Effect of intravitreal injection of dexamethasone implant on corneal endothelium in macular edema due to retinal vein occlusion

Objective: To evaluate the effects of dexamethasone (DEX) implant (Ozurdex®) on corneal endothelium in patients with retinal vein occlusion complicated with macular edema.

Materials and methods: Patients (n?=?31) received 1–3 intravitreal DEX implants in one eye. Measurements were intraocular pressure (IOP) at baseline and 1, 3, and 6 months after the first intravitreal injection and corneal specular microscopy and central corneal thickness (CCT) at baseline and 1 and 6 months. We analyzed endothelial cell density (ECD), coefficient of variation of cell size (CV), and percentage of hexagonality.

Results: Mean follow-up period was 9.7?±?3.3 months. Mean number of injections was 1.5?±?0.8. Mean IOP values were 15.6?±?2.6?mm Hg at baseline, 17.7?±?3.6?mm Hg at one month, 16.4?±?4.1?mm Hg at three months, and 16.0?±?2.7?mm Hg at six months. There was a significant difference in mean IOPs at one month and six months (p?=?0.008). There were no significant differences in mean ECD (p?=?0.375), CV (p?=?0.661), percentage of hexagonality (p?=?0.287), and CCT (p?=?0.331).

Conclusion: Although intravitreal injection of 0.7?mg DEX causes moderate elevation of IOP, it does not seem to have detrimental effects on corneal endothelium at six months.     

Accelerated corneal collagen cross-linking for progressive keratoconus

Purpose: To evaluate the efficacy of accelerated corneal cross-linking (CXL) procedure for progressive keratoconus.

Materials and methods: Twenty-three eyes of 23 patients undergone accelerated CXL procedure were evaluated preoperatively and postoperatively at 1st, 3rd and 6th month for uncorrected distant visual acuity (UDVA), best corrected distant visual acuity (CDVA), spherical error, cylindrical error, spherical equivalent (SE), keratometric values and thinnest corneal thickness (TCT) values with corneal topography by Scheimpflug camera and endothelial cell density (ECD).

Results: The mean UDVA was improved from 0.97?±?0.41 logarithm of minimal angle of resolution (logMAR) to 0.76?±?0.45 logMAR at the 6th month after CXL (p?=?0.332). The mean CDVA was improved from 0.49?±?0.30 logMAR to 0.34?±?0.22 logMAR at the 6th month after CXL (p?=?0.026). The mean sphere was decreased from ?4.47?±?4.1 diopter (D) to ?3.79?±?3.86?D and the mean cylinder was decreased from ?5.60?±?2.2?D to ?4.55?±?1.98?D and the mean SE was decreased from ?7.22?±?4.48?D to ?6.36?±?4.34?D at the 6th month after CXL (p?=?0.128, p?=?0.002 and p?=?0.045, respectively). Flat keratometry, steep keratometry, mean keratometry and maximum keratometry were significantly reduced at the 6th month after CXL (p?=?0.025, p?p?=?0.004 and p?=?0.03, respectively). TCT and ECD were not changed significantly the 6th month after CXL (p?=?0.135 and p?=?0.082, respectively).

Conclusion: Accelerated CXL procedure was effective to stabilize progression of keratoconus with significant reduction in topographic keratometric values and significant increase in CDVA in 6 months.     

Patient-reported treatment satisfaction with rivaroxaban in Japanese non-valvular atrial fibrillation patients: an observational study

Objectives: Rivaroxaban has previously been shown to be as efficacious and safe as warfarin for the prevention of stroke in non-valvular atrial fibrillation (NVAF). Therefore, treatment satisfaction becomes an important consideration. Here we examine treatment satisfaction in Japanese NVAF patients who were switched from warfarin to rivaroxaban.

Methods: Patient-reported outcome (PRO) data were collected as part of a prospective, multi-center, post-marketing surveillance (PMS) of a direct oral-anticoagulant, rivaroxaban, in Japan. The Anti-Clot Treatment Scale (ACTS) and the Treatment Satisfaction Questionnaire for Medication version II (TSQM-II) were collected at baseline, month 3, and month 6. Change in scores from baseline to month 3 and month 6 were assessed. Exploratory analyses included change in scores by patient characteristics. Safety and effectiveness of rivaroxaban were also assessed.

Results: ACTS Burdens scores significantly improved at month 3 (54.6?±?6.3) and month 6 (54.5?±?6.5) compared to baseline (51.0?±?7.6) (p?<?.001). ACTS Benefits score remained stable over time (baseline?=?10.1?±?2.8, month 3?=?10.2?±?3.1, month 6?=?10.1?±?3.1). Mean TSQM-II sub-scale scores significantly improved at month 3 and month 6 compared to baseline for all four domains (all p?<?.001).

