Preloaded Delivery System Research Articles

Small-Incision new generation implantable miniature telescope surgical technique and patient outcomes.

Various ocular implants were suggested as a means of enhancing vision in patients with advanced age related macular degeneration. Recently, a new generation of implantable telescopes has been released. The purpose of this study is to report the surgical technique of implantation along with patient outcomes. This work focuses on the surgical technique. Crucial surgical steps are carefully reported along with discussion on main drawbacks and limitations. This approach uses a preloaded delivery system with improved features and requires a smaller incision. First patient outcomes are also reported. Surgical steps to implant this preloaded intraocular telescope are easier than previous versions, however this remains a complex procedure. Initial patient functional outcomes look promising.

Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair

ObjectiveAnalyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. MethodsA multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. ResultsOverall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. ConclusionsThe MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.

Comparative evaluation of an automated preloaded delivery system with a non-preloaded system.

To evaluate a single surgeon's experience with an automated preloaded intraocular lens (IOL) delivery system and a nonpreloaded system. This was a prospective, observational case series. Phacoemulsification was performed under topical anesthesia by creating a temporal clear corneal incision. Patients were consecutively assigned to either the Clareon group (n = 50; the IOL was injected into the capsular bag by using an automated injector system) or the AcrySof group (n = 50; the IOL was injected into the capsular bag by using a conventional injector system). The main outcome measures were ease of implantation, intraoperative complications, postoperative centration, and visual acuity. Additional manipulation in the anterior chamber was not required in 38 (74%) eyes in the Clareon group and 41 (82%) eyes in the AcrySof group. However, seven eyes in the Clareon group and one eye in the AcrySof group required trailing haptic dislodgement from the optic. Furthermore, two eyes in the Clareon group and five eyes in the AcrySof group required injector rotation (varying from 10° to 90°) in the wound. Moreover, in two eyes of the Clareon group, the silicon plunger of the injector system crossed over the optic. None of the patients developed iris trauma and PCR during IOL manipulation. All the IOLs were centered in the capsular bag. The automated IOL delivery system enables the controlled delivery of an IOL in the capsular bag. The effect of carbon footprints created by plastic generated from the delivery system and the implications of the CO2 cylinder on the environment should be addressed.

Эффективность имплантации новой асферической гидрофобной акриловой монофокальной ИОЛ в краткосрочном периоде наблюдения

Perpose. To evaluate the results of implantation of a new hydrophobic acrylic monofocal IOL in an automated preloaded delivery system in the short-term follow-up period. Material and methods. The prospective study included 89 patients (114 eyes) after bilateral or monolateral Clareon IOL implantation with a mean follow-up of 2.1 ± 0.4 (1–4) months. The age range was 53 to 87 (71.1 ± 5.2) years. A corneal incision of 1.8 mm was used in all cases. For implantation using the AutonoMe® system, the incision was enlarged by 0.2 mm for implantation IOL 26 D and higher. IOL optical power was calculated using the SRK/T formula; retrospective analysis was performed using the Hoffer Q, Haigis, Holladay II, Olsen, Barrett Universal II, and Kane formulas. Results. In all studied periods (1 day, 1 week and 1 month) there was statistically significant (p < 0.05) increase both of NCDVA (from 0.13 ± 0.02 in the preoperative period to 0.81 ± 0.07 in 1 month after surgical intervention), and BCDVA (from 0.32 ± 0.15 before surgery to 0.94 ± 0.11 after surgery). When assessing the percentage of eyes with an BCDVA of 0.9 or higher, a statistically significant (p < 0.05) difference was shown in all studied periods. The lowest MAE was shown for the Barrett Universal II (0.292), SRK/T (0.312) Kane (0.301), and Olsen (0.325) formulas. For the Hoffer Q and Holladay 2 formulas, MAE values were significantly higher (p < 0.05). The highest frequency of achieving the target refraction of ±0.25 D was shown for the Barrett Universal II and Kane formulas (68 and 69 %, respectively), and the lowest for the Hoffer Q and Holladay 2 formulas (28 and 35 %, respectively). The primary endpoint of the study (BCDVA =1.0) was achieved in 95.6 % (n = 109), with a deviation in BCVA of ±0.1 noted in 4 eyes (3.5 %). No glistening was detected in the follow-up period up to 4 months. Conclusion. The paper presents an analysis of the first experience with the implantation of new Clareon monofocal IOLs in Russian Federation. The results of implantation of a new hydrophobic acrylic monofocal IOL in an automated preloaded delivery system showed a good clinical and functional effect, a high frequency of achieving the target result and the absence of significant side effects. The Kane, Barrett Universal II, and SRK/T formulas, using the Verion diagnostic navigation system, are recommended for calculating the optical power of the new IOL. Keywords: cataract; monofocal IOL; Clareon; glistening.

