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.

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.

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.

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.

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.

In Vivo Confocal Microscopy in Limbal Stem Cell Deficiency After Mesenchymal Stem Cell Transplantation: A Sub-analysis from a Phase I-II Clinical Trial.

INTRODUCTION: The aim of this work is to evaluate the effect of mesenchymal stem cell transplantation (MSCT) and cultivated limbal epithelial transplantation (CLET) therapies on the limbus of patients suffering from limbal stem cell deficiency (LSCD). METHODS: A sub-analysis of a phase I-II randomized, controlled, and double-masked clinical trial was performed to assess the changes in the anatomical structures of the limbus. In vivo confocal microscopy (IVCM) analysis was carried out in LSCD eyes before and 12 months after allogeneic MSCT or CLET. Epithelial phenotype of the central cornea, as well as the presence of transition zones and palisades of Vogt in the limbus, were assessed using Wilcoxon test. RESULTS: Twenty-three LSCD (14 MSCT and nine CLET) eyes were included. The epithelial phenotype of the central cornea improved significantly (p < 0.001) from 15 (eight MSCT, seven CLET) and eight (six MSCT, two CLET) LSCD eyes showing conjunctival and mixed phenotypes, respectively, to eight (five MSCT, three CLET), five (two MSCT, three CLET), and ten (seven MSCT, three CLET) eyes showing conjunctival, mixed, and corneal phenotypes, respectively. Transition areas and palisades of Vogt were observed in at least one quadrant in nine (five MSCT, four CLET) and 16 (nine MSCT, seven CLET), and in four (two MSCT, two CLET) and six (three MSCT, three CLET) LSCD eyes before and after surgery, respectively. Changes in the transition zones and palisades were solely significant (p = 0.046) for the nasal and inferior quadrants, respectively. CONCLUSIONS: MSCT and CLET improved the central corneal epithelial phenotype despite only minor changes in the anatomical structures of the limbus, as detected by IVCM technology. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01562002.

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.

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.

EVO/EVO+ Visian Implantable Collamer Lenses for the correction of myopia and myopia with astigmatism.

INTRODUCTION: Intraocular lens implantation in phakic eyes for the correction of refractive error is currently a widespread procedure. The EVO and EVO+ Visian Implantable Collamer Lenses (ICL) are two of the most prevalent lenses implanted. They incorporate a central orifice to avoid the need for iridotomy. The main difference between both ICL is the higher optical diameter zone provided by the EVO+, allowing a better quality of vision at night. This review aims to provide an overview of the current ICL models available for correcting myopia and myopic astigmatism. AREAS COVERED: During the last decade, more than 100 scientific papers analyzing the performance of EVO and EVO+ lenses have been published. This review describes the objective visual performance achieved with the implantation of central hole ICL lenses and the subjective perception of the patients implanted with these lenses. In addition, the safety and the potential complications associated with undergoing an EVO and EVO+ ICL implantation have been addressed. EXPERT OPINION: Refractive surgeons and candidates to undergo ICL implantation should be aware of the excellent safety and visual outcomes provided by the implantation of central hole ICL lenses. However, future research could address minor issues currently not resolved.

Reliability and agreement of apparent chord mu measurements between static and dynamic evaluations.

