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

Ophthalmology

OBJECTIVE: To estimate the incidence and assess the risk factors associated with 3 adverse events (AE) of interest after Nd:YAG 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: Nd:YAG-caps patients were identified using data from the French national 1/97(th) representative sample and followed-up for 12 months post-Nd:YAG-caps. The time to AE was assessed using Kaplan-Meier method. Factors associated with AE were assessed using Cox models. MAIN OUTCOME MEASURES: Nd:YAG-caps epidemiology; patients' characteristics; proportion of patients with AE; Hazard ratios (HRs) associated to variables identified as factors associated with AEs of interest, overall and by AE. RESULTS: During the study period, 6,210 patients with Nd:YAG-caps were identified (7,958 procedures). The mean age (±sd) at Nd:YAG-caps was 75.0 (±10.3) years. The 3-month and 12-month overall AE rates (≥1 AE of interest [OHT, ME, RD]) 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 similar for OHT and ME (≈5%). RD rate remained ≤0.5% over the entire follow-up. Cox models showed that patients with Nd:YAG-caps performed within 1-year post-cataract surgery were of higher risk of AE than those with later Nd:YAG-caps (HR 1.314 [1.034-1.669], p=0.0256). 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=<.0001) than non-diabetic ones. Patients with Nd:YAG-caps within 1-year post-cataract surgery were more at risk of ME (HR 1.500 [1.087-2.070], p=0.0137). Patients with Nd:YAG-caps performed between the first- and second-year post-cataract were more at risk of OHT than patients with later Nd:YAG-caps (HR 1.429 [1.185-1.723], p=0.0002). CONCLUSIONS: Based on a national claims database, OHT and ME were the most frequent AE of interest post-Nd:YAG-caps, mainly observed within the first 3 months post-procedure, highlighting the need for a close follow-up during this period or a delayed capsulotomy if possible. Diabetes and an early Nd:YAG-caps post-cataract surgery were among the main drivers for AE occurrence

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

Complications of cosmetic iris implants: French series of 87 eyes

International audienceIris 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