Conjunctival Staining Scores Research Articles

Impact of Full-Incision Double-Eyelid Blepharoplasty on Tear Film Dynamics and Dry Eye Symptoms in Young Asian Females.

Dry eye symptoms as a complication of double-eyelid blepharoplasty are controversial. This article evaluates tear film dynamics and changes in dry eye symptoms after cosmetic double-eyelid blepharoplasty in young Asian female. One hundred and twenty patients underwent full-incisional double-eyelid blepharoplasty. Subjective and objective parameters were documented before surgery, at 1week, 1month and 3months post-surgery, which included Ocular Surface Disease Index questionnaire (OSDI), tear meniscus height (TMH), noninvasive breakup time (NIBUT), Schirmer I test, corneal and conjunctival fluorescein staining scores, and palpebral fissure height. Dry eyes were defined based on the DEWS II criteria: OSDI ≥ 13 points and NIBUT < 10s. Patients were divided into two groups, group A included patients with redundant skin, while group B included patients with absence of redundant skin. The incident rate of dry eyes preoperatively, and at 1week, 1month and 3months were 12.5%, 12.5%, 32.5%, and 16.67%. OSDI scores were significantly increased at 1 week (9.71 ± 10.07, P < 0.001) and 1 month (11.35 ± 12.28, P < 0.001) postoperatively. A significant increase in TMH, NIBUT and Schirmer's test I values were observed at 1 week post-surgery (P < 0.001). Patients in group A showed higher OSDI scores compared to group B at 1 week and 1 month (P = 0.051) post-surgery, and the other variables showed no difference between the groups. Cosmetic double-eyelid blepharoplasty may temporarily affect tear film dynamics and aggravate dry eye symptoms in young females. However, these changes generally recover 3 months postoperatively. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Importance of tear volume for positivity of tear matrix metalloproteinase-9 immunoassay.

The tear matrix metalloproteinase-9 (MMP-9) immunoassay (Inflammadry) exhibits variable results in dry eye (DE) patients. We investigated if the tear volume in DE patients affects the results of MMP-9 immunoassay in clinical and in vitro settings. This cross-sectional study enrolled 188 eyes of 188 DE patients. The clinical symptoms and signs of DE were assessed using the Ocular Surface Disease Index and visual analog scale, strip meniscometry, tear break-up time, and tear meniscus height (TMH), area (TMA), and depth (TMD) using swept-source optical coherence tomography and corneal and conjunctival staining scores. For quantitative evaluation, the bands produced by the InflammaDry test were analyzed with ImageJ. DE subjects were grouped according to MMP-9 positivity and TMH. The InflammaDry-positive group showed greater TMH, TMA, and TMD than the MMP-9-negative group (p < 0.05). InflammaDry test band density in the high TMH group was significantly greater than that in the low and normal TMH groups (p < 0.05). InflammaDry test band density correlated positively with TMH, TMA, and TMD (all p < 0.05). InflammaDry test results were influenced by tear volume. Low tear volume in aqueous tear-deficient DE may induce false-negative results, and reflex tearing during the test may induce false-positive results.

Safety and efficacy of ALG-1007 topical ophthalmic solution – A synthetic peptide that regulates inflammation, in patients with dry eye disease: An exploratory Phase I, open-label, single-center clinical study

Objectives: The objective of the study was to evaluate the safety and efficacy of ALG-1007 topical ophthalmic solution in patients with dry eye disease (DED). Materials and Methods: This Phase I, prospective, open-label, 12-week study enrolled subjects ≥18 years old with symptoms of DED for at least 6 months and at least one of the following: Total ocular staining score ≥2 or tear film breakup time (TBUT) ≤7 s. Subjects were randomized to four treatment arms: 0.125%, 0.25%, 0.4%, and 0.6% ALG-1007. Subjects received the test drug, 1 drop twice daily, and were followed at multiple time points for 12 weeks. SICCA total ocular staining score, corneal and conjunctival staining score, TBUT, and subject-reported symptoms using the visual analog scale (VAS) symptom index were assessed at baseline and at every visit. The primary safety outcome was percentage and severity of adverse events (AEs). Results: Forty eyes (21 patients) were assigned randomly to four treatment groups (n = 10 per group). Improvement in TBUT, SICCA, and VAS was seen in all groups. The highest dose tested (0.6%) was compared to the lowest dose tested (0.125%) based on change from baseline for all assessments using analysis of variance. Improvement was significantly greater in 0.6% treatment group in terms of TBUT, conjunctiva staining, SICCA, burning, discomfort, photophobia, and the composite symptom score. No serious AEs were reported after 12 weeks of treatment. Conclusion: Outcome measures improved in all the treatment groups. At the highest dose, ALG-1007 demonstrated statistically significant improvement compared to the lowest dose in 7 out of 12 assessments, indicating a dose response. This suggests that the active pharmaceutical ingredient in ALG-1007 is effective in improving signs and symptoms of DED. ALG-1007 was well-tolerated with minimal instillation discomfort and no reported serious AEs.

