[Optical benchtop evaluation of special intraocular lens optics]. / Optische Bank-Evaluierung für spezielle Intraokularlinsenoptiken.

Intraocular lenses (IOL) featuring complex optical designs can pose a challenge in understanding their performance, which may hinder making an informed decision when selecting suitable lenses for patients. This underlines the importance of collecting optical quality data of IOLs and making them available. The deployment of benchtop systems for IOL testing offers not only insights into the design features of various IOL solutions but also provides a platform for objective comparisons of special optics designs, including information about their susceptibility to photic phenomena. Recent advances in IOL testing have improved the ability to predict functional effects on visual acuity and contrast sensitivity from objective optical quality metrics. This, for instance, can be used to study monofocal lenses and the impact of asphericity on vision and IOLs tolerance to misalignment. Monofocal-plus IOLs consistently show only a slight improvement in the depth of focus when tested on the optical bench and in clinical settings. Although the pupil dependence found in this technology may limit the advantages of monofocal-plus over standard monofocal technology to extend the range of vision, it is the key to reduce photic phenomena. Refractive and diffractive extended depth of focus (EDOF) IOLs can effectively enhance intermediate vision, with the latter offering a slightly broader depth of focus but potentially increasing the risk of dysphotopsia. However, the limitation of EDOF IOLs is that they often fail to deliver spectacle independence for reading, which can be overcome by trifocal technology. Still, the available trifocal IOLs differ in their location of intermediate and near foci and the susceptibility to produce glare effects. Therefore, the knowledge from optical benchtop testing of IOLs can support optimizing the IOL selection by aligning the patient's visual needs with the IOL's properties, setting the right expectations, and assessing the risk profile for the occurrence of photic phenomena, potentially leading to improved decision-making.

[Overview of intraocular lenses with optics for correcting presbyopia]. / Übersicht über Intraokularlinsen mit Presbyopie-korrigierenden Optiken.

BACKGROUND: In recent years intraocular lenses (IOLs) for correcting presbyopia have been significantly improved and diversified. There are currently many different IOL models based on a wide variety of optical designs. OBJECTIVE: The wide variety of available IOL solutions to correct presbyopia can be challenging for surgeons and patients. In everyday practice, the question is which IOL is best for which patient. MATERIAL AND METHODS: This overview describes and categorizes the currently available implants. The respective optical properties are analyzed and clinical study results are discussed, in particular those evaluating visual performance and the occurrence of photic phenomena. RESULTS: Monofocal-plus IOLs provide improved intermediate visual acuity with optimal distant visual acuity and minimal photic phenomena. Extended depth of field (EDoF) IOLs extend the depth of field through different optical principles and provide good distant and intermediate visual acuity. Trifocal lenses enable the greatest independence from spectacles at the price of a higher probability of dysphotopsia. CONCLUSION: The selection of the most suitable IOL for correction of presbyopia requires a balance between the patient's visual needs and possible side effects. An adequate knowledge of the currently available implants allows a patient-oriented selection of IOLs.

[Complex optical systems for individualized correction of presbyopia]. / Komplexe Optiksysteme für eine individualisierte Presbyopiekorrektur.

A multitude of available intraocular lens (IOL) models enable a personalized approach to presbyopia correction in order to meet each patient's needs. This review article discusses more complex approaches which can be useful in selected cases. The concept of reversible trifocality enables correction of presbyopia using a supplementary intraocular lens (IOL), which can be removed if necessary (e.g., intolerance to multifocal optics). The use of capsulotomy-fixated IOLs enables high precision for positioning of the lens and better stability compared to conventional capsular bag-fixated IOLs, which can be particularly advantageous in multifocal optics. The mix and match concept enables a combination of different IOLs with various optical principles to achieve the desired binocular effect. Binocular IOL systems, which consist of two complementary IOLs, can be seen as a further development of the mix and match concept. Knowledge of the available options and their application can further improve correction of presbyopia.

Inter-zonal epithelial thickness differences for early keratoconus detection using optical coherence tomography.