PURPOSE: To assess the repeatability and agreement of Cartesian coordinates and the length of apparent chord mu and pupil diameter measurements during static (Galilei G4) and dynamic (Topolyzer Vario) evaluations. SETTING: IOBA-Eye Institute, Valladolid, Spain. DESIGN: Case series. METHODS: 3 consecutive measurements per scenario (Galilei G4 and Topolyzer Vario under low mesopic and photopic conditions) were performed by the same clinician. The intrasession repeatability was assessed using the within-subject SD (Sw), the precision, the coefficient of variation, and the intraclass correlation coefficient (ICC). The agreement was analyzed using repeated-measures analysis of variance and the Bland-Altman method. RESULTS: Thirty-seven healthy participants were recruited. The Sw values for chord mu parameters and pupil diameter ranged from 0.01 to 0.03 and 0.08 to 0.21, respectively. The ICC was ≥0.89 for all parameters. Galilei G4 and Topolyzer Vario under low mesopic and photopic conditions provided significantly different measures of apparent chord mu length (0.23 ± 0.11 mm, 0.30 ± 0.10 mm, and 0.25 ± 0.11 mm, respectively, P ≤ .02), X-coordinate (-0.18 ± 0.12 mm, -0.27 ± 0.11 mm, and -0.21 ± 0.12 mm, respectively, P < .001), and pupil diameter (3.38 ± 0.50 mm, 6.29 ± 0.60 mm, and 3.04 ± 0.41 mm, respectively, P < .001). Y-coordinate values obtained by Galilei G4 and Topolyzer Vario under low mesopic conditions were significantly different (0.06 ± 0.13 mm vs 0.03 ± 0.11 mm, respectively, P = .02), in contrast to Galilei G4 and Topolyzer Vario under photopic conditions (0.05 ± 0.13 mm, P = .82) and both illumination conditions of Topolyzer Vario (P ≥ .23). CONCLUSIONS: Galilei G4 and Topolyzer Vario provide consistent measurements of apparent chord mu Cartesian coordinates and length, as well as pupil diameter; however, the measurements are not interchangeable. Ophthalmic surgeons should consider these findings when planning customized intraocular lens implantation and refractive surgery procedures.

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.

Influence of decentration and tilt of Tecnis ZCB00 on visual acuity and higher order aberrations.

BACKGROUND/OBJECTIVES: To determine the influence of decentration and tilt of a pseudophakic aspheric intraocular lens (IOL) on visual acuity (VA) and higher-order aberrations (HOAs), and to analyze the agreement between pupil center/axis and iridocorneal angles center/axis when assessing IOL decentration and tilt. SUBJECTS/METHODS: A prospective interventional case series study including thirty-three patients undergoing Tecnis ZCB00 (Abbott Medical Optics) implantation. IOL decentration and tilt with respect to two reference systems (pupil and iridocorneal angles centers/axes), in cartesian (X,Y) and polar (radius/tilt, polar angle/azimuth) coordinates, were assessed with optical coherence tomography. VA and internal and ocular HOAs were evaluated. Multiple linear regression models and intraclass correlation coefficient (ICC) were computed. RESULTS: IOL decentration only showed a significant effect on internal HOAs for [Formula: see text] (R2 = 0.20, P = 0.04). IOL decentration with respect to the pupil center showed a significant effect on ocular [Formula: see text] (R2 = 0.18, P = 0.05), [Formula: see text] (R2 = 0.36, P = 0.001) and [Formula: see text] (R2 = 0.24, P = 0.02); and with respect to the center of iridocorneal angles, on ocular [Formula: see text] (R2 = 0.21, P = 0.03), [Formula: see text] (R2 = 0.32, P = 0.003), primary coma (R2 = 0.41, P < 0.001), and coma-like (R2 = 0.40, P = 0.001). Poor agreement between both reference systems was found for IOL decentration measurements (ICC ≤ 0.41), except for the polar angle coordinate (ICC = 0.83). Tilt measurements showed good agreement (ICC ≥ 0.75). CONCLUSIONS: Tecnis ZCB00 decentration and tilt values after uneventful implantation appear not to have influence on VA, and their effect on HOAs are not high enough to clinically affect quality of vision. Pupil and iridocorneal angles used as reference systems may be interchangeable for IOL tilt measurements, but not for decentration.

Effect of a single vectored thermal pulsation treatment of Meibomian gland dysfunction patients under controlled environmental conditions.

To assess the prophylactic effect of LipiFlow treatment in Meibomian gland dysfunction (MGD) patients exposed to an adverse environmental humidity. MGD patients were exposed to normal (23 °C; 50% relative humidity; 30 min) and adverse (23 °C; 10% relative humidity; 2 h) controlled environments consecutively during baseline and follow-up visits (3, 6, and 12 months) after a single LipiFlow treatment. Ocular Surface Disease Index (OSDI), lipid layer thickness (LLT), fluorescein tear break-up time (TBUT), corneal and conjunctival staining, change in dry eye symptoms questionnaire (CDES-Q), and Meibomian gland yielding liquid secretion (MGYLS), were assessed. Linear mixed-effects and cumulative logit mixed models were fitted to assess the effect of the LipiFlow treatment over time and within the controlled environments. Seventeen females and 4 males (59.6 ± 9.4 years) completed the study. LLT and TBUT did not vary significantly (p > 0.05) after LipiFlow treatment. OSDI, corneal and conjunctival staining, and MGYLS scores were improved (p ≤ 0.01) 12 months after treatment. After the adverse exposure, corneal staining increased at all visits (p = 0.01), and there was no significant improvement in CDES-Q scores after LipiFlow treatment (p ≥ 0.07). One LipiFlow treatment improved objective and subjective outcomes in MGD disease for at least one year. Further studies are needed to support that LipiFlow might also help as an adjuvant to avoid acute flares against an adverse environmental humidity.

