Recombinant human nerve growth factor (cenegermin) for moderate-to-severe dry eye: phase II, randomized, vehicle-controlled, dose-ranging trial.

BACKGROUND: Dry eye disease (DED) includes neurosensory abnormalities as part of its multifactorial etiology. Nerve growth factor is important for maintaining corneal nerve integrity and wound healing. Cenegermin (recombinant human nerve growth factor) is a topical biologic that promotes corneal healing in patients with neurotrophic keratitis. The purpose of this study was to evaluate efficacy and safety of cenegermin in moderate-to-severe DED and identify an optimal dosing strategy. METHODS: This was a phase II, multicenter, randomized, double-masked, vehicle-controlled, dose-ranging clinical trial in patients with moderate-to-severe DED, including Sjögren's DED (NCT03982368). Patients received 1 drop of cenegermin 3 times daily (t.i.d.; 20 mcg/mL), cenegermin 2 times daily (b.i.d.; 20 mcg/mL) and vehicle once daily, or vehicle t.i.d. for 4 weeks. Follow-up continued for 12 additional weeks. The primary endpoint was change in Schirmer I score from baseline to week 4. Other key endpoints included rate of responders (Schirmer I test > 10 mm/5 min) after treatment and change in Symptoms Assessment iN Dry Eye (SANDE) scores from baseline to end of follow-up. A 1-sided test (α = 0.025) was used to evaluate statistical significance. RESULTS: At week 4, mean changes in Schirmer I scores were not statistically significantly different in either cenegermin group versus vehicle (cenegermin vs vehicle [treatment difference; 95% CI]: t.i.d., 2.60 mm and b.i.d., 3.99 mm vs 1.68 mm [t.i.d.: 0.93; -1.47 to 3.32, P = 0.078; b.i.d.: 2.31; -0.08 to 4.70, P = 0.066]). More patients responded to treatment with cenegermin t.i.d. and b.i.d. versus vehicle (t.i.d.: 25.9% [21/81, P = 0.028]; b.i.d.: 29.3% [24/82, P = 0.007] vs 11.9% [10/84]), with statistical significance (set at P < 0.025) observed in the b.i.d. group. Only cenegermin t.i.d. yielded statistically significant (P < 0.025) reductions in SANDE scores versus vehicle, which were sustained up to the end of follow-up (P value range, 0.002-0.008). Eye pain, primarily mild and transient, was the most frequently observed treatment-emergent adverse event with cenegermin. Similar results were observed in patients with Sjögren's DED. CONCLUSIONS: Cenegermin was well tolerated and although this study did not meet its primary endpoint, significant improvement in patient-reported symptoms of dry eye was observed through follow-up. Larger studies evaluating cenegermin in patients with DED are warranted. TRIAL REGISTRATION: NCT03982368; registered May 23, 2019.

Characterization of ophthalmic lesions and normal ocular parameters in a flock of captive MacQueen's (houbara) bustards (Chlamydotis macqueenii).

OBJECTIVES: To determine normal ocular parameters of the MacQueen's bustard (Chlamydotis macqueenii) and describe ophthalmic lesions in a captive bred population. ANIMALS STUDIED: Captive breeding population of 257 Macqueen's bustards. METHODS: All birds were screened for ocular abnormalities using direct ophthalmoscopy. Abnormalities were photographed. Normative values for Schirmer tear test-1 (STT-1), applanation tonometry, aerobic and anaerobic bacterial culture, fungal culture, and transcorneal ocular ultrasonography were derived from multiple cohorts of clinically normal adult birds. Five birds with ocular pathology also underwent transcorneal ultrasonography. Statistical comparisons for normative values between OD and OS, and males and females were made using a paired t-test or Mann-Whitney U-test, with a significance level of p < .05. RESULTS: Mean tear production based on Schirmer tear test 1 (STT-1) was 10.16 ± 4.61 mm/min (3-21 mm/min). Mean intraocular pressure (IOP) was 12.42 ± 4.94 mm Hg (5-26 mm Hg). Staphylococcus species were the most isolated bacteria from the conjunctival surfaces of normal birds (85%). Significant differences were found in transcorneal ultrasonographic measurements between males and females for axial globe length (p = .032), vitreous body depth (p = .049) and lens thickness (p = .0428). Corneal fibrosis was the most observed ocular abnormality amongst eyes with pathological changes (39%). CONCLUSIONS: Schirmer tear testing, tonometry and transcorneal ultrasound can easily be utilized in MacQueen's bustards and provide reproducible results. Normal parameters for these tests were determined, and common pathological ocular changes were described in this species.

