Safety of EVO ICL Implantation With an Ophthalmic Viscosurgical Device-Free Technique in the Early 24 h After Surgery.
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ABSTRACT:
SUBMITTER: Zhang Z
PROVIDER: S-EPMC8635781 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Purpose:To assess the efficacy and safety of a novel ophthalmic viscosurgical device-free (OVD-free) method for posterior chamber phakic intraocular lens (PIOL) implantation in myopic eyes. Methods:In this retrospective cohort study, the medical records of myopic eyes that underwent PIOL (Implantable Collamer Lens, ICL) implantation for myopia correction at the Eye Hospital of Wenzhou Medical University between May 2015 and March 2017 were reviewed. A total of 49 eyes with complete data that met follow up requirements (2?h, 1?day, 1?week, 3?months postoperatively) were recruited. Based on the surgical techniques used, the eyes were divided into the OVD-free method group and the standard method group. The clinical data, including intraocular pressure (IOP), corrected distance visual acuity (CDVA) and spherical equivalent (SE), at each follow-up were collected for comparison. Endothelial cell loss and complications were also investigated. Results:Twenty-one eyes received the standard method, and 28 eyes received the OVD-free method. A rise in IOP >?22?mmHg at 2?h was noted in 14 eyes (66.7%) in the standard group and none (0%) in the OVD-free group (p?<?0.001). The rise in IOP from baseline was significantly higher at 2?h in the standard group (10.5?±?5.2?mmHg vs. 2.2?±?3.3?mmHg, difference: 8.3, 95% CI 5.8 to 10.8; p <?0.001). There was a significant difference in the time course of LogMAR CDVA changes between the two groups (p?=?0.047). The LogMAR CDVA was significantly better in the OVD-free method group compared to the standard group at 1?day (-?0.076, 95% CI -?0.134 to -?0.018; p?=?0.012), 1?week (-?0.071, 95% CI -?0.135 to -?0.007; p?=?0.03), but not at 3?months (-?0.046, 95% CI -?0.107 to 0.015; p?=?0.134). There was no significant difference in the time course of SE changes between the two groups (p?=?0.471; p?=?0.705). In the OVD-free group, mean endothelial cell loss was 4.6% at 3?months (2522?±?281 vs. 2407?±?226 cells/mm2, difference: -115, 95% CI -?295 to 65; p?=?0.187). No complications were reported in both groups except for the early IOP elevation in the standard group during the observation period. Conclusions:The OVD-free method is safe and efficient for ICL implantation. It can be a safer method of ICL implantation compared to the standard method in that it completely eliminates ophthalmic viscoelastic devices-related complications without causing additional complications.
| S-EPMC7137322 | biostudies-literature
Project description:BackgroundOphthalmic viscoelastic devices (OVDs) used during small-incision cataract surgery have numerous advantages. However, OVDs have longer retention time in an eye after surgery resulting in intraocular pressure (IOP) spikes. The purpose of this study is to analyze and quantify the effect of various OVDs on both IOP and best corrected visual acuity (BCVA) by systematically reviewing the literature and performing meta-analysis.MethodsNumerous databases from January 1, 1985, to present were systematically searched. Thirty-six (3893 subjects) of 3313 studies identified were included for analysis. Standardized mean difference (SMD) was computed, and meta-analysis was performed.ResultsA total of 3313 records were retrieved including 1114 from database search and 2199 from grey literature search. Significant increase in postoperative IOP in 1-day follow-up with Healon (SMD = 0.37, CI: [0.07, 0.67]), Viscoat (SMD = 0.29, CI: [0.13, 0.45]), Provisc (SMD = 0.46, CI: [0.17, 0.76]), and Soft Shell (SMD = 0.58, CI: [0.30, 0.86]) was computed. On the other hand, results implied a nonsignificant increase in postoperative IOP with Healon GV (SMD = 0.07, CI: [-0.28, 0.41]), Healon5 (SMD = 0.15, CI: [-0.33, 0.64]), 2% HPMC (SMD = 0.32, CI: [-0.0, 0.64]), and OcuCoat (SMD = 0.26, CI: [-0.37, 0.9]). Additionally, a nonsignificant reduction in postoperative IOP was inferred with Viscoat + Provisc (SMD = -0.28, CI: [-2.23, 1.68]).ConclusionImprovement in IOP was shown with Viscoat + Provisc. Additionally, IOP nonsignificant upsurge was observed with Healon GV, Healon5, 2% HPMC, and OcuCoat compared to significant upsurge with Healon, Viscoat, and Soft Shell.