Phenotypic characterization of patients developing chronic dry eye and pain after refractive surgery: A cross-sectional study.

PURPOSE: To describe the clinical characteristics of patients suffering from chronic dry eye (DE) and pain after refractive surgery (RS). METHODS: Cross-sectional, observational, single-visit study. DE-, pain- and psychological-related symptoms were evaluated with specific questionnaires. DE-related tests evaluated tear osmolarity, conjunctival hyperemia, Meibomian gland dysfunction, tear stability and production, and ocular surface staining. Corneal mechanical sensitivity (Cochet-Bonnet) was measured pre/post topical anesthesia, and symptomatic variation post-anesthesia (anesthetic challenge test) was recorded. When pain was present, it was further categorized as neuropathic or nociceptive based on published criteria. RESULTS: We recruited 104 patients (39.5 ± 9.5 years). Most, 85.6%, had corneal RS as opposed to intraocular RS. Migraines, anxiety, depression (p < 0.0001), and central sensitization syndromes (p = 0.0214) were more frequent post-RS than pre-RS. Persistent DE-symptoms, severe in 86.5% patients, developed in a range of 0-204 months post-RS. Dryness and pain were the two most frequent symptoms. The only DE-related tests showing abnormal values were tear osmolarity (315.2 ± 17.1 mOsm/L; normal ≤308) and tear break-up time (4.1 ± 2.5 s; normal >7). Corneal sensitivity was 55.4 ± 7.0 mm, and decreased (p < 0.0001) after topical anesthesia, 6.0 ± 10.4 mm. However, it remained pathologically elevated, ≥10 mm in 61 (58.7%) patients. The normal symptomatic post-anesthesia improvement was absent in 58 (55.7%) patients. Ocular pain was present in 82 (78.8%) patients, and it was categorized as neuropathic in 66 (80.5%) of them, 63.5% of the entire cohort. CONCLUSIONS: Chronic ocular pain and its neuropathic subtype were diagnosed in 78.8% and 63.5% respectively of patients seeking consultation for persistent symptomatic DE post-RS.

Diurnal variation on tear stability and correlation with tear cytokine concentration.

PURPOSE: To investigate the effect of time of day on tear evaporation rate (TER) and tear break-up time, and its possible relationship with the concentration of inflammatory tear molecules (cytokines) in healthy subjects. METHODS: Participants with healthy ocular surfaces attended 3 visits, including the screening visit (V0), the 2nd visit (V1) and the 3rd visit (V2). There were 7-day intervals between visits. Participants with Dry Eye Disease (DED) were excluded by using appropriate clinical tests during V0. Clinical evaluation (TER and Non-Invasive Tear Break-Up Time (NITBUT)) and tear collection were performed during V1 and V2, between 9 and 10AM and 3-4PM. The relative humidity and temperature of the examination room were also measured. The tear fluid concentrations of 15 cytokines were measured by multiplex bead analysis. RESULTS: Seven men and 10 women (mean age ± S.D; 25.1 ± 6.63 years old) participated in the study. There were no differences in neither the TER and NITBUT outcomes, nor humidity and temperature among times or visits. Eleven out of the 15 cytokines measured were detectable in tear fluids in > 50% of the participants. In the tear levels, no significant (p > 0.05) inter- and/or intra-day differences were detected for EGF, fractalkine, IL-1RA, IL-1ß and IP-10. However, significant inter-day differences were found in the tear levels of IL-10 (p = 0.027), IFN-γ (p = 0.035) and TNF-α(p = 0.04) and intra-day differences in the tear levels of IL-8/CXCL8 (p = 0.034) and MCP-1 (p = 0.002). A significant correlation between TER and IL1-ß, IL-2, and Fractalkine (p = 0.03, p = 0.03 and p = 0.046, respectively) was found at V1. CONCLUSIONS: NITBUT and TER values had no significant variability over the course of a day (AM versus PM), or on different days in healthy participants when humidity and temperature were constant. However, some tear molecule levels did show inter- and intra-day variability, having an inconsistent and moderate correlation with TER diurnal variation.