Comparison of the efficacy and safety of lacrimal gland botulinum toxin injection in functional versus non-functional epiphora.

OBJECTIVE: To determine whether botulinum toxin is effective and safe for the treatment of epiphora, and to compare its utility in functional versus non-functional epiphora using both qualitative and quantitative methods. MATERIALS AND METHODS: Patients were divided into two groups (functional and non-functional epiphora) according to the presence of lacrimal drainage obstruction. All patients were injected with 2.5 units of botulinum toxin into the palpebral lobe of the lacrimal gland, and improvement in epiphora and quality of life were assessed both objectively and subjectively using Schirmer's I test, indoor and outdoor Munk scores, TEARS score, watery eye quality of life score, and tear meniscus measurements at pre-injection, and 1, 3, and 6 months post-injection. Functional and non-functional epiphora groups were compared. RESULTS: Botulinum toxin was injected into 72 lacrimal glands of 65 patients with functional and non-functional epiphora. In both the functional and non-functional epiphora groups, the mean Schirmer's I test value, indoor and outdoor Munk scores, TEARS score, watery eye quality of life score, tear meniscus height, depth, and area values improved significantly at 1, 3, and 6 months after injection compared with pre-injection values (p < 0.05). There were statistically significant differences in mean Schirmer's I test, tear meniscus height, depth, and area values between the functional and non-functional epiphora groups at 1, 3, and 6 months after botulinum toxin injection (p < 0.05). In the functional epiphora group, a greater proportion of patients reported improvement than in the non-functional group. All complications were minor and resolved within 2 weeks after the injection. CONCLUSION: Botulinum toxin injection into the lacrimal glands of patients with functional and non-functional epiphora was a simple, effective, and safe treatment. In addition to qualitative methods, quantitative methods, such as tear meniscus measurement, provided direct evidence that symptomatic improvement occurred more in those with functional versus non-functional epiphora after botulinum toxin injection.

[Current possibilities for the diagnosis and treatment of pterygium]. / Sovremennye vozmozhnosti diagnostiki i lecheniya pterigiuma.

Pterygium is a common inflammatory-proliferative disease characterized by the invasion of degeneratively altered fibrovascular tissue into the cornea. This literature review analyzes the etiological factors and pathogenetic concepts of its development, describes modern methods of diagnostics and surgical treatment of pterygium, and pays particular attention to the assessment of structural and functional changes in the cornea occurring during the growth of pterygium and after its excision.

Tear fluid and complement activation products in tears after ocular surgery.

PURPOSE: Due to technological advancements, surgical invasiveness has been reduced. However, cataract surgery has been implicated in causing postoperative inflammation, including dry eye syndrome. The innate immune system may be involved in postoperative inflammation, and complement activation could potentially play a crucial role in defense against pathogens, homeostasis, and wound healing. To investigate changes in the tear film complement activation products (CAPs) and ocular surface after vitrectomy combined with cataract surgery. METHODS: Forty-three patients (23 women; median age, 69 years) were enrolled in this prospective study and underwent phacoemulsification and vitrectomy. We measured Schirmer's test (ST) and CAPs in the tears at baseline (the day before surgery), 4 days and 1 month after the surgery. Tears were collected in microtubes. The CAPs in the tear fluid were analyzed by cytometric bead array. RESULTS: The median ST (8.5 mm) at baseline increased to 16 mm at 4 days ( P < 0.001) and 10 mm at 1 month (P = 0.44). The C3a levels (1202 pg/ml) at baseline increased to 2753 pg/ml at 4 days (P < 0.001), and 1763 pg/ml at 1 month (P = 0.049). The C4a levels (476 pg/ml) at baseline increased to 880 pg/ml at 4 days (P < 0.001), and 657 pg/ml at 1 month (P = 0.013). The C5a levels (22.6 pg/ml) at baseline increased to 470.9 pg/ml at 4 days (P < 0.001), and 38.3 pg/ml at 1 month (P = 0.0048). The surgical eyes were divided into the short ST group (≦ 10 mm, n = 22) and long ST group (> 10 mm, n = 21) based on the preoperative ST values. At 1 month postoperatively, the C3a levels were 2194 pg/ml in the preoperative short ST group and 1391 pg/ml in the long ST group, with significantly higher C3a concentrations in the short ST group (P < 0.001). CONCLUSIONS: The CAPs levels in tears increased after vitrectomy combined with cataract surgery. A preoperative deficit in tear secretion might induce prolonged complement activation and delayed recovery of ocular surface parameters postoperatively.

