanos , Pupila/fisiología , Estudios Prospectivos , Adulto , Persona de Mediana Edad , Masculino , Femenino , Adulto Joven , Reproducibilidad de los Resultados , Interferometría/instrumentación , Aberrometría/instrumentación , Iris , Rayos Infrarrojos , Técnicas de Diagnóstico Oftalmológico/instrumentación , DeslumbramientoRESUMEN
PURPOSE: To evaluate the ESCRS online calculator for intraocular lens (IOL) calculation in children undergoing lens extraction and primary IOL implantation. SETTING: Department of Ophthalmology, Goethe-University Frankfurt, Frankfurt am Main, Germany. DESIGN: Retrospective, consecutive case series. METHODS: Eyes that received phacoemulsification and IOL implantation (Acrysof SN60AT) due to congenital or juvenile cataract were included. We compared the mean prediction error (MPE), mean and median absolute prediction error (MAE, MedAE) of formulas provided by the recently introduced online calculator provided by the ESCRS with the SRK/T formula, as well as the number of eyes within ±0.5 diopters (D), ±1.0 D, ±2.0 D of target refraction. Postoperative spherical equivalent was measured by retinoscopy 4 to 12 weeks postoperatively. RESULTS: 60 eyes from 47 patients with a mean age of 6.5 ± 3.2 years met the inclusion criteria. Mean axial length was 22.27 ± 1.19 mm. Mean preoperative spherical equivalent (SE) was -0.25 ± 3.78 D, and mean postoperative SE was 0.69 ± 1.53 D. The MedAE was lowest in the SRK/T formula (0.56 D, ± 1.03) performed significantly better ( P = .037) than Hoffer QST and Kane, followed by BUII (0.64 D, ± 0.92), Pearl DGS (0.65 D, ± 0.94), EVO (0.69 D, ± 0.94), Hoffer QST (0.75 D, ± 0.99), and Kane (0.78 D, ± 0.99). All of those were significantly above zero ( P < .001). 41 eyes received an intraoperative optic capture (68%). When excluding eyes that did not receive intraoperative optic capture (n = 19; 32%), the MedAE was shown to be lower. CONCLUSIONS: Using modern IOL calculation formulas provided by the ESCRS calculator provides good refractive predictability and compares for most of the formulas with the results with SRK/T. In addition, the formulas seem to anticipate the postoperative refraction better for eyes that receive a posterior optic capture.
Asunto(s)
Biometría , Implantación de Lentes Intraoculares , Lentes Intraoculares , Facoemulsificación , Refracción Ocular , Humanos , Estudios Retrospectivos , Niño , Femenino , Masculino , Refracción Ocular/fisiología , Biometría/métodos , Preescolar , Adolescente , Óptica y Fotónica , Longitud Axial del Ojo/patología , Agudeza Visual/fisiología , Catarata/fisiopatología , Catarata/complicaciones , Catarata/congénito , Lactante , RetinoscopíaRESUMEN
PURPOSE: To determine the visual outcomes and safety 12 months after implantation of the Presbia Flexivue Microlens refractive corneal inlay. METHODS: In this prospective, non-randomized trial, 22 patients with a mean age of 52.54 ± 2.86 years were implanted with the Flexivue Microlens refractive corneal inlay in the non-dominant eye at the Department of Ophthalmology, Goethe University, Frankfurt, Germany. Corrected near, intermediate, and distance (CNVA, CIVA, and CDVA) visual acuity and uncorrected near, intermediate, and distance (UNVA, UIVA, and UDVA) visual acuity, manifest refraction, subjective quality of vision, endothelial cell count, and contrast sensitivity were measured 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. RESULTS: For binocular CDVA, no patient lost two or more lines and 30% lost only one line at the 12-month visit. In the eye that had surgery, 85% of the patients lost two or more lines of UDVA, which was statistically significant. Sixty-five percent of the patients gained one or more lines in binocular UIVA, and 80% achieved 20/40 or better in DCIVA. UNVA showed a statistically significant improvement, with 90% of the patients achieving 20/40 or better 12 months after implantation. A total of 85% gained two or more lines in binocular UNVA. CONCLUSIONS: This refractive corneal inlay showed an improvement in binocular UNVA, UIVA, CNVA, and CIVA, whereas binocular CDVA and UDVA were not statistically affected. [J Refract Surg. 2024;40(1):e1-e9.].