Safety of the artisan iris-fixated phakic intraocular lens

Refractive surgery is a subfield in ophthalmology that focusses on the surgical correction of ametropia. A multitude of refractive surgical methods are available to refractive surgeons.Individualized refractive correction, i.e. choosing the best available method for a particular patient, is one of the greatest challenges in refractive surgery. Choosing the appropriate treatment option should be based on the individual’s risk-benefit profile. For this, it is necessary for refractive surgeons to know the short- and long-term results of all current refractive correction methods and to be aware of the pitfalls and drawbacks of the anterior segment imaging techniques used for patient selection and follow-up.This thesis focusses on the safety of ametropic eyes optically corrected with the non-foldable iris-fixated phakic intraocular lens.The first part of this thesis reports on middle- and long-term clinical results after implantation of the non-foldable iris-fixated phakic intraocular lens for the correction of myopic and hyperopic refractive errors.In the second part of this thesis aspects of safety considerations with respect to patient selection criteria and follow-up are described.The research presented in this thesis was supported by grants from Stichting Blindenhulp, Ophtec BV, and the following through UitZicht: ANVVB and LSBS. The funding organizations provided unrestricted grants and had no role in the design or conduct of the research.; Financial support for printing this thesis was kindly supported by Stichting LOOStichting Blindenhulp, Oculenti BV, Oogfonds, Lameris Ootech, Ophtec BV, Visser ContactlenzenLUMC / Geneeskund

Two-year results after combined phacoemulsification and iris-fixated phakic intraocular lens removal

Purpose To describe and present results after a technique for cataract surgery combined with explantation of an iris-fixated phakic intraocular lens (IF-pIOL).Methods The medical records of all patients, who had undergone cataract surgery combined with IF-pIOL explantation and subsequent implantation of a posterior chamber IOL by the Single Incision Technique (SIT), were reviewed. Data collection included preoperative and postoperative corrected distance visual acuity (CDVA), manifest refraction, and endothelial cell density (ECD) up to a follow-up time of 24 months.Results Fifty myopic eyes (34 patients) and 9 hyperopic eyes (6 patients) had undergone a SIT procedure mainly because of cataract (67%). Postoperative CDVA improved in both the myopic eyes to 0.16 +/- 0.37 logMAR, as in the hyperopic eyes to - 0.10 +/- 0.55 logMAR with no eyes having loss of Snellen lines. Mean postoperative spherical equivalent was - 0.34 +/- 0.72 D and - 0.10 +/- 0.55 D, respectively. ECD loss 6 months after surgery was 5% and remained stable thereafter.Conclusion SIT for combined phacoemulsification and IF-pIOL removal yields good visual and refractive results and is a safe procedure in regard to ECD loss. The technique has advantages over the conventional procedure and is easy to perform.Neuro Imaging Researc

Improved interchangeability with different corneal specular microscopes for quantitative endothelial cell analysis

Introduction: During our clinical practice and research, we encountered an interchangeability problem when using the SP-2000P and SP-3000P TopCon corneal specular microscopes (CSMs) (TopCon Medical Systems, Tokyo, Japan) regarding the endothelial cell count (ECC). We describe a method to improve interchangeability between these CSMs. Methods: Five consecutive good-quality endothelial cell photographs were obtained in 22 eyes of 11 subjects. An ECC comparison between the two CSMs was performed after (I) gauging and calibration by the manufacturer, (II) adjustment of the magnification, (III) correction after external horizontal and vertical calibration. Results: There was a statistically significant difference between the ECC of the SP-2000P and SP-3000P at the start. The SP-2000P counted an average of 500 cells/mm2 more than the SP-3000P (p=0.00). After correction for magnification and determining a correction factor based on external calibration, the difference between the ECC of the SP-2000P and the SP-3000P was then found to be 0.4 cells/mm2 and was not statistically significant (p=0.98). Discussion: We propose a method for improving interchangeability, which involves checking magnification settings, re-checking magnification calibration with external calibration devices, and then calculating correction factors. This method can be applied to various specular or confocal microscopes and their associated endothelial cell analysis software packages to be able to keep performing precise endothelial cell counts and to enable comparison of ECCs when a CSM needs to be replaced or when results from different microscopes need to be compared

Implantation of an iris-fixated phakic intraocular lens for the correction of hyperopia: 15-year follow-up

