Reliability and agreement of subjective and objective non-invasive break-up time measurements in contact lens wearers.

PURPOSE: To assess the reliability and agreement of non-invasive break-up time (NIBUT) in symptomatic and asymptomatic contact lens (CL) wearers using automatic objective and conventional subjective techniques. METHODS: In this prospective cross-sectional study, soft CL wearers, classified into symptomatic and asymptomatic based on the Contact Lens Dry Eye Questionnaire-8, underwent NIBUT assessment with the CL in situ. The CA-800 Corneal Analyzer and the EasyTear® VIEW+ Tearscope were used for objective and subjective evaluation, respectively. The within-subject repeatability and intraclass correlation coefficient (ICC) were calculated. The agreement between the devices was compared using the Bland-Altman method. RESULTS: A total of 141 CL wearers (51 male and 90 female) with a mean age of 33.6 (SD = 12.2) years were included. The repeatability and ICC values obtained with the CA-800 device when measuring NIBUT were 5.4 s and 58.6% across the whole sample, 4.2 s and 48.8% for the asymptomatic group and 7.1 s and 68.4% for the symptomatic group. When using the subjective method (EasyTear®), the respective repeatability and ICC values were 7.3 s and 32.7% for the whole sample, 6.5 s and 30.4% for the asymptomatic group and 8.6 s and 35.9% for the symptomatic group. The CA-800 device provided significantly (p < 0.001) shorter NIBUT values compared with EasyTear® for the whole sample (3.3 [2.9] vs. 8.1 [3.4] s), the asymptomatic (3.3 [3.0] vs. 7.7 [3.6] s) and the symptomatic (3.8 [2.9] vs. 8.6 [3.0] s) groups. CONCLUSION: Objective (CA-800) NIBUT assessment provides more reliable measurements than the conventional subjective technique using the EasyTear® device. However, CL practitioners should also be aware that the objective method indicates shorter NIBUT values. Symptomatic CL wearers may also need a higher number of NIBUT measurements to obtain reliable estimations.

Reliability of Tear Meniscus Height Measurements in Contact Lens Wearers and Its Relationship With Discomfort Symptoms.

OBJECTIVES: To evaluate the reliability and agreement of tear meniscus height (TMH) measurements performed with a corneal analyzer and optical coherence tomography (OCT) technology in contact lens (CL) wearers and its correlation with contact lens discomfort symptoms. METHODS: Asymptomatic and symptomatic CL wearers classified through the Contact Lens Dry Eye Questionnaire-8 were evaluated with the Corneal Analyzer (Topcon CA-800) and OCT technology (Topcon 3D OCT-2000). The repeatability and intraclass correlation coefficient (ICC) were calculated. The agreement between devices was calculated using the Bland-Altman method. The relationship between TMH measurements and the Contact Lens Dry Eye Questionnaire-8 and Contact Lens Discomfort Index scores was assessed through the Spearman correlation coefficient. RESULTS: Seventy-nine asymptomatic and 42 symptomatic CL wearers aged 34.24±12.50 years were enrolled. The repeatability values obtained for the CA-800 were 0.07 mm in all cases, and the ICC was 0.93 for the whole sample. The CA-800 provided significantly ( P <0.01) higher TMH values than the OCT for the whole sample (0.22±0.08 vs. 0.17±0.06 mm). A weak indirect correlation (ρ=-0.22) between the OCT TMH measurement and Contact Lens Discomfort Index scores was found ( P ≤0.04). CONCLUSION: The CA-800 provides reliable TMH measurements during CL wear; however, they might not be interchangeable with OCT ones. Tear meniscus height measurements might be useful as a complementary sign to detect CL discomfort, but it cannot be used alone as a diagnostic tool.

Visual Performance and Higher Order Aberrations Obtained With Omafilcon A Dual-Focus and Single-Vision Contact Lens Designs.

OBJECTIVE: The purpose of this study was to assess the visual performance and monochromatic higher-order aberrations (HOAs) obtained while wearing a MiSight dual-focus (DF) contact lenses (CL) in comparison with a single-vision contact lens (SVCL). METHODS: A randomized, double-masked, cross-over study was performed. Participants were fitted with a DFCL and a SVCL composed of the same material (omafilcon A) and parameters. Logarithm of the Minimum Angle of Resolution high-contrast (100%) and low-contrast (10%) visual acuity (VA) and contrast sensitivity (CS) for 3, 6, 12, and 18 cycles per degree were measured. Higher-order aberrations were also evaluated using a Hartmann-Shack aberrometer with the CLs on. RESULTS: Twenty-four subjects (21 females and 3 males) with a mean age of 21.9±1.9 years (range: 18-27) were included. Low-contrast VA was significantly lower with the DFCL regarding the SVCL design (0.39±0.23 vs 0.25±0.18, P=0.002). However, there were no differences in high-contrast VA between both CLs (-0.03±0.10 vs -0.09±0.14, P=0.187). Contrast sensitivity was lower with the DFCL under all spatial frequencies (P≤0.048). Second-, third-, fourth-, and fifth-order aberrations were significantly (P<0.001) higher for the DFCL. There were also significant differences between DFCL and SVCL in defocus (0.87±0.28 vs 0.16±0.35, P<0.001), oblique trefoil (-0.16±0.27 vs -0.01±0.08, P=0.005), vertical coma (0.13±0.17 vs 0.00±0.08, P=0.002), and spherical aberration (0.09±0.11 vs -0.02±0.05, P=0.002). CONCLUSION: Visual performance for detecting low-contrast targets is reduced when wearing MiSight DFCL compared with a SVCL with the same material. The main reason might be the induction of second-order and HOAs by the DFCL design.

