Purpose To compare the outcomes of combined microbypass stent implantation, cataract extraction, and endocyclophotocoagulation (ECP) with those of implantation of the same microbypass stent with ...concomitant cataract surgery in patients with open-angle glaucoma (OAG). Setting Private Practice, Sioux Falls, South Dakota, USA. Design Retrospective consecutive case series. Methods Patients from January 2015 to August 2016 were included. The study group comprised eyes that had implantation of a microbypass stent in combination with cataract extraction and ECP. To compare outcomes, a control group of eyes with similar baseline characteristics that had implantation of a stent in combination with cataract surgery was established. Data were collected preoperatively and postoperatively at 1 day, 1 week, and 1, 3, 6, and 12 months. Data included intraocular pressure (IOP) and number of glaucoma medications. Results The mean preoperative IOP was 21.49 mm Hg ± 9.56 (SD) in the study group (51 eyes) and 20.66 ± 3.23 mm Hg in the control group (50 eyes). Twelve months postoperatively, the mean IOP reduction was 7.14 mm Hg in the study group and 4.48 mm Hg in the control group and the medication reduction was 38% (0.68) and 63% (1.06), respectively. Conclusions Patients who had implantation of the microbypass stent in combination with cataract surgery and ECP had significantly better IOP reduction than those who did not have ECP. The combination procedure was also effective in patients with severe OAG.
Introduction
This study evaluates the effects of the multi-pressure dial (MPD) on steady-state pattern electroretinography (ss-pERG) parameters. The study is a randomized, controlled, prospective, ...pilot trial in a private practice setting with ocular hypertensive (OHT), glaucoma suspect, and open-angle glaucoma (OAG) subjects.
Methods
This study included nine patients (64 ± 9.0 years, nine female) with OHT, glaucoma suspect, or mild OAG. One eye of each subject was randomized to receive negative periocular pressure, while the contralateral eye served as the intrasubject control through the goggle without negative pressure. The Diopsys High Contrast Sensitivity ss-pERG protocol was conducted on both eyes of each subject while wearing the MPD device. Application of negative periocular pressure was set at 50% of baseline intraocular pressure for each study eye.
Results
Following 2 h of negative periocular pressure application, the difference in MagnitudeD (MagD) from baseline for eyes randomized to receive negative periocular pressure (+ 0.17 versus − 0.26) was statistically significant (
p
= 0.023). Over the same period, the change in MagD/Magnitude (MagD/Mag ratio) from baseline for eyes randomized to receive negative periocular pressure was also higher (+ 0.14 versus − 0.16), compared to the control eyes, approached significance (
p
= 0.059).
Conclusions
Following 2 h of MPD wear, the measured MagD and MagD/Mag ratio improved compared to control, suggesting that negative periocular pressure application to the anterior globe can lead to short-term improvement in one measure of retinal ganglion cell function.
Abstract There are conflicting reports on the influence of lean and fat mass on bone accrual during childhood. No infant's studies have been reported that describe the influence of changes in body ...composition with changes in bone accrual during the first year of life. The objective of this research was to test the hypothesis that greater gains in lean mass will have a positive effect on bone mineral content (BMC) accrual, while greater gains in fat mass will have a negative effect on BMC accrual in infants. Longitudinal data from 3 previous infant studies were used. Linear mixed models, adjusting for age, sex, dietary calcium, and length were used to investigate longitudinal and cross-sectional associations between total body BMC and lean and fat mass in the individual studies and in a combined analysis. In both individual and combined analyses, we found that lean and fat mass were positively associated with whole body BMC accrual (all, P < 0.001). The cross-sectional association of BMC and dietary calcium was negative in one study ( P < 0.05). No differences in BMC change between sexes were observed in three studies. Our results showed positive cross-sectional and longitudinal associations between total body BMC and lean mass in infants. In contradiction to our hypothesis for fat mass, we found a positive cross-sectional and longitudinal association between total body BMC and fat mass in infants.