Differential Diagnosis of Sjögren Versus Non-Sjögren Dry Eye Through Tear Film Biomarkers.

Systemic implications necessitate the identification of dry eye patients with Sjögren syndrome (SS). This study aims to explore the utility of tear MUC5AC and inflammatory cytokine levels in the differential diagnosis of SS-related dry eye. A prospective, observational, case-control study was conducted on 62 patients (those with a definitive diagnosis of SS dry eye, non-SS dry eye, and age-matched healthy controls with no dry eye). Clinical evaluations included the following tests in the order listed here: noninvasive tear break-up time, osmolarity, tear sampling, Schirmer test without anesthesia, and ocular surface staining (lissamine green for conjunctiva and fluorescein for cornea). Tear MUC5AC levels were assessed with enzyme-linked immunosorbent assay, and cytokines [interferon-gamma, tumor necrosis factor alpha, interleukin (IL)-6, IL-17a, IL-1β, IL-8, IL-10, and IL-12p70] were measured using a Luminex assay in a masked fashion. The Bulbar conjunctival lissamine green staining score was significantly greater in patients or controls with SS versus non-SS dry eye. This greater conjunctival staining was associated with a reduction in tear MUC5AC (B = -17.8 ng/mL, 95% confidence interval = -31.8 to -3.9, P = 0.01). Among the tear cytokines, a significant association was found between IL-8 levels (hazard ratio [HR] = 1.002, 95% confidence interval = 1.000-1.003, P = 0.03) and SS diagnosis. When patients were stratified based on tear MUC5AC levels, significantly increased tear IL-8 levels were detected in patients with SS dry eye but not with non-SS dry eye, in comparison with healthy controls. Tear levels of goblet cell-specific MUC5AC combined with IL-8 can potentially serve as a useful biomarker for differential diagnosis of SS dry eye from non-SS dry eye.

Treating Uncomfortable Contact Lens Wear With Orthokeratology.

Many contact lens (CL) users permanently discontinue wear because of ocular dryness and discomfort. This study aimed to determine whether refitting symptomatic soft CL wearers in to orthokeratology could improve ocular symptoms and signs. This was a prospective, 3-month, open-label study of symptomatic (Contact Lens Dry Eye Questionnaire [CLDEQ-8] ≥12) soft CL wearers who were between the ages of 18 and 45 years. All subjects were refit into orthokeratology CLs (Emerald, Euclid Systems). The following tests were completed: CL history, Standardized Patient Evaluation of Eye Dryness (SPEED) questionnaire, CLDEQ-8, CLDEQ-4, logarithm of the minimum angle of resolution visual acuity, pupil size, refractive error, slit-lamp biomicroscopy, noninvasive tear break-up time, tear meniscus height, phenol red thread, conjunctival staining, corneal aesthesiometry, and corneal topography. Twenty-nine of 40 qualifying subjects (age=24.43±4.62 years) completed the study. No significant differences were detected between completed and noncomplete subjects. Completed subjects had significantly better CLDEQ-8, CLDEQ-4, and SPEED scores at 3 months compared with baseline. Completed subjects had significantly better conjunctival staining scores and flatter keratometry values at 1 month compared with baseline. Although not all symptomatic soft CL wearers were able to be refit into orthokeratology, subjects who were wearing orthokeratology at 3 months had a significant and clinically meaningful improvement in ocular symptoms. Additional work is needed to determine the mechanism leading to improved comfort because few clinical signs were changed after switching to orthokeratology.

The Association of Serum Vitamin D Level With the Severity of Dry Eye Parameters in Primary Sjögren Syndrome.

