Incidence of Retinal Detachment, Macular Edema, and Ocular Hypertension after Neodymium:Yttrium-Aluminum-Garnet Capsulotomy: A Population-Based Nationwide Study-The French YAG 2 Study.

PURPOSE: To estimate the incidence and assess the risk factors associated with 3 adverse events (AEs) after neodymium:yttrium-aluminum-garnet posterior capsulotomy (Nd:YAG-caps): ocular hypertension (OHT), macular edema (ME), and retinal detachment (RD). DESIGN: Observational cohort study using a nationwide claims database. PARTICIPANTS: Adults who underwent Nd:YAG-caps between 2014 and 2017, with no ocular disease history in the year before. METHODS: Patients who underwent Nd:YAG-caps were identified using data from the French national representative sample and followed up for 12 months postprocedure. The time to AE was assessed using the Kaplan-Meier method. Factors associated with AE were assessed using Cox models. MAIN OUTCOME MEASURES: Neodymium:YAG-caps epidemiology, patients' characteristics, proportion of patients with AE, and hazard ratios (HRs) associated with variables identified as factors associated with AEs. RESULTS: During the study period, 6210 patients received Nd:YAG-caps (7958 procedures). The mean age (± standard deviation) at Nd:YAG-caps was 75.0 (± 10.3) years. The 3-month and 12-month overall AE rates (≥ 1 AE of interest) were 8.6% and 13.3%, respectively. Among patients with ≥ 1 AE of interest, 68.4% of AEs occurred within 3 months post-Nd:YAG-caps. Three-month rates were ≈5% for OHT and ME. Retinal detachment remained ≤ 0.5% over follow-up. Cox models showed that patients with Nd:YAG-caps performed within 1 year after cataract surgery had a higher risk of AEs than those with later Nd:YAG-caps (hazard ratio [HR], 1.314 [1.034-1.669], P = 0.0256), notably ME (HR, 1.500 [1.087-2.070], P = 0.0137). Diabetic patients were more at risk of OHT (HR, 1.233 [1.005-1.513], P = 0.0448) and ME (HR, 1.810 [1.446-2.266], P < 0.0001) than nondiabetic patients. Patients with Nd:YAG-caps performed between 1 and 2 years after cataract surgery were more at risk of OHT than patients with later Nd:YAG-caps (HR, 1.429 [1.185-1.723], P = 0.0002). CONCLUSIONS: According to a national claims database, OHT and ME were the most frequent AEs of interest post-Nd:YAG-caps, mainly observed within 3 months postprocedure, highlighting the need for a close follow-up during this period or a delayed capsulotomy. Diabetes and an early Nd:YAG-caps after cataract surgery were among the main drivers for AE occurrence. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Incidence of Nd:YAG laser capsulotomy following cataract surgery: a population-based nation-wide study - FreYAG1 study.

RATIONALE: Nd:YAG (neodymium:yttrium-aluminum-garnet) capsulotomy (Nd:YAG-caps) is the gold standard for the treatment of PCO (Posterior Capsule Opacification). There is a lack of real-world data about Nd:YAG-caps use. PURPOSE: This study's objectives were to estimate Nd:YAG-caps incidence in France, to describe the patient characteristics, and to analyze the time between surgeries and capsulotomies. SETTING: The study was based on data extracted from the EGB database, a 1/97th sample representative of the French population. DESIGN: observational, retrospective, cohort study using national claims data. METHODS: French adult patients who underwent Nd:YAG-caps between 2014 and 2017 were selected. Main outcomes were the number of patients and procedures performed and the risk factors associated with early Nd:YAG-caps. RESULTS: During the study period, Nd:YAG-caps were performed in 8,425 patients accounting for 10,774 procedures. The extrapolation to the French population led to estimate that 253.103 patients had Nd:YAG-caps, representing 312.103 procedures in 2017. The mean age at Nd:YAG-caps was 75.1 (± 10.2) years. About 36% of patients presented at least one ocular comorbidity. Nd:YAG-caps was performed within 2 years after surgery in 33.0% of patients and within one year in 9.8% of patients. Patients with Nd:YAG-caps within the first year (OR CI95 0.721 [0.673-0.772]) or in the first two years (OR CI95 0.721 [0.673-0.772]) were younger than patients with later Nd:YAG-caps and had a more frequent history of treated ocular diseases (OR 1.516 and 1.178, respectively). CONCLUSIONS: This study brought new real-world and large-scale data regarding Nd:YAG-caps use and gave an updated insight into the patients' characteristics.

