Gemma Caterina Maria Rossi

The Italian version of the 25-item National Eye Institute Visual Function Questionnaire: Translation, validity, and reliability

ObjectiveTo test the Italian adaptation of the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) and to investigate its validity and reliability. MethodsThis prospective observational study enrolled nonhospitalized patients with 1 of 5 chronic eye diseases, and a reference sample of subjects without eye diseases. Eligible participants had to be cognitively able to respond to a health status interview and be affected by 1 of the following eye conditions: senile cataract, age-related macular degeneration, glaucoma, diabetic retinopathy, and cytomegalovirus retinitis or low vision. A control group was composed of subjects with no evidence of underlying eye diseases. The Italian self-administered versions of Medical Outcomes Study Short Form and of the NEI-VFQ 25 were administered to all participants. Reliability and validity of the Italian translation of the NEI-VFQ 25 were tested using statistical methods. ResultsStatistical analysis points out that the Italian version of the NEI-VFQ 25 has good validity, discriminatory power, internal consistency, and reliability. ConclusionsThis Italian version of the NEI-VFQ 25 shows psychometric properties comparable to those of the American version, and thus can be used in clinical research as a specific measure of quality of life in patients with chronic eye diseases.

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.

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.

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.

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 Fishers 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.

Efficacy and Safety of Netilmycin/Dexamethasone Preservative-Free and Tobramycin/Dexamethasone-Preserved Fixed Combination in Patients After Cataract Surgery

PURPOSE To compare the efficacy and safety of preservative-free Netilmycin/Dexamethasone with that of preserved Tobramycin/Dexamethasone, postcataract surgery. METHODS Prospective, randomized, single-blind study on patients submitted to phacoemulsification. During preoperatory visits, at 7 and 21 days conjunctival hyperemia, corneal edema, Tyndall, Shirmer I, corneal and conjunctival lissamine green and fluorescein staining, and intraocular pressure (IOP) were recorded. Postoperative pain (at day 7) and the subjective tolerability (at day 21) were investigated. RESULTS Eighty patients completed the study and the data collected were analyzed (44 on Netilmycin/Dexamethasone). Regarding the primary efficacy variable, intraocular inflammation, no microbial events were recorded, but aqueous flare was significantly lower with Tobramycin/Dexamethasone at 1 week (P = 0.002). Regarding secondary efficacy variables, conjunctival hyperemia was lower in patients under Tobramycin/Dexamethasone (P < 0.001), but corneal edema and ocular pain were similar. Regarding safety, no significant differences on ocular surface status were recorded. Both formulations were well tolerated, but Tobramycin/Dexamethasone caused an increased IOP at 1 week (P < 0.0001). CONCLUSIONS Both the studied fixed combinations are safe and effective in controlling postoperative inflammation and preventing postoperative ocular infections. Tobramycin/Dexamethasone has a quicker anti-inflammatory effect but needs IOP monitoring. Further studies on more patients using a sounder scientific design are needed to confirm our findings.

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 &agr; 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.

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.

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.

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.