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Vital Paulino Costa1, Hamilton Moreira2, Mauricio Della Paolera3, Maria Rosa Bet de Moraes Silva41Universidade Estadual de Campinas – UNICAMP, São Paulo, 2Universidade Federal do Paraná, Curitiba, 3Santa Casa de Misericórdia de São Paulo, São Paulo, 4Faculdade de Medicina de Botucatu, UNESP, BrazilPurpose: To assess the safety and efficacy of transitioning patients whose intraocular pressure (IOP) had been insufficiently controlled on prostaglandin analog (PGA) monotherapy to treatment with travoprost 0.004%/timolol 0.5% fixed combination with benzalkonium chloride (TTFC).Methods: This prospective, multicenter, open-label, historical controlled, single-arm study transitioned patients who had primary open-angle glaucoma, pigment dispersion glaucoma, or ocular hypertension and who required further IOP reduction from PGA monotherapy to once-daily treatment with TTFC for 12 weeks. IOP and safety (adverse events, corrected distance visual acuity, and slit-lamp biomicroscopy) were assessed at baseline, week 4, and week 12. A solicited ocular symptom survey was administered at baseline and at week 12. Patients and investigators reported their medication preference at week 12.Results: Of 65 patients enrolled, 43 had received prior travoprost therapy and 22 had received prior nontravoprost therapy (n = 18, bimatoprost; n = 4, latanoprost). In the total population, mean IOP was significantly reduced from baseline (P = 0.000009), showing a 16.8% reduction after 12 weeks of TTFC therapy. In the study subgroups, mean IOP was significantly reduced from baseline to week 12 (P = 0.0001) in the prior travoprost cohort (19.0% reduction) and in the prior nontravoprost cohort (13.1% reduction). Seven mild, ocular, treatment-related adverse events were reported. Of the ten ocular symptom questions, eight had numerically lower percentages with TTFC compared with prior PGA monotherapy and two had numerically higher percentages with TTFC (dry eye symptoms and ocular stinging/burning). At week 12, TTFC was preferred over prior therapy for 84.2% of patients (48 of 57) by the patients themselves, and for 94.7% of patients (54 of 57) by their physicians.Conclusion: When TTFC replaced PGA monotherapy in patients whose IOP had been uncontrolled, the outcome was a significant reduction in IOP and an acceptable safety and tolerability profile. Most patients and investigators preferred TTFC to prior PGA monotherapy.Keywords: fixed combination, glaucoma, intraocular pressure, prostaglandin analog, timolol, travoprost

Background: The stability of ophthalmic preparations in multidose containers is influenced by the preservative as well as the stability of the active ingredient. Unstable drugs may require refrigeration to preserve their active ingredient level and they are more likely to degrade over time, therefore becoming more susceptible to degradation based on patient mishandling. The purpose of this study was to determine the degree of molecular degradation that occurs in bimatoprost and latanoprost in a patient-use setting.Methods: This was an open-label, laboratory evaluation of the relative stability of bimatoprost and latanoprost. Patients presently using bimatoprost (n = 31) or latanoprost (n = 34) were identified at 2 clinical sites in Brazil. Patients were instructed to use and store their drops as usual and return all used medication bottles between day 28 and day 34 after opening.Results: Bimatoprost demonstrated no degradation, but latanoprost degraded at various levels. The mean age of bimatoprost was 43.0 +/- 3.4 days and the mean age of latanoprost was 43.9 +/- 2.8 days (P = .072). The mean percentage of labeled concentration was 103.7% in the bimatoprost bottles and 88.1% in the latanoprost bottles (P < 001).Conclusion: This study showed that bimatoprost maintained > or =100% concentration throughout the study period while latanoprost did not. [ABSTRACT FROM AUTHOR]

