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The effects of surgical factors on postoperative astigmatism in patients enrolled in the Infant Aphakia Treatment Study (IATS)

Following an infarction in the right cerebral hemisphere, massive cerebral edema developed in a woman and led to a marked intracranial hypertension and to a progressive "uncal and central herniation." The downhill course was reverted with a decompressive operation. Epidural pressure was monitored during the procedure and in the postoperative period. She showed progressive recovery from the initial motor, sensory, and visual field losses. Among 18 reported patients with cerebral infarction who underwent surgical decompression, 11 presented pupillary asymmetry, 14 were in stupor or coma, and 18 were either hemiplegic or hemiparetic preoperatively. Seven died following the operation. Among four cases of cerebellar infarction who underwent similar procedures, there were three survivors. Due to the lack of a controlled study the data available so far are not conclusive as to the beneficial effects of surgical decompression for cerebral or cerebellar infarcts. Some data of clinical relevance on cerebral edema and intracranial hypertension associated with cerebral infarction are reviewed.

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The purpose of this study was to investigate the usefulness of carotid haemodynamic parameters, i.e. the resistive index (RI) and the pulsatility index (PI), in estimating the risk of cerebral infarction in Type 2 diabetic patients. Three hundred and eighty-two Type 2 diabetic patients (223 men and 159 women; mean age 61 years, range 40-88; 40 had a history of cerebral infarction) and 110 control subjects were analysed in a cross-sectional study. All subjects underwent ultrasonography of the common carotid artery, with determination of intima-media thickness (IMT), RI, and PI. A SMART (Second Manifestations of ARTerial Disease) atherosclerosis risk score was determined for all diabetic patients. The mean values for IMT, RI, and PI were increased in diabetic patients compared with control subjects, and they were significantly elevated in patients with previous cerebral infarction compared with patients without cerebral infarction. (IMT 0.88 +/- 0.22 vs. 0.77 +/- 0.19, P < 0.005; RI 0.77 +/- 0.07 vs. 0.75 +/- 0.06, P < 0.05; PI 1.88 +/- 0.36 vs. 1.71 +/- 0.36, P < 0.01) Significant but weak correlations were found between SMART risk scores and IMT, RI and PI (IMT r = 0.390, P < 0.0001; RI r = 0.346, P < 0.0001; PI r = 0.393, P < 0.0001). The multiple logistic model showed that both the IMT [odds ratio (OR) 6.50, 95% confidence interval (CI) 3.42, 12.34] and the PI (OR 4.16, 95% CI 2.36, 7.34) were independent risk factors for cerebral infarction. The subjects who had an IMT of > 1.0 and a PI > 2.00 had a greater risk of developing a cerebral infarction than did the subjects who had an IMT of < 1.0 and a PI < 2.00 (OR 6.21, 95% CI 2.26, 17.05). The results of this cross-sectional study showed that the measurement of haemodynamic parameters was useful, together with IMT, in estimating the risk of previous cerebral infarction in Type 2 diabetic patients. The predictive value of these parameters in identifying the risk of future cerebral infarction must await the results of future prospective studies.

Purpose: This study evaluated the clinical efficacy and safety of bromfenac 0.09%, sodium hyaluronate 0.4% (SH) combination therapy, versus placebo and SH in a clinical model of pterygium I–III.Methods: A total of 166 eyes (99 patients) with pterygium grade I–III were randomized to bromfenac 0.09% ophthalmic solution+SH 0.4% or placebo+SH 0.4%. This was a Phase IV, prospective, parallel, double-masked, multicenter clinical trial. One drop of bromfenac or placebo was instilled two times a day (BID) for 20 days, both groups accompanied treatments with one drop of SH three times a day (TID). The primary efficacy endpoints were the conjunctival hyperemia and the Ocular Surface Disease Index (OSDI) score. Other results measured included burning, foreign body sensation, and photophobia. The safety was assessed by the tear break-up time (TBUT), visual acuity (VA), IOP, lissamine green, fluorescein stains, and the incidence of adverse events (AEs).Results: Compared with baseline, there was a significant reduction in the conjunctival hyperemia (p=0.0001) and OSDI score in both groups (p=0.0001). There was a significant improvement in ocular symptomatology for both, placebo/SH and bromfenac/SH groups (p=0.0001), the decrement in the ocular burning was 41.1% vs 24.6%, the foreign body sensation was 31.5% vs 36.2% and, for photophobia was 23.3% vs 30.5%, respectively. A statistically significant difference was observed in TBUT for bromfenac/SH (p=0.045), at day 20. There were no significant alterations in IOP (p=0.068) or VA (p=0.632). Similar improvements were observed in the fluorescein and green lissamine staining. Finally, the incidence of AE was similar between groups.Conclusion: The treatment with bromfenac 0.09% ophthalmic solution and SH 0.4% combination therapy for 3 weeks reduced clinical signs, in patients with pterygium I–III. The results suggest that bromfenac 0.09% can improve the symptomatology, reduce the presentation of clinical signs associated with superficial ocular inflammation.

