Efficacy and Safety of Sodium Hyaluronate/chondroitin Sulfate Preservative-free Ophthalmic Solution in the Treatment of Dry Eye: A Clinical Trial.

Purpose: To evaluate the efficacy of a preservative free sodium hyaluronate/chondroitin sulfate ophthalmic solution (SH/CS-PF) in patients with dry eye disease (DED).Methods: This was a randomized phase IV, multicentric, prospective, double-blind clinical trial. Intent-to-treat (ITT) and per-protocol (PP) analyses were performed. Patients were assigned to receive either SH/CS-PF, Systane® Ultra (PEG/PG) or Systane® Ultra PF (PEG/PG-PF) for 90 days. A total of 326 patients were included in the ITT, and 217 in the PP analysis. Efficacy endpoints were goblet cell density, Nelson's grades (conjunctival impression cytology), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), and Schirmer's test. Other parameters included were tolerability, measured by the ocular symptomatology; and safety, measured through corneal staining, intraocular pressure, visual acuity and adverse events.Results: In the ITT, there was a significant increase in mean goblet cell density in all treatments compared with their baseline (28.4% vs 21.4% and 30.8%), without difference between arms (p = .159). Eyes exposed to SH/CS-PF, PEG/PG and PEG/PG-PF showed Grade 0-I squamous metaplasia (85.5%, 87.9% and 93.2%, respectively). Similar improvements were observed for TBUT (1.24 ± 2.3s vs 1.27 ± 2.4s and 1.39 ± 2.3s) and OSDI scores at day 90 (-8.81 ± 8.6 vs -7.95 ± 9.2 and -8.78 ± 9.8), although no significant intergroup difference was found. Schirmer's test also presented improvement compared to baseline (1.38 ± 4.9 vs 1.50 ± 4.7 and 2.63 ± 5.9), with a significantly higher variation for PEG/PG-PF. There were no significant differences between treatments for any tolerability and safety parameter, nor between ITT and PP analyses for any outcome.Conclusions: The topical application of SH/CS-PF is as effective, safe and well tolerated as that of PEG/PG or PEG/PG-PF. The results suggest that SH/CS-PF may lead to normalization of clinical parameters and symptom alleviation in patients treated for DED.

Efficacy of a fixed combination of 0.09 % xanthan gum/0.1 % chondroitin sulfate preservative free vs polyethylene glycol/propylene glycol in subjects with dry eye disease: a multicenter randomized controlled trial.

BACKGROUND: Dry eye disease (DED) is multifactorial, affecting 5-34 % of the global adult population and reducing quality of life. The artificial tears or lubricants are the therapy most used for the treatment of DED, due to their low side effect profile, which attempt to modify the properties of the tear film. The aim of the present study was to evaluate the clinical efficacy of a fixed combination of xanthan gum and chondroitin sulfate preservative free on the ocular surface of patients with dry eye disease during 60 days of intervention. METHODS: A phase III, double-blind, masked, controlled, multicenter, clinical trial of 148 subjects, randomized to either a fixed combination of xanthan gum 0.09 % and chondroitin sulfate 0.1 % (XG/CS) ophthalmic solution (n = 76) or a fixed combination of polyethylene glycol 400 0.4 % and propylene glycol 0.3 % (PEG/PG) (n = 72). Subjects self-dosed four times daily during 60 days. Follow-up was set on days 2, 7, 15, 30 and 60. Assessments of anterior/posterior segment ocular signs were performed. The outcome measures included Schirmer test, tear film break-up time and OSDI score. Security variables included intraocular pressure, lisamine green and fluorescein ocular surface stains. RESULTS: The primary efficacy endpoints were similar between groups at baseline. After intervention time Schirmer test increased in both groups compared to baseline, XG/CS (6.4 ± 2.2 vs 11.0 ± 6.6; p = 0.002) and PEG/PG (6.5 ± 2.5 vs 10.5 ± 5.6; p = 0.019) respectively. Similar results were reported in the tear film break-up time in XG/CS (5.5 ± 2.1 vs 7.4 ± 2.9; p = 0.027) and PEG/PG (5.2 ± 2.0 vs 7.4 ± 2.7; p = 0.046) respectively. The OSDI score decreased to normal values in both groups, XG/CS (19.3 ± 7.4 vs 7.3 ± 5.9; p = 0.001) and PEG/PG (19.3 ± 7.5 vs 7.9 ± 8.2; p = 0.001) respectively. There was no significant difference between treatments for any parameter. Moreover, both groups decreased the presence of burning sensation, tearing, foreign body sensation, conjunctival hyperemia and photophobia. The adverse events were not related to the interventions. CONCLUSIONS: Xanthan gum/chondroitin sulfate preservative free showed similar clinical efficacy, evaluated with OSDI score, TBUT and Schirmer test compared to polyethylene glycol/propylene glycol in the treatment of dry eye disease. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01657253 . Date of registration May 19, 2014.