Clinical outcomes with a trifocal intraocular lens: a multicenter study.

PURPOSE: To evaluate the clinical results and safety obtained with a new type of multifocal intraocular lens (IOL) using a trifocal design to achieve pseudoaccommodation. METHODS: A pilot observational study of patients with a trifocal IOL (FineVision; PhysIOL, Liege, Belgium) implanted by 1 of 12 surgeons between March and December 2010. Visual outcomes that were assessed postoperatively included uncorrected and corrected distance, intermediate, and near visual acuity. RESULTS: One hundred ninety-eight eyes of 99 patients were analyzed. Patients were observed for an average of 6.44 ± 4.67 months (range: 0.2 to 17 months). Preoperative corrected distance visual acuity was 0.22 ± 0.26 logMAR. At the final follow-up visit, corrected distance visual acuity was 0.01 ± 0.10 logMAR, uncorrected distance visual acuity was 0.01 ± 0.06 logMAR, uncorrected intermediate visual acuity was 0.08 ± 0.10 logMAR, and mean uncorrected near visual acuity was 0.00 ± 0.04 logMAR. Postoperative binocular uncorrected distance visual acuity was 0.01 ± 0.07 logMAR, uncorrected intermediate visual acuity was 0.06 ± 0.08 logMAR, and uncorrected near visual acuity was -0.03 ± 0.04 logMAR. Postopeative mean residual sphere was 0.21 ± 0.48 diopters (D), with a residual cylinder of -0.24 ± 0.31 D. Postoperative spherical equivalent was 0.11 ± 0.36 D. CONCLUSIONS: The results demonstrated that the trifocal FineVision IOL is able to restore near, intermediate, and distance visual function.

Impact of a handpiece with a built-in fluidics pressure sensor on phacoemulsification: a multicentre prospective comparative study.

OBJECTIVE: We assessed whether the immediate pressure adjustments provided by a phacoemulsification handpiece with a built-in pressure sensor (Active Sentry, AS) could decrease the amount of energy delivered in the eye during cataract surgery. METHODS AND ANALYSIS: The Study of Active Sentry in Cataract Surgery was a multicentre prospective clinical trial. The Centurion system (Alcon Labs) was used and we compared phacoemulsifications performed with the AS handpiece with procedures using a sensor placed in the phacoemulsifier (non-AS). The primary outcome measure was the cumulative dissipated energy (CDE) used during the procedures. The secondary outcome measures were the total, longitudinal and torsional ultrasound (US) times, the duration of the surgery and the amount of fluid used during the surgeries. RESULTS: The study analysed 1432 (800 AS and 632 non-AS) procedures. The mean patient age was 72.4±10.0 years. The median CDE was respectively 6.3 (IQR 3.5-9.9) and 6.7 (IQR 4.5-11.5) with and without AS (p=0.0001). The median US time was, respectively, 48.0 s (IQR 34.0-68.0) and 55.0 s (IQR 38.0-80.0) with and without AS (p<0.0001). Torsional and longitudinal US times were reduced with AS. The median duration of the procedure was, respectively, 9.0 min (IQR 7.0-12.0) and 10.0 min (IQR 7.0-13.0) (p=0.0002) with and without AS. The median balanced salt solution volume used was 52.0 cm3 (IQR 41.0-72.0) and 57.0 cm3 (IQR 42.0-81.0) with and without AS (p=0.0018). CONCLUSION: The phacoemulsifications performed with a pressure sensor built in the handpiece delivered less energy in the eye and were shorter. TRIAL REGISTRATION NUMBER: NCT04732351.

Complications of cosmetic iris implants: French series of 87 eyes.

PURPOSE: Iris intraocular implants were developed to manage congenital or traumatic iris defects. However, they are also used to change the color of patient eyes. The aim of this retrospective series was to report complications in patients managed in France after cosmetic implantation. SETTING: Ophthalmological institutions and private ophthalmologists in France. DESIGN: Multicenter retrospective observational study. METHODS: Questionnaires were sent to all ophthalmology departments in university hospitals and to private ophthalmologists. This questionnaire listed demographic and clinical data for each implanted eye with a focus on safety, the description of ocular complications (corneal edema, endothelial cell loss, increased intraocular pressure, and intraocular inflammation), and the therapeutic management implemented. RESULTS: Forty-four questionnaires (87 eyes) were collected, and ultimately, 33 questionnaires (65 eyes) were considered complete and analyzed. Two types of implants were identified. Of the 65 eyes analyzed, only 5 eyes (7.7%) did not experience any complication and 60 eyes (92.3%) had at least 1 complication. The most commonly reported complication was corneal decompensation (78.5%). The diagnosis of glaucoma was made in over half (52.3%) of the cases. Explantation was needed in 81.5% of cases. The mean final visual acuity was 0.45 ± 0.08 logarithm of the minimum angle of resolution (logMAR) (0 to 2 logMAR). CONCLUSIONS: Several ocular complications with a decreased mean visual acuity were described in a young healthy population. In addition, patient information on the safety of this procedure appeared insufficient.