To correlate the ganglion cell complex (GCC) parameters with structural measures of the optic nerve head (ONH) and retinal nerve fiber layer (RNFL) as evaluated by Fourier-Domain optic coherence tomography (OCT). This retrospective study included patients with glaucoma, ocular hypertensive patients and glaucoma suspects who had previously undergone OCT examination with the RTVue-100. The parameters of GCC (average, superior, inferior, focal loss volume [FLV], global loss volume [GLV]) were correlated with the values of the ONH (cup volume, cup area, horizontal cup-to-disk ratio, vertical cup-to-disk ratio, and rim area) and RNFL (average, superior, and inferior) using Pearson's correlation coefficient. The sample included 74 eyes of 37 patients. All correlations between GCC parameters and RNFL were strong (r > 0.60). The correlation between GCC parameters and ONH were good for most parameters, except that for FLV and cup volume (r = 0.13), GLV and cup volume (r = 0.09), and GLV and cup area (r = 0.21). The GCC parameters can be used as structural measures of the glaucomatous optic neuropathy.

Background: Primary congenital glaucoma (PCG), occurs due to the developmental defects in the trabecular meshwork and anterior chamber angle in children. PCG exhibits genetic heterogeneity and the CYP1B1 gene has been widely implicated worldwide. Despite the diverse mutation spectra, the clinical implications of these mutations are yet unclear. The present study attempted to delineate the clinical profile of PCG in the background of CYP1B1 mutations from a large cohort of 901 subjects from India (n=601) and Brazil (n=300)., Methods: Genotype-phenotype correlations was undertaken on clinically well characterized PCG cases from India (n=301) and Brazil (n=150) to assess the contributions of CYP1B1 mutation on a set of demographic and clinical parameters. The demographic (gender, and history of consanguinity) and quantitative clinical (presenting intraocular pressure [IOP] and corneal diameter [CD]) parameters were considered as binary and continuous variables, respectively, for PCG patients in the background of the overall mutation spectra and also with respect to the prevalent mutations in India (R368H) and Brazil (4340delG). All these variables were fitted in a multivariate logistic regression model using the Akaike Information Criterion (AIC) to estimate the adjusted odds ratio (OR) using the R software (version 2.14.1)., Results: The overall mutation spectrum were similar across the Indian and Brazilian PCG cases, despite significantly higher number of homozygous mutations in the former (p=0.024) and compound heterozygous mutations in the later (p=0.012). A wide allelic heterogeneity was observed and only 6 mutations were infrequently shared between these two populations. The adjusted ORs for the binary (demographic) and continuous (clinical) variables did not indicate any susceptibility to the observed mutations (p>0.05)., Conclusions: The present study demonstrated a lack of genotype-phenotype correlation of the demographic and clinical traits to CYP1B1 mutations in PCG at presentation. However, the susceptibility of these mutations to the long-term progression of these traits are yet to be deciphered.

The purpose of the study was to correlate the Fourier-domain OCT ganglion cell complex (GCC) parameters with automated perimetry (AP) functional measures of the optic nerve. This retrospective study included patients who had previously undergone examination with the RTVue-100 OCT and AP, SITA strategy. The parameters of GCC (average, superior, inferior, S-I [superior inferior difference], S-I SD [standard deviation of S-I], GLV [global loss volume] and FLV [focal loss volume]) were correlated with the mean deviation (MD) and pattern standard deviation (PSD) values of AP using linear and logarithmic regression analysis. All correlations between GCC and automated perimetry parameters were strong (r > 0.60), except that for SI and MD (r = -0.05); SI and PSD (r = 0.09); SI-DS and MD (r = -0.06); and SI-SD and PSD (r = 0.08). In summary, GCC derived structural measures showed good correlation with functional parameters from AP.