Objective:To determine the relationship between tear function and ocular surface abnormalities with subjective symptoms of dry eye.Methods:Patients with various ocular irritation symptoms suggestive of dry eye were examined for tear break up time (TBUT), Schirmer's test 1, and Rose Bengal staining pattern. They were compared with a group of asymptomatic healthy subjects.Results:There were 63 subjects, mean age 43.8 years (+/−14.7 years) with various complaints of dryness presenting as having irritation or foreign body sensation. A group of 17 asymptomatic subjects, mean age 42.1 years (+/−12.7 years) were studied as controls. There were 22 (34. 9 %) males and 41(65.1%) females in the symptomatic group while the control group had 4 (23.5%) males and 13(76.5%) females. Ocular irritations included itching 38(60.3%), pricking and itching 10 (15.9%). Mean Shirmer's test values were lower for symptomatic subjects (mean 14.5mm +/−12.3 right eye; 14.9mm +/−12.4 left eye), compared to the controls (23.0mm +/−13.4 right eye; 17. 9mm +/−13.4 left eye) P=0.02, for right eye and 0.4 for left. The mean TBUT were also lower amongst the symptomatic subjects (10.5 seconds, right eye and 10.1 seconds left eye), while for controls mean TBUT was 12.7 seconds right eye and 12.1 seconds left eye (P=0.2). Fifty –six out of 126 (46.8%) eyes of all symptomatic subjects compared to 7 out of 34 (20.6%) eyes of asymptomatic subjects had positive staining of conjunctiva with rose Bengal (p=0.06). For subjects with itching as the primary symptom 44.7% of them as opposed to 23.5% of the controls were likely to stain positive with rose Bengal, (sensitivity of itching as screening tool for dry eye was 81%, specificity 38.2%). Itching and pricking sensation together (sensitivity 46.2% and specificity improved to 65%). Rose Bengal grades were also inversely correlated with mean Schirmers values (Pearson correlation −0.429; P = 0.001) and TBUT (Pearson correlation -0.316, P=0.005).Conclusion:Itching and other ocular irritation symptoms may be indicative of underlying abnormal tear function and ocular surface damage, their presence calls for further examination for tear deficiency and prompt institution of treatment for dry eye.