Brandon J Baartman,1 Kayla Karpuk,1 Bradley Eichhorn,2 Tanner J Ferguson,2 Ramu G Sudhagoni,3 John P Berdahl,1 Vance M Thompson11Vance Thompson Vision, Sioux Falls, SD, USA; 2University of South ...Dakota School of Medicine, Vermillion, SD, USA; 3Public, Health Department, School of Health, Sciences, University of South Dakota, Vermillion, SD, USAWe appreciate the letter by Prof. Srirampur regarding the recent publication ofour results of extended depth of focus (EDOF) lens implantation in post-radialkeratotomy (RK) patients. Prof. Srirampur brings up a few excellent points.Correspondence: Brandon J BaartmanVance Thompson Vision, 3101 W 57th, Street, Sioux Falls, SD 57108, USATel +1 605 361 3937Email Brandon.baartman@vancethompsonvision.comView the original paper by Baartman and colleaguesThis is in response to the Letter to the Editor
Ankle plantarflexion (PF) active range of motion (ROM) is traditionally assessed in a non-weight-bearing (NWB) position with a universal goniometer. However, a convenient, reliable, low-cost means of ...assessing functional PF active ROM in a weight-bearing (WB) position has yet to be established.
To compare the intra- and interrater reliability of PF active ROM measurements obtained from a goniometric NWB assessment, and a functional heel-rise test (FHRT) performed in WB.
Reliability study.
Two physical therapy student examiners, blinded to each other's measurements, assessed PF active ROM through a NWB goniometric technique and a FHRT on all subjects within the same test session. Intra- and interrater reliability values were calculated using an intraclass correlation coefficient (ICC
, ICC
) and 95% confidence intervals. Standard error of measurement (SEM) and minimal detectable change (MDC) were recorded for each method.
43 healthy participants (mean ± SD, age: 22.7 ± 1.7 years, height: 1.7 ± 0.1 m, mass: 77.8 ± 17.2 kg) completed testing procedures. The within-session intrarater reliability (ICC
) estimates were observed for goniometry (right: 0.96, left: 0.95 - 0.97) and FHRT (right: 0.99, left: 0.99), as well as the interrater reliability (ICC
) of goniometry (right: 0.79, left: 0.79) and FHRT (right: 0.79, left: 0.87). Goniometry SEM (3.3 - 3.6 °) and MDC (9.2 - 9.8 °) were observed, in addition to FHRT SEM (0.6 cm) and MDC (1.6 - 1.7 cm). A weak correlation was found between FHRT and goniometric measurements (r = -0.03 - 0.13).
The FHRT was found to have good to excellent intra- and interrater reliability, similar to goniometric measurement. The lack of agreement between these measurements requires further exploration of a WB assessment of ankle PF active ROM.
2b.
In longitudinal analysis, interest lies often in comparing parametric models over time. For example, if the trend over time is linear, commonly a test is performed to evaluate whether the rate of ...change in the mean response is the same for all treatment groups. For parametric models, treatment profiles can easily be compared using confidence bands. The authors propose simultaneous confidence bands and discuss two methods of calculating the associated critical point for comparing several parametric models over time. This issue has never been addressed before in the context of longitudinal studies. An example illustrates the proposed method.
PURPOSE:To evaluate the safety and efficacy of a trabecular microbypass stent combined with cataract surgery in patients with severe open-angle glaucoma.
PATIENTS:The series included 59 eyes with ...severe primary open-angle glaucoma and severe visual field loss as defined by American Academy of Ophthalmology preferred practice pattern criteria.
MATERIALS AND METHODS:Retrospective case series. Patients were implanted with 1 trabecular microbypass stent with concomitant cataract surgery. Primary outcome measures were intraocular pressure (IOP) and number of glaucoma medications. Safety measures included postoperative IOP pressure spikes ≥15 mm Hg or IOP<6 mm Hg at any time point, and the need for additional surgery.
RESULTS:The mean preoperative IOP was 19.25±6.97 mm Hg. Postoperatively, the mean IOP was 14.38±3.63 mm Hg (P<0.01) at 12 months and 14.92±3.86 mm Hg (P<0.01) at 24 months. The mean number of glaucoma medications was 2.27±1.06 preoperatively and 1.63±1.17 (P<0.01) at 24 months postoperative, indicating a 28% reduction in medication use. In total, 4 (7%) eyes required additional surgery. In total, 5 eyes (8%) experienced IOP spikes ≥15 mm Hg, 14 (24%) eyes had IOP spikes ≥10 mm Hg. Overall 55% of eyes had a 20% IOP reduction after 24 months of surgery. Eyes with baseline IOP≤19 had a mean reduction of 2.24 mm Hg 36 months after surgery.
CONCLUSIONS:Trabecular microbypass stent implantation during cataract surgery safely and effectively lowers IOP and medication use in patients with severe primary open-angle glaucoma.
