Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

Study Overview
=================
Brief Summary
-----------------
Primary objective of this study is to study the efficacy of travoprost without preservatives in the treatment of glaucoma patients and to monitor the ocular surface.

Detailed Description
-----------------
This is a prospective study including patients visiting the outpatient glaucoma clinic of the University General Hospital of Alexandroupolis for their standard evaluation. Study population is already under treatment with a travoprost preparation without preservatives. They will be fully informed about the procedure and the purpose of the study and a written consent will be obtained. For every patient included in the study intraocular pressure will be measured using a Goldman applanation tonometer, according to the standard way of practice at our clinic. Also, Tear Break-Up-Time (BUT), conjunctival hyperemia grading and Schirmer testing will be used to assess the ocular surface state. Visual field tests and OCT RNFL measurements will also be obtained. The above measurements will be repeated 6 months after the initial examination.

Official Title
-----------------
Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

Conditions
-----------------
Glaucoma, Glaucoma; Drugs, Ocular Surface Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Intraocular pressure (IOP)
* Diagnostic Test: Tear Break-up Time (TBUT)
* Diagnostic Test: Conjuctival Hyperemia
* Diagnostic Test: Schirmer Test
* Diagnostic Test: Visual Fields and OCT RNFL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with glaucoma treated with travoprost without preservatives. Exclusion Criteria: Co-administration of another anti-glaucoma preparation with or without preservatives, Sjogren's syndrome, poor eyelid occlusion of any etiology.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>100 patients with diagnosed glaucoma receiving travoprost without preservatives | Diagnostic Test: Intraocular pressure (IOP)<br>* Measurement of intraocular pressure in both eyes of the study population using the Goldman applanation tonometer.<br>Diagnostic Test: Tear Break-up Time (TBUT)<br>* TBUT will be calculated after instillation of a drop of fluorescein dye, by slit lamp biomicroscopy.<br>Diagnostic Test: Conjuctival Hyperemia<br>* Conjunctival hyperemia will be assessed by slit lamp biomicroscopy using a validated grading system.<br>Diagnostic Test: Schirmer Test<br>* Schirmer test will be performed on both eyes to asses tear production.<br>Diagnostic Test: Visual Fields and OCT RNFL<br>* Visual field examination using a Humphrey perimeter and measurement of peripapillary retinal nerve fiber layer thickness with optical coherence tomography.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | Intraocular pressure measurement in both eyes using the Goldman applanation tonometer. | 6 months | 
| Ocular Surface Disease | Tear breakup time (TBUT), conjuctival hyperemia scoring and Schirmer testing will be used to assess the ocular surface state of the study population. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, travoprost, prostaglandin without preservatives