Relationship between the main components of the crystalline lens and the anterior chamber depth after cataract formation.

PURPOSE: To assess the relationship between anterior chamber depth (ACD) and lens thickness (LT), as well as its three main components (anterior and posterior cortex and nucleus thickness), in cataractous and non-cataractous eyes, depending on the axial length (AxL). METHODS: Anterior and posterior cortex and nucleus thickness of the crystalline lens, ACD, and AxL were measured using optical low-coherence reflectometry in cataractous and non-cataractous eyes. They were also classified into hyperopia, emmetropia, myopia, and high myopia, depending on AxL; thus, eight subgroups were created. A minimum sample size of 44 eyes (of 44 patients) for each group was recruited. Linear models were fitted for the whole sample and each AxL subgroup to assess if there were differences in the relationships between the crystalline lens variables and ACD, including age as a covariate. RESULTS: Three hundred seventy cataract patients (237 females, 133 males) and 250 non-cataract controls (180 females, 70 males), aged 70.5 ± 9.4 and 41.9 ± 15.5 years, respectively, were recruited. The mean AxL, ACD, and LT for the cataractous and non-cataractous eyes were 23.90 ± 2.05, 24.11 ± 2.11, 2.64 ± 0.45, and 2.91 ± 0.49, 4.51 ± 0.38, 3.93 ± 0.44 mm, respectively. The inverse relationship of LT, anterior and posterior cortex, and nucleus thickness with ACD was not significantly (p ≥ 0.26) different between cataractous and non-cataractous eyes. Further subclassification of the sample depending on AxL showed that the inverse relationship between the posterior cortex and ACD was no longer significant (p > 0.05) for any non-cataractous AxL group. LT, anterior and posterior cortex, and nucleus thickness was not significantly (p ≥ 0.43) different between cataractous and non-cataractous eyes for the whole sample, and all AxL groups after adjusting for age. CONCLUSIONS: The presence of cataracts does not modify the inverse relationship of the LT, anterior and posterior cortex, and nucleus with ACD. And this relationship does not seem to depend importantly on AxL. Besides, the possible differences in LT, anterior and posterior cortex, and nucleus between cataractous and non-cataractous eyes may not be caused by lens opacification, but possibly by the progressive lens growth due to aging.

Inter-eye and postoperative prediction of vault after implantation of EVO + Visian phakic implantable collamer lens.

PURPOSE: To assess whether the postoperative outcomes of the implantation of an EVO + implantable collamer lens (ICL) in one eye can be used as a predictor of the vault of the fellow eye, and to evaluate the vault changes of the implantation in both eyes during the postoperative period. METHODS: A prospective study including 40 eyes of 20 patients with a bilateral EVO + ICL implantation was performed. Subjects were evaluated before the surgery and 1 day, 1 week and 1, 3 and 6 months postoperatively. Central vault was assessed using spectral-domain optical coherence tomography. The inter-eye and follow-up analyses were performed using lineal models and the Bland-Altman method. RESULTS: The vault of the first implanted eye at the 1-day visit highly predicts the vault of the second eye (R2 = .87; P < .001); the mean inter-eye difference was - 0.95 µm, and the superior and inferior limits of agreement were -50.27 µm and 148.37 µm, respectively. This relationship was maintained during the medium-term follow-up, not finding differences in the slopes among visits (P ≥ .09). A progressive decrease of vault was found during the follow-up (P < .001). Larger vault change 6 months after the surgery was associated with higher vault 1 day after the ICL implantation (R2 = .19;P = .005). CONCLUSION: One-day postoperative vault in the first eye can help to predict the optimal ICL sizing in the second eye. Vault tends to decrease during the first 6 months after EVO + ICL implantation. Eyes with higher initial vaults will also show larger reductions during the medium-term follow-up.

Assessment of the iridocorneal angle pigmentation and structures after the implantation of EVO+ Visian Implantable Collamer Lens.