To analyze the relationship between serum 25(OH)D3 level and dry eye parameters in primary Sjögren syndrome (SS). This study included 74 eyes of 74 patients diagnosed with primary SS. Dry eye parameters included tear breakup time, Schirmer I value, corneal staining score, conjunctival staining score, and Ocular Surface Disease Index. The serum concentration of 25(OH)D3 was evaluated. The mean serum 25(OH)D3 level was 20.4 ± 8.0 ng/mL. There were strong negative correlations between serum 25(OH)D3 level and corneal staining score (P < 0.001, r = -0.446) and conjunctival staining score (P < 0.001, r = -0.455). The Schirmer I value and tear breakup time showed significant positive correlations with serum 25(OH)D3 level (P = 0.038, r = 0.261 and P = 0.003, r = 0.352, respectively). The Ocular Surface Disease Index did not show any significant correlation with serum 25(OH)D3 level. This study demonstrates that serum 25(OH)D3 level might be associated with dry eye severity in primary SS.

Tear neuromediators in eyes on chronic topical antiglaucoma therapy with and without BAK preservatives

PurposeTo evaluate tear neuropeptides (NPs) (vasoactive intestinal peptide (VIP), neuropeptide Y (NPY), calcitonin gene-related peptide (CGRP), substance P (SP), nerve growth factor (NGF)) in chronic ocular topical hypotensive therapy with...

Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Conjunctival Staining in Patients with Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and 3 Clinical Trials.

Purpose: Keratoconjunctivitis sicca (KCS), a multifactorial disease, is the most common ocular condition for patients seeking medical treatment and is characterized by ocular burning, stinging, and dryness. This pooled analysis examined the effect of OTX-101 0.09% versus vehicle on the total and individual conjunctival staining in patients with KCS from phase 2b/3 and phase 3 studies. Methods: In these randomized, multicenter, double-masked, and vehicle-controlled studies, patients received 1 drop of OTX-101 0.09% or vehicle in both eyes twice daily. The time points for the pooled analysis were baseline (day 0) and study days 28, 56, and 84/early discontinuation. Conjunctival staining was graded on a 0- to 3-point scale per zone and averaged over both eyes at each assessment. Pooled safety assessments included adverse event (AE) reporting. Results: The total mean (standard deviation) conjunctival staining scores at baseline were 5.4 (1.7) for OTX-101 (n = 523) and 5.5 (1.7) for vehicle (n = 525). OTX-101 versus vehicle significantly reduced the total conjunctival staining scores (P = 0.0316, <0.0001, and 0.0002) for days 28, 56, and 84, respectively. The most common treatment-related AE was instillation site pain (21.8% OTX-101 vs. 4.0% vehicle); most AEs were mild in nature. Conclusions: Treatment with OTX-101 versus vehicle significantly improved the conjunctival staining in KCS as early as 4 weeks, and the improvement was maintained through 12 weeks. OTX-101 was effective and well tolerated for use in KCS.

Surgical Factors Affecting Changes in Ocular Surface Dynamics in the Early Postoperative Period After 25-Gauge Vitrectomy.

Because vitrectomy-associated postoperative ocular surface changes are not well known, we evaluated such changes before and after vitrectomy in eyes with posterior segment diseases and investigated their associations with patients' characteristics and surgical procedures. Thirty-five eyes of 32 consecutive patients (16 women; average age 66.6±11.1 years) were included in this prospective, noncomparative case series from tertiary care university hospital. Contact lens wearers and patients with history of ocular surgery or regular use of topical eyedrops were excluded. Patients had undergone primary 25-gauge vitrectomy at Osaka University Hospital in Japan between July and December 2016. Tear break-up time (TBUT), corneal and conjunctival fluorescein staining score (FSS), and tear meniscus height (TMH) were evaluated before, 1 week after, and 1 month after vitrectomy. Conjunctival FSS and TMH were significantly higher at 1 week after vitrectomy than preoperatively. However, they decreased significantly 1 month after. Changes in TBUT and corneal FSS showed a similar course at 1 week, but this was not statistically significant. Multiple linear regression analysis showed no significant correlation between significantly increased ocular parameters and patients' characteristics. By contrast, surgical time and combined cataract surgery significantly contributed to increased and decreased conjunctival FSS, respectively (P=0.011 and 0.033, respectively). Sclerotomy site suturing significantly contributed to increased TMH (P=0.025). We showed associations between ocular surface changes and specific surgical procedures. Caution should be exercised to minimize the effect of surgical procedures on the ocular surface during vitrectomy.