Background: The myocilin (MYOC) gene promoter polymorphism -1000C>G (MYOC mt.1) can be associated with faster progression of primary open angle glaucoma (POAG). The purpose of this study was to investigate the MYOC mt.1 in Brazilian patients with POAG and to evaluate its possible role on the phenotype and the severity of the disease., Material and Methods: One hundred sixty-seven POAG patients and 130 normal controls were enrolled. DNA samples were prepared and the MYOC mt.1 polymorphism was screened by real-time polymerase chain reaction (RT-PCR) in an Single-nucleotide polymorphism (SNP) assay. Frequencies of the MYOC mt.1 promoter polymorphism were determined for both groups and compared by Fisher's exact test and Chi-square test with Yate's correction. Intraocular pressure (IOP), cup-to-disc ratio (C/D), number of glaucoma medications, and number of glaucoma surgeries were compared between MYOC mt.1 carriers and non-carriers., Results: MYOC mt.1 genotype frequencies did not differ between POAG and controls (P  =  0.420); 14.6% of controls and 16.4% of POAG patients were MYOC mt.1 carriers (CG or GG). Frequencies of the G allele were similar between glaucomatous patients and controls (7.3% and 9.2%, respectively; P  =  0.477). Among POAG patients, there were no differences in mean C/D ratio, IOP, number of glaucoma medications, and surgical procedures for IOP control between carries and non-carriers of the MYOC mt.1 promoter polymorphism (p>0.05)., Conclusion: The G allele of the MYOC mt.1 promoter polymorphism was equally distributed among POAG patients and healthy subjects and it is possibly unrelated to the risk and severity of disease in the Brazilian population.

Purpose: To evaluate the frequency, location and pattern of visual field defects as measured by SITA strategy in primary open angle glaucoma (POAG)., Methods: Six thousand and two-hundred charts were reviewed. One hundred and fifty two patients who fulfilled the inclusion criteria were included. They were stratified according to severity into early, moderate and severe. The following visual field defects were defined: nasal step, paracentral scotomata, arcuate defect, Seidel scotomata, temporal defect, general reduction of sensitivity, annular scotomata and central island. Each examination was divided into sectors corresponding to optic disc regions. Student's t test was used to compare differences in frequency., Results: In the early glaucoma group, the nasal superior step was the most frequent visual field defect, followed by paracentral scotoma and inferior nasal step. General reduction of sensitivity was noted in 7.8%. Defects were more common in the superior hemifield (p<0.05)., Conclusion: The superior nasal step and paracentral scotoma were the most commun visual field defects in early primary open angle glaucoma as evaluated by SITA strategy, and the superior hemifield comprises most of the defects. General reduction of sensitivity was an early and rare visual field defect.

Purpose: To study the prevalence of glaucoma in employees of a public hospital in São Paulo and to analyze the role of frequency doubling perimetry along with non-contact tonometry and direct ophthalmoscopy, in the screening for glaucoma., Methods: 612 employees of the Central Hospital of the "Santa Casa de São Paulo" were evaluated from October 15 to 20, 2000; 438 were women and 174 men, with mean age of 45.05+/-7.7 years (range, 35 to 81 years); 437 were white, 104 mulatto, 43 black and 28 Asian. All examinations were done by 10 eye specialists with experience in glaucoma. All employees had both eyes examined, by means of frequency doubling perimetry (FDT), ophthalmoscopy (FO), and non-contact tonometry (TNC)., Results: 159 (25.98%) subjects presented with at least one abnormal testing; 5 (3.14%) had high IOP (TNC+); 13 (8.17%) presented suspicious disk (FO+); 110 (69.18%) presented abnormal FDT (FDP+); 8 (5.03%) TNC+ and FO+; 10 (6.28%) had TNC+ and FDT+; 9 (5.66%) presented FO+ and FDT+; 4 (2.51%) had TNC+, FO+ and FDT+; 12 (1.96%) individuals were diagnosed with glaucoma, four of whom (0.65%), with normal pressure glaucoma., Conclusions: Frequency doubling perimetry was found to be an important step in the screening for glaucoma in the study. Of the 12 individuals that had the diagnosis of glaucoma, 5 (41.6%) would not have been diagnosed if they had not undergone frequency doubling perimetry.