PURPOSE: To evaluate the effect of EVO+ Visian Implantable Collamer Lens (ICL) implantation on the iridocorneal angle pigmentation and structures. METHODS: Myopic refractive surgery candidates who underwent posterior chamber EVO+ ICL implantation were evaluated preoperatively and 3 and 6 months postoperatively. High-resolution images of the iridocorneal angle (nasal, superior, temporal and inferior quadrants) were acquired during gonioscopy. A masked observer, blinded to study visits and patients' information, evaluated the angle width, apparent iris root insertion, iris configuration, and trabecular meshwork pigmentation according to the Spaeth scale in two different occasions. The intra-rater reliability was estimated using the weighted Gwet's Agreement Coefficient (AC2). Differences between visits were analyzed using the Cochran Q test or the Friedman test. RESULTS: Twenty-one patients (13 females and 8 males) aging 31.3 ± 6.3 years old were recruited. The intra-rater reliability of gonioscopy assessment was excellent for every parameter assessed (AC2 ≥ 0.97). No significant differences were found among the study visits for any quadrant in the angle width (p ≥ 0.74), apparent iris root insertion (p ≥ 0.22), iris configuration (p ≥ 0.21) and trabecular meshwork pigmentation (p ≥ 0.24). Mean pigmentation of trabecular meshwork for the four quadrants did not vary either among visits (p = 0.25). CONCLUSIONS: The EVO+ ICL implantation after uneventful procedures appears not to clinically affect the iridocorneal angle pigmentation and/or structures during a short-medium follow-up using gonioscopy assessment. The intra-rater reliability of glaucoma specialists assessing iridocorneal angle structures using gonioscopy images is very high.

Monochromatic higher order aberrations in highly myopic eyes with Staphyloma.

BACKGROUND: Prevalence of high myopia is continuously increasing, thus, patients affected with staphyloma are abundant worldwide. Assessment of the quality of vision in these patients is mandatory for a proper clinical counselling, specially when undergoing surgical procedures that require intraocular lenses implantation. Thus, the purpose of the study was to assess monochromatic higher order aberrations (HOAs) in highly myopic eyes with staphyloma with or without a dome-shaped macula. METHODS: Participants underwent spectral-domain optical coherence tomography, ocular axial biometry, dual Scheimpflug photography and integrated Placido disk topography, and Hartmann-Shack wavefront analysis. Five groups were evaluated: a low-moderate myopia control group (< 6.00 diopters, n = 31) and four high myopia (≥6.00 diopters) groups: eyes without staphyloma (n = 18), eyes with inferior staphyloma (n = 14), eyes with posterior staphyloma without dome-shaped macula (n = 15) and eyes with posterior staphyloma with dome-shaped macula (n = 17). Subsequently, two new groups (including all participants) were created to assess differences between myopia with and without staphyloma. One-way analysis of covariance was performed using age and lens densitometry as covariates. RESULTS: Statistically significant (p ≤ 0.05) differences in anterior corneal fourth-order HOAs were observed between the low-moderate myopia and no-dome-shaped macula (Mean: 0.16 µm) and dome-shaped macula posterior staphyloma groups (Mean: 0.12 µm) in younger patients (≤45 years old). The same groups also showed (p ≤ 0.05) significant differences for anterior corneal primary spherical aberration (Mean: 0.19 and 0.13 µm, respectively). In addition, anterior corneal tetrafoil was significantly higher (p = 0.04) in dome-shaped macula compared to no-dome-shaped macula (Mean: 0.18 vs 0.06 µm, respectively). When all participants were grouped together, significantly lower mean anterior corneal primary spherical aberration (0.15 µm vs. 0.27 µm, p = 0.004) and higher internal primary spherical aberration (0.04 µm vs. -0.06 µm, p = 0.04) was observed in staphyloma compared to no-staphyloma myopic patients. CONCLUSIONS: Eyes with high myopia and staphyloma have less positive anterior corneal primary spherical aberration and less negative internal primary spherical aberration, suggesting that the anterior corneal surface tends to mimic in a specular fashion the posterior pole profile. This corneal behaviour appears to change in patients older than 45 years.

Contact Lens Discomfort Management: Outcomes of Common Interventions.

PURPOSE: To assess the consecutive implementation of habitual contact lens discomfort (CLD) management strategies: lid hygiene, daily disposable CL (DDCL) fitting, and artificial tear (AT) supplementation. METHODS: Contact lens (CL) wearers with CLD symptoms (CLDEQ-8 ≥12 points) were included in the study. Subjects with Meibomian gland dysfunction (MGD) were instructed to perform lid hygiene. All participants were fitted with a DDCL (delefilcon A) and evaluated 1 month later. After, half of them were randomly assigned to use AT (Povidone-2%) at least three times/day, and all participants were evaluated 1 month later. Tests performed were: lower tear meniscus area (LTMA), bulbar, limbal, and tarsal hyperemia, noninvasive tear break-up time (NITBUT), and corneal and conjunctival staining. Weighted combined clinical scores (CS) were created to analyze signs. Changes in symptoms (CLDEQ-8) and CS were analyzed using linear mixed models. RESULTS: Forty-two subjects (mean age: 23.2±4.9 years) completed the study. Two CS were created, CS 1 was composed of bulbar, limbal, and tarsal hyperemia and corneal staining, and CS 2 by NITBUT, LTMA, and conjunctival staining. CLDEQ-8 was reduced after lid hygiene (mean: -2.73±2.13; P=0.012) and DDCL use (mean: -10.1±3.54; P<0.01), but not after AT use (P=0.62). CS 1 did not change after any intervention. CS-2 was higher (P=0.04) in DGM subjects after lid hygiene, it decreased (P=0.04) after DDCL use. CONCLUSIONS: Lid hygiene is effective for reducing CLD symptoms in MGD patients. Refitting subjects with delefilcon A is an effective intervention for CLD to reduce symptoms and achieve a healthier ocular surface. Simultaneous administration of AT did not further improve CLD.