Conclusions: Findings suggest treatment satisfaction may improve in Japanese NVAF patients after a switch from warfarin to rivaroxaban. Higher treatment satisfaction may translate into improved treatment adherence, which is critical for the long-term prevention of stroke.     

The long-term effect of oral isotretinoin therapy on macula ganglion cell complex thickness

Purpose: To evaluate the long-term effect of oral isotretinoin therapy on macula ganglion cell complex (GCC) thickness by spectral domain optical coherence tomography (SD-OCT).

Materials and methods: Newly diagnosed cystic acne patients who received low dose for a long time systemic isotretinoin therapy were included in this study. Thorough ophthalmic evaluation and GCC thickness analysis by using SD-OCT were performed at baseline, and at 1, 3, 6, and 12 months of treatment.

Results: Forty-eight eyes of 24 patients (15 females, 9 males) were included in the study. The mean age of patients was 19.37?±?2.74 years (range 14–25 years). The full ophthalmologic examination was normal in all eyes before treatment. During the treatment there were no change in visual acuity, refractive error, intraocular pressure and tear break-up time. The mean GCC thicknesses were 81.45?±?4.91, 81.45?±?5.12, 81.81?±?4.68, 81.87?±?4.91 and 81.64?±?5.09?μm at pretreatment and at 1, 3, 6, and 12 months of treatment, respectively (p?=?0.803).

Conclusion: One-year systemic use of isotretinoin had no significant effect on the thickness of macula ganglion cell. Macular ganglion cell analysis is useful for determining and following the toxic effects of systemic drugs on the retina. However, it is more rational to consider it as an adjunct to electrophysiological testing rather than used alone.     

Exenatide effects on diabetes,obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years

ABSTRACT

Background: Exenatide, an incretin mimetic for adjunctive treatment of type 2 diabetes (T2DM), reduced hemoglobin A_1c (A1C) and weight in clinical trials. The objective of this study was to evaluate the effects of?≥?3 years exenatide therapy on glycemic control, body weight, cardiometabolic markers, and safety.

Methods: Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial. Patients were randomized to twice daily (BID) placebo, 5?µg exenatide, or 10?µg exenatide for 30 weeks, followed by 5?µg exenatide BID for 4 weeks, then 10?µg exenatide BID for ≥3 years of exenatide exposure. Patients continued metformin and/or sulfonylureas.

Results: 217 patients (64% male, age 58?±?10 years, weight 99?±?18?kg, BMI 34?±?5?kg/m², A1C 8.2?±?1.0% [mean?±?SD]) completed 3 years of exenatide exposure. Reductions in A1C from baseline to week 12 (?1.1?±?0.1% [mean?±?SEM]) were sustained to 3 years (?1.0?±?0.1%; p?<?0.0001), with 46% achieving A1C?≤?7%. Exenatide progressively reduced body weight from baseline (?5.3?±?0.4?kg at 3 years; p?<?0.0001). Patients with elevated serum alanine aminotransferase (ALT) at baseline (n?=?116) had reduced ALT (?10.4?±?1.5?IU/L; p?<?0.0001) and 41% achieved normal ALT. Patients with elevated ALT at baseline tended to lose more weight than patients with normal ALT at baseline (?6.1?±?0.6?kg vs. ?4.4?±?0.5?kg; p?=?0.03), however weight change was minimally correlated with baseline ALT (r?=??0.01) or ALT change (r?=?0.31). Homeostasis Model Assessment B (HOMA-B), blood pressure, and aspartate aminotransferase (AST) all improved. A subset achieved 3.5 years of exenatide exposure and had serum lipids available for analysis (n?=?151). Triglycerides decreased 12% (p?=?0.0003), total cholesterol decreased 5% (p?=?0.0007), LDL-C decreased 6% (p?<?0.0001), and HDL-C increased 24% (p <?0.0001). Exenatide was generally well tolerated. The most frequent adverse event was mild-to-moderate nausea. The main limitation of this study is the open-label, uncontrolled nature of the study design which does not provide a placebo group for comparison.

Conclusion: Adjunctive exenatide treatment for ≥3 years in T2DM patients resulted in sustained improvements in glycemic control, cardiovascular risk factors, and hepatic biomarkers, coupled with progressive weight reduction.     

Effect of topiramate on choroidal thickness and anterior chamber parameters in the treatment of patients with migraine

Objective: To investigate the effects of topiramate on choroidal thickness and anterior chamber parameters using optical coherence tomography in the treatment of patients with migraine.