Single-Center Experience with the Femoral-to-Brachial Preloaded Delivery System for Fenestrated-Branched Endovascular Repair of Complex Aortic Aneurysms

To assess technical aspects and outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) using a femoral-to-brachial (FTB) preloaded delivery system (PDS) with two separate configurations. Clinical data of all consecutive patients enrolled in a prospective study to evaluate FB-EVAR for complex abdominal and thoracoabdominal aortic aneurysms (CAAAs & TAAA) between 2013 and 2020 were reviewed. Patients treated with FTB-PDS were included. The two configurations included 4 trans-brachial preloaded wires (4BR) or 2 trans-brachial and 2 transfemoral preloaded wires (2BR-2FE). Outcome measures included technical success, procedural metrics, 30-day or in-hospital mortality, major adverse events (MAEs), and target-vessel outcomes. There were 115 patients with a mean age of 73.8 ± 8years, treated with FTB-PDS. Of these, 62 patients (54%) had 4BR and 53 patients (46%) had 2BR-2FE FTB-PDS. There were 106 TAAA (92%) and 9 CAAAs (8%). Technical success, defined as successful implantation of the stent-graft and all intended target-vessel stents without type I or III endoleak, was 97%, with no differences in total operating time, endovascular time, and radiation dose between groups. There were 3 deaths (3%) at 30days. MAEs were noticed in 21 patients (18%) with no difference between groups, including new-onset dialysis (2% vs. 4%, P = 0.59), and paraplegia (7% vs. 11%, P = 0.51), for 4BR and 2BR-2FE, respectively. Patient survival and freedom from aortic-related mortality at 2-years were 79 ± 5% and 97 ± 1.7%, respectively, with no difference between groups. The use of FTB-PDS for FB-EVAR is safe with high technical success and a reasonable rate of MAEs. Each configuration provides specific benefits based on patient anatomy, while having similar procedural metrics and clinical outcomes.

Single-center Experience With the Femoral-to-brachial Preloaded Delivery System for Fenestrated-branched Endovascular Repair of Complex Aortic Aneurysms

The role of fenestrated-branched endovascular aortic repair (FB-EVAR) in the treatment of complex aortic pathology has evolved rapidly over the last two decades. Much of this is due to the development and selective use of procedural adjuncts, such as low-profile devices, upper extremity access, and preloaded delivery systems (PDS). Our experience with femoral-to-brachial (FTB) PDS has advanced over the years. The aim of this study was to assess technical aspects and outcomes of FB-EVAR using FTB-PDS with two separate configurations.

Efficacy and Safety Analysis of the New Aspheric Hydrophobic Acrylic Monofocal IOL Implantation at Short-Term Follow-Up