Reliability of Blotting Techniques to Assess Contact Lens Water Content.

OBJECTIVES: To determine the reliability of wet and modified dry blotting techniques used in the gravimetric method to assess contact lens (CL) water content (WC), the accuracy of both techniques in comparison with the nominal WC, and also their agreement. METHODS: We evaluated hydrated and dry CL mass values and WC using the gravimetric method in 440 daily disposable CLs. Samples assessed corresponded to Dailies Total 1, Dailies AquaComfort Plus, 1-Day Acuvue TruEye, and Biotrue ONEday. Back vertex power ranged from +3.00 diopters (D) to -6.00 D. Within-subject coefficient of variation (CVw) and intraclass correlation coefficients were calculated. Bland-Altman analysis was also performed. RESULTS: The modified dry blotting technique yielded significantly (P≤0.0001) higher hydrated CL mass values. The wet blotting technique provided significantly (P≤0.04) better consistency than the modified dry one. Values of CVw for wet and modified dry blotting techniques ranged from 1.2% to 2.1% and from 3.7% to 5.4%, respectively. As for dry CL mass values, CVw values were not significantly different (P≥0.05) between wet (range: 1.1%-1.9%) and dry (range: 1.0%-5.1%) blotting techniques, except for Dailies AquaComfort Plus (P=0.03). Bland-Altman analysis showed poor agreement between the techniques. The wet blotting technique yielded WC values close (around 1%) to nominal ones, in contrast to modified dry blotting technique (≥2.5%). CONCLUSIONS: The wet blotting technique is not only more reliable than the modified dry one when obtaining hydrated CL mass but also provides more accurate nominal WC measurements. Agreement between the techniques was poor.

Comparison of specular microscopy and ultrasound pachymetry before and after cataract surgery.

PURPOSE: To compare specular microscopy (Topcon SP-3000P, Topcon Corporation, Tokyo, Japan) and ultrasound (US) technology when evaluating central corneal thickness (CCT) prior to and after phacoemulsification. METHODS: Corneal edema was assessed in phacoemulsification patients due to senile cataract by measuring CCT preoperatively and 1 day, 1 month, and 3 months postoperatively. Bland-Altman analysis was performed to assess interchangeability between pachymetry techniques for each visit. Repeated measures analysis of variance was performed to evaluate variation in CCT agreement depending on the degree of corneal edema. RESULTS: One hundred and eighteen patients aged 73.9 ± 10.1 years were recruited. Topcon SP-3000P provided significant (p < 0.0001) lower CCT values than US with and without induced corneal edema. Mean differences between CCT techniques for baseline, 1 day, 1 month and 3 months after cataract surgery were -28.9 ± 22.6, -30.5 ± 41.4, -32.3 ± 16.2 and -33.0 ± 16.9 µm, respectively. The systematic bias observed was not significantly different among the 4 visits (p = 0.59). The estimated limits of agreement (based on 1.96 standard deviation) were substantial, being 90.5, 165.8, 64.9 and 67.5 um at baseline, 1 day and 1 and 3 months. CONCLUSIONS: Topcon SP-3000P provides similar systematic bias in comparison with US technique for CCT measurements regardless of the degree of corneal edema after phacoemulsification, which should be reduced after applying a constant calibration adjustment of ∼30 µm. However, interchangeability between techniques may be still limited by the notable random measurement error.

Ocular response to environmental variations in contact lens wearers.