EVO+ Implantable Collamer Lens KS-aquaPORT Location, Stability, and Impact on Quality of Vision and Life.

PURPOSE: To determine the longitudinal variation in the KS-aquaPORT central hole location of the phakic EVO+I Implantable Collamer Lens (ICL) (STAAR Surgical) and analyze its influence on visual performance, quality of vision (QoV), and quality of life (QoL). METHODS: A prospective study was performed including 36 patients who had EVO+ ICL implantation. The KS-aquaPORT central hole location (Cartesian and polar coordinates) was determined with respect to the pupil center and visual axis. The effect of time (6-month follow-up) on central hole location was analyzed using linear mixed models. The effect of the KS-aquaPORT location on visual performance, QoV, and QoL parameters was assessed with multivariate regression models. RESULTS: With respect to the visual axis, no significant changes in KS-aquaPORT location were found during follow-up. With respect to the pupil center, the X-coordinate and radius of KS-aquaPORT location showed modest, but significant (P ≤ .05) differences between 1-week and 3-month postoperative visits, and between 1-week and 6-month visits. X-coordinate variation was significant (P = .022) between 1-and 6-month visits. With respect to the visual axis, greater KS-aquaPORT decentration was associated with worse visual acuity (X-coordinate: P = .004; radius: P = .006), and inferior decentration with longer xenon-type glare photostress recovery time (P = .021). With respect to the pupil center, a lower radius was associated with better QoV scores (P ≤ .01) and temporal decentration produced higher ring-shaped dysphotopsia (P = .007). CONCLUSIONS: EVO+ ICL KS-aquaPORT location appears to be clinically stable up to 6 months postoperatively. A central location of the EVO+ ICL KS-aquaPORT hole is preferred because it allows reduced perception of dysphotopic phenomena that can result in better QoV. [J Refract Surg. 2022;38(3):177-183.].

Mesopic Disability Glare in Stage-Two Dysfunctional Lens Syndrome.

INTRODUCTION: There is a lack of evidence about the exact deterioration of visual function associated with the age-related natural changes in the lens, particularly in intermediate (stage-2) dysfunctional lens syndrome (DLS). Standard photopic visual acuity and contrast sensitivity tests may not show the visual worsening in daily life activities, such as oncoming vehicle headlights at night. The purpose of this study was to analyze visual function under different conditions and glare sources in stage-2 DLS. METHODS: Forty patients over 49 years of age with initial bilateral lens opacification (Lens Opacities Classification System III [LOCS-III] scores up to 3), best-corrected visual acuity of 20/25 or better, and no ocular disease were evaluated. Binocular photopic and mesopic contrast sensitivity (CS) with/without halogen and xenon increasing glare sources were analyzed. Mesopic disability glare (MDG) was calculated as the difference between mesopic CS with/without the glare source. RESULTS: The median logarithmic CS (logCS) values were lower under mesopic conditions (1.05) than under photopic illumination (1.65; P < 0.001). Halogen and xenon glare further decreased mesopic CS (both, median logCS 0.75, P < 0.001). The mean MDG was 0.31 ± 0.10 log units for halogen glare and 0.33 ± 0.09 log units for xenon glare. The mesopic CS and MDG were not associated with any photopic test. The mesopic CS with glare but not photopic CS or mesopic CS was correlated with the LOCS-III scores. The best association was provided by MDG, which showed a pooled correlation with LOCS-III nuclear opalescence (r = 0.411, P < 0.001) and cortical scores (r = 0.226, P = 0.04). CONCLUSION: The mesopic CS under a glare source is an independent early indicator of visual impairment in stage-2 DLS patients, and appears to be substantial. Furthermore, the MDG is more sensitive than photopic and mesopic CS for evaluating patients with initial phacosclerosis. Surgeons should consider this in the decision-making process of the correct timing for lens surgery.