Methods: A total of 22 eyes of 22 adults (12 females, 10 males) diagnosed with migraine and scheduled to topiramate treatment for pain control were recruited in this prospective study. Choroidal thickness (CT), anterior chamber depth (ACD), anterior chamber angle (ACA), spherical refractive equivalent (SphEq) and intraocular pressure (IOP) measurements were recorded at baseline (prior the topiramate therapy), first and second month visits for the statistical analysis. One-way ANOVA with repeated measures test was used for the statistical evaluation.

Results: Mean age of the patients was 40.2?±?6.5?years. Mean CT at central fovea was 324?±?47?μm initially, 341?±?45?μm in the first month and 344?±?46?μm in the second month, thus first and second month measures were significantly higher than base values (p?p?=?0.001). Baseline ACD (3.66?±?0.22?mm) measures significantly decreased at the first month (3.63?±?0.22?mm) and second month (3.62?±?0.22?mm, p?=?0.009). Also, a significant reduction was detected in the first (36.2?±?4.9°) and second month (35.9?±?5.1°) ACA measures comparing with baseline (39.1?±?5.1°, p?=?0.05). A significant myopic shift was determined in the first and second month SphEq values (?0.08?±?0.6, ?0.10?±?0.6, respectively, p?=?0.05).

Conclusions: The study revealed increased CT and altered anterior chamber parameters and IOP due to topiramate therapy. Therefore, the patients using topiramate should be carefully monitored by an ophthalmologist considering the possible side effects.     

The effect of oral isotretinoin on visual contrast sensitivity and amount of lacrimation in patients with acne vulgaris

Context: Acne vulgaris is a puberty-onset chronic inflammatory disease of the pilosebaceous unit. Isotretinoin is a derivative of vitamin A commonly used for severe and nodulocystic acne. While isotretinoin has many side effects related to the eye, visual system and lacrimation, there is no information regarding isotretinoin’s influence on contrast sensitivity.

Aim: To investigate the effect of isotretinoin on visual contrast sensitivity and the amount of lacrimation.

Materials and methods: The study included 25 patients (16 females and 9 males) who underwent isotretinoin treatment. The treatment duration ranged from 4 to 7 months. Patients were examined both before the start and at the end of treatment using the Schirmer test in each eye. The contrast sensitivity measurement was performed both individually for each eye and in a binocular fashion using the Pelli–Robson Sensitivity Chart.

Results: The results of the Schirmer test before treatment were 19.74?±?3.63?mm for the right eye and 19.66?±?3.63?mm for the left eye. Post-treatment measurement results were 17.24?±?3.5?mm for the right eye and 16.68?±?3.73?mm for the left eye. There was a statistically significant difference between the before and after treatment measurements (p?<?0.000). Before treatment, contrast sensitivity was 1.45?±?0.19 for the right eye and 1.42?±?0.2 for the left eye. The binocular measurement was 1.54?±?0.14. After treatment, the right eye was 1.47?±?0.19, the left eye was 1.46?±?0.18, and the binocular measurement was 1.54?±?0.18. There were no statistically significant differences between before and after treatment (p?>?0.05).

Discussion: There are contradicting reports on the results of the Schirmer test. The only similar study that has evaluated contrast sensitivity used the drug acitretin, the results of which are consistent with those the present study.

Conclusion: Our study is significant in that it is the first to investigate the effects of isotretinoin on visual contrast sensitivity that is closely associated with real-world performance. Our results need to be supported by future studies.     

Effect of pramlintide as an adjunct to basal insulin on markers of cardiovascular risk in patients with type 2 diabetes

ABSTRACT

Objective: Intensification of insulin therapy in patients with type 2 diabetes, while improving glycemic control, often leads to an increase in body weight and other markers of cardiovascular risk. The effects of pramlintide as an adjunct to basal insulin titration (without mealtime insulin) on glycemia and cardiovascular risk markers were examined.

Research design and methods: This was a post hoc analysis of a 16-week, double-blind, placebo-controlled study in patients with type 2 diabetes (N?=?211) using insulin glargine (without mealtime insulin)?±?oral agents. Patients were randomized to treatment with placebo or pramlintide (60 or 120?µg with major meals), and insulin glargine was titrated to target a fasting plasma glucose concentration of ≥70 to <100?mg/dL.

Main outcome measures: Endpoints included the change from baseline to Week 16 in body weight, high sensitivity C-reactive protein (hsCRP), triglycerides, HDL, LDL, and blood pressure.

