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.

Effect of central hole location in phakic intraocular lenses on visual function under progressive headlight glare sources.

PURPOSE: To analyze the effect of the central hole location in the V4c implantable collamer lens (ICL) on the quality of vision, including progressive headlight glare simulation and quality of life. SETTING: IOBA-Eye Institute, Valladolid, Spain. DESIGN: Case series. METHODS: The central hole location was determined by slitlamp and dual Scheimpflug imaging for 6 months or more postoperatively. The visual acuity, mesopic contrast sensitivity, halogen glare contrast sensitivity, xenon glare contrast sensitivity, photostress recovery time after glare, de Boer scale, and Quality of Life Impact of Refractive Correction (QIRC) questionnaire results were evaluated. Multiple regression models were used to analyze the effect of the central hole location on parameters using the pupil center and visual axis as references based on Cartesian and polar coordinates. RESULTS: The safety index was 1.13 and the efficacy index, 1.12. Under all testing circumstances, central hole decentration did not affect the visual acuity or contrast sensitivity. With the visual axis as a reference, worse QIRC values were associated with greater upward central hole displacement (P = .03) and a lower polar angle value (P = .008); also, halogen glare discomfort was greater with a higher radius (P = .04). Using the pupil center as a reference, greater nasal central hole decentration was associated with longer xenon glare photostress recovery time (P = .002). CONCLUSIONS: Implantation of the ICL with a central hole yielded excellent visual outcomes, even under increasing glare sources, regardless of the hole's location. However, hole decentration might affect patient-perceived quality of life, bothersome halogen glare, and longer xenon glare photostress recovery time. Such complaints after the early postoperative period might be managed with discrete ICL centration if the central hole is decentered upward or nasally.

Efficacy and Safety of 0.2% Hyaluronic Acid in the Management of Dry Eye Disease.

OBJECTIVES: To evaluate the safety and efficacy of a new artificial tear containing 0.2% hyaluronic acid, as compared with 0.9% saline solution, in mild dry eye patients after 1-month use in a crossover study design with washout periods. METHODS: Overall, 16 mild dry eye patients were included. After a week of washout, every patient used the experimental product (Visaid 0.2%) and the control product (0.9% saline solution), each for a month (3-8 drops daily). Both products were preservative free. The percentage change for the following variables were calculated and analyzed: Ocular Surface Disease Index (OSDI) questionnaire, visual acuity, intraocular pressure, ophthalmoscopy evaluation, biomicroscopy findings, fluorescein corneal staining and lissamine green conjunctival staining, tear breakup time, contrast sensitivity, Schirmer's test, and subject satisfaction. RESULTS: Patients reported an improvement (a significant decrease of -19.5%±27.5%) in OSDI scores after using Visaid 0.2% and a worsening (a significant increase of 19.2%±32.4%) after using 0.9% saline solution; the difference was significant (P=0.0087, Student's t test). Significant changes (P≤0.04, Wilcoxon's test) were found comparing Visaid 0.2% with saline solution for bulbar hyperemia (-39.1%±50.8% vs. 7.8%±12.0%, respectively), corneal staining (-26.0%±53.0% vs. 36.5%±73.3%), conjunctival staining (-54.7%±53.4% vs. -7.8%±47.2%), and subjective satisfaction (26.8%±28.5% vs. -13.3%±22.5%). There were no significant differences in the safety parameters for either solution. CONCLUSION: This clinical trial demonstrates the safety of Visaid 0.2% and its clear benefit over 0.9% saline solution.

Safety and Efficacy of an Artificial Tear Containing 0.3% Hyaluronic Acid in the Management of Moderate-to-Severe Dry Eye Disease.

