Intraocular Pressure With Loteprednol and Dexamethasone

Federal University of São Paulo35 enrolled

Overview

The purpose of this study is to compare intraocular pressure (IOP) changes after pterygium surgery among patients using loteprednol and dexamethasone during the postoperative period.

Surgical management of pterygium is known to initiate an inflammatory process with different levels of intensity. Corticosteroids are anti-inflammatory agents used to reduce the inflammatory process observed after surgical interventions including after pterygium surgery. However, use of topical corticosteroids can induce an elevation in intraocular pressure (IOP) due to a reduction in the facility of aqueous outflow. Loteprednol etabonate (LE) was designed to maintain the anti-inflammatory efficiency of corticosteroids while lowering the risk of inducing IOP elevation. LE showed less effect on IOP than Prednisolone Acetate. This probably occurs due to lower levels of LE in the aqueous humor. Some trials compare LE to other corticosteroids or placebo in treatments of the anterior uveitis, allergic conjunctivitis and cataract surgery. To our knowledge, there are no trials studying the effect of LE on IOP after pterygium surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma, Open-Angle Ocular Hypertension

Interventions

Loteprednol Etabonate 0.5%DRUG

Patients in the Loteprednol Group received Loteprednol Etabonate 0.5% associated with Tobramycin 0.3% in separate eyedrops for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week

Dexamethasone 0.1%DRUG

The patients in Dexamethasone Group received Dexamethasone 0.1% associated with Tobramycin 0.3% in a single eyedrop for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age: eighteen years old or more * IOP: less than 22mmHg Exclusion Criteria: * History of previous ocular surgery * Use of topical or systemic corticosteroids for up to a month before the surgery * Extensive pterygia that disabled accurate IOP measurement

Locations (1)

Department of Opthalmology, Federal University of São Paulo

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Intraocular Pressure (IOP)

Time frame: Once a week for the first 4 weeks and 6 weeks after the procedure

Secondary Outcomes

IOP difference between the operated eye and the fellow eye

Time frame: Once a week for the first 4 weeks and then 6 weeks after the procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.