Treatment of Open-Angle Glaucoma and Ocular Hypertension with the Fixed-Dose Combination of Preservative-Free Tafluprost/Timolol: Clinical Outcomes from Ophthalmology Clinics in Italy.

Introduction: The VISIONARY study examined the intraocular pressure (IOP)-lowering efficacy and tolerability of the preservative-free fixed-dose combination of tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in a real-world setting. The country-level data reported herein comprise the largest and first observational study of PF tafluprost/timolol FC therapy in Italy. Methods: An observational, multicenter, prospective study included adult Italian patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) demonstrating insufficient response or poor tolerability with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Treatment was switched to PF tafluprost/timolol FC therapy at baseline. Primary endpoint was the absolute mean IOP change from baseline at Month 6. Exploratory and safety endpoints included change in IOP at Weeks 4 and 12, ocular signs, symptom severity and reporting of adverse events (AEs). Results: Overall, 160 OAG/OHT patients were included. Mean ± standard deviation IOP was reduced from 19.6 ± 3.6 mmHg at baseline to 14.5 ± 2.6 mmHg at Month 6 (reduction of 5.1 ± 3.7 mmHg; 24.1%; p < 0.0001). IOP reduction was also statistically significant at Week 4 (23.1%; p < 0.0001) and Week 12 (24.7%; p < 0.0001). Based on data cutoff values for mean IOP change of ≥20%, ≥25%, ≥30% and ≥35%, respective Month 6 responder rates were 68.1%, 48.7%, 36.2% and 26.9%. Most ocular signs and symptoms were significantly reduced in severity from baseline at Month 6. Two non-serious and mild AEs were reported during the study period, among which, one AE was treatment-related (eyelash growth). . Conclusion: Italian OAG and OHT patients demonstrated a significant IOP reduction from baseline at Week 4 that was maintained over a 6-month period following a switch from topical PGA or beta-blocker monotherapy to PF tafluprost/timolol FC therapy. Severity of most ocular signs and symptoms was significantly reduced during the study period, and PF tafluprost/timolol FC was generally well tolerated.

Exercise and probiotics attenuate the development of Alzheimer's disease in transgenic mice: Role of microbiome.

It has been suggested that exercise training and probiotic supplementation could decelerate the progress of functional and biochemical deterioration in APP/PS1 transgenic mice (APP/PS1TG). APP/PS1TG mice were subjected to exercise training and probiotic treatments and functional, biochemical and microbiome markers were analyzed. Under these conditions the mice significantly outperformed controls on The Morris Maze Test, and the number of beta-amyloid plaques decreased in the hippocampus. B. thetaiotaomicron levels correlated highly with the results of the Morris Maze Test (p < 0.05), and this group of bacteria was significantly elevated in the microbiome of the APP/PS1TG mice compared to the wild type. L. johnsonii levels positively correlated with the beta amyloid content and area. Data revealed that exercise and probiotic treatment can decrease the progress of Alzheimer's Disease and the beneficial effects could be partly mediated by alteration of the microbiome.

Diagnostic capability of optic nerve head rim width and retinal nerve fiber thickness in open-angle glaucoma.