Patching has been a mainstay in treating unilateral congenital cataract. However, its efficacy has not been rigorously assessed. To examine the association between patching and visual acuity in a cohort of children treated for unilateral congenital cataract. This study was a secondary analysis of a randomized clinical trial (Infant Aphakia Treatment Study) of infants born from August 1, 2004, through December 31, 2008, who were treated with 1 of 2 treatments for unilateral congenital cataract and followed up to 5 years of age. Data analysis was performed from March 1, 2013, to March 1, 2016. Cataract extraction and randomization to receipt of an intraocular lens vs being left aphakic for the first 5 years of life. Caregivers reported patching in the previous 48 hours in quarterly semistructured telephone interviews. The mean number of hours of patching per day was calculated from surgery to the first birthday (n = 92) and between 12 and 48 months of age (n = 102). Monocular optotype acuity was assessed at 4½ years of age by a traveling examiner using the Aphakia Treatment Study HOTV protocol. The Infant Aphakia Treatment Study enrolled 114 children; 57 were randomized to each treatment group. At 4½ years of age, optotype visual acuity was assessed in 112 children. The current analyses exclude an additional 3 children (2 who had adverse events that limited visual potential and 1 who had Stickler syndrome), leaving 109 total children analyzed (59 female [54.1%] and 92 white [84.4%]). Caregivers reported patching their children a mean (SD) of 3.73 (1.47) hours per day in the first year of life and 3.43 (2.04) hours per day thereafter. An association between reported patching and treatment was not identified (mean difference in first year, -0.29 hours per day; 95% CI, -0.90 to 0.33 hours per day; mean difference between 12 and 48 months of age, -0.40 hours per day; 95% CI, -1.20 to 0.40 hours per day). Visual acuity was associated with reported hours of patching in the first year of life (r = -0.32; 95% CI, -0.49 to -0.13) and between 12 and 48 months of age (r = -0.36; 95% CI, -0.52 to -0.18). However, patching accounted for less than 15% of the variance in logMAR acuity at 4½ years of age. These results support the association of occlusion throughout the preschool years with improved visual acuity in infants treated for unilateral congenital cataract. However, similar visual outcomes were achieved with varying amounts of patching. These conclusions should be interpreted in the context of limitations related to generalizability from incomplete data collected in a clinical trial. clinicaltrials.gov Identifier: NCT00212134.

To compare the use of contact lenses and intraocular lenses (IOLs) for the optical correction of unilateral aphakia during infancy. In a randomized, multicenter (12 sites) clinical trial, 114 infants with unilateral congenital cataracts were assigned to undergo cataract surgery with or without IOL implantation. Children randomized to IOL treatment had their residual refractive error corrected with spectacles. Children randomized to no IOL treatment had their aphakia treated with a contact lens. Grating acuity at 12 months of age and HOTV visual acuity at 4 1/2 years of age. This study should determine whether either treatment for an infant with a visually significant unilateral congenital cataract results in a better visual outcome. Enrollment began December 23, 2004, and was completed January 16, 2009. The median age at the time of cataract surgery was 1.8 months. Fifty patients were 4 to 6 weeks of age at the time of enrollment; 32, 7 weeks to 3 months of age; and the remaining 32, more than 3 to less than 7 months of age. Fifty-seven children were randomized to each treatment group. Eyes with cataracts had shorter axial lengths and steeper corneas on average than the fellow eyes. The optimal optical treatment of aphakia in infants is unknown. However, the Infant Aphakia Treatment Study was designed to provide empirical evidence of whether optical treatment with an IOL or a contact lens after unilateral cataract surgery during infancy is associated with a better visual outcome.

To explore patient perception of vision loss in glaucoma and, specifically, to test the hypothesis that patients do not recognize their impairment as a black tunnel effect or as black patches in their field of view. Clinic-based cross-sectional study. Fifty patients (age range, 52-82 years) with visual acuity better than 20/30 and with a range of glaucomatous visual field (VF) defects in both eyes, excluding those with very advanced disease (perimetrically blind). Participants underwent monocular VF testing in both eyes using a Humphrey Field Analyzer (HFA; Carl Zeiss Meditec, Dublin, CA; 24-2 Swedish interactive threshold algorithm standard tests) and other tests of visual function. Participants took part in a recorded interview during which they were asked if they were aware of their VF loss; if so, there were encouraged to describe it in their own words. Participants were shown 6 images modified in a variety of ways on a computer monitor and were asked to select the image that most closely represented their perception of their VF loss. Forced choice of an image best representing glaucomatous vision impairment. Participants had a range of VF defect severity: average HFA mean deviation was -8.7 dB (standard deviation [SD], 5.8 dB) and -10.5 dB (SD, 7.1 dB) in the right and left eyes, respectively. Thirteen patients (26%; 95% confidence interval [CI], 15%-40%) reported being completely unaware of their vision loss. None of the patients chose the images with a distinct black tunnel effect or black patches. Only 2 patients (4%; 95% CI, 0%-14%) chose the image with a tunnel effect with blurred edges. An image depicting blurred patches and another with missing patches was chosen by 54% (95% CI, 39%-68%) and 16% (95% CI, 7%-29%) of the patients, respectively. Content analysis of the transcripts from the recorded interviews indicated a frequent use of descriptors of visual symptoms associated with reported blur and missing features. Patients with glaucoma do not perceive their vision loss as a black tunnel effect or as black patches masking their field of view. These findings are important in the context of depicting the effects of glaucomatous vision loss and raising awareness for glaucoma detection. The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Evidence from past studies indicates that children with traumatic brain injury experience difficulties with inhibitory control. Less is known about inhibitory control in children with frontal brain injury related to cerebral infarction. We compared the inhibitory performance of children with frontal infarcts related to sickle cell disease with that of a control group of children with sickle cell disease but no history of cerebral infarction. On a stimulus-response reversal task, children with frontal infarcts made significantly more accuracy errors in the inhibitory condition than controls. Findings from this study and from previous research suggest that impairments in inhibitory control are common following frontal injury in a range of pediatric populations.

Objectives In patients with coronary artery calcification (CAC), a predictor of adverse cardiovascular events, coronary computed tomography angiography (CCTA) also shows valvular calcification. In this study, we evaluated common clinical indicators in CAC patients with aortic (AoVC) and mitral valve (MVC) calcification. Methods CAC and valvular calcification were quantified using the Agatston score in 636 hospitalised patients with CAC who underwent CCTA. Results Valvular calcification was found in 30.5% of patients, with 25.2% (160 patients) showing AoVC. Age was an independent predictor of AoVC in both men (odds ratio (OR), 1.086; 95% confidence interval (CI), [1.054–1.119]; p < 0.001) and women (OR, 1.109; CI, [1.066–1.154]; p < 0.001). In men, we also found that a history of cerebral infarction was an independent predictor of AoVC (OR, 2.402; CI, [1.177–4.902]; p < 0.05). The independent predictors of AoVC in the 60- to 69-years age group were BMI (OR, 1.181; CI, [1.061–1.316]; p < 0.01) and history of cerebral infarction (OR, 3.187; CI, [1.283–7.919]; p < 0.05). Conclusions Age is a key independent predictor of AoVC in CAC patients. History of cerebrovascular disease was also an independent predictor of AoVC, but only in men and patients aged 60–69 years. Our results indicate that a history of cerebral infarction may be used as a risk factor when identifying AoVC in patients with CAC.

A Two-Week, Randomized, Double-masked Study to Evaluate Safety and Efficacy of Lubricin (150 μg/mL) Eye Drops Versus Sodium Hyaluronate (HA) 0.18% Eye Drops (Vismed®) in Patients with Moderate Dry Eye Disease

BackgroundUniversal postoperative guidelines for cataract extraction surgery are yet to be introduced. Artificial tears are gaining popularity as an additional integral component of the postoperative regime. The primary objective of this study was to explore the impact of two prevalent artificial tear preparations on postoperative discomfort following cataract extraction surgery.MethodsA total of 180 patients that underwent cataract extraction surgery were randomly divided into three groups according to their postoperative regime: a) Study group 1 (SG1) received a fixed combination of tobramycin and dexamethasone (FCTD) quid for 3 weeks and, additionally polyethylene glycol 400/propylene glycol/hydroxypropyl-guar quid, for 6 weeks, b) Study group 2 (SG2) received FCTD quid for 3 weeks and, additionally 0.1% sodium hyaluronate provided in the COMOD® device quid, for 6 weeks, and, c) Control Group (CG) received only FCTD quid for 3 weeks. The following indexes were evaluated at three postoperative checkpoints: 1) Subjective discomfort index (SDI) derived from four direct 10-scale Likert-type questions that were addressed to the patient and pertained to: a) foreign body sensation (FBS), b) blinking discomfort (BD), c) stinging sensation (SS), d) tearing sensation (TS), 2) Tear break-up time (TBUT), 3) Central corneal thickness (CCT) and, 4) Central Corneal Sensitivity (CCS).ResultsBoth groups showed increased CCT values at the first examination point and reduced CCS values at all examination points. Furthermore, both SGs had better TBUT times at all examination points compared to CG (CG: 8.86 ± 1.08, SG1: 9.59 ± 1.45, CG2: 9.45 ± 1.33, p < 0.05). BD was significantly better in both SGs only at the 1st week of examination, while SDI values were better until the 3rd week and only borderline better at 6th week. Lastly, no significant differences were detected between SGs, regarding all parameters, at all examination points.ConclusionPolyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate provided in the COMOD® device seem to be equally efficient in alleviating OSD symptoms following cataract extraction surgery and any of them should be routinely added to the postoperative regime.Trial registrationClinicalTrials.gov Identifier: https://clinicaltrials.gov/ct2/show/NCT02558218NCT02558218