Design of a questionnaire for detecting contact lens discomfort: the Contact Lens Discomfort Index.

CLINICAL RELEVANCE: Questionnaires can provide unique information regarding the status of a condition from the perspective of the patient. Contact lens (CL) discomfort (CLD) is a condition subjectively reported by CL users; thus, updated and reliable questionnaires are needed. BACKGROUND: The objective of this study was to design a new questionnaire for identifying CLD, based on the currently established CLD definition considered in the Tear Film and Ocular Surface CLD Workshop. METHODS: A survey to characterise CL wearers was created and administered. Some items of the survey were selected by a focus group and analysed using a Rasch model to develop a questionnaire to identify CLD. Unidimensionality was checked applying principal components analysis. To build a plausible CLD classification (symptomatic vs asymptomatic), an unsupervised cluster analysis was used. Gower's general similarity coefficient, the partitioning around medoids algorithm, and the silhouette width were calculated. The reliability of the questionnaire was assessed using the intraclass correlation coefficient and Cohen's kappa coefficient. A study was performed to compare this questionnaire with the Contact Lens Dry Eye Questionnaire (CLDEQ)-8. RESULTS: The 31-item survey was completed by 1104 volunteers, and the posterior analysis resulted in a 9-item questionnaire, the Contact Lens Discomfort Index (CLDI). It showed a good fit with the model (mean square infit and outfit values range was 0.76-1.10), and good unidimensionality (eigenvalues ≤ 1.3). The CLDI score range was 0-18 and the cut-off score for identifying CLD was 8. The intraclass correlation coefficient was 0.88 (95% confidence interval, 0.75-0.94), and kappa was 0.67 (95% confidence interval, 0.41-0.93). Comparison of the CLDI with the CLDEQ-8 in a sample of 58 CL wearers showed that 70.7% were classified equally by both questionnaires. CONCLUSIONS: The CLDI is a well-structured instrument, with acceptable psychometric properties, making it a valid and reliable tool to measure CL-related symptoms.

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.

Usefulness of a global rating change scale for contact lens discomfort evaluation.

OBJECTIVES: To evaluate the usefulness of a global rate of change scale (GRCS) to detect variations in contact lens discomfort (CLD). METHODS: Symptomatic contact lens (CL) wearers were recruited according to the 'Contact Lens Dry Eye Questionnaire-8' (CLDEQ-8). At the baseline visit, subjects scored their comfort following insertion of their habitual CL using a 0-100 visual analogue scale (VAS). After 4-10 h of CL wear, comfort was again self-evaluated with the VAS and with a GRCS (range, -50 to +50). Then, a daily disposable CL (DDCL) was fitted. After one month of DDCL wear, a follow-up visit was conducted where the same evaluations as the baseline visit were performed. Changes in comfort were estimated using a Student's t-test for normal variables and the Friedman test for multiple comparisons of non-parametric variables. Internal responsiveness was measured by calculating the standardised response mean. Agreement between scales was estimated by the intraclass correlation coefficient (ICC). RESULTS: Twenty-nine (22 females and 7 males) CL wearers with a mean age of 23.4 ± 5.4 years participated in the study. There was a significant decrease in comfort at both visits detected by the GRCS (baseline = -13.58 ± 17.48, p < 0.001; follow up = -6.86 ± 12.69, p = 0.007). However, the VAS did not detect that change, either at baseline (insertion = 64.28 ± 18.72 vs removal = 52.89 ± 17.64, p = 1.000) or follow-up visit (insertion = 81.97 ± 12.91 vs removal = 76.48 ± 16.02, p = 1.000). Comfort at insertion and removal times was significantly higher with the DDCL (p = 0.008 at insertion and p = 0.004 at removal). The standardised response mean was greater with the GRCS than the VAS at baseline (0.78 vs 0.63) and follow-up (0.54 vs 0.37) visits. Agreement between both scales was moderate and significant (p < 0.001) for both visits, ICC: 0.674 (95 % confidence interval (CI):0.411-0.833) (baseline) and 0.652 (95 % CI:0.377-0.821) (follow-up visit). CONCLUSIONS: The GRCS can detect slight changes in CL wear comfort and shows higher responsiveness than the VAS. This subjective scale can allow detection of changes in comfort in a simple and quick way.