RETRACTED ARTICLE: Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients: a randomized, blinded, multicenter clinical trial

BackgroundThis study is aim to compare the clinical effectiveness between the two most prominent dry eye disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ).MethodsThis is a multi-centered, randomized, masked, prospective clinical study. A total of 153 DED patients were randomly allocated to use CN twice per day or DQ six times daily. Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score were measured at baseline, 4 and 12 weeks after treatment.ResultsAt 12 weeks after treatment, NEI scaled scores were significantly reduced from the baseline by − 6.60 for CN and − 6.63 for DQ group (all P < 0.0001, P = 0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P = 0.0034, P < 0.0001 for TBUT, P = 0.0418, P = 0.0031 for Schirmer test). However, for DQ, TBUT showed significant improvement at 12 weeks only (P = 0.0281). Mean OSDI score differences from the baseline to 12 weeks were improved by − 13.03 ± 19.63 for CN and − 16.11 ± 20.87 for DQ, respectively (all P < 0.0001, P = 0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was less than that of DQ (P < 0.001). There were no statistically significant intergroup differences in safety evaluation.ConclusionsThe level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups. However, with regards to the early improvement of TBUT and patient compliance, patients using CN improved faster and with greater adherence to drug usage than did those treated with DQ.Trial registrationKCT0002180, retrospectively registered on 23 December 2016.

Safety and efficacy of amniotic cytokine extract in the treatment of dry eye disease.

Purpose: Evaluate the safety and efficacy of cryopreserved amniotic cytokine extract (ACE) in the treatment of subjects with dry eye disease (DED).Patients and methods: This was a retrospective, multicenter, chart review of adult patients with DED that instilled cryopreserved ACE drops twice-daily for 4 or 12 weeks. Patients had corneal fluorescein staining (0–20 range) and/or a lissamine green conjunctival staining score (0–18 range) of ≥3 and ≤9 in at least 1 eye and a score ≥40 (0–100 range) of eye dryness/irritation on a visual analog scale (VAS). Following completion of a treatment course, medical records were reviewed from the initiation of therapy (baseline), and at post-treatment visits (4 weeks, 8 weeks, and 12 weeks). Patient records for visual acuity, adverse events, corneal fluorescein staining, conjunctival lissamine green staining, and symptom scores of ocular dryness/irritation were reviewed for each visit, as available. Safety and tolerability were assessed through the evaluation of patient-reported adverse events recorded in the medical records.Results: A total of 54 eligible patients were identified at 7 clinical sites; 16 patients administered ACE drops for 4-weeks, and 38 patients instilled ACE drops for 12 weeks. Significant improvements in the mean changes from baseline were observed for corneal fluorescein staining, lissamine green staining, visual acuity (LogMar) and VAS ocular symptom scores at the 4-week post-treatment visit (p<0.01). Additional improvements continued out to the 12-week follow-up assessment visits. Two patients discontinued therapy due to reports of ocular burning or foreign body sensation.Conclusion: The cryopreserved ACE formulation was well-tolerated and effective in reducing the clinical signs and symptoms of DED. Conduct of a vehicle-controlled prospective study is warranted.

Evaluation of the Efficacy and Safety of A Novel 0.05% Cyclosporin A Topical Nanoemulsion in Primary Sjögren’s Syndrome Dry Eye

ABSTRACTPurpose: To evaluate the efficacy and safety of a novel topical cyclosporin A 0.05% nanoemulsion in comparison with a conventional emulsion in primary Sjögren’s syndrome dry eyes.Methods: Prospective, randomized, double-blinded study was conducted.Results: Corneal and conjunctival staining score was improved in both groups, with a faster change noted in the nanoemulsion group at 12 weeks (p < 0.05). Tear film break-up time was significantly improved in the nanoemulsion group at 12 weeks (p < 0.05), while ocular surface disease index score was improved in both groups without a difference at 12 weeks. Schirmer I value and goblet cell grade did not change in both groups. IL-6 and MMP-9 were significantly decreased in both groups at 12 weeks.Conclusions: Both nanoemulsion and conventional cyclosporin A improved ocular signs, symptoms, and conjunctival inflammation. However, the novel cyclosporin A nanoemulsion showed faster improvement of ocular surface staining scores than the conventional emulsion.