PURPOSE: To assess the influence of different indoor environments simulated in an environmental chamber on soft contact lens (CL) wearers. METHODS: Fifty-four CL wearers were grouped based on their symptoms while wearing their CLs. Subjects were fitted with two different CL types, conventional hydrogel (Omafilcon A) and silicone hydrogel (comfilcon A), and exposed to two controlled indoor environmental conditions, standard [50% relative humidity (RH), 23°C, 930 mb of atmospheric pressure] and adverse (in-flight air cabin environment: 5% RH, localised air flow, 23°C, 750 mb atmospheric pressure), for 90 min in an environmental chamber, making a total of four visits. Symptoms, tear osmolarity, pre-lens tear breakup time (PLBUT), phenol red thread test, visual acuity, bulbar and limbal hyperaemia, corneal and limbal staining, and CL dehydration were assessed using repeated measures analysis of variance. A linear mixed model was used to analyse the effect of environment, CL type, discomfort-based grouping, and time on blink rate. RESULTS: Environment was found to significantly (p ≤ 0.018) affect limbal and bulbar hyperaemia, PLBUT, tear osmolarity, and CL dehydration. Likewise, CL type significantly (p ≤ 0.04) affected nasal and total corneal staining, limbal conjunctival staining, CL dehydration, comfort, and blurred vision. The environment, CL type, and time had significant effects (p ≤ 0.0001) on the blink rate. CONCLUSIONS: Ocular surface integrity and blink rate in CL wearers depend on the environment CL users are exposed to, as well as on the soft CL type that they are wearing. Tight control of environmental conditions can contribute to a better understanding of CL-related discomfort.

Topical Fluorometholone Protects the Ocular Surface of Dry Eye Patients from Desiccating Stress: A Randomized Controlled Clinical Trial.

PURPOSE: To assess the efficacy of topical 0.1% fluorometholone in dry eye disease (DED) patients for ameliorating the worsening of the ocular surface when exposed to adverse environments. DESIGN: Single-center, double-masked, randomized, vehicle-controlled clinical trial. PARTICIPANTS: Forty-one patients showing moderate to severe DED. METHODS: Patients randomly received 1 drop 4 times daily of either topical 0.1% fluorometholone (FML group) or topical polyvinyl alcohol (PA group) for 22 days. Corneal and conjunctival staining, conjunctival hyperemia, tear film breakup time (TBUT), tear osmolarity, and the Symptom Assessment in Dry Eye (SANDE) questionnaire scores were determined at baseline. Variables were reassessed on day 21 before and after undergoing a 2-hour controlled adverse environment exposure and again on day 22. MAIN OUTCOMES MEASURES: Percentage of patients showing an increase 1 point or more in corneal staining and a reduction of 2 points or more (0-10 scale) in SANDE score, after the controlled adverse environment exposure and 24 hours later. RESULTS: After 21 days of treatment, the FML group showed greater improvements in corneal and conjunctival staining, hyperemia, and TBUT than the PA group (P≤0.03). After the adverse exposure, the percentage of patients having a 1-grade or more increase in corneal staining was significantly (P = 0.03) higher in the PA group (63.1% vs. 23.8%, respectively). Additionally, the FML group showed no significant changes in corneal staining (mean, 0.86; 95% confidence interval [CI], 0.47-1.25; vs. mean, 1.05; 95% CI, 0.59-1.51, for visit 2 and 3, respectively), conjunctival staining (mean, 0.95; 95% CI, 0.54-1.37 vs. mean, 1.19; 95% CI, 0.75-1.63), and hyperemia (mean, 0.71; 95% CI, 0.41-1.02 vs. 1.14; 95% CI, 0.71-1.58) after the exposure, whereas for the PA group, there was significant worsening (P≤0.009) in these variables (corneal staining: mean, 1.95; 95% CI, 1.57-2.33 vs. mean, 2.58; 95% CI, 2.17-2.98; conjunctival staining: mean, 1.68; 95% CI, 1.29-2.08 vs. mean, 2.47; 95% CI, 2.07-2.88; hyperemia: mean, 1.95; 95% CI, 1.63-2.26 vs. mean, 2.84; 95% CI, 2.62-3.07). CONCLUSIONS: Three-week topical 0.1% fluorometholone therapy is effective not only in reducing ocular surface signs in DED patients, but also especially in preventing exacerbation caused by exposure to a desiccating stress.

Corneal Sensitivity and Inflammatory Biomarkers in Contact Lens Discomfort.

PURPOSE: The aim of this study was to analyze whether symptoms of discomfort in hydrogel contact lens (HCL) wearers were associated with changes in corneal sensitivity or levels of tear inflammatory mediators. METHODS: Sixty-six subjects were included: 47 HCL wearers, further divided into 24 symptomatic and 23 asymptomatic wearers by the Contact Lens Dry Eye Questionnaire short form and 19 non-contact lens wearers. At least 24 h after HCL removal, we obtained scores from the Ocular Surface Disease Index and mechanical, hot, and cold corneal thresholds using a Belmonte esthesiometer. We collected 4 µl of tears with a capillary micropipette and measured levels of 12 inflammatory markers using a bead-based array: epidermal growth factor, fractalkine, interleukin-10 (IL-10), IL-1ß, IL-1 receptor antagonist, IL-2, IL-4, IL-6, IL-8, monocyte chemoattractant protein 1, tumor necrosis factor-α, and matrix metalloproteinase 9. RESULTS: There were no significant differences between groups in corneal sensitivity thresholds and levels of tear molecules. The following significant correlations were found in the total sample pooled: Ocular Surface Disease Index correlated with mechanical threshold (p < 0.01; rho = -0.324) and epidermal growth factor (p < 0.01, rho = -0.330), and mechanical threshold correlated with heat threshold (p < 0.01, rho = -0.321). CONCLUSIONS: Twenty-four hours after HCL removal, symptoms of discomfort in HCL wearers are not related to changes in corneal sensitivity or tear inflammatory mediator levels. This might indicate either that HCL wear has no effect on these parameters or that ocular surfaces recover from HCL-caused effects during the first hours after HCL removal. However, there were correlations for associations between symptoms, corneal sensitivity, and some molecules in tears.