Systemic exposure to intracameral vs topical mydriatic agents: in cataract surgery.

OBJECTIVE: The objective of this study was to compare systemic exposure to tropicamide/phenylephrine following intracameral or topical administration before cataract surgery. PATIENTS AND METHODS: Mydriatics exposure was calculated in patients randomized to intracameral fixed combination of mydriatics and anesthetic ([ICMA]: tropicamide 0.02%, phenylephrine 0.31%, and lidocaine 1%, N=271) or mydriatic eye drops ([EDs]: tropicamide 0.5% and phenylephrine 10%, N=283). Additional doses were permitted if required. Mydriatic plasma levels were determined by mass spectrometric HPLC in 15 patients per group before and after administration. RESULTS: Most ICMA patients (73.6%) received a single dose (200 µL) representing an exposure to tropicamide of 0.04 mg and phenylephrine of 0.62 mg. None of these patients received additional mydriatics. In the control group (three administrations), the exposure was 0.45 (11.3-fold higher than ICMA) and 10.2 (16.5-fold higher) mg. When additional ED was used in this group (9.2% of patients), it was 37.5-fold higher for tropicamide (10 drops, 1.5 mg) and 54.8-fold higher for phenylephrine (10 drops, 34 mg) than the recommended ICMA dose. Tropicamide plasma levels were not detectable at any time point in ICMA patients while it was detectable in all ED patients at 12 and 30 minutes. Phenylephrine was detectable in 14.3% of ICMA patients compared to all ED patients at least at one time point. More ED patients experienced a meaningful increase in blood pressure and/or heart rate (11.2% vs 6.0% of ICMA patients; P=0.03). CONCLUSION: Systemic exposure to tropicamide/phenylephrine was lower and cardiovascular (CV) effects were less frequent with ICMA. This could be of particular significance in patients at CV risk.

European multicenter study of the AcrySof ReSTOR apodized diffractive intraocular lens.

OBJECTIVE: To report the safety and effectiveness of the AcrySof ReSTOR apodized diffractive intraocular lens (IOL), model MA60D3, when implanted into the capsular bag. DESIGN: Multicenter European study including university clinics, eye hospitals, and private ophthalmic surgical centers. PARTICIPANTS: One hundred twenty-seven subjects implanted in cataractous eyes in an open multicenter study. INTERVENTION: After phacoemulsification, the foldable 3-piece hydrophobic acrylic apodized diffractive IOL was implanted in the capsular bag using a Monarch injector with an A-cartridge. The mean preoperative patient age was 68.4+/-12 years. Intraocular lens implant power ranged from 18.0 to 25.0 diopters (D) in 0.5-D increments. MAIN OUTCOME MEASURES: Distance visual acuity (VA), near VA, spectacle dependence, unwanted visual symptoms, and patient satisfaction. RESULTS: At the 6-month postoperative visit, binocular (both eyes simultaneously) mean uncorrected distance and near logarithm of the minimum angle of resolution VAs for the MA60D3 were 0.04+/-0.14 and 0.09+/-0.12 (n = 118), respectively. In addition, 88.0% and 84.6% of ReSTOR subjects achieved spectacle independence for distance and near vision, respectively. Glare and halos were reported as severe by only 8.5% and 4.2% of patients, respectively. Ninety-two percent of patients stated that they would choose to have the same lens implanted again after the first implant, and 95.7% answered likewise after the second implant. CONCLUSIONS: The AcrySof ReSTOR MA60D3 IOL demonstrated excellent near VA without compromising distance vision. Spectacle independence and patient satisfaction were high, whereas unwanted photic phenomena were clinically acceptable.

Early opacification of silicone intraocular lenses: Laboratory analyses of 6 explants.