Correlación entre tomografía óptica coherente Cirrus y Stratus para medición de área de disco y capa de fibras nerviosas en una población Colombiana / Agreement between cirrus and stratus optical coherence tomography in the measurement of optic disc area and retinal nerve fiber layer in a Colombian population

Propósito: Determinar la correlación en las medidas del nervio óptico y grosor de la capa de fibras nerviosas retinianas, usando Tomografía Óptica Coherente Cirrus y Stratus en la Fundación Oftalmológica Nacional. Métodos: Estudio comparativo y descriptivo de 71 ojos sanos de sujetos voluntarios. Cada sujeto tuvo una evaluación oftalmológica completa; se realizó campimetría y Tomografía óptica coherente de nervio óptico usando tecnología Spectral domain y Time domain. El área del disco óptico, área del anillo, relación Excavación/Disco, relación Excavación/Disco vertical y el grosor promedio de la capa de fibras nerviosas retinianas fueron comparadas en todos los sujetos usando ambas tecnologías. Resultados: El área promedio del disco óptico fue de 2,12 mm2 con Cirrus y 2,77 mm2 con Stratus. El área promedio del anillo fue de 1,43 mm2 para Cirrus y 2,05 mm2 para Stratus. La relación Excavación/Disco fue 0,53 y 0,26 y relación Excavación/Disco vertical fue 0,50 y 0,45 respectivamente. El grosor promedio de la capa de fibras nerviosas retinianas fue de 102,25 micras con Cirrus y 100,84 micras con Stratus. Todos estos valores mostraron una correlación importante usando el coeficiente de Pearson, (p=0.000), sin embargo hubo una diferencia significativa entre las medidas obtenidas por estas dos tecnologías (p=0.000). Conclusiones: El promedio del área de disco óptico y el área del anillo fueron menores cuando se midió con Cirrus, comparado con Stratus. La relación Excavación/Disco y relación Excavación/Disco vertical fueron mayores cuando se midieron con Cirrus, comparado con Stratus. Sin embargo hay una buena correlación entre las medidas de la población estudiada, hay una diferencia importante en los resultados obtenidos de la cabeza del nervio óptico entre las dos tecnologías y no pueden ser considerados intercambiables.

Purpose: To determine the agreement and correlation of the measurement of the optic disc head and retinal nerve fi ber layer thickness parameters using Cirrus and Stratus Optical Coherence Tomography at Fundación Oftalmológica Nacional. Methods: This comparative and descriptive study involved 71 healthy eyes of voluntary individuals. Each individual had a complete ophthalmological examination; computerized visual field and optic nerve Optical Coherence Tomography using spectral domain and time domain technologies where performed. Optic disc area, Rim area, Cup/Disc ratio, Cup/Disc vertical ratio, and average retinal nerve fiber layer thickness were compared in all the individuals using both technologies. Results: Th e average optic disc area found was 2,12 mm2 with Cirrus and 2,77 mm2 with Stratus technology. The average rim area was 1,43 mm2 for Cirrus and 2,05 mm2 for Stratus. The cup/disc ratio was 0,53 and 0,26 and cup/disc vertical ratio was 0,50 and 0,45 respectively. The average retinal nerve fiber layer thickness were 102,25 microns with Cirrus and 100,84 microns with Stratus. All these values showed an important correlation with the Pearson coeffi cient, (p=0.000), although there was a significant diff erence between the measurements done by the two machines (p=0.000). Conclusions: The average optic disc area and the rim area were smaller when measured with Cirrus compared to Stratus. The cup/disc ratio and the cup/disc vertical ratio were larger when measured with Cirrus compared to Stratus. Although there is a good correlation between the measurements in the population studied, there is an important diff erence in the results of the optic nerve head between the two technologies and cannot be considered interchangeable.

Prevalencia del glaucoma y su contribución a la discapacidad visual en Colombia / Glaucoma prevalence and its contribution to visual impairment in Colombia

Objetivo: determinar la prevalencia de glaucoma en Colombia por grupos de edad y sexo al año 2005, además de su contribución a la discapacidad visual. Métodos y Materiales: se tomaron como casos prevalentes de glaucoma los notificados por el estudio de Carga de Enfermedad Colombia CENDEX 2008 (datos año 2005) y como base poblacional los datos demográficos y de discapacidad del Departamento Administrativo Nacional de Estadística (DANE) para el mismo período. Se estimó la frecuencia del evento por grupos de edad y sexo (prevalencia estandarizada), así como la prevalencia sobre el total de casos de discapacidad visual; los resultados se presentaron en tablas de distribución de frecuencia. Resultados: La prevalencia general de glaucoma en Colombia para el año 2005, fue de 1,1% siendo más común en mujeres (razón de feminidad 2,1:1), contribuyendo al 2,7% del total de discapacidad visual al mismo período. Conclusiones: Se halló la prevalencia de glaucoma en Colombia para el año 2005, por grupos de edad y sexo así como su contribución a la discapacidad visual para el mismo período. Es importante contar con registros actualizados para determinar la prevalencia de esta patología, para así conocer la frecuencia de ésta en la actualidad y su aporte a la discapacidad visual en Colombia. Los resultados de este estudio servirán de partida a quienes diseñen modelos de prevención para el glaucoma como causa prevenible de discapacidad visual.

Objectives: to determine the prevalence of glaucoma in Colombia for 2005 by age and sex groups and its contribution to visual impairment. Methods and materials: prevalent cases were defined as those cases reported with glaucoma by the study Burden of the Diseases in Colombia CENDEX 2008 (2005 data). The population for Colombia for this investigation was defined by the demographics and disability data reported by DANE for 2005. The frequency of the event was estimated by age and sex groups (standardized prevalence), and the prevalence of total cases of visual impairment was also estimated; the results are presented in frequency distribution tables. Results: the overall prevalence of glaucoma in Colombia for 2005 was 1.1%, being more common in women (femininity ratio 2,1:1), contributing to 2.7% of all visual impairment the same period. Conclusions: the prevalence of glaucoma was found in Colombia for 2005, by age and sex groups and its contribution to visual impairment for the same period. It is important to have available updated data in order to determine the prevalence of this pathology, the current frequency and contribution to visual impairment in Colombia. The results of this study will be useful as a starting point to those who design prevention models for glaucoma as a preventable cause of visual impairment.