Visual performance comparison of 2 extended depth-of-focus intraocular lenses.

PURPOSE: To compare the visual acuity and satisfaction outcomes of 2 different concepts of extended depth-of-focus intraocular lenses (EDOF IOLs). SETTING: University Eye Hospital Bochum, Germany. DESIGN: Prospective randomized comparative clinical trial. METHODS: Patients undergoing cataract surgery with the implantation of 2 different concept EDOF IOLs. In the first group (IC-8 Group), a monofocal 1-piece Tecnis Z B00 IOL (Johnson & Johnson Vision Care, Inc.) was implanted in the dominant eye, and an IC-8 IOL (AcuFocus) was implanted in the nondominant eye. In the second group (Symfony Group), a Tecnis Symfony IOL (Johnson & Johnson Vision Care, Inc.) was implanted in both eyes. The target refraction of the dominant eye was emmetropia and slight myopia (mini-monovision, -0.75 diopters) in the nondominant eye. Visual and refractive outcomes and patient satisfaction rates were evaluated 3 months postoperatively. RESULTS: This study comprised 76 eyes of 38 patients. No intraoperative or postoperative complications occurred in either group. Target refraction was reached in both groups without statistically significant differences. The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significantly better results in the IC-8 goup (logarithm of the minimum angle of resolution; IC-8 Group (0.1 ± 0.07 logarithm of the minimum angle of resolution [logMAR]; Symfony Group 0.07 ± 0.1 logMAR, P value .02 [photopic]; IC-8 group 0.12 ± 0.09 logMAR, Symfony group 0.22 ± 0.1 logMAR, P value < .01 [mesopic]). Binocular uncorrected intermediate visual acuity (UIVA) and uncorrected near visual acuity (UNVA) were also good in both groups without statistically significant differences (UIVA: IC-8 Group, 0.01 ± 0.07 logMAR, Symfony Group 0.01 ± 0.08 logMAR, P value .35; UNVA: IC-8 Group 0.14 ± 0.11, Symfony Group 0.09 ± 0.08, P value .14). Subjective satisfaction was high in both groups. CONCLUSIONS: Both EDOF IOLs provided a very good UDVA with superior results in the IC-8 Group, and a good UIVA and UNVA under photopic light conditions. Subjective patient satisfaction was higher in the IC-8 Group.

Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts from Brain Dead Donors: Protocol for a Prospective Pilot Study.

BACKGROUND: Kidney transplantation is the only curative treatment option for end-stage renal disease. The unavailability of adequate organs for transplantation has resulted in a substantial organ shortage. As such, kidney donor allografts that would have previously been deemed unsuitable for transplantation have become an essential organ pool of extended criteria donor allografts that are now routinely being transplanted on a global scale. However, these extended criteria donor allografts are associated with significant graft-related complications. As a result, hypothermic oxygenated machine perfusion (HOPE) has emerged as a powerful, novel technique in organ preservation, and it has recently been tested in preclinical trials in kidney transplantation. In addition, HOPE has already provided promising results in a few clinical series of liver transplantations where the liver was donated after cardiac death. OBJECTIVE: The present trial is an investigator-initiated prospective pilot study on the effects of HOPE on extended criteria donor allografts donated after brain death and used in kidney transplantation. METHODS: A total of 15 kidney allografts with defined inclusion/exclusion criteria will be submitted to two hours of HOPE via the renal artery before implantation, and are going to be compared to a case-matched group of 30 patients (1:2 matching) who had kidneys transplanted after conventional cold storage. Primary (posttransplant dialysis within 7 days) and secondary (postoperative complications, early graft function, duration of hospital and intensive care unit stay, and six-month graft survival) endpoints will be analyzed within a six-month follow-up period. The extent of ischemia-reperfusion injury will be assessed using kidney tissue, perfusate, and serum samples taken during the perioperative phase of kidney transplantation. RESULTS: The results of this trial are expected in the first quarter of 2020 and will be presented at national and international scientific meetings and published in international peer-reviewed medical journals. The trial was funded in the third quarter of 2017 and patient enrollment is currently ongoing. CONCLUSIONS: This prospective study is designed to explore the effects of HOPE on extended criteria donor kidney allografts donated after brain death. The present report represents the preresults phase. TRIAL REGISTRATION: Clinicaltrials.gov NCT03378817; https://clinicaltrials.gov/ct2/show/NCT03378817.