Objective: To explore the related factors of internal border-zone (IBZ) infarcts in patients with symptomatic chronic internal carotid artery occlusion (CICAO). Methods: From January 2011 to May 2019, the symptomatic CICAO patients in the Second Affiliated Hospital of Soochow University and the Ninth People's Hospital of Suzhou were retrospectively analyzed. The patients were divided into IBZ group and non-IBZ group. The demographic data, laboratory examination and imaging data of the two groups were collected. Binary logistic regression analysis was used to identify the related factors of IBZ infarcts in patients with symptomatic CICAO. Results: A total of 185 patients (147 males and 38 females) were finally enrolled, with a mean age of (65±11) years old. There were 64 and 121 cases in IBZ group and non-IBZ group, respectively. The ratio of patients with ophthalmic artery (OA) reflux in IBZ group was 64.1% (41/64), which was significantly higher than that in non IBZ group [47.8% (55/121), P=0.037], while the ratio of patients with collateral compensation (ASTIN/SIR 3-4) in non-IBZ group was 66.1% (80/121), which was significantly higher than that in IBZ group [29.7% (19/64), P<0.001]. Multivariate logistic regression analysis showed that history of cerebral infarction (OR=2.233, 95%CI: 1.023-4.874), low density lipoprotein (LDL) (OR=1.516, 95%CI: 1.006-2.285) and OA reflux (OR=5.060, 95%CI: 1.160-22.081) were independent risk factors for IBZ infarcts in patients with symptomatic CICAO (all P<0.05); while prothrombin international normalized ratio (INR) (OR=0.010, 95%CI: 0.000-0.970) and collateral compensation (ASTIN/SIR 3-4) (OR=0.172, 95%CI: 0.079-0.373) were protective factors (all P<0.05). Conclusion: OA reflux, LDL, and history of cerebral infarction are independent risk factors for IBZ infarcts in patients with symptomatic CICAO, while INR and collateral compensation scores (ASTIN/SIR 3-4) are the protective factors.

In our study, we focused on the fact that platelets play a significant role in thrombus formation in the arterial vessels, and started exploratory research on the antiplatelet agent with a vasodilating action in order to discover a more effective drug for arterial thrombosis. We synthesized many 2(1H)-quinolinone derivatives and evaluated their inhibition of platelet aggregation and their vasodilating activities. First we found cilostamide, which has an amide moiety in the side chain. This compound possessed desired activities, but it caused a side effect of tachycardia, and so, unfortunately, we were unable to pursue its development. After many efforts to modify the side chain moiety to eliminate this side effect, we finally invented cilostazol (OPC-13013), a 2(1H)-quinolinone derivative with a tetrazol ring in the side chain. Cilostazol inhibited human platelet aggregation induced by various stimuli including shear stress in vitro and showed potent antiplatelet effects both in vitro and ex vivo. It was also shown that the drug has antithrombotic effects in experimental thrombus models and a vasodilating activity of the femoral artery and vertebral artery. The mechanism of the action for cilostazol is specific inhibition of cyclic nucleotide phosphodiesterase type 3 (PDE3). Cilostazol was marketed first in Japan in 1988 and later in seven other countries for the treatment of chronic arterial occlusion. It was launched in the U.S. in 1999, and approved in United Kingdom for the treatment of intermittent claudication. More recently, cilostazol was shown to be effective in a clinical prevention study on recurrence of cerebral infarction, and has been applied to the approval of the indication in Japan.