PURPOSE: To develop and test a parameter for early keratoconus screening by quantifying the localized epithelial thickness differences in keratoconic eyes. METHODS: The cross-sectional study included 189 eyes of 116 subjects in total: 86 eyes of 54 keratoconus patients with bilateral ectasia and 40 eyes of 20 healthy subjects in the parameter-development dataset and 42 eyes of 21 keratoconus patients with asymmetric ectasia and 21 eyes of 21 healthy subjects in the parameter-validation dataset. Epithelial thickness maps were obtained using anterior segment optical coherence tomography and the inter-zonal epithelial thickness differences were calculated. The developed parameter was tested in keratoconus patients with asymmetric ectasia. RESULTS: Compared to healthy controls, the inferior-temporal and global inter-zonal epithelial thickness differences were higher not only in eyes with tomographically significant keratoconus (median [interquartile range] of 4.42 [3.13] µm vs. 0.78 [0.42] µm, p < 0.001, and 3.05 [1.51] µm vs. 1.07 [0.26] µm, p < 0.001, respectively), but also in tomographically normal keratoconus fellow eyes (1.36 [0.85] µm vs. 0.78 [0.42] µm, p = 0.005, and 1.31 [0.32] µm vs. 1.07 [0.26] µm, p = 0.01, respectively). The inferior-temporal inter-zonal epithelial thickness differences had an area under the receiver operating characteristic curve (95% confidence interval) of 0.991 (0.972-1) for detecting tomographically significant keratoconus and 0.749 (0.598-0.901) for differentiating between tomographically normal keratoconus fellow eyes and healthy controls. CONCLUSIONS: The inter-zonal epithelial thickness differences are increased in keratoconus fellow eyes which still have a normal Scheimpflug corneal tomography, and therefore may serve as a useful parameter to detect early ectatic changes.

Viscoelastic, Optical, and Surgical Properties of Vitreous Body Replacement Hydrogels After Aging Compared to Porcine Vitreous Bodies And Silicone Oils.

Purpose: First- (monomers), second- (pre-gelated), and third- (in situ gelating after injection) generation hydrogels were previously introduced to replace the vitreous body after vitrectomy surgery. In this study, we evaluated the surgical, optical, and viscoelastic properties of vitreous body replacement hydrogels before and after an accelerated aging protocol previously applied to intraocular implants. Methods: Measurements of injection force, removal speed using a clinically established vitrectomy setup, as well as evaluation of forward light scattering and viscoelastic properties before and after an accelerated aging protocol were conducted. Results were compared to porcine and human vitreous bodies, as well as currently clinically applied lighter- and heavier-than-water silicone oils. Results: Removal speed of all tested hydrogels is substantially lower than the removal speed of porcine vitreous body (0.2 g/min vs. 2.7 g/min for the best performing hydrogel and porcine vitreous body, respectively). Forward light scattering in second-generation vitreous body replacement hydrogels was higher after the aging process than the straylight of the average 70-year-old vitreous body (9.4 vs. 5.5 deg2/sr, respectively). The viscoelastic properties of all hydrogels did not change in a clinically meaningful manner; however, trends toward greater stiffness and greater elasticity after aging were apparent. Conclusions: This study demonstrates surgical weaknesses of the hydrogels that need to be addressed before clinical use, especially low removal speed. Pre-linked hydrogels (second-generation) showed inferior performance regarding surgical properties compared to in situ gelating hydrogels (third-generation). Translational Relevance: This study highlights possible pitfalls regarding surgical and optical properties when applying vitreous replacement hydrogels clinically.

Early intraocular lens explantations: 10-year database analysis.

BACKGROUND: The aim of this study was to analyze the causes and characteristics of IOL explantation within the first year after primary implantation. METHODS: In this retrospective, cross sectional database study, a database consisting of over 2500 IOL explants sent from 199 national and international doctors over the past 10 years was analyzed. All IOLs explanted within the first year after implantation were included in this analysis. Explants with insufficient information as well as phakic and Add-on IOLs were excluded. Main outcome measures were the reason for explantation, the time between implantation and explantation, as well as IOLs' and patients' characteristics. Additionally, the explanted IOLs were microscopically and histologically analyzed, as required. RESULTS: Of all explanted IOLs from the database, 1.9% (n = 50) were explanted within the first year after implantation. The most frequent reasons for early IOL explantation were IOL dislocation (32%), visual intolerance (26%), opacification (20%), and intraoperative complications (16%). The time between implantation and explantation was the shortest in cases with intraoperative complications (1.5 ± 3.1 days), followed by IOL dislocation (90.9 ± 103.9 days), visual intolerance (98.3 ± 86.5 days), opacifications (253.5 ± 124.0 days) and other indications (249.7 ± 124.0 days). Calcification of hydrophilic IOLs was the main type of opacification (80%). Notably, seven IOLs required immediate intraoperative exchange due to an intraoperative crack in the optic or a torn off haptic. CONCLUSION: Indications for early IOL explantation were IOL dislocation, visual intolerance, opacification, and intraoperative complications. Especially intraoperative damages to the IOL and early calcification show a potential for improvement of affected IOLs and implantation systems.

Biomechanical changes following corneal crosslinking in keratoconus patients.

