NCT05319470

Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Democritus University of Thrace · Academic / Other
• Sex: All
• Age: 35 Years – 90 Years
• Healthy volunteers: —

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.

Conditions

• Glaucoma
• Glaucoma; Drugs
• Ocular Surface Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Intraocular pressure (IOP)	Measurement of intraocular pressure in both eyes of the study population using the Goldman applanation tonometer.
DIAGNOSTIC_TEST	Tear Break-up Time (TBUT)	TBUT will be calculated after instillation of a drop of fluorescein dye, by slit lamp biomicroscopy.
DIAGNOSTIC_TEST	Conjuctival Hyperemia	Conjunctival hyperemia will be assessed by slit lamp biomicroscopy using a validated grading system.
DIAGNOSTIC_TEST	Schirmer Test	Schirmer test will be performed on both eyes to asses tear production.
DIAGNOSTIC_TEST	Visual Fields and OCT RNFL	Visual field examination using a Humphrey perimeter and measurement of peripapillary retinal nerve fiber layer thickness with optical coherence tomography.

Timeline

• Start date: 2022-03-15
• Primary completion: 2023-04-15
• Completion: 2023-05-15
• First posted: 2022-04-08
• Last updated: 2023-07-05

Locations

1 site across 1 country: Greece