PURPOSE: This study was performed to test the diagnostic capability of the minimum rim width compared to peripapillary retinal nerve fiber layer thickness in patients with glaucoma. METHODS: A case control, observer masked study, was conducted. Minimum rim width and retinal nerve fiber layer thickness were assessed using the patient-specific axis traced between fovea-to-Bruch's membrane opening center axis. For both minimum rim width and retinal nerve fiber layer thickness, the regionalization in six sectors (nasal, superior-nasal, superior-temporal, temporal, inferior-temporal, and inferior-nasal) was analyzed. Eyes with at least one sector with value below the 5% or 1% normative limit of the optical coherence tomography normative database were classified as glaucomatous. The area under the receiver operator characteristic curve, the accuracy, sensitivity, specificity, and predictive positive and negative values were calculated for both minimum rim width and retinal nerve fiber layer thickness. RESULTS: A total of 118 eyes of 118 Caucasian subjects (80 eyes with open-angle glaucoma and 38 control eyes) were enrolled in the study. Accuracy, sensitivity, and specificity were 79.7%, 77.5%, and 84.2%, respectively, for minimum rim width and 84.7%, 82.5%, and 89.5% for retinal nerve fiber layer thickness. The positive predictive values were 0.91% and 0.94% for minimum rim width and retinal nerve fiber layer thickness, respectively, whereas the negative predictive values were 0.64% and 0.70%. The area under the receiver operator characteristic curve was 0.892 for minimum rim width and 0.938 for retinal nerve fiber layer thickness. CONCLUSION: Our results indicated that the sector analysis based on Bruch's membrane opening and fovea to disk alignment is able to detect glaucomatous defects, and that Bruch's membrane opening minimum rim width and retinal nerve fiber layer thickness showed equivalent diagnostic ability.

Evaluation of the progression of visual field damage in patients suffering from early manifest glaucoma.

BACKGROUND: This retrospective study aimed to determine how often a perimetric examination should be carried out in order to identify visual field (VF) changes in patients with relatively early manifestation glaucoma. MATERIALS AND METHODS: Patients included had a relatively recent manifestation of primary open-angle glaucoma. Patients with a minimum follow-up of 5 years and a minimum of seven VF tests were included. Statistical analysis was performed to verify the trend of variations in mean defect (MD) over time (PeriData). The results were subjected to a t-test for a comparative analysis of progression of VF changes over time. The annual rate of progression provided by PeriData considering all the VFs analyzed was compared with that obtained on half of the VF examinations during the same follow-up period. An analysis of the MD trend over time was also carried out in relationship to the number of VF tests done and by dividing the sample into a high-frequency group (more than eight VFs) and a low-frequency group (fewer than eight VFs) in the follow-up period. RESULTS: A total of 96 eyes of 96 patients were included, and overall 846 VFs were examined. The paired t-test performed comparing the MD index of all the VFs against half of them did not show statistical significance (P=0.537). The high-frequency group comprised 39 eyes (average VF 11.05±1.91, average time interval 0.76 years) while the low-frequency group comprised 57 eyes (average VF 6.95±0.6, average time interval 1.21 years). The analysis of the MD trend in the high-frequency patients showed significance (P=0.017); the low-frequency group did not show statistical significance (P=0.08). CONCLUSION: The number of VFs in a determined time interval was not significant. However, a greater frequency of tests provides a predictive evaluation of the rate of progression of early manifestation open-angle glaucoma.

Ganglion Cell Complex Evaluation in Exudative Age-Related Macular Degeneration after Repeated Intravitreal Injections of Ranibizumab.

Purpose. To detect the effects of intravitreal ranibizumab injections on GCC in patients with wet AMD. Methods. 32 wet AMD eyes were selected and submitted at three ranibizumab injections. RTVue-OCT GCC and MM5 protocol were performed before treatment and twenty days after each injection. Results. At baseline mean GCC thickness was 93.9 ± 18.5 µm. Twenty days after each intravitreal injection it was, respectively, 85.8 ± 10.1, 86.5 ± 9.3, and 91.1 ± 11.5 µm, without statistical significance. A significant improvement in visual acuity (P = 0.031) and a reduction of mean foveal (P = 0.001) and macular thickness (P = 0.001) were observed. Conclusion. The clinical results confirm therapeutic efficacy of intravitreal injections of ranibizumab in wet AMD. A contemporary not statistically significant reduction of GCC thickness suggests that the loading phase of ranibizumab does not have any toxic effects on ganglion cell complex.

Validity and limits of the rebound tonometer (ICare®): clinical study.

