Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Keywords
Intraocular pressure, Pterygium, Surgery, Steroids, Glaucoma
Brief summary
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.
Detailed description
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.
Interventions
DRUGLoteprednol Etabonate 0.5%
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
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.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular Pressure (IOP) | Once a week for the first 4 weeks and 6 weeks after the procedure |
Secondary
| Measure | Time frame |
|---|---|
| IOP difference between the operated eye and the fellow eye | Once a week for the first 4 weeks and then 6 weeks after the procedure |
Countries
Brazil
Outcome results
None listed