A Phase 3, Randomized, Double-Masked Study of OTX-101 Ophthalmic Solution 0.09% in the Treatment of Dry Eye Disease

To evaluate the safety and efficacy of OTX-101, a novel aqueous nanomicellar formulation of cyclosporine (0.09%), in the treatment of patients with dry eye disease (DED). A randomized, multicenter, vehicle-controlled, double-masked, phase 3 clinical trial. Adults (18-90 years of age) with a history and clinical diagnosis of DED, a global symptom score of 40 or more (range, 0-100), and a lissamine green conjunctival staining score of 3 or more and 9 or less (range, 0-12) in at least 1 eye. Eligible patients entered a run-in period of 14 to 20 days in which all patients administered vehicle twice daily. Patients who remained eligible at the baseline (day 0) visit were randomized in a 1:1 ratio to twice-daily treatment with OTX-101 0.09% or vehicle for 84 days. Efficacy assessments included signs (unanesthetized Schirmer tear test, corneal and conjunctival staining) and symptoms (global symptom score) of DED. The primary end point was the proportion of eyes with a clinically meaningful improvement (increase of ≥10 mm) in Schirmer test score at day 84. Safety evaluations included adverse events (AEs), visual acuity, and intraocular pressure monitoring, slit-lamp, dilated ophthalmoscopy, and fundus examinations. A total of 744 patients were randomized and received study medication (371 to OTX-101 0.09% and 373 to vehicle). The primary end point was achieved; a significantly greater percentage of eyes in the OTX-101 0.09% treatment group achieved an increase of 10 mm or more in the Schirmer test score at day 84 (OTX-101 0.09%, 16.6%; vehicle, 9.2%; P < 0.001). Significant improvements relative to vehicle also were observed for corneal (days 28, 56, and 84) and conjunctival (days 56 and 84) staining. The global symptom score was reduced from baseline in both treatment groups by approximately 30%; however, no significant separation between groups was observed. The OTX-101 0.09% formulation was well tolerated. Treatment-emergent AEs were primarily mild in intensity. Clinically and statistically significant improvements in tear production and ocular surface integrity were observed in patients treated with OTX-101 0.09% for DED.

The Use of Conjunctival Staining to Measure Ocular Surface Inflammation in Patients With Dry Eye.

To investigate the expression levels of inflammatory cytokines in the conjunctival epithelium and correlations with clinical parameters in dry eye disease (DED). This study evaluated 28 patients with Sjögren syndrome (SS) DED, 28 patients with non-SS DED, and 10 controls. The messenger ribonucleic acid (mRNA) expression of inflammatory cytokines such as tumor necrosis factor-α, interleukin (IL)-1β, IL-6, interferon (IFN)-γ, IL-17, and matrix metalloproteinase 9 (MMP9) from conjunctival epithelium was investigated by real-time polymerase chain reaction. Protein expression was confirmed by immunofluorescence staining. Correlations were evaluated between the mRNA expression of inflammatory cytokines and clinical DED parameters such as ocular surface disease index score, Schirmer I value, tear film breakup time, and corneal and conjunctival staining scores. Patients with non-SS DED expressed significantly more IFN-γ, IL-6, and MMP9 genes in the conjunctival epithelium than the controls (P < 0.05), and all cytokine gene expression was significantly higher in patients with SS DED than in the controls (P < 0.01). Tumor necrosis factor-α, IL-1β, IL-6, and IL-17 gene expression was higher in patients with SS DED than in the non-SS DED group (P < 0.05). Immunofluorescence staining of conjunctival epithelium demonstrated that positive cells with IL-6 or MMP9 were significantly higher in non-SS DED than in controls (P < 0.01) and much higher in SS DED than in non-SS DED (P < 0.05). Conjunctival staining scores significantly correlated with the expression of IFN-γ, IL-6, IL-17, and MMP9 in both DED groups (P < 0.05 in non-SS DED and P < 0.01 in SS-DED). Interestingly, correlation coefficients of all cytokines were much higher in SS DED compared to non-SS DED. Corneal staining scores showed positive correlations with IFN-γ, IL-17, and MMP9 (P < 0.05), and correlation coefficients were lower than those of conjunctival staining scores. Conjunctival staining scores may be useful to measure ocular surface inflammation in SS and non-SS DED.

Characteristics of dry eye in patients with pre-existing Sjögren's syndrome according to the revised 2016 ACR-EULAR classification criteria.

To compare the characteristics of dry eye (DE) patients who did and did not satisfy the 2016 American College of Rheumatology (ACR)-European League Against Rheumatism (EULAR) classification criteria for primary Sjögren's syndrome (SS) among patients with pre-existing SS diagnosed according to the 2012 ACR criteriaThis cross-sectional study evaluated 91 patients with pre-existing SS and 55 with non-SS DE. Patients with SS were divided into 2 groups according to whether they met the revised 2016 ACR-EULAR classification criteria for primary SS. Group 1 (n = 71) was comprised of patients who satisfied the revised 2016 criteria and group 2 (n = 20) was comprised of patients who did not satisfy the newly revised criteria. Group 3 consisted of 55 patients with non-SS DE. The ocular surface disease index (OSDI) score, tear break-up time (TBUT), Schirmer score, tear clearance rate (TCR), and corneal and conjunctival staining scores were evaluated and compared between the groups. Laboratory profiles, including antinuclear antibodies, rheumatoid factor levels, erythrocyte sedimentation rate, and C-reactive protein levels, and focus scores were analyzed.TBUT, Schirmer, and corneal/conjunctival staining scores were significantly worse in both groups of patients with SS (groups 1 and 2) than in those with non-SS DE (group 3). However, there were no significant differences between groups 1 and 2 in laboratory findings as well as in ocular surface findings, including OSDI, TBUT, Schirmer score, TCR, and corneal/conjunctival staining scores. The focus score, which shows the level of lymphocytic infiltration in the salivary glands, was higher in group 1 than in group.Of the patients with pre-existing SS who were diagnosed according to the 2012 ACR classification, patients who did not satisfy the 2016 ACR-EULAR classification criteria for primary SS showed similar ocular surface parameters and laboratory findings to patients who did meet the revised classification, except for focus score. There is no need to change the direction of treatment of DE in patients with pre-existing SS who did not meet the revised 2016 ACR-EULAR criteria.

A randomized multicenter study comparing seawater washes and carmellose artificial tears eyedrops in the treatment of dry eye syndrome.

PurposeTo investigate the safety and efficacy of sterile isotonic seawater washes vs standard treatment with carmellose artificial tears in dry eye syndrome (DES).Patients and methodsThis is a randomized multicenter prospective study with 12 weeks of follow-up. A group of patients with DES (N=60) were treated with seawater spray (Quinton®) five times daily, and another similar group (N=60) were treated with carmellose artificial tears eyedrops (Viscofresh® 0.5%) five times a day. The parameters studied and measured were as follows: Ocular Surface Disease Index questionnaire score, Schirmer I test (without anesthesia) score, tear osmolarity (TearLab®), tear breakup time, tear meniscus height (meniscography OCT), fluorescein corneal staining score (National Eye Institute scale), lissamine green conjunctival staining score, and levels of IL-1 beta and IL-6 in tears (Luminex® 200).ResultsIn the group treated with seawater, symptoms decreased by 68%, and the decrease was 26% statistically superior to the group treated with carmellose artificial tears eyedrops (P<.001). Levels of IL-1 beta and IL-6 in tears significantly decreased in the seawater group compared to the carmellose artificial tears group (19%/17% vs 52%/51%) (P<0.001). There were no statistically significant differences in the other measured parameters. There were no cases of poor tolerance or side effects.ConclusionAdministration of seawater is more effective than treatment with carmellose artificial tears in reducing symptoms and pro-inflammatory molecules (IL-1 beta and IL-6) in tears of patients with DES.

Comparison of Meibomian Gland Imaging Findings and Lipid Layer Thickness between Primary Sjögren Syndrome and Non-Sjögren Syndrome Dry Eyes

ABSTRACTPurpose: To compare meibomian gland (MG) imaging findings and lipid layer thickness (LLT) between patients with primary Sjögren syndrome (SS) dry eyes (DE) and non-SS DE.Methods: A total of 60 patients—30 with SS DE and 30 with non-SS DE were evaluated. Infrared image findings of MGs and LLT were assessed using the LipiView II interferometer.Results: The maximum LLT was significantly lower in the SS DE group. SS DE exhibited significantly higher MG dropout compared to the non-SS DE. Average and maximal LLT showed significant negative correlations with MG dropout in both groups (p<0.05). Conjunctival staining scores showed significant correlations with average and maximum LLT and MG dropout values in the SS DE group (p<0.05).Conclusion: These findings suggest that the new interferometer will be useful in understanding the pathophysiology of SS DE.

Tear film change and ocular symptoms after reading printed book and electronic book: a crossover study.