Aim. To evaluate the results of implantation of a new hydrophobic acrylic monofocal IOL in an automated preloaded delivery system in the short-term follow-up period.Patients and methods. The prospective study included 89 patients (114 eyes) after bilateral or monolateral Clareon IOL implantation with a mean follow-up of 2.1 ± 0.4 (1–4) months. The age range was 53 to 87 (71.1 ± 5.2) years. A corneal incision of 1.8 mm was used in all cases. For implantation using the AutonoMe® system , the incision was enlarged by 0.2 mm for implantation IOL 26 D and higher. IOL optical power was calculated using the SRK/T formula; retrospective analysis was performed using the Hoffer Q, Haigis, Holladay II, Olsen, Barrett Universal II, and Kane formulas.Results. In all studied periods (1 day, 1 week and 1 month) there was statistically significant (p < 0.05) increase both of NCDVA (from 0.13 ± 0.02 in the preoperative period to 0.81 ± 0.07 in 1 month after surgical intervention), and BCDVA (from 0.32 ± 0.15 before surgery to 0.94 ± 0.11 after surgery). When assessing the percentage of eyes with an BCDVA of 0.9 or higher, a statistically significant (p < 0.05) difference was shown in all studied periods. The lowest MAE was shown for the Barrett Universal II (0.292), SRK/T (0.312) Kane (0.301), and Olsen (0.325) formulas. For the Hoffer Q and Holladay 2 formulas, MAE values were significantly higher (p < 0.05). The highest frequency of achieving the target refraction of ± 0.25 D was shown for the Barrett Universal II and Kane formulas (68 and 69 %, respectively), and the lowest for the Hoffer Q and Holladay 2 formulas (28 and 35 %, respectively). The primary endpoint of the study (BCDVA = 1.0) was achieved in 95.6 % (n = 109), with a deviation in BCVA of ± 0.1 noted in 4 eyes (3.5 %). No glistening was detected in the follow-up period up to 4 months.Conclusion. The paper presents an analysis of the first experience with the implantation of new Clareon monofocal IOLs in Russian Federation. The results of implantation of a new hydrophobic acrylic monofocal IOL in an automated preloaded delivery system showed a good clinical and functional effect, a high frequency of achieving the target result and the absence of significant side effects. The Kane, Barrett Universal II, and SRK/T formulas, using the Verion diagnostic navigation system, are recommended for calculating the optical power of the new IOL.

One-year multicenter evaluation of a new hydrophobic acrylic intraocular lens with hydroxyethyl methacrylate in an automated preloaded delivery system.

To assess a single-piece monofocal hydrophobic acrylic intraocular lens (IOL) with hydroxyethyl methacrylate (HEMA) (Clareon) contained in automated preloaded delivery system (AutonoMe). 18 surgical sites in Japan. Observational study. In patients undergoing phacoemulsification and IOL implantation of a new hydrophobic acrylic IOL using an automated injector, clinical data were collected preoperatively and at 1 day, 1 week, and 1 month, 6 months, and 12 months postoperatively. The degree of glistenings was graded on a 4-point scale. The surgeons rated usability and performance of the IOL delivery system on a 5-point scale. The study enrolled 384 eyes of 384 patients, ranging in age from 41 to 93 (73.8 ± 8.2, mean ± SD) years. The percentage of eyes with corrected distance visual acuity of 20/25 or better at 1 day, 1 week, and 1 month, 6 months, and 12 months postoperatively was 82.6%, 91.9%, 92.8%, 96.6%, and 95.2%, respectively. Refractive error was within 1.0 diopter in approximately 90% of cases. No glistenings were found in all cases throughout the study period. The rate of Nd:YAG laser posterior capsulotomy was 0.9% at 1 year. The IOL delivery system received high ratings on its usability and performance by the surgeons. The new hydrophobic acrylic IOL with HEMA showed excellent visual and refractive outcomes without developing glistenings throughout the 1-year study period. The surgeons gave high marks for usability and performance of the automated preloaded delivery system.

Multicenter Evaluation of Time, Operational, and Economic Efficiencies of a New Preloaded Intraocular Lens Delivery System versus Manual Intraocular Lens Delivery.

PurposeTo evaluate intraoperative intraocular lens (IOL) delivery time and total surgical case time using the UltraSert preloaded delivery system (System U) during routine cataract surgeries and to compare with the manually loaded Monarch delivery system (System M). Physician satisfaction with System U was also assessed.Patients and MethodsIn this prospective observational study, subjects ≥18 years old underwent cataract surgery in 1 eye and received the AcrySof IQ IOL via the manually loaded System M (n=103) or the AcrySof IQ IOL model AU00T0 via the preloaded System U (n=93). Procedures were digitally recorded by an external camera or by a camera within the operating microscope. Device preparation, IOL delivery, and IOL positioning times were evaluated by 2 independent graders. Pearson χ2 test or Fisher exact test was used for categorical variables and Student’s t-test or Wilcoxon rank-sum test for continuous variables (all tests were 2-sided and performed at a 5% α-level). Physician satisfaction levels were assessed using questionnaires.ResultsLens delivery time was similar for System U and System M (12.9±5.1 and 12.2±6.3 s; P=0.412). Mean device preparation time for System U was significantly shorter compared with System M (30.3±6.6 versus 59.8±31.0 s; P<0.05). This resulted in a significantly shorter total intraoperative time (device preparation + lens delivery) with System U versus System M (43.0±8.6 versus 72.0±32.5 s; P<0.05). Total surgical case time (device preparation + lens delivery + lens positioning and unfolding) was shorter for System U versus System M (56.6±12.6 versus 89.6±34.6 s; P<0.05). Physicians reported greater satisfaction levels with System U compared with other devices.ConclusionUse of the preloaded delivery system (System U) resulted in faster device preparation and reduced total surgical time compared with the manually loaded system (System M). System U was intuitive to use, and physicians preferred it to other devices.

Preloaded vs manually loaded IOL delivery systems in cataract surgery in the largest ambulatory surgery center of northwestern China: an efficiency analysis

BackgroundTo compare the efficiency of preloaded vs manually loaded IOL (P-IOL vs M-IOL, respectively) delivery systems in cataract surgery in the largest ambulatory surgery center of Northwestern China.MethodsA total of 200 cases were included in this prospective, observational study. Time and motion data were collected in a one- or two-operating room (1-OR or 2-OR, respectively) scenario. A model of the efficiency and revenue implications of introducing a preloaded delivery system for IOLs in cataract surgery was used to estimate the changes in cataract throughput and hospital revenue through transitioning from the M-IOL delivery system to the P-IOL system.ResultsIn the 1-OR scenario, the mean total case time was 16.9 min using P-IOL, which was a 7.7% reduction compared with M-IOL (P < 0.01). In the 2-OR scenario, the mean total surgeon time was 10.8 min using P-IOL, which was a 7.8% reduction compared with M-IOL (P < 0.05). By switching from M-IOL to P-IOL, annual throughput will increase by 5.2% (960 cases) in the 1-OR scenario and 7.7% (1440 cases) in the 2-OR scenario, accompany by an increase in revenue of approx. 284,352 USD in the 1-OR scenario and approx. 426,528 USD in the 2-OR scenario.ConclusionThis report is the first of a comparison of two IOL delivery systems in China using different settings in the scenario. IOL delivery with preloaded systems is time saving in both the 1-OR scenario and the 2-OR scenario. Moreover, switching from the M-IOL delivery system to the P-IOL system holds potential to increase cataract throughput and hospital revenue.

Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery.

PurposeTo evaluate the clinical handleability and acceptability of a novel preloaded intraocular lens (IOL) delivery system for implantation of the TECNIS ZCB00 IOL (Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USA) during routine small-incision cataract surgery.Subjects and MethodsIn this prospective, open-label, noncomparative, unilateral or bilateral, multicenter study, adult subjects with unilateral or bilateral cataracts scheduled for IOL implantation were enrolled. Surgeons and surgical technicians completed per-eye day-of-surgery and end-of-surgical-day questionnaires. The primary endpoint of the study was the rate of acceptable overall clinical performance of the preloaded IOL delivery system. Other endpoints included additional responses from the questionnaires, preimplantation incision size, and safety.ResultsThe study included 91 eyes that underwent cataract surgery and IOL implantation using the preloaded delivery system and were available for the 1-day postoperative visit. Five surgeons and 14 surgical technicians from four investigational sites participated in the study. The rate of acceptable overall clinical performance was 100% (91/91) of eyes, with most responses (78/91; 85.7%) being the highest possible rating of 5 (very satisfied). Favorable responses by most surgeons and surgical technicians regarding additional endpoints further highlighted the handleability and acceptability of the preloaded delivery system. No ocular adverse events or lens findings (ie, no cases of IOL instability, haptic breakage, IOL marking, or crimping) were reported.ConclusionThe results of this study demonstrated that this preloaded IOL delivery system was safe and effective during routine small-incision cataract surgery.Trial RegistrationGerman Clinical Trials Register identifier, DRKS00014757.

Comparative assessment of the corneal incision enlargement of 4 preloaded IOL delivery systems.