PURPOSE: The aim of this study was to evaluate the measurement of intraocular pressure (IOP) using a new induction/impact rebound tonometer (ICare®) compared with Goldmann applanation tonometry (GAT). We also aimed to quantify the systematic and random errors (bias) of the 2 methods, to evaluate the sensitivity and specificity of the ICare® tonometer in identifying patients with 21 mmHg or more measured with the GAT, and to study the influence of corneal thickness on IOP measurement with the 2 tonometers. METHODS: We compared the IOP values obtained with the 2 instruments in 97 patients. RESULTS: Analysis based on the Bland and Altman method revealed that the IOP values recorded with the ICare® tonometer were slightly higher than those obtained with the GAT. The estimated bias for right eye measurements was 0.78 mmHg with 95% limits of agreement ±3.55 mmHg. This overestimation, which is not clinically relevant, was confirmed when we used the IOP values corrected according to central corneal thickness for data analysis. The sensitivity and specificity were 0.90 and 0.95, respectively. CONCLUSIONS: The ICare® tonometer proved to be comparable with other nonconventional tonometers and can be used by nonophthalmologists and paramedical personnel during screening tests of populations. In addition, the ICare® tonometer could be considered a valid alternative to GAT when GAT is not available.

Efficacy of 2% ibopamine on the dilation of patients with pseudoexfoliation syndrome.

PURPOSE: To compare the mydriatic effects of 2% ibopamine and collyrium containing 10% phenylephrine + 0.5% tropicamide and to study the associated drug in patients with ocular pseudoexfoliation (PEX) syndrome. METHODS: This was a prospective, comparative, interventional clinical study. The study group consisted of 20 patients with ocular PEX syndrome. Intervention procedures included administration of 10% phenylephrine-0.5% tropicamide versus 2% ibopamine versus 2% ibopamine followed by the combination drug. Main outcome measurement was mydriatic efficacy measured in terms of mean pupil diameter. Adverse effects on intraocular pressure (IOP) were measured with a Goldmann applanation tonometer. Mean premedication pupil diameters in all patients were less than 3.5 mm. RESULTS: Instillation of 10% phenylephrine-0.5% tropicamide caused significantly greater mydriasis than 2% ibopamine (pupil diameters: 6.17 mm, SD=1.14 versus 5.33 mm, SD=1.34; p<0.001). Combined use of both collyria significantly increased mydriasis (7.19 mm; SD=0.69) compared with that induced by either of the products alone (p<0.001). Inadequate mydriasis (pupil diameters < 5.5 mm) was observed in 2 patients after administration of 10% phenylephrine-0.5% tropicamide and in 10 following instillation of 2% ibopamine, but the addition of 10% phenylephrine -0.5% tropicamide to ibopamine-treated eyes resulted in adequate dilation in all cases. IOP increases of 4 mmHg over baseline values were observed in 12 (60%) patients after 2% ibopamine. CONCLUSIONS: In patients with ocular PEX, instillation of 2% ibopamine exerts a significant additive effect on mydriasis induced with 10% phenylephrine-0.5% tropicamide with only minimal increases in IOP.

Validity and limitations of the Nidek NT-4000 non-contact tonometer: a clinical study.

Using Goldmann applanation tonometry (GAT) as a gold standard, we evaluated the accuracy of Nidek NT-4000 pneumotonometry (NPT) in adults without corneal disease. Bland and Altman analysis of serial intra-ocular pressures (IOPs) measured with NPT and GAT in 10 healthy subjects revealed that the repeatability coefficients for the two methods were similar. NPT, GAT and ultrasonic pachymetry were then performed in 100 patients. Bland and Altman analysis showed that NPT yielded significantly higher readings than GAT [mean biases for right and left eye measurements were 1.37 mmHg (95% limits of agreement: -3.02-5.76) and 1.17 mmHg (95% limits of agreement: -2.76-5.11) respectively] and was more affected by corneal thickness variations. For detection of IOPs > or =21 mmHg, NPT displayed very high sensitivity (0.90) and good specificity (0.95). NPT may be useful in screening and clinical settings but borderline-high IOP readings should be confirmed with GAT.