Purpose: To assess the predictability, efficacy, stability, and safety of implantation of an Artisan iris-fixated phakic intraocular lens (IF-pIOL) for the correction of hyperopia with a follow-up of up to 15 years.Setting: Leiden University Medical Center, the Netherlands.Methods: Patients operated by a single surgeon up to 2007 were identified, and data on refraction, corrected distance visual acuity (CDVA), uncorrected distance visual acuity, endothelial cell (EC) density, and complications were collected.Results: A total of 61 eyes (32 patients) were analysed. The mean spherical equivalent decreased from +6.43 +/- 1.78 diopters (D) preimplantation to -0.22 +/- 0.57 D at 1 year postimplantation and remained stable throughout follow-up. A stable CDVA with safety indices ranging from 0.91 to 1.10 and efficacy indices between 0.43 and 0.86 were observed. Follow-up time had a significant effect on EC density with an estimated annual decline of 58 cells/mm(2) after IF-pIOL implantation. IF-pIOL explantation was performed in a 10 eyes (16.4%) after 8.13 +/- 5.11 years. The main reason for IF-pIOL explantation was EC loss (4 eyes [6.6%]). Pigment dispersion was the most encountered complication, observed in 9 eyes ( 14.8%).Conclusions: Visual and refractive results after implantation of an IF- pIOL to correct hyperopia show favorable and stable results with long-term follow- up. Lifelong monitoring of EC counts is mandatory. Pigment dispersion might be a problem in hyperopic eyes implanted with an IF-pIOL; a shallower anterior chamber depth and a convex iris configuration might be predisposing factors. Copyright (C) 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of ASCRS and ESCRSNeuro Imaging Researc

Preeclampsia and coronary plaque erosion: Manifestations of endothelial dysfunction resulting in cardiovascular events in women

Therapeutic cell differentiatio

Prevalence of myopic macular features in Dutch individuals of European ancestry with high myopia

IMPORTANCE Highmyopia incidence and prevalence is increasing worldwide, and the visual burden caused bymyopia is expected to rise accordingly. Studies investigating the occurrence ofmyopic complications in individuals of European ancestry with highmyopia are scarce, hampering insights into the frequency ofmyopic retinal complications in European individuals and their visual burden.OBJECTIVE To assess the frequency ofmyopic macular features in individuals of European ancestry with highmyopia.DESIGN, SETTING, AND PARTICIPANTS This cross-sectional analysis of the Dutch Myopia Study (MYST) and individuals with highmyopia from the Rotterdam Study (RS) included 626 patients with highmyopia (spherical equivalent of refractive error [SER] = 26 mm) who underwent an extensive ophthalmic examination including multimodal retinal imaging. In addition to this combination of a population-based cohort study and mix-based highmyopia study, a systematic literature review was also performed to compare findings with studies of individuals of Asian ancestry.EXPOSURES Highmyopia, age, and AL.MAIN OUTCOMES AND MEASURES Frequency ofmyopic macular and optic disc features: tessellated fundus, myopic macular degeneration (MMD), staphyloma, peripapillary intrachoroidal cavitation, peripapillary atrophy (PPA), and "plus" lesions (choroidal neovascularization, Fuchs spot, and lacquer cracks).RESULTS The mean (SD) SER of the combined study population (MYST and RS) was -9.9 (3.2) D; the mean (SD) age was 51.4 (15.1) years, and 387 (61.8%) were women. The prevalence of MMD was 25.9% and increased with older age (P for trend <.001), lower SER (odds ratio [OR], 0.70; 95% CI, 0.65-0.76; P <.001), and higher AL (OR, 2.53; 95% CI, 2.13-3.06; P <.001). Choroidal neovascularization or Fuchs spot was present in 2.7%(n = 17), both lesions in 0.3% (n = 2), and lacquer cracks in 1.4%(n = 9). Staphyloma, PPA, and MMD were highly prevalent in visual impaired and blind eyes (frequency was 73.9%[20 of 27], 90.5%[19 of 21], and 63.0%[17 of 27] of unilateral blind eyes for MMD, staphyloma, and PPA, respectively). Seven previous studies in Asian populations reported a variable MMD frequency ranging from 8.3% to 64%, but frequencies were similar for comparable risk profiles based on age and SER.CONCLUSIONS AND RELEVANCE In this cross-sectional study of a highlymyopic Dutch population of European ancestry, myopic retinal features were frequent; were associated with age, SER, and AL; and occurred in all visually severely impaired eyes. The absence of treatment options for most of these retinal complications emphasizes the need for effective strategies to prevent highmyopia.Ophthalmic researc

Cardiovascular RiskprofilE - IMaging and gender-specific disOrders (CREw-IMAGO): Rationale and design of a multicenter cohort study