Repeatability of corneal pachymetry and epithelial thickness measurements with spectral-domain optical coherence tomography (SD-OCT) and correlation to ocular surface parameters.

PURPOSE: To assess the repeatability of corneal pachymetry and epithelial thickness measurements with spectral-domain optical coherence tomography (SD-OCT) and identify correlations between epithelial thickness and ocular surface parameters. METHODS: Adults who happened to have prolonged computer use were recruited, excluding those with conditions interfering with corneal measurements or tear production. All subjects filled in the ocular surface disease index (OSDI) questionnaire. Three consecutive measurements of central and peripheral corneal and epithelial thickness were performed with SD-OCT (RTVue XR). Schirmer test I and tear film break-up time (TBUT) were performed. Repeatability was evaluated with intraclass correlation coefficient (ICC), coefficient of variation and repeatability limit. Spearman correlation was used for non-parametric variables. RESULTS: 113 eyes of 63 subjects were included in the study. ICC was ≥ 0.989 for all corneal and ≥ 0.944 for all epithelial pachymetry segments. The best repeatability was found centrally and the worst superiorly both for corneal and epithelial measurements. Central epithelial thickness was weakly correlated with Schirmer test I (rho = 0.21), TBUT (rho = 0.02), OSDI symptoms and OSDI score (rho <|0.32|). OSDI symptoms and OSDI score were weakly correlated with Schirmer test I (rho <|0.3|) and TBUT (rho <|0.34|). CONCLUSION: RTVue XR measurements of corneal and epithelial thickness are highly repeatable in all segments. The lack of correlation between epithelial thickness and ocular surface parameters could suggest the assessment of epithelial integrity with reliable methods such as SD-OCT.

Changes of Subjective Symptoms and Tear Film Biomarkers following Femto-LASIK.

Femtosecond laser-assisted in situ keratomileusis (Femto-LASIK) represents a common treatment modality in refractive surgery and shows excellent results in terms of safety, efficacy, predictability, and long-term stability. However, patients may be affected by dry eye symptoms. The aim of this study was to identify a potential association between subjective dry eye symptoms, objective dry eye markers, and possible changes in the tear film, which could be a target for future therapy development. Therefore, clinical (dry eye) examinations (OSDI, Schirmer test, lissamine green and fluorescein staining, BUT, visual acuity) were carried out before LASIK as well as 5 and 90 days post-OP. The dry eye marker MMP-9, cytokines (IL-1ß, IL-8), and pain markers (NGF, CGRP) were quantified in tear samples with immunoassays. In addition, correlation analyses were performed. Clinical examinations revealed an upregulated OSDI score 5 days post-OP and an increased lissamine green staining score 90 days post-OP. Downregulated CGRP levels were noted 5 days post-OP, while other protein markers were not significantly altered after Femto-LASIK. Hence, Femto-LASIK surgery induced subjective symptoms like that of dry eye which could objectively rather be classified as Femto-LASIK-related discomfort. In the future, this could possibly be better detected and treated using pain markers such as CGRP.

Ocular manifestations of systemic isotretinoin in patients with acne: a systemic review and meta-analysis.