To compare the corneal incision size enlargement after intraocular lens (IOL) implantation of a new, automated, preloaded delivery system, AutonoMe (system A), vs that of 3 other available preloaded systems (UltraSert [system U], Vivinex iSert [system V], and Tecnis iTec [system T]). Alcon Vision LLC, Fort Worth, Texas, USA. Experimental study. Human cadaver eyes were randomly assigned to receive IOLs implanted with the preloaded delivery devices. Corneal incisions were imaged using optical coherence tomography, and incision sizes were measured using an Asico incision gauge before and after IOL delivery. Differences in mean incision enlargement between delivery devices were evaluated using a paired t test. System A (mean ± standard deviation, 0.29 ± 0.03 mm) and system U (0.29 ± 0.03 mm) had the smallest mean incision size enlargement compared with system T (0.31 ± 0.03 mm) and system V (0.36 ± 0.06 mm). System V had the largest corneal incision enlargement and was significantly larger than system A (P = .001), system U (P = .001), and system T (P = .002). System A was noninferior to system U; the paired difference in corneal incision enlargement between the devices was -0.01 ± 0.04 mm (90% CI, -0.03 to 0.01). The new system A preloaded delivery system provided smaller corneal incision enlargement compared with system T or system V and was noninferior to system U.

Outcomes of a novel upper extremity preloaded delivery system for fenestrated-branched endovascular repair of thoracoabdominal aneurysms

ObjectiveThe aim of this study was to evaluate the feasibility and outcomes of endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) using a novel low profile (LP) device with upper extremity preloaded guidewire system (PGS) and compare procedural metrics and outcomes with a standard multibranch stent graft (t-Branch; Cook Medical, Bloomington, Ind). MethodsWe reviewed the clinical data of 232 consecutive patients treated by fenestrated-branched endovascular aortic repair for TAAA and enrolled in a prospective nonrandomized trial between 2014 and 2017. Patients who had repair using t-Branch or patient-specific TAAA devices using upper extremity LP-PGS were included. End points were technical success, operative and fluoroscopic time, patient radiation exposure, time from arterial access to complete device deployment, total contrast volume, and 30-day rates of major adverse events (MAEs) and mortality. ResultsThere were 54 patients, including 33 males (67%) and 21 females (33%), with a mean age of 73 ± 9 years old. Forty-nine patients (91%) had extent I-III and five patients (9%) had extent IV TAAAs. Device design was t-Branch in 24 patients (44%) and LP-PGS in 30 patients (56%). A total of 206 renal-mesenteric arteries were incorporated with no difference between groups (mean, 3.8 ± 0.6 target vessels/patient; P = .92). Patients treated by t-Branch device had larger mean aneurysm diameter (79 ± 16 vs 66 ± 10 mm; P = .0006). All patients had transbrachial approach. Technical success was achieved in all patients in both groups. Patients treated by LP-PGS devices had lower radiation dose (1250 ± 849 vs 3154 ± 2421 mGy; P = .003) and shorter operating time for complete device deployment (105 ± 42 vs 123 ± 34 minutes; P = .043). There was no difference in mean operative time (252 ± 69 vs 273 ± 56 minutes; P = .23), fluoroscopy time (82 ± 29 vs 96 ± 35 minutes; P = .08) or contrast volume (163 ± 59 vs 197 ± 75 mL; P = .07) comparing LP-PGS and t-Branch respectively. There was no 30-day or in-hospital mortality. There were no differences in MAEs, which occurred in 18 patients (33%) in both groups (P > .05). ConclusionsEndovascular TAAA repair using the standard or LP-PGS multibranch stent graft was associated with high technical success, no mortality, and a low rate of MAEs in this study. Patients treated by upper extremity LP-PGS had shorter time to complete device deployment, suggesting decreased technical demand with preloaded systems.

In vivo and in vitro results of an automated preloaded delivery system for IOL implantation in cataract surgery.