PURPOSE: To evaluate the biomechanical and tomographic outcomes of keratoconus patients up to four years after corneal crosslinking (CXL). METHODS: In this longitudinal retrospective-prospective single-center case series, the preoperative tomographic and biomechanical results from 200 keratoconus eyes of 161 patients undergoing CXL were compared to follow-up examinations at three-months, six-months, one-year, two-years, three-years, and four-years after CXL. Primary outcomes included the Corvis Biomechanical Factor (CBiF) and five biomechanical response parameters obtained from the Corvis ST. Tomographically, the Belin-Ambrósio deviation index (BAD-D) and the maximal keratometry (Kmax) measured by the Pentacam were analyzed. Additionally, Corvis E-staging, the thinnest corneal thickness (TCT), and the best-corrected visual acuity (BCVA) were obtained. Primary outcomes were compared using a paired t-test. RESULTS: The CBiF decreased significantly at the six-month (p < 0.001) and one-year (p < 0.001) follow-ups when compared to preoperative values. E-staging behaved accordingly to the CBiF. Within the two- to four-year follow-ups, the biomechanical outcomes showed no significant differences when compared to preoperative. Tomographically, the BAD-D increased significantly during the first year after CXL with a maximum at six-months (p < 0.001), while Kmax decreased significantly (p < 0.001) and continuously up to four years after CXL. The TCT was lower at all postoperative follow-up visits compared to preoperative, and the BCVA improved. CONCLUSION: In the first year after CXL, there was a temporary progression in both the biomechanical CBiF and E-staging, as well as in the tomographic analysis. CXL contributes to the stabilization of both the tomographic and biomechanical properties of the cornea up to four years postoperatively.

Evaluation of Parameters and Nozzle Tip Damage after Clinical Use of Three Hydrophilic Intraocular Lens Injector Models.

Purpose: To assess the nozzle tip damage and the parameters of three different hydrophilic intraocular lens (IOL) injector models. Methods: After routine cataract surgeries at the University Eye Hospital Heidelberg, all the used IOL injectors were collected from the operating room and sent to our laboratory. Nozzle tip damage was assessed under a microscope and graded as follows: no damage (grade 0), slight scratches (1), deep scratches (2), extensions (3), cracks (4), and bursts (5). Each damage grade was assigned a score from 0 to 5, and the total damage score for each injector system was calculated and compared. Nozzle tip parameters (diameters and areas), plunger tip parameters, and tip angles were also measured in each model. Results: The damage scores were (median, Q3-Q1): 1 (1-1) for Accuject, 1 (1-1) for Bluemixs, and 1 (1-1) for RayOne. There was no statistically significant difference in the damage scores between the study groups (P > 0.05). The outer cross-sectional vertical and horizontal diameters were 1.69 and 1.69 mm for Accuject, 1.69 and 1.69 mm for Bluemixs, and 1.70 and 1.71 mm for RayOne. Plunger tip areas were 0.78 mm2 for Accjuect, 0.74 mm2 for Bluemixs, and 0.43 mm2 for RayOne. Plunger tip area/inner cross-sectional area of the nozzle tip (%) was 31.2% for RayOne, 66.7% for Accuject, and 63.8% for Bluemixs. The tip angles for three injector models were 56° (Accuject), 56° (Bluemixs), and 44° (RayOne). Conclusions: All the injector models showed mild to moderate damage to the nozzle tip after IOL implantation, even with smaller diameter tips. RayOne resulted in the lowest ratio between plunger tip area and inner cross-sectional area of the nozzle tip and a better distribution of damage categories than the other two groups. All three injector models had relatively small tip parameters. If smaller incisions are required in certain patients, smaller tip parameters should be considered.

Evaluation of Dry Eye Treatment with Sodium Hyaluronate- and Dexpanthenol-Containing Eye Drops on Ocular Surface Improvement after Cataract Surgery.

BACKGROUND: To clinically evaluate how dry eye symptoms in preoperatively diagnosed dry eye patients change with the use of sodium hyaluronate- and dexpanthenol-containing eye drops (HYLO CARE (HC), URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany) after cataract surgery. The aim of the study was not to compare different eye drops but to implement standard treatment in patients with dry eye undergoing cataract surgery. The impact of treatment was evaluated using Symptom Assessment Tools for Dry Eye. METHODS: In this prospective, single-center, open-label clinical trial, 49 patients undergoing cataract surgery were included who showed signs and symptoms of dry eye disease assessed by the Symptom Assessment in Dry Eye (Visual Analogue Scale (VAS)) questionnaire, Ocular Surface Disease Index (OSDI), and fluorescein tear break-up Time (TBUT). Patients were instructed to apply HC three to four times a day for 5 weeks in the operated eye in addition to the standard postoperative topical anti-inflammatory regimen. The primary endpoint was the change in TBUT. Secondary endpoints were the assessment of the subjective symptoms (VAS), corrected distance visual acuity (CDVA), and slit-lamp examination including the corneal staining score, Schirmer test, and intraocular pressure. RESULTS: At 5 weeks after operation, the mean TBUT increased from 6.42 ± 1.57 s (s) to 7.81 ± 1.83 s in the per-protocol (PP) population (p > 0.001) and from 6.33 ± 1.64 s to 7.71 ± 2.05 s in the intention-to-treat (ITT) population (p < 0.001). There was a statistically significant decrease in all scores (p < 0.05) from the VAS questionnaire except for the tearing score (p = 0.062) at 5 weeks after operation. The mean total corneal staining score also decreased statistically significantly from 8.85 ± 2.49 before operation to 5.61 ± 3.37 at 5 weeks after operation on a 15-point scale. CONCLUSIONS: Controlled standardized dry eye treatment (with HC) improved tear film stability, ocular surface defects, and subjective symptoms of dry eye disease in patients 5 weeks after undergoing cataract surgery. Both the patient and physician assessments indicated high efficacy, tolerability, and a reliable safety profile, as indicated by the low number of at least possibly related adverse events (AE), suggesting its beneficial role in the postoperative management of the ocular surface (OS) in patients with dry eye symptoms prior to and after cataract surgery.

Intraocular lens calcification in a patient with Ehlers-Danlos syndrome.

Introduction: Calcification of hydrophilic intraocular lenses (IOL) is a rare complication following cataract surgery. Secondary calcification is described as due to host factors or changes in the IOL environment and uveitis, proliferative diabetic retinopathy and sequelae of ocular surgery are recognised potentiators. The impact of systemic connective tissue disease on IOL opacification is yet to described. Purpose: To describe the clinical presentation and management of a young patient, with a rare subtype of Ehlers-Danlos syndrome, who presented with secondary IOL calcification 14 years after primary IOL insertion. Observations: Floret-like lesions were observed on the IOL surface. Positive staining for calcification was observed with Alizarin red and von Kossa method on laboratory analysis. Conclusions and importance: Patients with systemic connective tissue disease, such as a subtype of Ehlers-Danlos, may present with secondary IOL calcification many years after primary lens insertion. This poses an additional consideration when implanting IOLs in these patients.Good visual acuity can be achieved with IOL exchange.

Early REperfusion therapy with intravenous alteplase for recovery of VISION in acute central retinal artery occlusion (REVISION): Study protocol of a phase III trial.

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.

Ectasia Detection by Anterior Segment Optical Coherence Tomography in Scheimpflug Tomographically Normal Keratoconus Fellow Eyes.

PURPOSE: The purpose of this study was to determine whether the Scheimpflug tomographically normal fellow eyes of keratoconus patients are also classified as normal using an ectasia screening algorithm based on anterior segment optical coherence tomography (AS-OCT). METHODS: This monocentric cross-sectional study included 22 very asymmetric ectasia patients with tomographically significant keratoconus in 1 eye and normal Scheimpflug tomography in the fellow eye. Twenty-two eyes of 22 healthy subjects served as a control group. We performed corneal tomography using Pentacam AXL (Oculus, Wetzlar, Germany) and used Belin/Ambrósio Enhanced Ectasia total deviation index as well as Belin ABCD keratoconus classification to identify Scheimpflug tomographically normal eyes. We also performed AS-OCT using Anterion (Heidelberg Engineering, Heidelberg, Germany) and analyzed for the presence of ectasia using the Screening Corneal Objective Risk of Ectasia (SCORE) algorithm, with positive values indicating ectasia suspect tomography. RESULTS: The SCORE value was positive in 9.1% (n = 2) of the healthy eyes, in 45.5% (n = 10) of the Scheimpflug tomographically normal eyes of keratoconus patients and in all eyes (n = 22) with tomographically significant keratoconus. The Scheimpflug tomographically normal eyes of keratoconus patients had higher SCORE values compared with healthy controls (P < 0.001). The median (interquartile range) SCORE value was -1.7 (1.3) in healthy controls, -0.5 (2.2) in Scheimpflug tomographically normal eyes of keratoconus patients, and 11.1 (11.0) in tomographically significant keratoconus eyes. CONCLUSIONS: The Scheimpflug tomographically normal fellow eyes of keratoconus patients had higher AS-OCT-based SCORE values than healthy controls, with positive SCORE values found in 46% of the eyes, indicating early tomographic ectatic changes.