Giovanni Milano

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.

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.

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.

An evaluation of therapeutic noninferiority of 0.005% latanoprost ophthalmic solution and xalatan in patients with glaucoma or ocular hypertension.

Purpose:To assess the therapeutic noninferiority of 0.005% latanoprost ophthalmic solution versus Xalatan in the treatment of patients with primary open-angle glaucoma or ocular hypertension. Patients and Methods:This was a double-masked, randomized, multicenter study. A total of 184 patients with a diagnosis of unilateral or bilateral primary open-angle glaucoma or ocular hypertension were randomly assigned to either 0.005% latanoprost ophthalmic solution or Xalatan for 12 weeks. The primary end-point was the change in intraocular pressure (IOP) at 12 weeks in the 2 groups. Noninferiority was reached if the 2-sided 95% confidence intervals (CI) for the difference between adjusted treatment means were entirely within the interval from −1.5 to +1.5 mm Hg. Results:The difference between treatments in the change of IOP from baseline to the end of treatment was 0.12 mm Hg (95% CI: −0.47, 0.71) in the intention-to-treat population and 0 mm Hg (95% CI: −0.58, 0.57) in the per protocol population. There was no statistically significant difference between the 2 groups in terms of drug-related adverse events. The most commonly reported drug-related local adverse events were: ocular hyperemia, eyelashes growth, and eye irritation. Conclusions:This study demonstrates that 0.005% latanoprost ophthalmic solution is noninferior to Xalatan in lowering IOP and is generally well tolerated.

Morphologic and functional analysis of the optic nerve in premature and term children with OCT, HRT, and pVEP: A 10-year resurvey

PURPOSE Most studies on premature newborns have focused on infants of less than 28 weeks of gestational age (GA) due to their increased risk of developing diseases, such as premature retinopathy. Studies on premature infants born between 28 and 35 weeks GA with normal development are less frequent. The aim of our study was to identify subclinical morphologic or functional defects in these children. METHODS We evaluated 14 premature newborns at birth (mean gestational age, 33.45 weeks) with a neuro-ophthalmologic examination and patterned visual evoked potentials (pVEP). The same subjects were surveyed when they were young children (mean age, 7.5 ± 0.2 years) using Heidelberg retinal tomography (HRT) and optical coherence tomography (Stratus OCT). The pVEP studies were performed as transient (temporal frequency, 1.96 Hz) and steady-state (7.5-Hz temporal frequency). A complete ophthalmic examination also was performed. The data were compared to those from 15 term newborns who were examined in the same manner (mean age, 9.8 ± 0.3 years). RESULTS A statistically significant thickening of the macular temporal and inferior nerve fibers was found on OCT in premature newborns. The thickness of the superior and inferior retinal nerve fiber layer (RFNL) also was reduced. A difference also was found in rim area thickness based on HRT. Multiple significant P values were found in the VEP P100 peak time and steady-state amplitudes at the time of birth, but not at the time of morphologic analysis. CONCLUSIONS Healthy, premature newborns may have morphologic abnormalities of the optic nerve. These abnormalities do not cause visual acuity or functional decreases.

Structure/Function relationship and retinal ganglion cells counts to discriminate glaucomatous damages