Influence of Climate on Clinical Diagnostic Dry Eye Tests: Pilot Study.

PURPOSE: To analyze dry eye disease (DED) tests and their consistency in similar nonsymptomatic population samples living in two geographic locations with different climates (Continental vs. Atlantic). METHODS: This is a pilot study including 14 nonsymptomatic residents from Valladolid (Continental climate, Spain) and 14 sex-matched and similarly aged residents from Braga (Atlantic climate, Portugal); they were assessed during the same season (spring) of two consecutive years. Phenol red thread test, conjunctival hyperemia, fluorescein tear breakup time, corneal and conjunctival staining, and Schirmer test were evaluated on three different consecutive visits. Reliability was assessed using the intraclass correlation coefficient and weighted kappa (κ) coefficient for quantitative and ordinal variables, respectively. RESULTS: Fourteen subjects were recruited in each city with a mean (± SD) age of 63.0 (± 1.7) and 59.1 (± 0.9) years (p = 0.08) in Valladolid and Braga, respectively. Intraclass correlation coefficient and κ values of the tests performed were below 0.69 and 0.61, respectively, for both samples, thus showing moderate to poor reliability. Subsequently, comparisons were made between the results corresponding to the middle and higher outdoor relative humidity (RH) visit in each location as there were no differences in mean temperature (p ≥ 0.75) despite RH values significantly differing (p ≤ 0.005). Significant (p ≤ 0.05) differences were observed between Valladolid and Braga samples on tear breakup time (middle RH visit, 2.76 ± 0.60 vs. 5.26 ± 0.64 seconds; higher RH visit, 2.61 ± 0.32 vs. 5.78 ± 0.88 seconds) and corneal (middle RH, 0.64 ± 0.17 vs. 0.14 ± 0.10; higher RH, 0.60 ± 0.22 vs. 0.0 ± 0.0) and conjunctival staining (middle RH, 0.61 ± 0.17 vs. 0.14 ± 0.08; higher RH, 0.57 ± 0.15 vs. 0.18 ± 0.09). CONCLUSIONS: This pilot study provides initial evidence to support that DED test outcomes assessing the ocular surface integrity and tear stability are climate dependent. Future large-sample studies should support these outcomes also in DED patients. This knowledge is fundamental for multicenter clinical trials. Lack of consistency in diagnostic clinical tests for DED was also corroborated.

Senile Cataract Formation Does Not Affect Crystalline Lens Thickness.

INTRODUCTION: Characterizing lens thickness (LT) in patients with cataracts is important for better understanding the lens aging process and for designing new intraocular lens power formulas. This study aimed to analyze the influence of common senile cataract formation on the LT, anterior (ACS) and posterior (PCS) cortex space, and nuclear thickness (NT), controlling for sex, age, and axial length. METHODS: A cross-sectional study was performed. A consecutive sample of 603 volunteers (403 women, 200 men) aged 59.1 ± 18.8 years was recruited. The standardized Lens Opacification Classification System (LOCS)-III was used to classify eyes (randomly selected) into cataractous and non-cataractous groups. Also, they were classified according to the cataract location (presence or absence of cortical, nuclear, or posterior subcapsular cataract). Optical biometry was performed to measure LT, ACS, NT, and PCS. Propensity score was used to match participants one-to-one for sex, age, and axial length. Groups were compared using the Student's t test or Yuen's test. RESULTS: The four classifications divided unmatched eyes into: 361 cataractous lenses and 242 non-cataractous, 226 cortical and 377 non-cortical cataractous, 313 nuclear and 290 non-nuclear cataractous and 242 subcapsular and 361 non-subcapsular cataractous. Before matching, cataractous eyes showed significantly higher LT (4.52 ± 0.39 vs. 3.94 ± 0.46 mm, p < 0.001), ACS (0.75 ± 0.20 vs. 0.58 ± 0.23 mm, p < 0.001), NT (3.34 ± 0.23 vs. 3.18 ± 0.25 mm, p < 0.001) and PCS (0.42 ± 0.19 vs. 0.37 ± 0.19 mm, p = 0.003). Matched lens, cortical, nuclear, and subcapsular cataract samples comprised 146, 258, 182, and 226 eyes, respectively. After matching, no significant differences were observed in LT (4.34 ± 0.37 vs. 4.33 ± 0.36 mm, p = 0.94), ACS (0.72 ± 0.20 vs. 0.76 ± 0.19 mm, p = 0.08), NT (3.31 ± 0.22 vs. 3.30 ± 0.23 mm, p = 0.24) and PCS (0.42 ± 0.19 vs. 0.43 ± 0.16 mm, p = 0.79). CONCLUSIONS: The presence of senile cortical, nuclear, and posterior subcapsular cataract have no effect on LT, ACS, NT, and PCS. Confounding factors should be controlled for when measuring LT and its main components.

