open angle glaucoma
Conditions
Interventions
There will be included in the study patients with primary open angle glaucoma or ocular hypertension from glaucoma departmet of Centro Oftalmologico hospital. Control group (n=30) was defined as any p
29770
Sponsors
centro oftalmologico de minas gerais
centro oftalmologico de minas gerais
Eligibility
Age
17 Years to No maximum
Inclusion criteria
Inclusion criteria: 18 years of age minimum; ocular hypertension with intraocular pressure levels greater than or equal to 21 mmHg; carrier of open angle glaucoma presenting intraocular pressure levels greater than or equal to 18 mmHg; reduction of intraocular pressure in relation to baseline values ??<30%; patients intolerant of current treatment due to ocular surface symptoms; meet the criteria of the control group for at least 3 months;
Exclusion criteria
Exclusion criteria: monoaminoxidase users; patients with asthma or severe chronic obstructive pulmonary disease; patients with sinus bradycardia, atrioventricular block of 2 or 3 degrees not controlled with a pacemaker, decompensated congestive heart failure; patient known to be allergic to any of the components of TRIPLENEX; pregnant patients; patients with any corneal irregularity that hinder the perfect reading of intraocular pressure by Goldman's tonometer (intra stromal ring, corneal transplant or scars with important corneal thinning); patients undergoing anti-glaucoma surgical procedures in the last 3 months (laser trabeculoplasty; incisional procedures such as trabeculectomy; glaucoma drainage devices, among others)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate IOP reduction in TRIPLENEX group when compared to control group through t student test ( comparing the mean between groups). We decided to use significance level of 0,05% and 90 % of power. IOP values more than 2.52 mmHg between groups will be considered statistical significance taking into account a calculated effect of 85 % for the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate whether with the use of TRIPLENEX there is a change in the symptoms of ocular surface disease through the application of the OSDI questionnaire (ocular surface disease index) | — |
Countries
Brazil
Contacts
Public ContactCláudio Gonçalves da Silva
Outcome results
None listed