| S-EPMC7593745 | biostudies-literature
Project description:PurposeTo investigate the morphological changes of concave iris in myopic patients after EVO implantable collamer lens (ICL) implantation.MethodsEVO ICL candidates with posterior bowing iris were observed using ultrasound biometric microscopy (UBM) in this prospective nonrandomized observational study. Forty patients were enrolled, with 20 patients in the concave iris group and the other 20 patients in the control group. None of the patients underwent laser peripheral iridotomy. All patients received preoperative and postoperative examinations, which included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), subjective manifest refraction and intraocular pressure. UBM was used to observe iris curvature (IC), irido-corneal angle (ICA), posterior chamber angle (PCA), iris-lens contact distance (ILCD), iris-zonule distance (IZD) and ciliary process length (CPL). Anterior chamber angle pigment was observed by gonioscopy. The preoperative and postoperative data were analyzed using SPSS.ResultsThe average follow-up period was 13.3 ± 5.3 months. The mean efficacy indices were 1.10 ± 0.13 and 1.07 ± 0.11 (P = 0.58), and the safety indices were 1.19 ± 0.09 and 1.18 ± 0.17 in the control group and the concave iris group (P = 0.93), respectively. The IOP postoperatively were 14.13 ± 2.02 mmHg and 14.69 ± 1.59 mmHg in control and concave iris groups (P = 0.37). Preoperatively, the concave iris group was presented with greater IC (P < 0.0001), longer ILCD (P < 0.0001), wider ICA (P = 0.004), narrower PCA (P = 0.01), and shorter IZD (P = 0.03) than the control group. In the concave iris group, IC, ILCD and ICA were significantly decreased after ICL implantation (P < 0.0001), while PCA and IZD were significantly increased (P = 0.03 and P = 0.04, respectively). Postoperative IC, ILCD, ICA, PCA and IZD were not statistically different between groups (P > 0.05). There was no significant difference in pigment deposition grades between the two groups (P = 0.37).ConclusionAfter EVO ICL implantation, the morphology of concave iris was significantly improved, which may reduce the risk of intraocular pigment dissemination caused by iris concavity. The concave iris has no impact on the safety of EVO ICL surgery during the follow-up.
| S-EPMC10068169 | biostudies-literature
Project description:PurposeTo evaluate the safety and effectiveness of a new dispersive ophthalmic viscosurgical device (OVD) (ClearVisc) compared with an approved dispersive OVD (Viscoat) when used in cataract surgery.Setting16 clinics in the United States.DesignProspective multicenter controlled randomized 1:1 (ClearVisc:Viscoat; stratified by site, age group, and cataract severity). Patients and examiners masked.MethodsPatients aged 45 years or older with age-related noncomplicated cataract considered amenable to treatment with standard phacoemulsification cataract extraction and intraocular lens (IOL) implantation were included. Patients were randomized to receive either ClearVisc or Viscoat using standard techniques. 5 postoperative visits occurred at 6 hours, 24 hours, 7 days, 1 month, and 3 months. The primary effectiveness outcome was the change in endothelial cell density (ECD) from baseline to 3 months. The primary safety end point was the proportion of patients who experienced at least 1 intraocular pressure (IOP) measurement ≥30 mm Hg at any follow-up visit. Noninferiority was tested. Inflammation and adverse events were evaluated.Results372 patients were randomized: 184 patients in the ClearVisc group and 188 patients in the Viscoat group. ClearVisc was noninferior to Viscoat in mean percentage of ECD loss from baseline to 3 months (8.4% and 6.8%, respectively). ClearVisc was significantly noninferior to Viscoat in the proportion of patients with postoperative IOP ≥30 mm Hg at any follow-up visit (17.4% and 20.3%, respectively, P = .0002).ConclusionsClearVisc dispersive OVD provides surgeons with a new option in the continuum of approved dispersive OVDs with beneficial properties as a surgical aid in cataract extraction and IOL implantation.
| S-EPMC9415196 | biostudies-literature
Project description:PurposeThe purpose of this study was to compare the efficacy and safety of cataract surgery by the phacoemulsification technique with and without the use of ophthalmic viscosurgical devices (OVDs).SettingThis study was conducted at a tertiary eye care center in a rural area of Central India.DesignThis was a prospective, randomized, observational study.MethodsIn this study, 220 patients underwent phacoemulsification for cataract surgery with OVDs (OVD group) or without OVDs (BSS group) (n = 110 in each group). Patients with operable, nuclear Grade 2-4 cataracts were included in the study. The study was conducted from June 2017 to September 2018. The frequency of intraoperative complications, surgical time, and ease of the surgical procedure (easy, difficult, or very difficult) were recorded.ResultsThere was no statistically significant difference in the nuclear opalescence, axial length, and intraocular lens (IOL) power between the two groups. Capsulorhexis extension was seen in two eyes in the OVD group and none of the eyes in the BSS group. The problems that occurred during IOL implantation included flip (OVD group, 2; BSS group, 1), haptic breakage (OVD group, 1; BSS group, 1), sulcus implantation (OVD group, 0; BSS group, 2), and stuck haptic (OVD group, 1; BSS group, 3). The total surgical time was almost equal in the two groups (OVD group, 9.2 min ± 3; BSS group, 9.5 min ± 3.5; P = 0.521). None of the patients had iris trauma or posterior capsular rupture.ConclusionsOVD-less phacoemulsification surgery is a safe and effective technique for treating age-related cataracts that requires no additional instrumentation and saves the cost of the OVD.
| S-EPMC7276164 | biostudies-literature
Project description:Bacterial endotoxins are lipopolysaccharides bound to the bacterial cell wall and released when bacteria rupture or disintegrate. Possible contamination of endotoxin in ophthalmic devices can cause a painful eye inflammation or result in toxic anterior segment syndrome after cataract surgery. Measurement of bacterial endotoxin in medical device materials is difficult since endotoxin binds with polymer matrix and some of the materials are very viscous and non-water soluble, where traditional enzyme-based Limulus amebocyte lysate (LAL) assay cannot be applied. Here we propose a rapid and high throughput ambient ionization mass spectrometric (MS) method using direct analysis in real time (DART) for the evaluation of endotoxin contamination in medical device materials. Large and structurally complex endotoxin instantaneously breaks down into low-mass characteristic fragment ions using DART and is detected by MS in both positive and negative ion modes. This method enables the identification and separation of endotoxin from medical materials with a detection limit of 0.03 ng mL-1 endotoxins in aqueous solution. Ophthalmic viscosurgical device materials including sodium hyaluronate (NaHA), non-water soluble perfluoro-n-octane (PFO) and silicone oil (SO) were spiked with different known concentrations of endotoxin and analyzed by DART MS, where the presence of endotoxin was successfully detected and featured small mass fragment ions were generated for NaHA, PFO and SO as well. Current findings showed the feasibility of measuring endotoxin contamination in medical device materials using DART-MS, which can lead to a one-step analysis of endotoxins in different matrices, avoiding any potential contamination during sample pre-treatment steps.
| S-EPMC5500980 | biostudies-literature
Project description:PurposeTo evaluate the safety and effectiveness of collamer posterior chamber phakic refractive lenses with a central port design (EVO and EVO+ Sphere and Toric implantable collamer lenses [ICLs]) for correction of moderate myopia with or without astigmatism.Patients and methodsSix-month results of a multicenter clinical trial were performed under United States FDA Investigational Device Exemption. Subjects 21 through 45 years of age with manifest refraction spherical equivalent ranging from -3.00 D to -6.00 D and astigmatism up to 4.00 D underwent implantation of EVO or EVO+ Sphere or Toric ICLs. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, intraocular pressure (IOP), endothelial cell density, and adverse events were evaluated over 6 months.ResultsThis report includes a retrospective review of 200 eyes of 114 subjects with mean age 35.1 ± 5.1 years that completed the 6-month visit. Mean preoperative spherical equivalent (SE) measured -4.61 ± 0.87 D (range: -3.00 to -6.00 D). At 6 months, mean SE was -0.085 ± 0.26 D, with 91.5% within ± 0.50 D of target and 100.0% within ±1.00 D of target. Mean postoperative UDVA and CDVA were -0.065 ± 0.08 logMAR and -0.14 ± 0.07 logMAR, respectively. About 98.0% of eyes maintained or gained lines of CDVA, and no eye lost more than 1 line CDVA. Efficacy and safety indices were 1.03 and 1.21, respectively. No eye experienced pupillary block, required preoperative or postoperative peripheral iridotomy or iridectomy, developed anterior subcapsular cataract or had elevated IOP due to angle narrowing or pigment dispersion. Mean endothelial cell density declined by 2.2%.ConclusionEVO ICL lenses demonstrated accuracy, predictability and stability of refractive correction with achievement of high levels of UDVA and an excellent safety profile for patients with moderate myopia with or without astigmatism.
