Long-term Observation of Tear Proteomic Profiles and Ocular Surface in Trabeculectomy Patients Before and After Surgery
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveMaladies oculaires
+ Hypertension oculaire
+ Glaucome
Cas précis
Analyse des caractéristiques de personnes atteintes pour explorer les facteurs (génétiques, environnementaux, etc.) liés à la maladie.Résumé
Date de début de l'étude : 1 novembre 2013
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.36 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cas précis
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 21 à 99 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Singapore National Eye Centre/ Singapore Eye Research Institute
Singapore, SingaporeOuvrir Singapore National Eye Centre/ Singapore Eye Research Institute dans Google Maps