Clinical characterisation of contact lens discomfort progression.

PURPOSE: This study aimed to assess the subjective and objective differences among the steps of the contact lens discomfort (CLD) progression classification established by the Tear Film & Ocular Surface Society (TFOS) using questionnaires and clinical signs, and to propose a simplified classification. METHODS: Contact lens (CL) wearers were evaluated in a single visit. The Contact Lens Dry Eye Questionnaire (CLDEQ)-8, the Contact Lens Discomfort Index, and Visual Analog Scales for discomfort and dryness were administered. The non-invasive break-up time, the tear film lipid layer thickness, conjunctival hyperaemia and papillae, lid-parallel conjunctival folds, the fluorescein tear film break-up time, corneal and conjunctival staining, lid wiper epitheliopathy, and the Schirmer test were assessed. Sign and symptom scores were compared among TFOS CLD progression steps using analysis of variance or the Kruskal-Wallis H test. Steps 1 and 2 (reduced comfort), and steps 3 and 4 (reduced wearing time) of the TFOS classification were combined to obtain a simplified classification, and the same comparison was performed. A p-value ≤ 0.05 was considered statistically significant. RESULTS: One hundred-fifty CL wearers (97 women and 53 men) aged 34.4 ± 12.6 years were included. In the TFOS classification, there were significant differences between step 0 (no CLD) and the rest of the severity steps for the scores obtained in all questionnaires (p ≤ 0.015). All steps were differentiated (p ≤ 0.032) based on the simplified classification for all questionnaires, except steps 1 and 2 for the CLDEQ-8 and dryness VAS (p = 0.089 and p = 0.051, respectively). There were no differences (all p ≥ 0.06) between the sign scores among the steps of either classification. CONCLUSION: CLD management is encouraged from its first appearance. Simplifying the phases of CLD severity may allow a more accurate classification and a better awareness of the problem by clinicians and CL wearers by using more straightforward simple messages.

Short-Term Efficacy of Ophthalmic Cyclosporine: A 0.1% Cationic Emulsion in Dry Eye Patients Assessed Under Controlled Environment.

INTRODUCTION: To evaluate the short-term efficacy of cyclosporine A (CsA)-0.1% cationic emulsion (CE) in patients with dry eye disease (DED) and mitigation of the inflammatory flares triggered by desiccating stress environments. METHODS: A single-center non-randomized clinical trial was performed at a tertiary care setting. Twenty patients with DED treated with CsA 0.1% CE were exposed to a normal controlled environment (NCE) (23 °C, 50% relative humidity) and an adverse controlled environment (ACE) (23 °C, 10% relative humidity, 0.43 m/s localized airflow) during baseline and the 1- and 3-month visits. Patients underwent the following evaluations: conjunctival hyperemia and staining, corneal fluorescein staining (CFS) using the Oxford and Cornea and Contact Lens Research Unit (CCLRU) scale, meibomian gland (MG) secretion quality, Dry Eye Questionnaire-5, Symptom Assessment in Dry Eye (SANDE II), and Change in Dry Eye Symptoms Questionnaire. Multivariate models were adjusted for statistical analysis. RESULTS: Nineteen women and one man (mean age, 58.9 ± 12.3 years) completed the study. All symptom questionnaires, CFS, conjunctival hyperemia and staining, and MG secretion quality improved (p ≤ 0.003) with 1 month of treatment; improvements were maintained after 3 months (p ≤ 0.02), except for SANDE II (p ≥ 0.07). The CFS worsening (total CCLRU) after baseline ACE exposure (from 8.6 to 10.1) was higher, although not significant (p = 0.64), compared with 1 month (from 5.4 to 5.8) and 3 months (from 5.0 to 5.9) after treatment. CONCLUSION: Topical CsA-0.1% CE improved DED signs and symptoms after 1 month of treatment under controlled environmental conditions. Future studies should confirm the benefit of CsA-0.1% CE in desiccating stress environments. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04492878.

Tear Cytokines as Predictive Biomarkers of Success in Contact Lens Discomfort Management.

