Overview

Blood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With POAG

Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
All
Summary
Glaucoma, a progressive optic disc neuropathy causing visual field reduction, is the second leading cause of world blindness. The treatment of glaucoma is mainly based in reducing intraocular pressure (IOP) with topical medications. Many patients required two or more medications to achieve a target IOP. Combinations of B-blockers and prostaglandin analogs (PGA) are frequently used in clinical practice because their additive effect in lowering IOP levels. The aim of this study was to investigate the effects of fixed combinations of timolol maleate and PGA on the blood-aqueous barrier and evaluate the measurement of foveal thickness in pseudophakic patients with primary open-angle glaucoma (POAG).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Campinas, Brazil
Treatments:
Bimatoprost
Cloprostenol
Dextrans
Latanoprost
Maleic acid
Timolol
Travoprost
Criteria
Inclusion Criteria:

- Patients were eligible for participation if they met the following inclusion criteria:
age older than 18 years, pseudophakia and diagnosis of primary open angle glaucoma (an
untreated IOP levels of more then 21 mmHg, specific changes in the optic disc or
specific visual fields changes. Optic disc changes were focal notching, optic disc
haemorrhage, retinal nerve fiber layer (RNFL)defects, overpass-blood vessel crossing
over an area of neuroretinal rim loss.Visual fields changes were the glaucoma
hemifield test outside normal limits or a cluster of three or more non-edge points in
a typical location of glaucoma or a corrected pattern standard deviation that occurs
in less than 5% of normal visual fields

Exclusion Criteria:

- Exclusion criteria included history of uveitis or CME, substantial ocular irritation
at baseline, or a history of intraocular surgery or a laser procedure within 6 months
of baseline, the presence of systemic disorders that could be associated with uveitis
or CME (ie, diabetes mellitus and rheumatologic diseases), presence of age-related
macular degeneration and other macular diseases, pregnancy, breastfeeding, and
inadequate contraception (in females), treatment with systemic beta-blocker, history
of bronchial asthma, chronic obstructive pulmonary disease , sinus bradycardia, second
and third degree atrioventricular block , sinoatrial block and functionally
significant visual field loss