PURPOSE: To examine the effects of systemic isotretinoin treatment on the eye using several ocular examination parameters. METHODS: We conducted a systemic review for literature published up to June 2021 in both PubMed and Web of Science databases. We included prospective observational or interventional studies evaluating ocular manifestations of isotretinoin in acne patients. The primary outcome measures were anaesthetized and non-anaesthetized Schirmer test, tear break-up time (TBUT), central corneal thickness (CCT), average retinal nerve fibre layer (RNFL) thickness, ganglion cell-inner plexiform layer (GC-IP) thickness, subfoveal choroidal thickness, axial length, ocular surface disease index (OSDI), meibomian gland expression (MGE) and conjunctival stain. The National Institute of Health (NIH) quality assessment tools were used to assess the data quality. The effect size used to analyse the included studies was the weighted mean difference (WMD) and its related confidence intervals (95%CIs). RESULTS: Twenty-one publications involving 1105 eyes of 842 participants met the inclusion criteria. Isotretinoin use was significantly associated with reduction in the scores of anaesthetized Schirmer (WMD = -2.23, 95%CI: -3.28 to -1.18), non-anaesthetized Schirmer (WMD = -3.74, 95%CI: -4.23 to -3.25), TBUT (WMD = -3.47, 95%CI: -5.09 to -1.86), and CCT (WMD= -7.39, 95%CI: -13.91 to -0.88). Isotretinoin use was significantly associated with increase of OSDI (WMD = 18.29, 95%CI: 7.54-29.03), MGE (WMD = 1.02, 95%CI: 0.70-1.33) and conjunctival stain scores (WMD = 0.61, 95%CI: 0.47-0.76). No significant change was noted in RNFL thickness (WMD = -0.64, 95%CI: -1.80 to 0.51); GC-IP thickness (WMD = 0.42, 95%CI: -1.08 to 1.92); subfoveal choroidal thickness (WMD = -1.80, 95%CI: -6.69 to 3.09), and axial length (WMD = 0.08, 95%CI: -0.19 to 0.35). A significant heterogeneity was found between the study estimates in each of anaesthetized Schirmer, TBUT, MGE, OSDI, and conjunctival stain tests. CONCLUSION: Isotretinoin use results in a statistically significant reduction of the central corneal thickness, TBUT, and Schirmer test scores. A statistically significant increase in MGE, OSDI and conjunctival stain scores was found. No statistically significant change of average RNFL, GC-IP thickness, subfoveal choroidal thickness, or axial length was observed. Further well-designed studies should evaluate the long-term effect of isotretinoin on the eye and reach a firmer conclusion.

Conjunctival impression cytology and tear film parameters in patients with multiple sclerosis.

PURPOSE: To evaluate conjunctival impression cytology (CIC) findings and tear film parameters in patients with multiple sclerosis (MS) compared with controls. METHODS: Thirty-three patients with MS (MS group) and 33 age- and sex-matched healthy subjects (control group) were included in this cross-sectional comparative study. CIC grades, tear break-up time (TBUT), Schirmer 1 test results, and Ocular Surface Disease Index (OSDI) scores were compared between the two groups, and correlations between CIC grade, TBUT, Schirmer 1 test result, OSDI score, Expanded Disability Status Scale score, and disease duration were analyzed. RESULTS: Mean CIC grade was higher in the MS group than in the control group (1.48 ± 0.71 and 0.39 ± 0.56, respectively; p < 0.001). In the MS group, CIC of the 14 participants (42.4%) was grade 2-3. In the control group, CIC of the only one participant (3.3%) was grade 2, and none of them was grade 3. TBUT (8.12 ± 3.16, 13.06 ± 4.23 s in MS and control groups, respectively; p < 0.001) and Schirmer 1 test results (8.45 ± 5.75, 17.36 ± 10.89 mm in MS and control groups, respectively; p < 0.001) were lower, and OSDI score (36.36 ± 19.19, 13.70 ± 15.36 in MS and control groups, respectively; p < 0.001) was higher in the MS group compared to the control group. CONCLUSION: In patients with MS, objective findings of dry eye, subjective symptoms related to dry eye, and CIC abnormalities, including high grades of conjunctival squamous metaplasia and goblet cell loss, are more common. Patients with MS should be monitored for ocular surface alterations and dry eye disease.

Prevalence and risk factors associated with dry eye disease among adults in a population-based setting in South-West Nigeria.