PURPOSE: To analyze changes in tear levels of inflammatory mediators in symptomatic contact lens (CL) wearers after refitting with daily disposable CLs and to identify potential biomarkers of success in CL discomfort (CLD) management. METHODS: Symptomatic CL wearers (CLDEQ-8 ≥ 12) were refitted (V1) with daily disposable CLs (Delefilcon A). After one month (V2), participants were classified into the post-fitting non-symptomatic (CLDEQ <12) and symptomatic (CLDEQ ≥12) groups. At each visit, the participants were clinically evaluated, tears were collected, and 20 inflammatory mediators and substance P (SP) were measured using multiplex immunobead analysis and ELISA, respectively. The detection rates and concentrations were compared between visits and groups, and logistic regression models were performed. RESULTS: Forty-three subjects (32 women/11 men; mean age: 23.2 ± 4.9 years) were enrolled. The IL-1ß and IL-9 detection rates were higher at V2 (p ≤ 0.044). The detection rates of IL-1ß, IL-9, MIP-1α/CCL3, and MMP-9 at V1 (p ≤ 0.045) and IL-17A at V2 (p ≤ 0.014) were higher in the post-fitting symptomatic group. The tear IL-9 concentration was increased at V2 (p = 0.018). The tear concentrations of fractalkine/CX3CL1, IL-2, IL-6, IL-10, MCP-3/CCL7, MIP-1ß, NGF, RANTES/CCL5, and TNF-α were higher in the post-fitting symptomatic group (p ≤ 0.044). Additionally, levels of fractalkine/CX3CL1, IL-2, IL-6, IL-10, RANTES/CCL5, and TNF-α at V1 were significantly associated with the post-fitting grouping (p ≤ 0.044). CONCLUSIONS: Low tear concentrations of specific inflammatory mediators may be used as a predictive biomarker of success for refitting symptomatic CL wearers with daily disposable CLs. However, complementary treatments might be required for symptomatic CL wearers with higher levels of these inflammatory molecules.

Design and evaluation of a customized reading rehabilitation program for patients with age-related macular degeneration.

PURPOSE: To evaluate the efficacy of a reading rehabilitation program (RRP) specifically designed for patients with impaired central vision from age-related macular degeneration (AMD) and the impact of the program on the quality of life (QoL) and to determine any predictable reading performance improvements between visits. DESIGN: Prospective case series. PARTICIPANTS: Forty-one patients with AMD who attended to the Institute of Applied Ophthalmobiology Eye Institute. METHODS: An ad hoc-created RRP comprising 4 customized in-office training and in-home training visits over 6 weeks was undertaken by AMD patients. The RRP was based on the principle of stepwise progressive goal achievement: the difficulty of training tasks increased depending on the success obtained when performing previous easier ones. Reading performance was evaluated during each in-office training visit, and the individual's perception of his or her QoL was assessed before and after the RRP. Reading performance parameters were assessed to evaluate RRP effectiveness. MAIN OUTCOME MEASURES: Best-corrected visual acuity (BCVA), reading speed, reading duration, near visual acuity (VA), font size, and the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire scores. The effect sizes (mean differences and standard deviations) also were calculated. RESULTS: The mean distance BCVA was 0.81±0.29 logarithm of the minimum angle of resolution units. The mean near VA with the appropriate low-vision aid was 0.91±0.18 (M notation) at baseline. The mean near magnification was 4.32±1.15 at the last in-office visit. The mean reading speed, reading duration, and font size improvement after the reading rehabilitation program were 48.31±22.06 words per minute (P<0.001), 35.46±15.68 minutes (P<0.001), and -4.08±2.19 font points (P<0.001), respectively. The effect sizes of reading speed, reading duration, and font size after the last visit were 2.19, 2.26, and -1.86, respectively. The final score of each WHOQOL-BREF domain improved significantly (P≤0.004) after the RRP. The increased ability to read a smaller font size was correlated with improvement in the physical health domain score of the WHOQOL-BREF (r=0.35; P=0.04). CONCLUSIONS: This customized RRP significantly enhanced reading performance and perceived QoL in patients with AMD. The improvement between visits seemed to be consistent. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

A new manual retinal thickness measurement protocol to evaluate high myopia patients.

PURPOSE: To validate a manual measurement protocol for quantifying retinal thickness (RT) using an optical coherence tomography (OCT) device in pathologic myopia patients. METHODS: The macular Cross Hair protocol of Stratus OCT3 (Carl Zeiss Meditec, Inc., Dublin, Calif., USA) was applied and manual RT gauging was performed using the caliper tool. Foveal and paramacular RT, located at 1 and 2 mm distances from the fovea in both vertical and horizontal scans, were measured. Three consecutive RT measurements were taken to assess measurement reliability. The within-subject coefficient of variation (CVw) and intraclass correlation coefficients (ICC) were calculated to validate the manual method. RESULTS: The mean axial length of the 29 eyes assessed was 28.28 ± 2.72 mm and the mean spherical refraction was -13.61 ± 6.68 diopters. CVw ranged from 0.86 to 8.73% and ICC varied from 0.81 to 0.98. CONCLUSION: A manual RT measurement protocol could reliably be used in the daily clinic for assessing pathologic myopic patients when OCT software segmentation fails.