To compare the corneal tissue trauma after the use of an automated preloaded injector and a manual injector and assess scanning electron microscope (SEM) and atomic force microscope (AFM) features of both injector cartridges. Ophthalmology Clinic and Laboratory of Stem Cells and Regenerative Medicine University "G. d'Annunzio" of Chieti-Pescara, Chieti, Italy; DESIGN: Prospective randomized clinical study METHODS: Forty eyes of 40 patients for phacoemulsification were divided into two groups: implantation of intraocular lens was performed with AutonoMe automated delivery system (AutonoMe group: 20 eyes) and Monarch III injector system (Monarch group: 20 eyes). In vivo confocal microscopy (IVCM) and anterior segment optical coherence tomography (AS-OCT) were performed before surgery, at 1h, 1day and 1month post-operatively. In addition, SEM and AFM were performed on cartridges of both injector systems after injection of the IOL. A greater increase in central corneal thickness and corneal thickness at the incision site were observed in Monarch group versus AutonoMe group 1h and 1day post-operatively (p < 0.05). Endothelial cell count loss was significantly higher in Monarch group compared with AutonoMe group (p < 0.05) at 1 and 24h. AS-OCT showed less endothelial misalignment at 30days (p < 0.05), and IVCM showed less tunnel inflammation at all time points (p < 0.05) in AutonoMe group compared with Monarch group; roughness analysis at AFM of the AutonoMe cartridge was significantly lower compared to Monarch D cartridge (p < 0.05). The AutonoMe injector provided less corneal tissue trauma compared with Monarch III injector. The AutonoMe cartridge showed lower roughness at AFM compared to the Monarch D cartridge.

Use of a Custom-made Four-Vessel Fenestrated Endograft to Repair an Enlarging Juxtarenal Aneurysm With Type IA Endoleak After Prior ZFEN Repair

A 73-year-old woman with a history of a 6-cm juxtarenal abdominal aortic aneurysm who underwent a fenestrated endovascular aortic repair using the Zenith fenestrated endovascular (ZFEN) device (Cook Medical, Bloomington, Ind) presented with a type IA endoleak found on routine surveillance computed tomography angiography (CTA). The previously placed ZFEN device included a scallop for the superior mesenteric artery (SMA) and bilateral stented fenestrations to the renal arteries. A custom-made fenestrated endovascular aortic endograft was designed on the basis of measurements obtained from high-resolution CTA images on a three-dimensional workstation using standard centerline flow orthogonal techniques (TeraRecon, Foster City, Calif). The graft design included fenestrations to the celiac artery, SMA, and bilateral renal arteries. The main body fenestrated graft was designed with a modified preloaded delivery system using a preloaded cannulation catheter for the bilateral renal artery fenestrations. Balloon-expandable bridging stent grafts were deployed through the fenestrations to the SMA and bilateral renal arteries. The celiac artery was found to be occluded and covered with an aortic cuff to eliminate the potential for an endoleak. Completion angiography showed excellent stent graft architecture with no kinks or component separations, no evidence of endoleak, and patent visceral branches. The 1-month surveillance imaging demonstrated elimination of the type IA endoleak, patent stent grafts, and a small type II endoleak arising from a lumbar artery. Type IA endoleak from prior ZFEN repair can be successfully treated with a custom-designed fenestrated endovascular aortic endograft.