Background: Dry eye disease (DED) occurs as a result of an abnormality in tear production, tear consistency, and tear evaporation. Aim: The aim of this study is to determine the prevalence and risk factors associated with dry eye disease in a population-based setting in Southwest Nigeria. Patient and Methods: A cross-sectional study was conducted at a medical outreach at Iperu Remo in Nigeria. A systematic random sampling technique was used to select 415 participants. Symptoms of dry eye were evaluated using the Ocular Surface Disease Index questionnaire. Tear film break-up time (TBUT), fluorescein staining, Schirmer test with anesthesia, and meibomian gland were evaluated. The diagnosis of DED was confirmed when the OSDI score is ≥13 and TBUT is less than 10 seconds. Data were analyzed using descriptive statistics, Chi-square, and logistic regression analyses at a 0.05 level of significance. Results: The overall prevalence of DED was 28.2%. Adults aged between 31 and 40 years were 23 times more likely to be diagnosed with dry eyes (aOR = 23.13; 95% CI: 1.32 - 405.99; P = 0.032) compared to those between 16 and 20 years. Female adults were about four times more likely to be diagnosed with dry eyes (aOR = 3.59; 95% CI: 1.44 - 8.94; P = 0.006). The use of drugs was also significantly associated with dry eyes. Conclusion: This study shows a fairly high prevalence of DED among adults in a semi-urban area in Southwest Nigeria. Ophthalmologists and other eye care workers need to be cautious about the DED and offer appropriate treatment options to patients.

[Changes in precorneal tear film and ocular surface in keratoconic patients after corneal collagen cross-linking]. / Izmenenie sostoyaniya prerogovichnoi sleznoi plenki i glaznoi poverkhnosti posle krosslinkinga rogovichnogo kollagena pri keratokonuse.

The article reviews the current available data on the signs and symptoms of dry eye syndrome (DES) in patients with keratoconus (KC), describes the clinical features of DES in KC patients and the morphological features of this type of keratectasia that lead to manifestations of the «dry eye¼, and highlights the risk factors, consequences of therapeutic measures, concomitant ophthalmological and general somatic diseases that contribute to the development of DES in KC.

Determination of copper by AAS in tear fluid of patients with keratoconus.

Keratoconus (KC) is the most common degenerative corneal disease and no single biomarker for KC has been discovered. Its causes have not yet been clarified and this work aims to be a contribution to the deepening of the knowledge of this disease and a preliminary data to the evaluation of the possibility of the use of copper (Cu) concentration in the tear fluid as a specific marker. A tear fluid sampling and Cu determination by spectrometric atomic absorption method was optimized to determine Cu levels in the tear fluid of patients with KC compared to that of healthy patients. Results demonstrate that in the KC subjects (n = 6) the concentration of Cu ions was 325.5 ± 110.7 ng/ml, while in the control group was 141.3 ± 71.1 ng/ml. A significant increase in Cu ion levels in the tear fluid was observed in the KC group compared to the control group (p value < 0.001).

A Multicenter Study of the Prevalence of Dry Eye Disease in Chinese Refractive Surgery Candidates.

OBJECTIVE: The aim of this study was to determine the prevalence of preoperative dry eye disease and evaluate tear film function in refractive surgery candidates in China. METHODS: In this prospective noninterventional cross-sectional study, refractive surgical candidates from 13 preselected eye hospitals in China were recruited from July 2015 to February 2016. Patient histories, subjective symptoms, tear film breakup time (TBUT), ocular surface fluorescein staining, and Schirmer I tests (SIT), were assessed to conduct subgroup analysis. RESULTS: A total of 1,849 patients were recruited, 41.4% were diagnosed with dry eye disease (766/1,849) and 44.9% (830/1,849) of subjects had a positive history of contact lens (CL) wear. The overall mean TBUT and SIT values were 7.3 ± 3.7 s and 15.2 ± 8.8 mm, respectively. The total prevalence of ocular surface fluorescein staining was 23.46% (422/1,849); 44.62% of patients had TBUT <5 s and 23.20% of patients had SIT <5 mm. CL wearers were observed to have a higher prevalence of dry eye than non-CL wearers (54.1 vs. 35.2%, OR = 2.17, 95% CI: 1.77-2.65). CONCLUSIONS: In this study, the most common abnormal finding in dry eye disease was tear film instability. A high proportion of refractive surgery candidates have preexisting dry eye disease and a history of CL wear prior to surgery. Careful attention should be given to the evaluation of preoperative dry eye in refractive surgery candidates.

The use of Schirmer strips to measure salivary and lacrimal flow in non-Sjögren patients.