PURPOSE: To report laboratory analyses of 6 intraocular lenses (IOLs) explanted from patients who had visual disturbances caused by early postoperative opacification of the lens optic. SETTING: John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA. METHODS: Six patients with 3-piece silicone lenses presented with optic cloudiness as early as a few hours after implantation. The lenses were implanted in 4 locations in Brazil and in France. The lenses in Brazil were stored at the same location before implantation. Gross and microscopic analyses were performed (dry and hydrated states). One half of each specimen underwent gas chromatography/mass spectrometry (GC/MS) analysis and/or extraction by isopropyl alcohol or acetonitrile. One lens also underwent scanning electron microscopy (SEM) with energy dispersive x-ray spectroscopy (EDS). The IOLs were examined for the presence of contaminants or deposits that could cause fast optic opacification. RESULTS: The IOLs showed a white optic discoloration in the hydrated state but became transparent on complete dehydration. Suspect exogenous chemical compounds were identified in GC/MS analyses; general classes included terpenes and ketones, typically found in industrial cleaning agents and fumigants. Surface analysis (SEM and EDS) did not show any significant deposits on the external surfaces and sagittal cut in 1 of the specimens. CONCLUSIONS: Most IOLs are enclosed in semipermeable packages to allow sterilization by ethylene oxide gas. During cleaning or disinfection of storage rooms, aerosolized solutions may introduce chemicals through the package and onto the IOLs. This may cause surface changes in the IOL, promoting opacification by water ingress in the aqueous environment. Cleaning and disinfection procedures of IOL storage areas should be monitored carefully.

Evaluation of visual outcomes and patient satisfaction after implantation of a diffractive trifocal intraocular lens.

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.

Assessment of capsular block syndrome with anterior segment optical coherence tomography.

A 59-year-old woman developed progressive, moderate myopia 1 year after routine phacoemulsification and insertion of a soft posterior chamber intraocular lens (IOL). After biomicroscopy, late capsular block was diagnosed and treated with a neodymium:YAG laser posterior capsulotomy. The myopia disappeared immediately. This case was illustrated using optical coherence tomography developed for the anterior segment. After capsulotomy, the IOL moved backward by 448 microm, corresponding to -0.75 diopter of induced myopia.

Visual and refractive outcomes after implantation of a fully diffractive trifocal lens.

BACKGROUND: The purpose of this study was to record the visual outcomes of patients treated by six surgeons after implantation of a trifocal lens. METHODS: The setting for this study comprised six ophthalmology units and eye clinics in Belgium and France, with a coordinating center in France, and data management and statistical analysis in France and Belgium. Ninety-four eyes from 47 patients were implanted with a trifocal FineVision(®) intraocular lens by six surgeons. Monocular and binocular, uncorrected and best distance-corrected, and photopic and mesopic visual acuity was measured, as well as the defocus curve between +4 D and -4 D with best distance correction. RESULTS: Near and far monocular visual acuities were similar to the data published after bifocal intraocular lens implantation. Intermediate vision was improved, and was demonstrated by scores of near visual acuity as well as far visual acuity with defocus -1.5 D-add lens. Far vision is maintained in mesopic conditions. CONCLUSION: The trifocal intraocular lens provides good far, intermediate, and near visual acuity.

Assessment of patient satisfaction with outcomes of and ophthalmic care for cataract surgery.

PURPOSE: To assess patient satisfaction with cataract surgery care. SETTING: Private and public health ophthalmic centers, France. METHODS: This prospective longitudinal multicenter observational study enrolled patients attending consultation for a preoperative visit from September 2007 to February 2008. Patients were eligible if they had uncomplicated cataract and agreed to participate. At the preoperative visits, medical data and disease history were collected. At the first postoperative visit (at 1 to 7 days), the following data were collected: patient status, surgical procedure, and follow-up (patient management, complications, medications). Patients completed a questionnaire after each visit to assess satisfaction with their management and follow-up before, during, and after surgery (up to 30 days postoperatively). RESULTS: Of the 781 patients enrolled by 91 ophthalmologists, 41 were excluded for not meeting eligibility criteria, leaving 740 patients in the statistical analysis. Cataract extraction was by phacoemulsification. The incision was 2.2 to 3.2 mm in 94.7% of cases, and the intraocular lens was acrylic in 96.3% of cases. Anesthesia was mainly topical (56.8%) or local (42.1%). The most frequent postoperative treatments were nonsteroidal antiinflammatory eyedrops and combined steroidal and antibacterial eyedrops (95.9% and 94.7%, respectively). Most patients (96.4%) said the surgery results met their expectations, and 67.2% reported being able to perform activities they could not do preoperatively. Overall, 98.2% of patients said they were satisfied with their management. CONCLUSION: Assessment of the management and follow-up of patients having cataract surgery showed that the care provided was in accordance with the expectations of French patients. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.