Safety First - Evaluation of IOL Injector Systems

Improvements in cataract surgery led to the availability of preloaded IOL delivery systems. These are expected to reduce overall surgery time while being safe and effective. This study evaluates the safety and manageability of the 2-component autoloading system SAFELOADER® (HumanOptics AG, Erlangen, Germany) and compares these results to two other systems. A total of 167 eyes were enrolled to this single centre prospective study. In 67 eyes, the IOLs were implanted via the SAFELOADER system, in 50 eyes via another preloaded system (TECNIS iTec® Preloaded Delivery System, Johnson & Johnson Vision, Santa Ana, CA, USA) and in 50 eyes via a manual implantation system (UNFOLDER® Platinum 1 Series Delivery System, Johnson & Johnson Vision, Santa Ana, CA, USA). IOL preparation time and implantation time were measured in seconds for each device. The OR workflow and handling of the device by the surgeon and the scrub nurse were rated by a grading system from 1 (very good) to 5 (very poorly). The SAFELOADER and iTec were faster and handier than the manually loaded system. Regarding preparation time, the SAFELOADER with a median of 6.5 (5.3 - 6.9) seconds (s) was about one second slower (p < 0.0001) than iTec with 5.2 s (4.5 - 6.5). Both were significantly faster (p < 0.0001) than the UNFOLDER with 26.9 s (20.6 - 30.1). Implantation time was similar between SAFELOADER with 7.2 s (5.3 - 8.6), iTec with 7.3 s (5.9 - 8.3) and UNFOLDER with 7.2 s (5.9 - 7.6). When graded, SAFELOADER 2.0 (1.0 - 3.0) and iTec 1.0 (1.0 - 3.0) were significantly (p < 0.0001) better than the manual system 5.0 (3.0 - 5.0) with respect to overall OR workflow. The surgeon rated the handling of SAFELOADER and iTec (both median 1.0; 1.0 - 2.0) similarly and significantly better (p < 0.001) than that of the UNFOLDER 2.5 (1.0 - 4.0). For the scrub nurse, SAFELOADER 1.0 (1.0 - 2.0) was significantly better (p < 0.0001) in handling than iTec 2.0 (1.0 - 3.0) and UNFOLDER 4.0 (2.0 - 5.0). The 2-component autoloading system SAFELOADER® is intuitive in handling, fast and effective in implantation of the IOL and very safe.

ПЕРВЫЙ ОПЫТ ИСПОЛЬЗОВАНИЯ ТРЕХМЕРНОЙ СИСТЕМЫ ВИЗУАЛИЗАЦИИ NGENUITY® 3D VISUALIZATION SYSTEM В ХИРУРГИИ КАТАРАКТ С ИМПЛАНТАЦИЕЙ PRE-LOADED ИНТРАОКУЛЯРНЫХ ЛИНЗ ACRYSOF IQ ULTRASERT

Aim - to evaluate the clinical efficacy and features of use new three-dimensional visualization system "NGENUITY' in surgery of cataract with implantation of "pre-loaded" intraocular lens "AcrySof IQ Ultrasert" (ALCON). Materials and methods. We investigated the clinical results of using a 3D visualization system "NGENUITY' cataract surgery in 100 patients (100 eyes) age of 64.3+6.1 years; 83 women and 17 men. Implanted monofocal IOLs "AcrySof IQ Ultrasert" company "Alcon" with a goal refraction Em+0,5 diopters with the use of navigation systems "VERION" (Alcon). Results. There were no intraoperative or postoperative complications. Examination of patients was carried out on 1 and 7 days and 1 and 3 months after surgery. The postoperative period was smooth, without injections. As a result of treatment, uncorrected visual acuity in the distance was 0.74+0.02 (0.2 to 1.0) and depended on the fundus condition. The average sphericules clinical refraction 0,38+0,47 dioptres. Refraction of the target was achieved in 91% of patients. Loss of corneal posterior epithelial cells was 3.8+1.5%. The results of the use of 3D imaging system "NGENUITY" in cataract surgery suggest that it has a number of significant advantages over the use of traditional methods of modern microsurgery. Summary. 1. A new three-dimensional visualization system "NGENUITY 3D Visualization System" provides the surgeon much more than just improved visuals. 2. Practical development and further technological development of the system "NGENUITY 3D Visualization System" opens new scientific and practical prospects in cataract surgery. 3. The use of the new system "ULTRASERT Preloaded IOL Delivery System" the implantation of a monofocal IOL significantly optimizes the surgery of cataracts. 4. New technological features of the system design "ULTRASERT Pre-loaded IOL Delivery System" enable to eliminate the risk of infection and damage to the lens, allow quick and stable placement in the capsular bag, a smooth postoperative period.

Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system.