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Background: In the COSMIC-021 phase 1b study (NCT03170960) evaluating cabozantinib plus atezolizumab in advanced solid tumors, this combination therapy demonstrated encouraging clinical activity ...in patients with advanced non-clear cell renal cell carcinoma (nccRCC) with a median follow-up of 13 mo (Pal. JCO 2021). Results after extended follow-up in nccRCC are presented. Methods: Patients with advanced nccRCC and ECOG PS 0/1 who had ≤1 prior VEGFR-targeting tyrosine kinase inhibitor (TKI) were eligible. Prior treatment with TKIs targeting MET or immune checkpoint inhibitors was not allowed. Patients received cabozantinib 40 mg PO QD plus atezolizumab 1200 mg IV Q3W until unacceptable toxicity or progression; dose reductions of cabozantinib (40 mg QD to 20 mg QD, then to 20 mg QOD) were permitted to manage adverse events. The primary endpoint was objective response rate (ORR) per RECIST v1.1 by the investigator; other endpoints included safety, duration of response (DOR), PFS, and OS. Results: The study enrolled 32 patients with nccRCC (2 from dose escalation phase, and 30 from expansion phase of the study): median age, 62 y; male, 81%; ECOG PS 0/1, 75%/25%; histology, papillary/chromophobe/clear cell/other, 47%/28%/3%/22%; sarcomatoid feature, 13%; IMDC risk favorable/intermediate/poor, 50%/41%/9%; ≥3 tumor sites, 56%; tumor sites, lung/kidney/bone/liver, 50%/25%/16%/16%; prior nephrectomy, 63%; prior VEGFR TKI, 22%; 0/1 lines of prior therapy (locally advanced/metastatic setting), 81%/19%. As of July 21, 2022, median follow-up was 37.2 mo (range 32.1–58.5) with 5 (16%) patients remaining on study treatment. ORR by investigator was 31% (all PRs) and disease control rate was 94% (Table); median DOR was 8.1 mo. Median PFS was 9.3 mo (95% CI 5.5–12.3), and median OS was not reached (95% CI 23.0–NE). PFS and OS estimates at 12 mo were 34% and 84%, respectively; 24-mo estimates were 6% and 70%. Treatment-related AEs occurred in 97% (grade 3/4, 53%); the most common AEs included diarrhea (69%), palmar-plantar erythrodysesthesia (50%), fatigue (44%), dysgeusia (41%), hypertension (31%) and nausea (31%). One grade 5 treatment-related AE of pulmonary hemorrhage occurred. Treatment-related AEs leading to discontinuation of both study treatments occurred in 13% of patients. Conclusions: Extended 3-year follow-up reinforces the encouraging clinical activity of cabozantinib plus atezolizumab in advanced nccRCC with a manageable safety profile. Clinical trial information: NCT03170960 . Table: see text
PURPOSETo compare effects of the MKO Melt (midazolam 3 mg, ketamine 25 mg, and ondansetron 2 mg) with intravenous (IV) sedation on vital signs of patients who underwent cataract surgery. SETTINGTwo ...private ophthalmology practices in Sioux Falls, South Dakota, USA. DESIGNRetrospective analysis. METHODSPreoperative, intraoperative, and postoperative vital signs were compared between individuals who underwent cataract surgery and received exclusively either MKO (n = 991) or traditional IV methods (n = 120) for sedation. Clinical significance was defined as a 5 mm Hg change in blood pressure, 3 beats per minute (bpm) change in heart rate, a change of 2 respirations per minute, or a change of 3% in O2 saturation. MKO Melt but not IV sedation was given before the reported preoperative vital signs. RESULTSThere were 1111 patients included in this study. Preoperative systolic blood pressure (SBP) was 133.7 ± 15.6 mm Hg in the MKO group and 139.6 ± 17.3 mm Hg in the IV group (P = .0001). Postoperative SBP was 130.8 ± 12.9 mm Hg in the MKO group and 135.8 ± 19.3 mm Hg in the IV group (P < .01). Postoperative heart rate was 66.3 ± 10.4 bpm in the MKO group compared with 69.8 ± 10.5 bpm in the IV group (P < .001). No other clinically and statistically significant differences were found. The mean number of melts used was 1.5. CONCLUSIONSClinically and statistically significant improvements in preoperative and postoperative SBP and postoperative heart rate were observed in patients who received MKO Melt. The MKO Melt was safe, effective, and well tolerated and a viable alternative to IV sedation.
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