To evaluate and compare tear film changes and ocular symptoms after reading an electronic book (e-book) and a printed book. Clinical and experimental. Crossover study was conducted in 30 healthy volunteers, some of whom read an e-book and others a printed book for 20 minutes and then switched the following week. Tear meniscus height (TMH), non-invasive break-up time (NIBUT), fluorescein break up time (FBUT), corneal and conjunctival staining score, and questionnaires about seven ocular symptoms were evaluated before and after reading by both reading methods. After reading an e-book, FBUT and NIBUT were significantly decreased (p<0.001for both). Similar to printed book readers (p=0.006, p=0.04, respectively). TMH and corneal and conjunctival staining score showed no significant differences in either group. Comparing the two groups, the e-book group showed more decrease in TMH, FBUT, and NIBUT (p>0.05). Ocular symptoms were significantly increased in both groups. The e-book group showed more increase in all symptoms, but only tearing (p=0.03) and burning sensation (p=0.02) were significantly different. Reading an e-book affected tear film instability and significantly increased burning sensation and tearing to a larger extend than reading a printed book.

TearCare® system extension study: evaluation of the safety, effectiveness, and durability through 12 months of a second TearCare® treatment on subjects with dry eye disease.

PurposeEvaluation of the safety and effectiveness of a TearCare® retreatment in adult subjects with clinically significant dry eye disease (DED).Patients and methodsThis was an extension of an initial 6-month, prospective, single-center, randomized, parallel-group pilot study. In the initial study, subjects with DED were randomized to either a single TearCare® treatment or 4 weeks of daily warm compress therapy. The extension study involved retreatment of those subjects assigned to the TearCare® treatment group following the initial 6-month end point. At 6 months, subjects were evaluated for the clinical signs and symptoms of DED prior to retreatment in the extension study that would measure the safety, effectiveness, and durability of a TearCare® retreatment for another 6 months through a 12-month end point. The TearCare® retreatment procedure consisted of 12 minutes of thermal eyelid treatment immediately followed by manual meibomian gland clearance. The primary effectiveness end point was the change in tear break-up time (TBUT) from baseline to 1-month follow-up. Secondary end points included meibomian gland scores, corneal and conjunctival staining scores, and assessment of dry eye symptoms. Safety was evaluated through monitoring intraocular pressure, best-corrected visual acuity, and device-related adverse events.ResultsTwelve subjects participated in the 6-month extension study. At 1-month clinic visit following retreatment, a significant improvement from baseline in mean (± SD) TBUT of 12.4 (±3.3) seconds was observed (P<0.001). Significant improvements in the mean change from baseline in meibomian gland scores, corneal and conjunctival staining scores, and symptoms of DED were also observed following retreatment. The second treatment was well tolerated.ConclusionThe findings of the extension study through 12 months suggest that a second TearCare® treatment after 6 months provides additional improvement in the signs and symptoms of DED.

Effect of Eyelid Hygiene Detergent on Obstructive Meibomian Gland Dysfunction.

To investigate the efficacy of eyelid margin cleansing with lid hygiene detergent in patients with obstructive meibomian gland dysfunction (MGD). As a pilot study, we investigated the safety and efficacy of lid hygiene using tap water and/or lid hygiene shampoo in fourteen eyes of 7 normal subjects. All subjects were instructed to cleanse the eyelid margin with tap water and/or lid hygiene shampoo. As a main prospective clinical study, thirty-four eyes of 34 patients with obstructive MGD were enrolled. All subjects were instructed to cleanse the eyelid margin with lid hygiene shampoo at least once daily for 1 month. Ocular surface conditions were observed before and 1 month after study initiation. A significant exacerbating change (p < 0.05) was not detected after either method in the pilot study. In the main study, significant improvements were observed in tear break-up time (TBUT), lid margin lissamine green staining scores, vascular dilatation, and meibum status (p < 0.05). No significant improvements in corneal or conjunctival fluorescein staining scores, the mucocutaneous junction, lid margin deformation, or plugging were observed (p ≥ 0.05). Subjective improvements were observed in 27 subjects. Meibography revealed that 28 subjects had normal meibomian glands, and 6 subjects had meibomian gland atrophy. Significant improvements were observed in TBUT, vascular dilatation, and meibum status only in the group with normal meibomian glands (p < 0.05), but subjective symptoms and lid margin lissamine green staining scores improved in both groups (p < 0.05). No subjects experienced any problems throughout the study. Daily routine use of lid hygiene detergent can alleviate the symptoms of MGD regardless of meibomian gland atrophy.