PurposeTo compare corneal incision size and intraocular lens (IOL) performance/behavior following implantation with the following delivery systems: system U (UltraSert®), system S (Hoya iSert® 250/251), system T (Tecnis® iTec), and a manual system (Monarch® III Delivery System).SettingSix study sites (four in Spain and two in France).DesignProspective, multicenter, parallel-group, randomized, subject-masked, postmarket clinical study.Materials and methodsSubjects were enrolled based on predetermined inclusion/exclusion criteria. The effectiveness end points compared corneal incision size and enlargement after IOL implantation (day of surgery) among all delivery systems. Exploratory end points included mean enlargement of corneal incision size, rates of trapped trailing haptic, IOL adherence to the plunger tip, nozzle tip splitting, and mean surgically induced astigmatism (SIA) at postoperative visit.ResultsOne hundred and nine subjects participated in the study. The mean corneal incision size following IOL implantation was 2.35±0.019 mm for system U, 2.47±0.016 mm for system T, 2.54±0.019 mm for system S, and 2.49±0.011 mm for the manual system. There were five instances of trapped trailing haptic (all system T group, N=26), one instance of IOL adherence to the plunger tip (system S group, N=26), and six instances of nozzle tip splitting (all system S group, N=26). System U had the least SIA (postoperative Day 1) (SIA Centroid = 0.10 diopters [axis: 83.06°]).ConclusionPreloaded delivery system U supported the completion of surgery with the smallest incision size, the least SIA (postoperative Day 1), and no trapped trailing haptics or nozzle tip splitting compared to two other preloaded systems and one manual system.

Evaluation of Preloaded IOL Delivery System and Hydrophobic Acrylic Intraocular Lens in Cataract Surgery.

Background:Advancements in cataract surgery have necessitated the availability of intraocular lens preloaded delivery systems that can safely, effectively and predictably deliver IOLs in the eye. Preloaded delivery systems simplify and reduce procedural variability during surgery preparation.Objective:The objective of this study was to evaluate clinical acceptability, delivery characteristics and clinical outcomes in patients implanted with new generation hydrophobic acrylic Intraocular Lens with Preloaded delivery system.Methods:This was a single centre retrospective study. Total 41 patients were enrolled in the study to get at least 38 patients for evaluation. All patients were assessed on day1 and 1, 3 and 6 months after surgery.Results:EYECRYL-SERT showed ‘excellent’ ease of insertion and handling in all 41(100%) patients. Corrected Distance Visual Acuity (CDVA) improved from 0.74±0.58 logMAR during screening to 0.03±0.04 logMAR 6 months after surgery. The Corrected Intermediate Visual Acuity (CIVA) and Corrected Near Visual Acuity (CNVA) were 0.10±0.04 and 0.01±0.02 logMAR post 6 months surgery, respectively. The refractive spherical equivalence was -1.94±2.51 D during screening, which improved significantly (p=0.0018) to -0.21±0.47 D post 6 months surgery. The low and high contrast sensitivity was 0.06±0.06 and -0.05±0.06 logMAR after 6 months surgery, respectively. The endothelial cell loss was 5.67%, 7.22% and 9.75% at 1, 3, and 6 months after surgery, respectively, as compared to screening. None of the subjects reported any adverse event during the study period.Conclusion:The IOL delivery system (EYECRYL_SERT) provided desired delivery characteristics during cataract surgery and was effective in improving clinical outcomes in cataract patients.

Corneal incision architecture after IOL implantation with three different injectors: an environmental scanning electron microscopy study.

To evaluate by Environmental Scanning Electron Microscopy (ESEM) the corneal incision architecture after intraocular lens (IOL) implantation in pig eyes, using manual, automated injectors or preloaded delivery systems. Twenty-four pig eyes underwent IOL implantation in the anterior chamber using three different injectors: manual (Monarch III) (n=8), automated (AutoSert) (n=8), or a preloaded system (UltraSert) (n=8). Acrysof IQ IOLs, 21 Dioptres (D) (n=12) and 27D (n=12), were implanted through 2.2mm clear corneal incisions. Incision width was measured using corneal calipers. The endothelial side of the incision was analyzed with ESEM. In each group, the final size of the corneal wound after IOL implantation, measured by calipers, was 2.3-2.4mm. The incision architecture resulted more irregular in the Monarch group compared with the other injectors. In every group the 27D IOL-implanted specimens showed more alterations than in 21D IOL-implanted samples, and this was less evident in the UltraSert group. The Descemet tear length was higher in the Monarch group than AutoSert and UltraSert group. The automated and preloaded delivery systems provided a good corneal incision architecture; after high-power IOL implantation the incisions were more regular and less damaged with the preloaded system than with the other devices.