Results: Pramlintide-treated patients lost weight and placebo-treated patients gained weight during 16 weeks of treatment (?1.6?±?0.3?kg vs. +0.7?±?0.3?kg, p?<?0.001; mean?±?SE). hsCRP was reduced in pramlintide-treated versus placebo-treated patients (?0.8?±?0.2?mg/L vs. 0.1?±?0.2?mg/L, p?<?0.01; mean?±?SE). Patients with baseline hsCRP?>?3?mg/L (high cardiovascular risk) demonstrated greater hsCRP reductions with pramlintide versus placebo treatment at Week 16 (p?<?0.05). Patients with baseline triglycerides ≥150?mg/dL or ≥200?mg/dL (high cardiovascular risk) showed significant reductions from baseline in triglyceride concentrations with pramlintide (?43?±?14?mg/dL or ?59?±?19?mg/dL; p?<?0.05; mean?±?SE) but not with placebo (1?±?29?mg/dLor ?3?±?54?mg/dL; mean?±?SE). No significant differences between pramlintide and placebo were observed for changes in HDL, LDL, or blood pressure. Pramlintide treatment was generally well tolerated. The most frequent adverse event related to pramlintide was mild-to-moderate nausea (31% pramlintide vs. 10% placebo). Pramlintide added to basal insulin did not increase the incidence of hypoglycemia. A limitation of the study was its relatively short duration.

Conclusions: Pramlintide, as an adjunct to basal insulin, was associated with improvements in several cardiovascular risk markers, warranting long-term clinical studies to determine its potential effects on cardiovascular risk.     

Effects of smoking on visual acuity of central serous chorioretinopathy patients

Background: The aim of this study was to evaluate the differences, in terms of visual outcome and treatment needs, between smokers and non-smokers central serous chorioretinopathy (CSCR) patients.

Methods: The files of 252 patients diagnosed with CSCR who had presented to the Retina Unit of the Ophthalmology Clinic at Dicle University Medical School in Turkey were retrospectively evaluated. Eighty-four smokers, with a known history of smoking of at least one pack-year, and 133 non-smokers were included, whereas 35 patients with additional pathologies were excluded from the study.

Results: Of the patients, 192 (88.5%) were male and 25 (11.5%) were female. The mean patient age was 38.8?±?8.1 years (range: 20–68 years). Visual acuity (VA) of the smoker and non-smoker groups was measured as 0.45?±?0.35 and 0.24?±?0.28 logarithm of the minimum angle of resolution (logMar), respectively, at the first visit; 0.19?±?0.29 and 0.06?±?0.14 logMar at the sixth month; and 0.07?±?0.14 and 0.02?±?0.05 logMar at the ninth month. VA measurements at presentation and during all examinations (1th, 6th and 9th month) were significantly different for the two groups. VA was lower in the smoker group. In 27 patients (12.4%), an additional treatment modality was needed. Of the 27 patients, only 8 (6%) were non-smokers, whereas 19 (22.6%) were smokers. There was no difference between groups in the recurrence rate during follow-up (p?=?0.907); 14 (16.7%) smokers and 8 (19.0%) non-smokers experienced a recurrence.

Conclusion: This study has shown that patients selected and who are current smokers have poorer vision and need longer treatment.     

Effect of chronic smoking on lens nucleus as assessed by Pentacam HR lens densitometry in young adults

Objective: To evaluate the effects of chronic tobacco smoking on lens nucleus by Pentacam HR lens densitometry (LD) in young adults.

Design: Prospective cross-sectional case series.

Methods: Thirty subjects (23?M, 7 F) who were chronic cigarette smokers (≥10 cigarettes/day for at least 2 years) (group 1) and another 30 subjects (23?M, 7 F) who did not smoke (group 2), were included in this study. The patients were matched for age and sex between the groups. The exclusion criteria were any history of ocular surgery, any systemic disorders and any ocular diseases except for mild refractive disorders. Lens densitometry measurements were done with the Pentacam HR (Oculus, Wetzlar, Germany). The Schirmer test and pachymetry measurements were also performed.

Results: Mean age of the patients for both groups was 28.90?±?8.20 years (range: 18–40 years). Mean lens densitometry (LD) measurements of Group 1 (chronic cigarette smoking group) were higher than those of Group 2 (control group) in all LD techniques; however only mean “peak” LD measurements showed a statistically significant difference between these two groups (Group 1: 8.67?±?0.61, Group 2: 8.44?±?0.70, p?=?0.04). The mean Schirmer test value was 12.43?±?5.60?mm in Group 1 and 13.00?±?4.26?mm in Group 2 (p?=?0.55). The mean central corneal thickness (CCT) value was 564.23?±?34.61?µm in Group 1 and 550.47?±?32.94?µm in Group 2 (p?=?0.03).

Discussion: The Pentacam HR LD seems to be an important option for the evaluation of lens nucleus in young adults, because it gives objective and quantitative data.

Conclusion: Although chronic smoking increases lens nucleus density in young adults, the effect is not statistically significant when compared with the control group.     

