Primary open angle glaucoma
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical study. Experimental group: 20 glaucoma patients will perform the DE Social Stress Test (TSST) protocol, a protocol for inducing psycholo
Sponsors
Hospital Oftalmológico de Brasília
Aché Laboratórios Farmacêuticos
Eligibility
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects older than 50 years of age. Primary open-angle glaucoma in early or moderate stage. Submitted to selective laser trabeculoplasthy in both eyes or in use of topical prostaglandin analogue (PGA) therapy in both eyes
Exclusion criteria
Exclusion criteria: Presence of any other ocular disease (with the exception of primary open-angle glaucoma and refractive errors). Anxiety or depressive disorders. Use of medication for anxiety or depressive disorders. History of ocular trauma or surgery. Use of anti-glaucoma drugs. Use of any kind of oral/topical steroids. Cushing syndrome. Congenital adrenal hyperplasia. Adrenal insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Based on a previous study, it is expected to establish that the effect of psychological stress results in an increase of 3 mmHg in relation to baseline measurements, considering a standard deviation of 2 mmHg. With an alpha level (type I error) set at 0.05. and study power of 80%, the sample size for each group will be estimated at least 17 subjects per group. The normality of variables will be assessed by the Skewness-Kurtosis test. Descriptive statistics will include the mean and standard deviation and Student's t-tests for normal distribution (using one-tailed test) and median, interquartile range and Wilcoxon rank sum for variables with non-parametric distribution. For categorical variables, Fisher's exact test will be used. We will assess the magnitude of change for different time points (baseline, stress, post-stress and recovery) for variables such as: intraocular pressure (IOP), salivary cortisol and amylase, heart rate and Trier Social Stress Test (TSST) scores. All statistical analyzes will be performed with STATA, version 13 (StataCorp LP, College Station, Texas, USA). | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactNathalie Ferreira
Hospital Oftalmológico de Brasília
Outcome results
None listed