Background: Reproductive disorders, such as polycystic ovary syndrome (PCOS), primary ovarian insufficiency (POI) and hypertensive pregnancy disorders (HPD) like pre-eclampsia (PE), are associated with an increased risk of cardiovascular disease (CVD). Detection of early signs of cardiovascular disease (CVD), as well as identification of risk factors among women of reproductive age which improve cardiovascular risk prediction, is a challenge and current models might underestimate long-term health risks. The aim of this study is to assess cardiovascular disease in patients with

Phenotypic consequences of the GJD2 risk genotype in myopia development

PURPOSE. To study the relatively high effect of the refractive error gene GJD2 in human myopia, and to assess its relationship with refractive error, ocular biometry and lifestyle in various age groups.METHODS. The population-based Rotterdam Study (RS), high myopia case-control study MYopia STudy, and the birth-cohort study Generation R were included in this study. Spherical equivalent (SER), axial length (AL), axial length/corneal radius (AL/CR), vitreous depth (VD), and anterior chamber depth (ACD) were measured using standard ophthalmologic procedures. Biometric measurements were compared between GJD2 (rs524952) genotype groups; education and environmental risk score (ERS) were calculated to estimate gene-environment interaction effects, using the Synergy index (SI).RESULTS. RS adults carrying two risk alleles had a lower SER and longer AL, ACD and VD (AA versus TT, 0.23D vs. 0.70D; 23.79 mm vs. 23.52 mm; 2.72 mm vs. 2.65 mm; 16.12 mm vs. 15.87 mm; all P < 0.001). Children carrying two risk alleles had larger AL/CR at ages 6 and 9 years (2.88 vs. 2.87 and 3.00 vs. 2.96; all P < 0.001). Education and ERS both negatively influenced myopia and the biometric outcomes, but gene-environment interactions did not reach statistical significance (SI 1.25 [95% confidence interval {CI}, 0.85-1.85] and 1.17 [95% CI, 0.55-2.50] in adults and children).CONCLUSIONS. The elongation of the eye caused by the GJD2 risk genotype follows a dose-response pattern already visible at the age of 6 years. These early effects are an example of how a common myopia gene may drive myopia.Ophthalmic researc

National laboratory-based surveillance system for antimicrobial resistance: a successful tool to support the control of antimicrobial resistance in the Netherlands

An important cornerstone in the control of antimicrobial resistance (AMR) is a well-designed quantitative system for the surveillance of spread and temporal trends in AMR. Since 2008, the Dutch national AMR surveillance system, based on routine data from medical microbiological laboratories (MMLs), has developed into a successful tool to support the control of AMR in the Netherlands. It provides background information for policy making in public health and healthcare services, supports development of empirical antibiotic therapy guidelines and facilitates in-depth research. In addition, participation of the MMLs in the national AMR surveillance network has contributed to sharing of knowledge and quality improvement. A future improvement will be the implementation of a new semantic standard together with standardised data transfer, which will reduce errors in data handling and enable a more real-time surveillance. Furthermore, the

Differences between Scheimpflug and optical coherence tomography in determining safety distances in eyes with an iris-fixating phakic intraocular lens

Purpose To investigate the agreement and reliability of anterior segment optical coherence tomography (AS-OCT) and Scheimpflug imaging in measuring the distance from the anterior edge of an iris-fixated phakic intraocular lens (IF-pIOL) to the corneal endothelium. Methods Anterior segment configuration was assessed in a total of 62 eyes of which 25 hyperopic and 37 myopic eyes, all corrected with an IF-pIOL. Measurements were performed by two independent observers using AS-OCT (Visante, Model 1000, Carl Zeiss Meditec Inc.) and Scheimpflug imaging (Pentacam HR, Oculus Optikgerate). The distance from the anterior edge of the pIOL to the endothelium was measured in five different positions using both modalities with their corresponding pIOL software. The measurements as well as the inter- and intra-observer reliability of the two imaging modalities were then compared. Results Distance measurements for all positions performed by AS-OCT were found to be significantly larger than those performed by Scheimpflug imaging, with mean differences ranging from 0.11 to 0.22 mm. Both instruments exhibited good inter- and intra-observer reliability. Conclusion Anterior pIOL edge to endothelium distance measurements by AS-OCT and Scheimpflug imaging have good intra- and inter-observer reliability. However, as AS-OCT provides larger measurements, these two modalities cannot be used interchangeably. Correction of this difference might be essential for proper decision-making during pre-operative screening for pIOL implantation and post-operative safety monitoring