In vitro inhibitory effects of thymol and carvacrol on dendritic cell activation and function

Context: Thyme has been used in traditional medicine for medicinal purposes since ancient times.

Objective: The objective of this study was to investigate the effects of thymol and carvacrol as two major constituents of thyme on dendritic cells (DCs) maturation and T cell activation.

Materials and methods: Splenic DCs were treated with non-cytotoxic concentrations of the components and then analyzed for MHC II, CD86, and CD40 expression by flow cytometry. The effects of compounds on mitogenic, as well as allogenic T cell responses in mixed lymphocyte culture (MLR) and the release of cytokines were investigated.

Results: At 0.1?µg/ml, reduced mean fluorescent intensity (MFI) of CD86 for thymol (80.3?±?0.2% of untreated control) and CD40 for carvacrol (79.5?±?0.14%) was observed (p?<?0.001). Decreased mitogenic T cell proliferation by thymol [proliferation index (PI) from 0.93?±?0.11 at 1?µg/ml to 0.42?±?0.16 at 100?µg/ml (p?<?0.01)] and carvacrol [PI from 1.08?±?0.3 at 1?µg/ml to 0.28?±?0.1 at 100?µg/ml (p?<?0.001)] was seen. Ten micrograms/ml thymol (PI, 0.85?±?0.04) and carvacrol (PI, 0.89?±?0.03) inhibited allogenic T cell response (p?<?0.05). Decreased IFN-γ level in MLR supernatant from 1441?±?27.7?pg/ml in untreated cells to 944?±?32.1 at 10?µg/ml of thymol and of carvacrol (886?±?31.7?pg/ml) (p?<?0.01) was found. IL-4 levels were decreased in the presence of both compounds (p?<?0.01).

Conclusion: These data showed the suppressive effects of thymol and carvacrol on DCs maturation and function, as well as T cell responses.     

Effect of oral photochemotherapy (8-methoxypsoralen + UVA) on the electrophysiologic function of retina

Context: Since we had observed electroretinographic (ERG) abnormalities in some patients undergoing photochemotherapy with normal eye examination, we decided to investigate the effects of this therapy on retinal function.

Objective: To investigate the effects of oral photochemotherapy (8-methoxypsoralen?+?Ultraviolet-A) on electrophysiologic function of retina.

Materials and methods: Patients with vitiligo, psoriasis or eczema were enrolled. Patients with any abnormal eye exam or a positive drug or family history for retinal disease were excluded. Baseline standard ERG was provided with the RETIport32 device. The second ERG was performed 6 months after the first and at least 1 week after the last photochemotherapy session (mean number of sessions: 45?±?11). The outcome measures were changes in rod response, standard combined response, single-flash cone response, 30-Hz flicker (N1-P1) and oscillatory potentials amplitudes.

Results: Forty patients were enrolled; 20 of them (mean age: 31.1?±?12 years) completed the study. The mean rod response b-wave amplitude decreased from 88.9?±?47.5 to 86.4?±?36.6 and standard combined response b-wave amplitude decreased from 266.52 to 261.85?µV (p?=?0.422 and p?=?0.968, respectively) and the standard combined response a-wave amplitude increased from 155.4?±?40.0 at baseline to 165.1?±?48.4 in the follow-up ERG (p?=?0.092). The mean single-flash cone response a-wave amplitude decreased insignificantly in the follow-up ERG trace (34.5?±?13.7 and 29?±?15.4, respectively, p?=?0.242). The mean single-flash cone response b-wave amplitude showed an insignificant increase (p?=?0.087). The amplitudes of 30-Hz flicker wave and oscillatory potentials did not change significantly in the follow-up ERG (p?=?0.551 and p?=?0.739, respectively).

Conclusion: Since no significant change in ERG traces was observed, oral photochemotherapy seems safe for retinal electrophysiologic function.     

Efficacy of intravitreal dexamethasone implant for the treatment of macular oedema after pars plana vitrectomy for rhegmatogenous retinal detachment: long-term outcomes

Abstract

Purpose: To investigate the efficacy and safety of intravitreal dexamethasone implant as initial and only treatment for macular oedema after pars plana vitrectomy (PPV) for rhegmatogenous retinal detachment (RRD).

Methods: This study included 14 patients, who were diagnosed with macular oedema after PPV for RRD and who were treated with intravitreal dexamethasone implant. Patients were examined at the time of macular oedema diagnosis (baseline) and 1, 6 and 12?months after treatment, using best corrected visual acuity (BCVA) measurement and optical coherence tomography (OCT).

Results: The mean BCVA at baseline was 0.72?±?0.29 logMAR and improved significantly to 0.37?±?0.21, 0.42?±?0.19 and 0.35?±?0.22 logMAR at month 1, 6 and 12 after treatment with dexamethasone implant. The mean central retinal thickness (CRT) was 623?±?142?μm at baseline and decreased significantly to 339?±?163?μm, 428?±?131?μm and 356?±?147?μm at month 1, 6 and 12 after treatment. Total resolution of macular oedema was observed in 10 out of 14 patients (71.4%) at month 12. Ellipsoid zone was intact in 71.4% of patients at the end of the follow-up, while 71.4% of patients received only one implant until the end of the 12-month follow-up. No adverse events were observed.

Conclusions: Intravitreal dexamethasone implant was found to be effective and safe as initial treatment for macular oedema after PPV for RRD.     

Efficacy and safety of stabilised hydrogen peroxide cream (Crystacide) in mild-to-moderate acne vulgaris: a randomised,controlled trial versus benzoyl peroxide gel

Background: Benzoyl peroxide (BP) is a first-line topical treatment in acne vulgaris (AV). However, its use can cause mild skin irritation and dryness. A new formulation of hydrogen peroxide stabilised (HPS) in monoglycerides cream (Crystacide 1%), indicated in the topical treatment of superficial skin infections, is now available as an alternative treatment.

Study aim: To evaluate efficacy and local tolerability of HPS in mild-to-moderate AV in comparison with BP gel.

Methods and patients: In a randomised, prospective, investigator-masked parallel-group, 8-week trial, 60 patients (24 men, 36 women, mean age 25?±?6 years) with mild-to-moderate AV, affecting mainly the face, were enrolled in the study, after their informed consent. HPS or BP (PanOxyl gel 4%) was applied topically twice daily for 8 weeks.

Study outcomes: The study endpoints were: (1) Reduction in mean inflammatory (IL), non-inflammatory (NIL) and total (TL) acneic lesions in comparison with baseline; (2) Local tolerability assessed evaluating erythema, dryness and burning sensation, using a 0-3 qualitative score (score 0?=?poor tolerability; score 3?=?very good tolerability).

Results: TL, NIL, and IL were assessed by an investigator unaware of treatment allocation at baseline, and week 8. The tolerability score (TS) was assessed at week 4 and 8. At baseline, the two groups were well matched for the main clinical and demographic characteristics. All patients concluded the trial. At week 0, in the HPS group TL, NIL and IL (mean?±?SD) were: 35?±?8, 20?±?6 and 16?±?7. At week 8, HPS reduced TL to 16?±?7; NIL to 9?±?3 and IL to 7?±?3 (p?<?0.001). At baseline, TL, NIL and IL, in the BP group, were 32?±?9, 24?±?8 and 18?±?7, respectively. At week 8, BP reduced TL, NIL and IL to 14?±?9; 7?±?5 and 7?±?3 (p?<?0.001). In comparison with baseline values, the percentage reductions of IL were 58% and 61% for HPS and BP, respectively (p?=?n.s.). At the end of the study the TS was 2.9?±?0.2 in HPS group and 2.4?±?0.8 in BP group (p?<?0.025). Two patients in HPS group (6%) and seven patients (23%) in BP group suffered from mild-to-moderate local erythema.

Conclusions: HPS has shown to be as effective as BP in reducing both inflammatory and noninflammatory AV lesions in patients with mild-to-moderate disease. In comparison with BP 4% gel, HPS cream shows a better local tolerability profile.     

The short-term and long-term adverse ocular effects of fesoterodine fumarate

Aim: To evaluate the short-term and long-term effects of fesoterodine fumarate treatment which is used for overactive bladder (OAB) on pupil diameter (PD), intraocular pressure (IOP) and accommodation amplitude (AA).

Method: Ophthalmic examination was performed before and after receiving medication (on the 30th and 90th day) on 120 eyes of 120 women whom were planned to begin anticholinergic treatment (fesoterodine fumarate, 4?mg/day, peroral) for OAB, prospectively. The changes in PD, IOP and AA were analyzed statistically.

Results: The mean age of 120 women was 52.06?±?9.39 years (30–70 years). The mean PD, IOP and AA values were 4.12?±?0.61?mm (3.00–5.70?mm), 15.58?±?1.74?mmHg (11–20?mmHg) 2.28?±?1.26?Diopter (D) (0.50–5.50?D) at baseline; 4.68?±?0.65?mm (3.20–5.80?mm), 16.11?± 1.72?mmHg (11–20?mmHg), 1.68?±?1.04?D (0.25–4.50?D) at 30th day; and 4.28?±?0.58?mm (3.10–5.70?mm), 16.09?±?1.96?mmHg (11–19?mmHg), 2.18?±?1.19?D (0.50–5.00?D) at 90th day, respectively. Although increases in PD values and decreases in AA values were statistically significant (p?<?0.001 for each), the changes in IOP values were not as such (p?=?0.642). Visual complaint was not observed in any patient.

Discussion: The newest anticholinergic medication in women with OAB increased the PD and decreased the AA statistically significantly. Clinically, it seems to be well-tolerated by the patient.     

Spectral domain-optical coherence tomographic findings in patients with ankylosing spondylitis under anti-tumor necrosis factor-alpha therapy

Objective: To evaluate the effect of tumor necrosis factor-alpha (TNF-α) blockade on the thickness of the peripapillary retinal nerve fiber layer (RNFL), the ganglion cell-inner plexiform layers (GCIPL), and the macula in ankylosing spondylitis (AS) patients under anti-TNF-α therapy.

Materials and methods: Twenty-one patients with AS received etanercept, or adalimumab, or infliximab for at least 6 months. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) levels, and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores were measured before and 6 months after the beginning of the treatment. Peripapillary RNFL, four regional fields (superior, inferior, nasal, and temporal), GCIPL, and macular thicknesses of the patients were analyzed by optical coherence tomography before the treatment, at 3 months and 6 months after the beginning of the treatment.

Results: The mean BASDAI, ESR, and CRP values were 5.2?±?1.5, 31.6?±?21.7, and 15.7?±?13.9, respectively, at the beginning of the treatment and 2.3?±?1.7, 21.3?±?15.1, and 10.1?±?10.3, respectively, 6 months after the beginning of treatment. There were significant differences among the mean BASDAI, ESR, and CRP values at the beginning of treatment and 6 months later (p?p?=?0.007, and p?=?0.009, respectively). There were no significant differences among peripapillary RNFL (p?=?0.24), four regional fields (p?=?0.98, p?=?0.23, p?=?0.09, p?=?0.47), GCIPL (p?=?0.25), or macular (p?=?0.33) thicknesses of the patients during anti-TNF-α treatment. In addition, the mean intraocular pressure levels throughout the follow-up did not show significant variation on repeated-measures ANOVA (p?=?0.77).

Conclusions: TNF-α blockade does not seem to influence RNFL, GCIPL, or macular thickness of patients with AS in the short term.     

Swept-source optical coherence tomography analysis in asthmatic children under inhaled corticosteroid therapy

Purpose: To evaluate retinal nerve fiber layer thickness (RNFLT), ganglion cell layer thickness (GCLT), subfoveal choroidal thickness (SFCT), and central retinal thickness (CRT) in asthmatic children who were under inhaled corticosteroid treatment by using Swept-Source Optical Coherence Tomography (SS-OCT).

Material and methods: Fifty-three children were prospectively analyzed in the study. Group 1 included 31 asthmatic children and group 2 included 22 healthy children. Asthmatic children received a dose 250?μg daily of inhaled fluticasone propionate (Flexotide, GlaxoSmithKline, Middlesex, UK). Allergy parameters including, exposure to smoke, eosinophil count, percentage of eosinophils, immunoglobuline (Ig) E levels, number of asthma attacks, number of sensitivity to allergens and follow-up time were recorded. The RNFLT, GCLT, SFCT, and CRT were analyzed with SS-OCT and the data were compared between the groups.

Results: There were 13 girls (41.9%) and 18 boys (58.1%) in group 1 and 13 girls (59.1%) and 9 boys (40.9%) in group 2 (p?=?0.22). The mean age was 9.3?±?2.2 years in group 1 and 9.9?±?1.5 years in group 2 (p?=?0.08). The mean CRT (239.26?±?34.56 µm versus 226.82?±?26.23 µm, p?=?0.22) and mean SFCT (273.97?±?40.95 µm versus 280.41?±?32.78 µm, p?=?0.54) did not significantly differ between the groups. The superior, inferior, and average RNFLT were significantly lower in group 1 than group 2 (p?p?p?Conclusions: The SS-OCT revealed that asthmatic children under inhaled corticosteroid treatment have lower RNFLT than healthy subjects.     

Effect of isotretinoin treatment on the inflammatory markers in patients with acne vulgaris: can monocyte/HDL be a new indicator for inflammatory activity of isotretinoin treatment?

Abstract

Background: Oral isotretinoin (ISO) can effect markers of inflammation in patients with acne vulgaris. To our knowledge, there are no data on the relationship between ISO and monocyte to HDL cholesterol ratio (MHR). In this study, it is aimed to examine the effect of the ISO treatment on the MHR and other inflammatory markers in patients with acne vulgaris.

Materials and methods: In this study, 89 out of 120 patients with severe/very severe acne vulgaris according to the Global Acne Grading Scale who received at least 3 months of ISO treatment were evaluated. The complete blood counts including mean levels of mean platelet volume, plateletcrit (PTC), neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), MHR, and serum biochemistry panel were evaluated before and after ISO treatment.

