Long-term Observation of Tear Proteomic Profiles and Ocular Surface in Trabeculectomy Patients Before and After Surgery
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades Oculares
+ Hipertensión Ocular
+ Glaucoma
Solo Casos
Examinando las características de las personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.Resumen
Fecha de inicio: 1 de noviembre de 2013
Fecha en la que se inscribió al primer participante.Study Objectives and Purpose There are two primary aims in this study: To assess changes in the tear proteomic profiles in pre-trabeculectomy and post-trabeculectomy patients To assess the changes in clinical signs of the eye and tear film as well as dry eye symptoms. Study Material Human Tears will be collected from patients in SNEC clinic Study Design: 120 patients will be recruited for this study (details as described below). Schirmers I test, Tear Osmolarity, Tear Break Up Time (TBUT), Anterior segment optical coherence tomography (ASOCT) and Impression cytology will be done during the study visits. Subjective symptom and severity of dry eye disease will be assessed through Visual Analog Scale (VAS). No. of visits: There will be 4 visits in this study. Visit 1: Pre-trabeculectomy operation Visit 2: 6 month after trabeculectomy surgery Visit 3: 1 year after trabeculectomy surgery Visit 4: 3 years after trabeculectomy surgery Selection and Withdrawal of Subjects Recruitment Criteria 120 patients will be recruited from glaucoma clinics in SNEC Patients age ≥ 21 years old Patients who require trabeculectomy operation Treatment of subjects Study Procedures: Fluorescein staining will be used to visualize patient eyes. Schirmer's test will be used to measure the amount of tear production A small strip of filter paper will be inserted inside the lower eyelid A topical aneasthetic is placed into the eye before the filter paper to prevent tearing due to the irritation from the paper The eyes are closed for 5 minutes. The paper is then removed and the amount of moisture is measured Impression cytology will be performed to collect the superficial conjunctival cells for analysis While the eye is still anaesthetized from Schirmer's test, one end of a filter paper will be impressed upon the temporal conjunctiva whilst the other hand is grasped in place with a blunt smooth edged forceps. The filter paper is removed from the conjunctiva with a peeling motion after 2-3 seconds. The paper is placed into an eppendorf tube for future analysis. Tear osmolarity, Tear Break Up Time (TBUT) will be measured in all patients a) Tear osmolarity will be measured using the osmolarity chip, 3 chips per eye Anterior segment optical coherence tomography will be performed to assess the tear meniscus and image for any conjunctivochalasis a) The patient will be asked to look at a target in the instrument while blinking normally. The instrument will scan the lower eyelid margin for imaging of the tear meniscus and conjunctivochalasis Symptoms and severity of dry eye disease will be assessed through the Visual Analog Scale (VAS) system Assessment of efficacy Outcome Measures Symptoms and severity of dry eye disease will be quantified based on the Visual Analog Scale (VAS)11 Amount of moisture of the filter paper will be measured in Schirmer's test Clinical assessment of dry eye disease through Tear break up time (TBUT) and Tear Osmolarity measurements Tear meniscus height and area in the images obtained with optical coherence tomography Target sample size 120 subjects will be enrolled in the study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 36 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Solo Casos
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 21 a 99 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Singapore National Eye Centre/ Singapore Eye Research Institute
Singapore, SingaporeAbrir Singapore National Eye Centre/ Singapore Eye Research Institute en Google Maps