INTRODUCTION: Oral and ocular dryness are the most common symptoms reported during ophthalmological and dental examinations. It is becoming a serious and growing problem due to the huge variety of affecting factors and with population aging. OBJECTIVES: The purpose was to demonstrate an application of the Schirmer test for xerostomia. Subsequently, to compare and correlate the results achieved from the lacrimal Schirmer test and salivary Schirmer test in non-Sjögren patients. METHODS: Study group consisted of 642 patients with/without subjective or/and objective symptoms of dry eye or mouth who did not fulfill the criteria for diagnosis of Sjögren syndrome. The lacrimal Schirmer test (lST) and the salivary Schirmer tests (sST) were performed (sSTm was put on the floor of the mouth, sSTp in front of the parotid gland duct). The results were recorded after 1 min (sSTm), 3 min (sSTp), and 5 min (lST). RESULTS: The lST and sST test scores were considerably higher in the healthy group than in others, p < 0.001. The results of sST1 and sST2 decreased with the appearance of subjective and objective symptoms, p < 0.001. There were positive correlations between lST and sSTm outcomes between the groups, p < 0.001. CONCLUSIONS: We present the Schirmer test adapted to measure salivary gland hypofunction that is a time-saving tool in our daily practice. Results of this study reveal an excellent correlation between the eye Schirmer test and the salivary Schirmer tests. CLINICAL RELEVANCE: The salivary Schirmer tests seem to be rapid, convenient, and reliable objective screening tools for salivary gland hypofunction in non-Sjögren patients.

A New Approach for Dry Eye Management By Mucoadhesive In situ Gel of Vitamin B12: Formulation, In vitro and In vivo Assessment.

The commitment of the existent study was to develop a mucoadhesive in situ gel systems of vitamin B12 for the management of dry eye disease. The gels were prepared using pluronic F-127 and either of chitosan, carbapol 971P, sodium alginate, or hydroxy propyl methyl cellulose. Drug-excipients compatibility was investigated by means of differential scanning calorimetry and Fourier transform infrared spectroscopy. The gels were characterized for pH, clarity, gelling capacity, viscosity, and adhesion. In vitro release of vitamin B12 from the selected gels was investigated. In vivo effectiveness of the selected gel was determined in rabbit models using Schirmer's and fluorescein tests. The compatibility studies revealed the possibility of incidence of drug/polymer interaction in some formulations. F2-containing pluronic F127 and hydroxypropyl methyl cellulose showed the most appropriate physical characterization and in vitro release profile. The prepared gels showed prolonged drug release with drug release mechanism of combined diffusion and erosion. The in vivo study revealed good effectiveness of the prepared mucoadhesive in situ gel system of vitamin B12 in the treatment of dry eye disease that was comparable to that of the marketed drops.

Dry eye and percentage of body fat: a cross-sectional prospective study.

BACKGROUND: Dry eyes are common in the general population. Some studies associate high prevalence of dry eyes with lipid metabolic changes and body fat composition. AIM: To study the association of dry eye with percentage of body fat. METHODS: One hundred and thirty five individuals (44 males and 91 females; median age of 42 years) were studied in a cross-sectional prospective study. Schirmer test and TBUT (tear breakup time) test were used to access dry eye. Body composition (percentage of lean and fat mass) were calculated using anthropometric measurements that included height, weight, abdominal, waist and neck circumference. RESULTS: About 44.4% of the sample had abnormal Schirmer test, and 70.3% had abnormal TBUT. Schirmer tests values were associated with age (p = 0.0006) female gender (p = 0.04) and percentage of body fat (p = 0.02). Abnormal TBUT test associated only with age (p = 0.0005). CONCLUSIONS: Percentage of body fat is associated with abnormal Schirmer but not TBUT test.

Differential time-course tear film quantitative changes following limbal relaxing incisions.

BACKGROUND: The study aims at evaluating the time-course changes of pre-corneal tear film after simultaneous phacoemulsification and limbal relaxing incisions (LRIs) performed in 2 groups of patients; group-A had vertical and group-B had horizontal LRIs. METHODS: Fourty-two eyes of 28 patients with co-existing cataract and corneal astigmatism were studied before and after simultaneous cataract surgery and LRIs (at weeks 1, 4 and 12), patients were classified into 2 groups according to the orientation of LRIs; vertical (A) and horizontal (B) groups. Pre-corneal tear film stability was assessed by measuring the tear break-up time (TBUT) and the tear volume was determined using Schirmer's I test (Basic Schirmer's test; BST), both preoperatively and postoperatively. RESULTS: TBUT was significantly reduced in both the study groups (P = 0.001) without significant reduction regarding basic Schirmer's test values except for the first postoperative week in the horizontal LRI group-B (P = 0.04). CONCLUSIONS: Precorneal tear film stability is altered in the early postoperative period after simultaneous cataract and LRI incisions shown by TBUT measurement values. These changes do not appear to differ significantly depending on the orientation of LRI incisions.

