Cystoid Macular Edema, Uveitis, Anterior
Conditions
Keywords
primary open angle glaucoma, timolol, prostaglandin analogues
Brief 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).
Detailed description
Most studies found a lower incidence of systemic and ocular adverse events with fixed combinations than with the unfixed combinations. Fixed combinations are better tolerated than their respective prostaglandin analogue. However, among the most serious side effects induced by PGA are the breaking down of the blood-aqueous barrier (BAB) and the development of cystoids macular edema (CME). Also, timolol maleate drops increase protein concentration in the human and benzalkonium chloride, eye drops preservative induces anterior chamber inflammation. This randomized, masked-observer, prospective clinical trial was approved by the Ethics Committee of the University of Campinas, and it adhered to the tenets of the Declaration Of Helsinki. Written informed consent was obtained from each patient.
Interventions
DRUGtravoprost and timolol maleate fixed combination
travoprost 0.004% and timolol maleate 0,5%, 1 eye drop at 8p.m. for 6 months
DRUGlatanoprost and maleate timolol fixed combination
Latanoprost 0.005% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
DRUGbimatoprost and timolol maleate fixed combination
bimatoprost0.03% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
DRUGdextran and hypromellose
Dextran 70 and hypromellose, lubricant eye drop at 8 a.m and 8 p.m for 6 months
Sponsors
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of mean flare values from baseline at 6 months | Flare measurements occurred at baseline; after 15 days; and after 1, 2, 3, 4, 5, and 6 months of treatment | A flare measure of a laser flare meter (FM 500; Kowa Co Ltd, Tokyo, Japan) was used to determine the status of the blood-aqueous barrier at all follow-up visits. According to information provided by the manufacturer, flare readings greater than 26 photon counts per millisecond (p/ms) are indicative of a disruption in the blood-aqueous barrier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of mean macular thickness values from baseline at 6 months | Macular optical coherence tomography images were taken at baseline, after one month and six months of treatment, or if a patient has reduced visual acuity during follow-up | Foveal macular thickness wiht Spectral Domain Optical Coherence Tomography (Cirrus Model 4000; Carl Zeiss Meditec, Dublin, California, USA) examination was conducted to investigate the occurrence of cystoid macular edema (CME). If CME was detected, the patient was instructed to discontinue taking the medication and a nonsteroidal anti-inflammatory drug was prescribed. |
Countries
Brazil
Outcome results
None listed