Results: The mean platelet value, NLR, and PLR levels underwent a statistically significant decrease after ISO treatment (p?<?0.05) while MHR increased significantly 3 months after ISO treatment (p?=?0.017). The mean platelet value, NLR, and PLR levels were 9.56?±?1.05, 2.15?±?0.81, and 142.45?±?48.33 before treatment while were 9.32?±?1.45, 1.90?±?0.99, and 127.94?±?41.38 after treatment, respectively. On the other hand, MHR was 9.76?±?4.27 and 10.86?±?4.12 before and after treatment, respectively.

Conclusions: In this study, we found that ISO may have both inflammatory and anti-inflammatory effects by using MPV, PTC, NLR, PLR, and MHR. The inflammatory effects of ISO may be associated with possible inflammatory diseases. MHR can be used as a novel marker to investigate the inflammatory effect of the ISO.     

Ocular surface changes following oral anticholinergic use for overactive bladder

Objective: To investigate the effect of oral solifenacin succinate on Schirmer I test results, tear break-up time (TBUT) and Ocular Surface Disease Index (OSDI) scores in overactive bladder (OAB) patients and to compare these results with those of healthy control subjects.

Materials and methods: The female OAB patients who were prescribed oral solifenacin succinate 5?mg/day (Group I, N?=?80) and age-matched healthy female subjects (Group II, N?=?40) were recruited for the study and underwent ophthalmological examination prior to oral treatment and after 4 weeks. They completed the OSDI questionnaire and underwent ocular surface tests including Schirmer I test and TBUT.

Results: The statistical analysis of the Schirmer I test and TBUT revealed no significant difference between the baseline and 4th week values in both groups (Group I, p?=?0.506 and p?=?0.070 consecutively) (Group II, p?=?0.810 and p?=?0.823 consecutively). OSDI scores were found to be significantly increased in group I (21.8?±?4.2 vs 23.1?±?4.6, p?=?0.020) and remained unchanged in group II (20.5?±?7.0 vs 20.7?±?7.0, p?=?0.805).

Conclusions: Short-term solifenacin succinate treatment has no effect on the Schirmer I test results and TBUT, but ocular surface symptoms appeared to be exacerbated in respect with increased OSDI scores. However, the clinical significance needs to be further evaluated with larger studies.     

Assessment of the therapeutic activity of a combination of almitrine and raubasine on functional rehabilitation following ischaemic stroke

Background and objectives: Stroke is a major cause of disability. Certain experimental studies have suggested that a combination of almitrine?+?raubasine (Duxil) increases the supply of oxygen to cerebral tissues and may be beneficial in post-stroke rehabilitation. This multicentre clinical study was carried out in order to assess the efficacy of this combination on post-stroke rehabilitation.

Methods: The trial was a randomised, double-blind, placebo-controlled study. Patients that had experienced an ischaemic cerebrovascular accident (confirmed by CT scan) were included 4-6 weeks after the acute onset and received randomised treatment of either almitrine?+?raubasine or placebo 2 tablets daily for 3 months. Before treatment, there was a 2-week washout period for stopping all other drugs, except for antihypertensive and antidiabetic drugs. We assessed the patients by Barthel Index (BI), Neurological Functional Deficit Scores (NFDS), and Hasagawa Dementia Scales (HDS) each month after treatment.

Results: A total of 83 patients were entered into the study and data were available for 74. Of these, 38 patients received almitrine?+?raubasine and 36 received placebo. The baseline characteristics were comparable between both groups. Almitrine?+?raubasine was significantly more effective than placebo at increasing BI at 1, 2 or 3 months (14.6?±?13.8 versus 3.3?±?13.2, p?=?0.01; 19.3?±?13.6 versus 8.8?±?14.0, p?=?0.02; 22.6?±?14.7 versus 10.7?±?17.0, p?=?0.02 respectively) and reducing NFDS at 1 month (3.6?±?3.2 versus 1.9?±?3.5, p?=?0.034) after treatment. More almitrine?+?raubasine-treated patients' NFDS had improved compared with placebo-treated patients at 2 and 3 months (97 versus 78%, p?=?0.013; 100 versus 86%, p?=?0.023 respectively). Compared with pre-treatment, there was a strong tendency towards an improvement of HDS with almitrine + raubasine. The number of adverse events reported was low for the almitrine + raubasine-treated group and the placebo group and all events were mild, of short duration and resolved without treatment. Almitrine + raubasine had no clinically significant effect on blood pressure, heart rate or other laboratory tests.

Conclusion:The results indicate that almitrine + raubasine can accelerate neurological function recovery after stroke to some degree and is well tolerated.