| S-EPMC9738966 | biostudies-literature
Project description:PurposeTo evaluate the safety and effectiveness of Collamer posterior chamber phakic refractive lenses with a central port design (EVO and EVO+ Sphere and Toric Visian ICLs) for correction of moderate-to-high myopia with or without astigmatism.Patients and methodsSix-month results of a multicenter clinical trial performed under United States FDA Investigational Device Exemption. Subjects 21 through 45 years of age with myopia ranging from -3.00 D to -20.00 D and astigmatism up to 4.00 D underwent implantation of EVO or EVO+ Sphere or Toric Visian ICLs. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, intraocular pressure (IOP), endothelial cell density, and adverse events were evaluated over 6 months.ResultsThis clinical trial enrolled 629 eyes of 327 subjects with mean age 35.6 ± 5.09 years. Mean preoperative spherical equivalent (SE) measured -7.62 ± 2.75 D (range: -3.00 to -15.62 D). At 6 months, mean SE was -0.079 ± 0.33 D, with 90.5% within ± 0.50 D of target and 98.9% within ±1.00 D of target. Mean postoperative UDVA and CDVA were -0.059 ± 0.10 logMAR and -0.13 ± 0.08 logMAR, respectively. 52.3% of eyes gained lines of CDVA. Efficacy and safety indices were 1.06 and 1.24, respectively. No eye experienced pupillary block, required peripheral iridotomy or iridectomy, developed anterior subcapsular cataract or had elevated IOP due to angle narrowing or pigment dispersion. Mean endothelial cell density declined by 2.3%.ConclusionEVO ICL lenses demonstrated accuracy of refractive correction and achievement of high levels of UDVA. This clinical trial confirmed that the central port design of EVO and EVO+ Sphere and Toric Visian ICL lenses functions effectively to allow physiologic flow of aqueous humor, thus eliminating the requirement for preoperative peripheral iridotomies. The results of this clinical trial resulted in FDA approval on March 25, 2022.
| S-EPMC9132105 | biostudies-literature
Project description: Not available
| S-EPMC8299043 | biostudies-literature
Project description:ObjectivesSeveral studies have shown the potential advantage of less-invasive surgery (LIS) for left ventricular assist device (LVAD) implantation. This study aims to determine the impact of LIS on stroke and pump thrombosis events after LVAD implantation.MethodsBetween January 2015 and March 2021, 335 consecutive patients underwent LVAD implantation using either conventional sternotomy (CS) or the LIS technique. Patient characteristics was prospectively collected. All patients were followed up until October 2021. Logistic multivariate regression and propensity-matched analyses were performed to account for confounding factors.ResultsA total of 242 patients (F = 32; 13.0%) underwent LVAD implantation with CS and 93 patients (F = 8; 8.6%) with the LIS approach. Propensity matching generated two groups, including 98 patients in the CS group and 67 in the LIS group. Intensive care unit stay for the LIS group patients was significantly shorter than that for the CS group patients [2 (IQR: 2-5) days vs. 4 (IQR: 2-12) days, p < 0.01]. There were no significant differences in the incidence of stroke events (14% in CS vs. 16% in the LIS group; p = 0.6) or in pump thrombosis (6.1% in CS vs. 7.5% in the LIS group; p = 0.8) between the groups. The hospital mortality rate in the matched cohort was significantly lower in the LIS group (7.5% vs. 19%; p = 0.03). However, the 1-year mortality rate showed no significant difference between both groups (24.5% in CS and 17.9% in LIS; p = 0.35).ConclusionsThe LIS approach for LVAD implantation is a safe procedure with potential advantage in the early postoperative period. However, the LIS approach remains comparable to the sternotomy approach in terms of postoperative stroke, pump thrombosis, and outcome.
| S-EPMC10213891 | biostudies-literature