Investigation of the relationship between sleep disorders and xerostomia.

OBJECTIVES: To investigate the relationship between sleep disorders, morning hyposalivation, and subjective feeling of dry mouth. MATERIALS AND METHODS: A cross-sectional, observational, clinical study was carried out in a homogenous population sample which consists of Greek male soldiers without any medical history. After the application of oral modified Schirmer test, the sample was divided into a study group (n = 63) (MST < 25 mm/3 min) and a control group (n = 110) (MST ≥ 25 mm/3 min). In order to assess daytime sleepiness, risk of obstructive sleep apnea (OSA), sleep quality, sleep bruxism (SB), and subjective feeling of dry mouth, all the participants filled in the following scales in Greek version: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Berlin Questionnaire (BQ), a SB questionnaire, and Xerostomia Inventory (XI) respectively. In every subgroup that came of ESS, PSQI, BQ, and SB questionnaire scoring, subjective feeling of dry mouth was evaluated, based on XI values. RESULTS: Statistically significant difference (p < 0.001) through PSQI scores was found between the study and control group. In contrast, a statistically significant difference was not obtained for the scores of ESS (p = 0.293), BQ (p = 0.089), and SB questionnaire (p = 0.730). XI scores introduced statistically significant difference between the subgroups of PSQI (p < 0.001), BQ (p = 0.001), SB questionnaire (p = 0.004)  and statistically weak between the subgroups of ESS (p = 0.049). CONCLUSIONS: This is the first research study so far suggesting that patients with morning hyposalivation exhibit poor sleep quality using an objective method. The present results have, also, shown that subjective feeling of dry mouth is related to excessive daytime sleepiness, poor sleep quality, high risk of obstructive sleep apnea, and sleep bruxism, but larger-scale studies are still needed. CLINICAL RELEVANCE: These findings should keep dentists aware of a possible association between xerostomia and sleep disorders and support larger-scale studies.

Application of classification criteria of Sjogren syndrome in patients with sicca symptoms: Real-world experience at a medical center.

BACKGROUND: Patients who have symptoms of sicca, such as dry eyes and mouth, may have Sjögren's syndrome (SS). However, the conservative culture makes patients hesitate to undergo an invasive biopsy, which contributes to the difficulty of confirming a diagnosis. We aimed to identify the characteristics of patients with sicca symptoms to develop a better predictive value for each item included in the three different diagnostic criteria for SS and clarify the best diagnostic tools for the local population. METHODS: This is a single-center retrospective case-control study from January 2016 to December 2017. Patients who underwent sialoscintigraphy because of clinical symptoms of xerostomia and xerophthalmia at one medical center were reviewed via the patients' electronic medical records. RESULTS: Of 515 patients enrolled, the severity of results for sialoscintigraphy and Schirmer's test was correlated with a diagnosis of SS and generated receiver operator characteristic curve. The area under curve (AUC) was 0.603 for positive Schirmer's test, 0.687 for positive anti-Ro/La results, 0.893 for a positive salivary gland biopsy. The AUC was 0.626 and 0.602 for Schirmer's test which is redefined as <10 mm/5 minutes in either eye and according to 2016 the American College of Rheumatology/ European League Against Rheumatism criteria, respectively. CONCLUSION: Our results indicate the cut-off point for defining a positive test result in the Schirmer's test is worth modified to <10 mm/5 minutes in either eye.

[Severe polyneuropathy in primary Sjögren's syndrome : Sjögren's syndrome should be considered in patients with motor neuropathy]. / Schwere Polyneuropathie bei primärem Sjögren-Syndrom : Bei Patienten mit motorischen Neuropathien auch an Sjögren-Syndrom denken!

A 64-year-old male patient developed over a period of 20 years a peripheral neuropathy symmetrically affecting the upper and lower limbs. The histological examination of a sural nerve biopsy revealed a severe axonal neuropathy. Despite extensive laboratory investigations including immunological and metabolic tests the origin could not be identified. Finally, a Schirmer test revealed xerophthalmia. A subsequent salivary gland biopsy from the lower lip revealed a grade III lymphocytic inflammation according to Chisholm and Mason and confirmed the diagnosis of Sjögren's syndrome.