PURPOSE: To evaluate the safety and efficacy of a new 0.3% hyaluronic acid artificial tear compared with 0.9% saline solution (0.9% NaCl) in moderate-to-severe dry eye patients after 1 month's use. METHODS: A total of 16 patients with moderate-to-severe dry eye were included in this crossover study. After a 1-week washout period, patients used the experimental (Visaid 0.3%) or control solution (0.9% NaCl), selected randomly, applying three to eight drops daily for a month. After another washout period, patients used the other solution in the same way. Percentage of change (ΔY) was calculated and analyzed for (1) safety variables: visual acuity, intraocular pressure, and ophthalmoscopy evaluation; (2) efficacy variable: Ocular Surface Disease Index (OSDI) questionnaire; and (3) secondary variables: biomicroscopy findings, fluorescein corneal staining, lissamine green conjunctival staining, tear breakup time (TBUT), contrast sensitivity, Schirmer test, and subject satisfaction. RESULTS: There were no significant differences in the safety parameters for either solution. After using Visaid 0.3%, patients showed significant improvements in OSDI score (ΔY: -9.66%±10.90), tarsal hyperemia (ΔY: -16.67%±27.89), corneal staining extension (ΔY: -34.90%±42.41), TBUT (ΔY: 13.98%±26.19), and subjective satisfaction (ΔY: 38.06%±47.06). When using 0.9% NaCl, Schirmer test results were significantly worse (ΔY: -11.47%±19.27). A significant difference between the 2 solutions was found in TBUT (ΔY: 13.98%±26.19 vs. 10.15%±42.34, respectively; P=0.0214). CONCLUSION: Visaid 0.3% is a safe product with some benefits over 0.9% NaCl in reducing ocular symptoms and improving some ocular signs in patients with moderate-to-severe dry eye.

Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses / Evaluación de la seguridad y eficacia de una nueva solución multipropósito en lentes de contacto de hidrogel de silicona

Purpose: To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. Methods: This is a prospective, randomized, double-masked clinicaltrial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. Results: Twenty subjects (10 women, 10 men) (mean age, 27.7 ± 5.6 years; range, 20---41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p = 0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p = 0.18). The study MPDS received higher rates in comfort (study: 8.14 ± 1.09, control: 7.94 ± 0.92; p = 0.56) and satisfaction at day 30 (study: 8.63 ± 0.91, control: 8.29 ± 0.80; p = 0.19), however the scores were not significantly different with the control MPDS. Conclusions: The clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation (AU)

Objetivo: Evaluar la seguridad y la eficacia de una nueva solución única desinfectante (MPDS), con una formulación que incluye aloe vera en su composición. Métodos: El estudio consistió en un ensayo clínico prospectivo, aleatorio y de doble ciego, con un diseño cruzado que incluyó siete exámenes. Se utilizaron durante un mes dos MPDS diferentes, Avizor Alvera® (solución en estudio) y All Clean Soft® (solución de control). Durante el ensayo se utilizaron lentes de contacto de hidrogel de silicona Comfilcon A. Las principales variables evaluadas fueron la tinción corneal y los depósitos sobre la superficie de las lentes de contacto. Se analizaron otros parámetros, que incluían la respuesta de la superficie ocular, la humectabilidad de las lentes de contacto, y los eventos adversos, de acuerdo con la normativa 11980:2010 de la Organización Internacional de Normalización (ISO) para investigación clínica. Resultados: El estudio incluyó a veinte sujetos (10 mujeres, 10 hombres) (edad media, 27,7 ± 5,6 años; rango, 20-41). No se hallaron diferencias entre ambas MPDS en cuanto al porcentaje de sujetos con tinción corneal > 0 al mes (estudio: 35%, control: 50%; p = 0,46), ni el porcentaje de sujetos con depósitos en la superficie de las lentes de contacto > 0 al mes (estudio: 26,32%, control: 52,63%; p = 0,18). La MPDS en estudio obtuvo valoraciones superiores en cuanto a confort (estudio: 8,14 ± 1,09, control: 7,94 ± 0,92; p = 0,56) y satisfacción (estudio: 8,63 ± 0,91, control: 8,29 ± 0,80; p = 0,19); sin embargo, las puntuaciones no fueron significativamente diferentes en relación a la MPDS de control. Conclusiones: El ensayo clínico reflejó que la MPDS en estudio es segura y eficaz, mostrando una tolerancia fisiológica aceptable, de acuerdo con la normativa ISO 11980:2010 para investigación clínica (AU)

Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses.

PURPOSE: To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. METHODS: This is a prospective, randomized, double-masked clinical trial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. RESULTS: Twenty subjects (10 women, 10 men) (mean age, 27.7±5.6 years; range, 20-41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p=0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p=0.18). The study MPDS received higher rates in comfort (study: 8.14±1.09, control: 7.94±0.92; p=0.56) and satisfaction at day 30 (study: 8.63±0.91, control: 8.29±0.80; p=0.19), however the scores were not significantly different with the control MPDS. CONCLUSIONS: The clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation.