Randomised, Single Blind, Controlled, Three-Month Clinical Trial on the Evaluation and Treatment of the Ocular Surface Damage Following Phacoemulsification.

Background: To determine efficacy of two lacrimal substitutes on signs and symptoms of ocular surface disease after phacoemulsification; to determine impact of surgery on patients' vision related quality of life. Monocentric, randomised, physician blinded, three parallel groups clinical trial. Design and Methods: Patients in the operative list for phacoemulsification have been screened for eligibility; they underwent (at time 0, 15, 45 and 90 days): slit lamp examination; tear film break-up time (BUT); corneal staining; tear volume; 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ); Ocular Surface Disease Index (OSDI). Treatments to be compared were: 1. standard of care-SOC (lomefloxacine and tobramicine/dexamethasone fixed combination 4 times a day for 2 weeks), 2. SOC + carboxymethylcellulose sodium 0.5% and glycerin 0.9%, 3. SOC + Sodium Hyaluronate 0.15%. Study treatment started at T15. Groups were compared with parametric or nonparametric tests, and with Pearson's χ2 test. Correlation between continuous variables was assessed by means of Pearson's or Spearman's coefficient. Results: Fifty-three patients were enrolled. At 45 and at 90 days from surgery, the group receiving lacrimal substitutes presented better BUT and Schirmer I test (p = 0.009, <0.001, <0.001 and 0.001, respectively); dry eye presence showed significant difference by group at time 90 (p = 0.019). General vision, near activity and vision-specific dependency subscales improved after surgery (p = <0.001, 0.004 and 0.048, respectively). At 45 and 90 days from surgery, the OSDI score significantly changed (p < 0.001).Conclusions: Cataract surgery causes the onset or the worsening of dry eye. Use of artificial tears can significantly reduce symptoms and signs of dry eye in patients after phacoemulsification.

Multicenter, Prospective, Randomized, Single Blind, Cross-Over Study on the Effect of a Fixed Combination of Citicoline 500 mg Plus Homotaurine 50 mg on Pattern Electroretinogram (PERG) in Patients With Open Angle Glaucoma on Well Controlled Intraocular Pressure.

Purpose: To evaluate the potential beneficial and synergistic effects of oral intake of a fixed combination of citicoline 500 mg plus homotaurine 50 mg (CIT/HOMO) on retinal ganglion cell (RGC) function in subjects with glaucoma using pattern electroretinogram (PERG) and to investigate the effects on visual field and quality of life. Methods: Consecutive patients with primary open-angle glaucoma with controlled IOP (<18 mmHg) receiving beta-blockers and prostaglandin analogs alone or as combination therapy (fixed or un-fixed); with stable disease (progression no more than -1 dB/year at the visual field MD); and an early to moderate visual field defect (MD < -12 dB) were randomized to: arm A. topical therapy + CIT/HOMO for 4 months, 2 months of wash out, 4 months of topical therapy alone; arm B. topical therapy alone for 4 months, topical therapy + CIT/HOMO for 4 months, 2 months of wash out. All patients underwent 4 visits: complete ocular examination, visual field, PERG and quality of life assessment (NEI-VFQ25) were performed at each visit. Results: Fifty-seven patients completed the study: 26 in group A and 31 in group B. At the end of the intake period, PERG's P50 and N95 waves recorded a greater amplitude. The increase was statistically significant in the inferior and superior P50 waves amplitude: 0.47 µV (95%CI, 0.02-0.93; p = 0.04) and 0.65 µV (95% CI, 0.16-1.13; p = 0.009), respectively, and in the inferior N95 wave amplitude 0.63 µV (95% CI, 0.22-1.04; p = 0.002). A significantly shorter peak time of 3.3 µV (95% CI, -6.01- -0.54; p = 0.01) was observed for the superior P50 wave only. Conclusions: Daily oral intake of the fixed combination CIT/HOMO for 4 months improved the function of inner retinal cells recorded by PERG in the inferior and in the superior quadrants, independently from IOP reduction. This interesting association could represent a valid option for practicing neuromodulation in patients with glaucoma to prevent disease progression.

Effect of palmitoylethanolamide on inner retinal function in glaucoma: a randomized, single blind, crossover, clinical trial by pattern-electroretinogram.

Glaucoma is a neurodegenerative disease, our study aimed to evaluate the potential effects of Palmitoylethanolamide (PEA) supplementation on RGCs function by PERG examination, and to record effects on intraocular pressure, visual field and quality of life. It was a single centre, randomized, prospective, single blind, two treatment, two period crossover study on stable glaucoma patients on topical monotherapy comparing current topical therapy alone or additioned with PEA 600 mg one tablet a day. At baseline, at 4 and at 8 months, all patients underwent to complete ophthalmic examination, pattern electroretinogram, visual field, and quality of life evaluation. 40 patients completed the study: mean age 66.6 ± 7.6 years; 21 (52.5%) male; 35 POAG (87.5%). At baseline, most patients had an early visual field defect, the IOP was well controlled. At the end of the PEA 600 mg supplementation, a significantly higher (mean 0.56 µV, 95% CI 0.30-0.73, p < 0.001) in the P50-wave amplitude was observed; in the PEA period a significantly lower IOP (- 1.6 mmHg, 95% CI - 2 to 1.2, p < 0.001) and higher quality of life scores (+ 6.7, 95% CI 4-9.9, p < 0.001) were observed. Our study is the first to show promising effects of PEA on PERG and on quality of life in glaucoma patients.

An in vivo confocal, prospective, masked, 36 months study on glaucoma patients medically treated with preservative-free or preserved monotherapy.

The aim of this study was to evaluate the in vivo effects at 3 years of preservative-free tafluprost on corneal health. It was a prospective, masked, study on consecutive patients with a new prescription of preservative-free (PF) tafluprost (naïve-N or switched-S, 44 and 14 patients), and preserved (P) bimatoprost 0.003% or travoprost 0.004% (P-group, 35 patients). A complete ophthalmic examination and an in vivo corneal confocal microscopy evaluation were performed at baseline and every 6 months for 3 years. Ninety-three patients were enrolled, clinical parameters were similar in the groups at baseline, apart from intraocular pressure (IOP) which was lower in the S-group (p = 0.012). Both at baseline and over time, confocal microscopy parameters had different trends. At baseline, keratocyte activation was similar in the three groups (p = 0.43) but over the next months naïve patients treated with PF-tafluprost presented a significant (p = 0.004) reduction in keratocyte activation. Sub-basal nerves tended to increase in patients switched to PF-tafluprost (p = 0.07) while were stable in the other two groups (p = 0.11 in PF and 0.40 in P group). Grade of tortuosity was stable over time in the three groups. Beading-like formations were stable over time for the P- and the PF-group, while significantly increased in the S-group (p = 0.027). Endothelial density values were statistically different at baseline (p = 0.007), they decreased both in PF-group and in S-group (p = 0.048 and 0.001, respectively), while increased in P-group (p = 0.006). Our study is the first to show that a PF-tafluprost formulation does not significantly alter the corneal structures as examined by confocal microscopy after 36 months of topical daily therapy, while improving corneal alterations due to chronic preserved therapies.

Prevalence of dry eye in video display terminal users: a cross-sectional Caucasian study in Italy.

PURPOSE: To estimate the prevalence of dry eye among video-terminal (VDT) users and to assess risk factors for dry eye in this population. STUDY DESIGN: A single-centre, cross-sectional study was carried out on subjects employed as VDT workers and on a control group. METHODS: Demographic data, years spent working at a VDT, number of effective hours at VDT/day, number and hours of breaks/day were considered. All subjects underwent a complete ophthalmic examination and completed the Italian version of the computer vision symptom scale 17-item (CVSS17) questionnaire. Both groups were classified as definite, suspect and non-dry eye syndrome (DES). RESULTS: One-hundred and ninety four subjects completed the study; 70 (36.1%) of which represented the control group, and 124 (63.9%) represented the VDT group. Among VDT workers, 29 (23.4%) presented definite DES and 55 (44.4%) suspect DES, while among controls, only 2 (2.9%) presented definite DES and 37 (52.8%) suspect DES. In the univariate analysis, the DES group was older (p < 0.001), spent more time a day at VDT (p < 0.001), used VDT from more time (p < 0.001), instilled artificial tears (p = 0.031), and presented worst quality of life (p < 0.001). At the multivariate analysis, only age and time at VDT retained association with DES (OR 1.05; 95% CI 1.01-1.09; p = 0.01 and OR 1.57; 95% CI 1.07-2.02; p = 0.017, respectively). CONCLUSIONS: The global increase of VDT workers is accompanied by a higher frequency of ocular complaints. Older subjects and people spending more than 4 h a day at VDT are at major risk to develop DES and should take precautions to prevent the onset of the disease.

From benzalkonium chloride-preserved Latanoprost to Polyquad-preserved Travoprost: a 6-month study on ocular surface safety and tolerability.

BACKGROUND: To evaluate the safety and tolerability of Polyquad-preserved Travoprost (PQ-Travoprost) in patients previously treated with benzalkonium chloride (BAK)-preserved Latanoprost. METHODS: Cohort 6-month study on open-angle glaucoma or ocular hypertension patients. Complete ophthalmic examination, intraocular pressure (IOP) measurement and ocular surface status (tear film break-up time [TF-BUT], corneal staining and ocular surface disease index [OSDI]) were evaluated at baseline and 6 months later. RESULTS: A total of 44 patients were enrolled. Median (interquartile range [IQR]) baseline IOP was 18 (15.5 - 21) and 16 (14 - 17) mmHg (p < 0.0001) after 6 months. At baseline, 18 (40.9%) patients presented an IOP of < 18 mmHg, 11 (25%) < 16 mmHg, 2 (4.3%) < 14 mmHg and 1 (2.3%) < 12 mmHg; 6 months later the proportions were 36 (81.8%) (p < 0.0001), 21 (47.7%) (p = 0.00075), 8 (18.2%) (p = 0.0143) and 6 (13.6%) (p = 0.0253). Concerning safety, TF-BUT improved from 8 [IQR 6 - 10] to 10 [IQR 8 - 12] s (p < 0.0001). No eye developed corneal staining; punctate keratitis was absent in 13 (29.5%) patients at baseline and in 31 (70.4%) after 6 months (p < 0.001). OSDI changed from 16 (10 - 30) to 9 (2 - 20). CONCLUSIONS: No patient treated with PQ-Travoprost developed ocular surface disease after 6 months of monotherapy, whereas many patients reached a good IOP control with lower IOP values. Ocular surface status statistically improved when examined by TF-BUT and corneal staining.

Effect of preservative-free tafluprost on keratocytes, sub-basal nerves, and endothelium: a single-blind one-year confocal study on naïve or treated glaucoma and hypertensive patients versus a control group.

PURPOSE: To record the impact of preservative-free Tafluprost on corneal status examined by in vivo confocal microscopy. METHODS: A prospective cohort study on consecutive naïve or previously treated patients with a new prescription of preservative-free Tafluprost. All subjects underwent a complete ophthalmic examination [comprehensive of intraocular pressure (IOP) and central corneal thickness (CCT) measurements], and an in vivo corneal confocal microscopy evaluation, at baseline and 12 months later. A healthy control group was selected and examined at the same time. RESULTS: Seventy-five subjects (16 controls, 20 naïve, and 39 treated) were enrolled. At baseline, IOP was 16 (13.8-18.6), 21.5 (18-23.7), and 18 (16-22) mmHg, (P=0.01); and CCT did not differ among the groups (P=0.25). Epithelial cells, keratocyte activation, a number of sub-basal nerves, and the grade of nerve tortuosity were similar (P=0.233, 0.11, 0.417, and 0.05, respectively), in naïve and controls, while previously treated patients had significantly less epithelial cells and sub-basal corneal nerves (P<0.0001), keratocyte activation, increased number of bead-like formations, and nerve tortuosity (P<0.0001). At month 12, IOP decreased in both patient groups (P<0.001); CCT did not change. Previously treated patients showed an improvement in confocal parameters: increased epithelial cells (P=0.0006), reduced keratocyte activation (P=0.003), increased number of corneal nerves (P=0.0004), decreased number of bead-like formations (P=0.0013), and nerve tortuosity (P=0.0008). Naïve patients did not show significant changes. CONCLUSION: The study confirmed the efficacy of preservative-free Tafluprost in reducing IOP, and underlined the drug's safety in naïve glaucoma patients with regard to corneal status. In the balance between efficacy and tolerability, formulations with low cytotoxicity may ensure fewer side effects, with higher tolerability and better compliance.

Risk factors to develop ocular surface disease in treated glaucoma or ocular hypertension patients.

PURPOSE: To identify risk factors for developing ocular surface disease (OSD), to verify the prevalence of OSD, and to record efficacy of questionnaires in identifying symptoms' impact on patients' quality of life.
 METHODS: . This was an observational, cross-sectional study of patients with topically treated glaucoma. Tear film break-up time (TFBUT) and punctate keratitis were evaluated; 2 quality-of-life questionnaires (National Eye Institute-Visual Function Questionnaire 25 and Glaucoma Symptom Scale) were submitted to all patients. Class of previous and current intraocular pressure (IOP)-lowering drugs, number of drugs, number of drops/day, and total and current benzalkonium chloride (BAK) exposure were collected.
 RESULTS: . A total of 233 patients completed the study. TFBUT was abnormal in 71 (30.5%) eyes; punctate keratitis was present in 74 (31.7%). Keratitis was more frequent with increasing number of eyedrops (p=0.008) and number of instillations per day (p=0.009). Ocular surface disease was present in 97 (41.6%) patients and was statistically related to number of medications used (p=0.026). The univariate analysis pointed out that patients with OSD were older (p=0.04), had lower IOP values (p=0.03), were topically treated for more time (p<0.0001), had assumed more BAK (p<0.0001), and presented worst quality of life (p<0.01). The multivariate analysis found that OSD was related to number of medications used (p=0.002), prolonged use of preserved medications (p=0.005), and total BAK exposure (p<0.001).
 CONCLUSIONS: There is clinical evidence that the number of medications, their prolonged use, and the total BAK exposure are risk factors to develop OSD in patients with glaucoma. To prevent OSD onset, BAK exposure and the number of topical medications should be reduced.

The Italian version of the Glaucoma Symptom Scale Questionnaire: translation, validation, and reliability.

PURPOSE: To validate the Italian version of the Glaucoma Symptom Scale (GSS) Questionnaire and its symptoms and function subscales. METHODS: This transversal validation study enrolled nonhospitalized patients with glaucoma, and a reference sample of patients without eye diseases. Eligible participants had to be cognitively able to respond to a health status interview. The Italian self-administered versions of the 25-item National Eye Institute-Visual Function Questionnaire and the GSS Questionnaire were administered to all participants. Reliability and validity of the Italian translation of the GSS Questionnaire were tested using standard statistical methods for questionnaire validation. RESULTS: Ninety-seven patients were enrolled. Cronbach α coefficient ranged from 0.72 to 0.92 across subscales and eyes. Test-retest stability was >85% for each subscale and eye. The control group of participants had better scale scores across all dimensions of vision-targeted health-related quality of life captured by the GSS Questionnaire (P<0.05) and there were good correlations between responses GSS Questionnaire subscales and analogous domains of the 25-item National Eye Institute-Visual Function Questionnaire. CONCLUSIONS: The Italian version of the GSS Questionnaire has good validity, discriminatory power, internal consistence and reliability, showing psychometric properties comparable with those of the English version, and can therefore be used in clinical research as a specific measure of vision-related quality of life in Italian-speaking patients with ocular hypertension or glaucoma.

Ocular surface disease and glaucoma: how to evaluate impact on quality of life.

PURPOSE: To record signs and symptoms of ocular surface disease (OSD) in patients treated with Intra Ocular Pressure (IOP)-lowering medications; to evaluate the relationship between signs and symptoms; and to identify how to diagnose and follow OSD and its impact on the quality of life in such patients. METHODS: A prospective observational study of enrolled consecutive topically treated open-angle glaucoma or ocular hypertension patients: patients presenting systemic or ocular conditions that could interfere with ocular surface status were excluded. Enrolled patients underwent a complete ophthalmic examination comprehensive of evaluation of tear film break-up time (TF-BUT) and fluorescein corneal staining (keratitis punctatae) and who completed the Italian version of both the National Eye Institute-Visual Function Questionnaire (NEI-VFQ) 25 and the Glaucoma Symptom Scale (GSS) questionnaires. RESULTS: 233 patients adhered to a study protocol. Punctatae keratitis was detected in 70 (30%) eyes; abnormal TF-BUT in 67 (28.8%) patients: 97 patients (42.1%) presented an OSD. The abnormal values were gender-independent, keratitis was statistically related to age (P=0.01) and number of instillations/die (P=0.0007). TF-BUT was related to the IOP value (P<0.0001). The NEI ocular pain subscale was statistically related to TF-BUT (P=0.017); GSS was both related to TF-BUT and punctatae keratitis (P<0.00001). CONCLUSIONS: Many patients present an OSD related to therapy, and this affects their quality of life. The use of fixed combinations to reduce surface exposition and of benzalkonium chloride-free formulations should be encouraged to reduce and contain the onset or worsening of this secondary condition in glaucoma patients. The GSS has shown a good relation to signs and should be routinely used to evaluate the impact of OSD on the quality of life.

Efficacy and ocular surface tolerability of preservative-free tafluprost 0.0015%: a 6-month, single-blind, observational study on naïve ocular hypertension or glaucoma patients.

OBJECTIVES: The aim of this study was to evaluate the safety of preservative-free tafluprost in newly diagnosed patients and to confirm its efficacy in lowering intraocular pressure (IOP). METHODS: Naïve patients were submitted to an ophthalmic examination, including ocular surface status and quality of life evaluation. All examinations were performed at baseline and after 1 and 6 months. RESULTS: 28 patients were enrolled and treated with tafluprost, once a day, in the evening. TF-BUT changed from 9 (interquartile range (IQR) 6 - 11) s at baseline to 10 (IQR 7 - 10) s at 1 month (p = 0.106) and 9 (IQR 6 - 12) s at 6 months (p = 0.003). No eye developed corneal staining. Quality of life was (median (IQR)) 91.6 (79.2 - 95.8) at baseline and 95.8 (66.7 - 100) at 6 months (p = 0.62). Only a few adverse events occurred during the follow-up period (three patients experienced ocular burning and one developed redness). The mean IOP reduction was 5.5 mm Hg (95% CI 3.8 - 7.2). The median (IQR) baseline IOP was 18.7 (15 - 23.7) mm Hg; 14 (13 - 16) mm Hg and 16 (14 - 16) mm Hg (p < 0.0001) after 1 and 6 months, respectively. CONCLUSION: No patient developed ocular surface disease and quality of life perception was preserved. Preservative-free tafluprost is therefore an effective drug that is safe for the ocular surface after 6 months of daily therapy.

Pentacam sensitivity and specificity in detecting occludable angles.

PURPOSE: To assess the sensitivity and specificity of Pentacam measurements in detection of occludable angles and to provide cutoff values. METHODS: Observational, single-center, cross-sectional study on 64 Caucasian eyes: 28 (43.7%) primary narrow angles or primary angle-closure glaucoma, and 36 (56.2%) controls: all subjects were evaluated and classified by gonioscopy (Shaffer classification). The following measurements have been considered: superior and inferior anterior chamber angle (ACA), temporal and nasal ACA, anterior chamber depth (ACD) using 5 value representation (central, superior, inferior, nasal, temporal), and anterior chamber volume (ACV). Validity of Pentacam parameters to detect patients in Shaffer 0 or I class was assessed by receiver operating characteristic (ROC) curves analysis; cutoffs were chosen as to maximize sensitivity and specificity. RESULTS: All the considered Pentacam measures were statistically different between the 2 groups (p<0.0001). All Shaffer grade groups differed in all parameters (p<0.001), except for grade 0 and I, which did not differ in any. Area under the curve ROC analysis revealed high discriminant power of all Pentacam measures: ACA = 0.94; ACD = 0.91; ACD central = 0.89; and ACV = 0.89. Chosen cutoff values (ACA = 22.4°; ACD = 1.12 mm; ACD central = 1.93 mm; ACV = 84 mm3) allowed correct classification of narrow angles. CONCLUSIONS: The study pointed out a high power of Pentacam AVA, ACV, and ACD in detecting occludable angles. Pentacam is simple to use, reliable, and noncontact, provides parameters in a short period, and represents a possible screening tool.

From dorzolamide 2%/timolol 0.5% to brinzolamide 1%/timolol 0.5% fixed combination: a 6-month, multicenter, open-label tolerability switch study.

PURPOSE: To assess ocular surface status and tolerability after switching glaucoma patients from dorzolamide/timolol to brinzolamide/timolol fixed combination (FC). METHODS: Six-month, multicenter, open-label, prospective study that switched 72 patients from dorzolamide/timolol to brinzolamide/timolol FC. Intraocular pressure (IOP), tear film break-up-time (TF-BUT), fluorescein staining and Glaucoma Symptom Scale (GSS) questionnaire were recorded at baseline and after 6 months. RESULTS: Median interquartile range (IQR) IOP was 16 (IQR 15 - 18) mmHg at baseline and 16 (15 - 17) mmHg and 6 months. TF-BUT significantly improved (p < 0.0001); the regression analysis found a negative association between TF-BUT changes and age at baseline and at month 6 (r = -0.32; p = 0.0082 and r = -0.31; p = 0.0085). Patients with no corneal fluorescein staining statistically increased after substitution (p = 0.04). Quality of life - as examined by the GSS symptoms (SYMP) score - statistically improved (p < 0.0001), revealing an association between GSS SYMP score and age [coefficient -0.67, 95% confidence interval (CI) -1.13 to -0.21, p = 0.0005), superficial keratitis (coefficient -8.26, 95% CI -15.73 to -0.80, p = 0.031) and TF-BUT (coefficient 4.94, 95% CI 1.71 to 8.17, p = 0.003). CONCLUSION: Brinzolamide/timolol FC is associated with reduced topical discomfort and improved signs of ocular surface disease. The good tolerability and comfort of this FC might contribute to good patient adherence.

Signs and symptoms of ocular surface status in glaucoma patients switched from timolol 0.5% to brinzolamide 1%/timolol 0.5% fixed combination: a 6-month efficacy and tolerability, multicenter, open-label prospective study.

PURPOSE: To examine the impact of switching glaucoma patients from timolol 0.5% to brinzolamide 1%/timolol 0.5% fixed combination (Brinz/Tim FC) on quality of life and on ocular surface status; to assess efficacy after the switch. METHODS: 6-month, multicenter, open-label, prospective, switch study in 119 early to moderate glaucoma patients. Intraocular pressure (IOP), tear film break-up time (TF-BUT), fluorescein staining and Glaucoma Symptom Scale (GSS) questionnaire were recorded at baseline and after 6 months. RESULTS: Median (interquartile range) IOP significantly decreased from 20 to 16 mmHg, independent of sex and age. Most patients (95.8%) reached an IOP < 18 mmHg. TF-BUT improved, with a negative weak correlation to age at baseline and at 6 months. The percentage of patients with no fluorescein staining improved. The quality of life recorded by GSS also improved, being related both to age and corneal staining. CONCLUSION: Brinz/Tim FC is effective and well tolerated. In this study, patients switched to Brinz/Tim FC obtained further reduction in IOP with no effects on ocular surface status and improved quality of life perception: a better quality of life could determine a better adherence to prescribed therapy.

Do adherence rates and glaucomatous visual field progression correlate?

PURPOSE: To assess the relation between visual field progression and adherence rate in patients with glaucoma using Travatan Dosing Aid® (TDA). METHODS: In this 36-month retrospective study, 35 patients with primary open-angle glaucoma on travoprost or travoprost/timolol fixed combination monotherapy were submitted to ophthalmic examination and to visual field (VF) test from 2007 to 2009. Adherence was recorded with TDA. The association between VF progression (from 2007 to the end of the follow-up period) and a number of predictors (adherence rates at 12 months) was tested by means of chi-square test (or Fisher exact test) or Mann-Whitney test as appropriate. RESULTS: The mean (±SD) adherence rates were 71.9%±27.8% after 1 month of follow-up and 76.8%±20.9% at 12 months. A total of 25 (71.4%) patients with stable VF had a median adherence rate (IQR) of 85% (75%-97%); patients who worsened (n=10; 28.6%) recorded a median (IQR) adherence of 21% (9%-45%) (p<0.001). No association was found between VF progression and any of the other variables (age, sex, schooling, visual acuity, intraocular pressure (IOP) at baseline and over time, other ocular diseases, time since diagnosis and actual therapy, number of concomitant systemic therapies). Patients who were at least 90% adherent did not progress, while 43.5% of the patients with lower adherence worsened (p=0.01). CONCLUSIONS: Our data suggest that adherence rate may play a role in glaucomatous damage and/or progression; the target IOP therefore should be adjusted by adherence rates. Monitoring tools, educational programs, use of videos, a better doctor-patient relationship, or other means to improve adherence are desirable and necessary to preserve visual function.

Monitoring adherence rates in glaucoma patients using the Travatan Dosing Aid. A 6-month study comparing patients on travoprost 0.004% and patients on travoprost 0.004%/timolol 0.5% fixed combination.

OBJECTIVE: To assess adherence in glaucoma patients using the Travatan Dosing Aid (TDA); to record differences in adherence by age, sex, therapy, systemic therapies, years from diagnosis, type of therapy and intraocular pressure (IOP). RESEARCH DESIGN AND METHODS: Sixth-month cohort study; fifty-six Caucasian, primary open-angle glaucoma patients on travoprost (T) or travoprost/timolol fixed combination (TTFC) monotherapy were submitted to four visits: at baseline and months 1, 3 and 6 (M1, M3, M6). Adherence was recorded with TDA and classified as 'high' if greater than 90%. Self-reported and physician-presumed adherence data were collected. Kruskall-Wallis and Fisher's exact tests were applied. RESULTS: Thirty-two patients (54.2%) were treated with T. Age, sex, level of schooling, presence of systemic comorbidities, duration of current therapy and IOP were similar between T and TTFC. Seventeen subjects (30.3%) recorded high adherence at every visit, 13 (23.2%) at two visits, 26 (46.4%) otherwise. Adherence was maintained over time with a slight decrease from month 1 to month 6 without statistical differences within and between groups. Adherence was statistically influenced by age (p = 0.007) and duration of therapy (p = 0.004). CONCLUSION: The typical nonadherent patient is elderly. TDA records indicate that only a minority of patients are really adherent: predictive models to screen for poor adherence are needed.

Switching from concomitant latanoprost 0.005% and timolol 0.5% to a fixed combination of travoprost 0.004%/timolol 0.5% in patients with primary open-angle glaucoma and ocular hypertension: a 6-month, multicenter, cohort study.

PURPOSE: To assess the usefulness and tolerability of systematically switching glaucoma patients from latanoprost 0.005% and timolol 0.5% (Lat + Tim) to a fixed combination of travoprost 0.004%/timolol 0.5% (TTFC), and to record the effects of this switch on tear-film break-up time (TBUT). MAIN OUTCOME MEASURES: Intraocular pressure (IOP) reduction, patients reaching IOP < 18 mmHg; the rate of discontinuation; TBUT; and the onset of adverse events (AEs). METHODS: Multicenter, observational cohort, 6-month study: 309 patients on concomitant Lat + Tim were switched to TTFC (evening dosage). IOP, TBUT, and AEs were recorded at baseline and after 1 and 6 months. RESULTS: IOP was significantly decreased (from 18.3 +/- 2.9 to 16.6 +/- 2.7 mmHg) after substitution (p < 0.0001). Many patients (82%) reached an IOP < 18 mmHg (p < 0.0001). TBUT improved significantly (from 8.4 +/- 3.6 to 9.2 +/- 3.8 s, p < 0.0001). A few patients reported AEs (8.7%), which caused discontinuation in a low percentage (4.5%). CONCLUSION: TTFC appeared useful in this selected population. In this study, patients who underwent a regimen modification to TTFC obtained further reduction in IOP with a lower exposition to preservative toxicity. The low discontinuation rate at 6 months indicates a good tolerability profile.

Dry eye syndrome-related quality of life in glaucoma patients.

PURPOSE: To verify the presence of dry eye syndrome (DES) in treated patients with glaucoma and to analyze DES's impact on the patients' quality of life (QOL) versus the control group. METHODS: In this observational cross-sectional study, 61 patients were enrolled at a clinical practice. Patients were divided into three groups by number of glaucoma drops instilled per day (G1=1 drop/day, G2=2 drops/day, G3=3 drops/day). A control group of 20 subjects was also selected (G0). All subjects were submitted to a complete ocular examination (including tear function and ocular surface status) and completed the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ), Glaucoma Symptom Scale (GSS) questionnaire, and Ocular Surface Disease Index (OSDI). DES was defined as presence of punctate keratitis and decreased break-up time. Statistical analysis was performed applying the Kruskal-Wallis analysis of variance and Mann-Whitney U tests (to compare median values between groups) as well as the chi2 and Fisher test (to verify significant differences). RESULTS: A total of 40% of G3 and 39% of G2 patients presented DES versus 11% of G1 and 5% of G0 (p=0.01). QOL was significantly influenced and altered (NEI-VFQ 25 total mean and GSS total mean and symptoms average: p=0.0085, p=0.006, and p=0.03, respectively). OSDI pointed out differences by group: 26% of G2 and 15% of G3 presented moderate OSDI and 15% of G3 and 8.7% of G2 severe OSDI (p>0.05). CONCLUSIONS: Patients with topically treated glaucoma present DES more often than a similar control group (p=0.01). The presence of DES negatively influences the patient's QOL. The patients with glaucoma's ocular surface status should be evaluated regularly to ensure the timely detection and treatment of pathologic signs on the ocular surface.