BackgroundGlaucoma is an optic neuropathy characterized by retinal ganglion cells (RGC) loss and retinal nerve fiber layer (RNFL) injury: this results in functional and morphological changes. The first can be observed by Standard Automated Perimetry (SAP), the second by Optic Coherence Tomography (OCT) that measures the RNFL and ganglion cell complex (GCC) thicknesses. Nevertheless, diagnosis of early glaucoma may be difficult. Recently, Medeiros et al. derived an empirical formula combining the measurement of structural and functional tests to provide an estimate of RGC. The aim of the current study is to analyse the correlation between RGC count, estimated by Medeiros’ formula, and the structural and functional parameters in patients examined for glaucoma and to evaluate SAP, OCT and RGC counts capability to discriminate the weight of the disease itself.MethodsNinety four eyes of 50 consecutive patients clinically referring to glaucoma service of the Universitary Eye Clinic were submitted to a complete ophthalmic evaluation including SAP and Spectral Domain OCT (SD-OCT) of RNFL and macular GCC. Average thickness of RNFL and macular GCC, parameters Global Loss Volume (GLV) and Focal Loss Volume (FLV) over the entire GCC map were taken into account. Estimates of RGC were obtained with the help of a model already published by Medeiros et al. combining light sensitivities from SAP and retinal thickness from OCT. The RGC count was estimated in the entire visual field (central 24°) and in the GCC macular area and then compared with functional and morphological parameters applying Pearson’s correlation coefficient.ResultsAfter the classification of the patients by the Glaucoma Staging System 2 of Brusini, we noticed a good correlation among the functional parameters considered, even if the Visual Field Index is unable to identify early glaucoma. An analogous result can be observed for structural data (RNFL and GCC). The correlation detected between functional and structural parameters was moderate. Great differences in RGC counts were found between groups at various stages of glaucoma. GLV showed highest level of correlation (r > −0.8) with RCG counts.ConclusionsEstimate circumpapillary and macular RGC counts can discriminate various stages of the disease and there is also a good/very good correlation with both functional and structural parameters. GLV could be used instead of RGC counts in clinical practice.

Color Doppler Imaging and Glaucoma: Comparison of Doppler Waveform of Retrobulbar Vessels between a Glaucomatous Patient and a Healthy Subject

Ocular blood flow abnormalities are believed to play an important role in the pathogenesis of primary open angle glaucoma (POAG). For this reason the Color Doppler Imaging (CDI) evaluation of the retro bulbar vessels is used for research purposes to investigate the degree of these abnormalities and their role in the pathogenesis of PAOG. The most widely measured variables are peak systolic velocity (PSV), end-diastolic velocity (EDV) and resistivity index (RI) of the ophthalmic artery, central retinal artery, and short posterior ciliary arteries. According to a recent study that has found statistically significant differences in two variables measured in the ophthalmic artery, the early systolic acceleration (ESA) and the ratio between the mean velocities of the systolic and diastolic components (Sm/Dm), we present the CDI evaluation of a case of normal tension glaucoma (NTG) compared to a healthy subject. The values obtained are in agreement with the literature and all the measured velocities, except for the PSV and the RIs in the ophthalmic artery that were respectively reduced and increased as compared to the healthy volunteer. Moreover, ESA is reduced and Sm/Dm increased. Further studies are needed to evaluate the degree of the pathological alterations and their role in the progression of the optic nerve injury.

Cataracts and Dupuytren disease: a case report and review of the literature

Purpose. Dupuytren disease is an inherited proliferative and progressive connective disease. Ectopic disease may, however, be located distant from the palmar fascia. Methods. Case report and review of the literature. Results. We describe a case of symmetric bilateral posterior subcapsular cataracts associated with symmetric bilateral Dupuytren disease and symmetric bilateral Ledderhose disease in a 56-year-old Caucasian man. His medical history was negative for glucocorticoids intake, diabetes, and exposure to radiation. Serum transforming growth factor β (TGF-β)1 concentration has been evaluated and was found to be almost double compared to the controls. Conclusions. We speculate that the TGF-β plays an important role for ocular and connective tissue disorders.

Computer-aided ophthalmic artery waveform analysis in healthy individuals and glaucoma patients

We thank Michael Brodsky for his interest in our study and for drawing our attention to a paper by Brodsky and Klaehn that examined optokinetic responses in humans with infantile esotropia using what the authors labeled an ‘‘optokinetic uncover test.’’ We commend Brodsky and Klaehn on the observations and conclusions that they draw from their study. However, we would like to point out some key differences between their study and our study. A major difference is in the construction and delivery of the stimulus. Brodsky and Klaehn presented the patients with an optokinetic stimulus, first monocularly to the fixating eye and then binocularly. Further, the stimulus itself was full field, that is, not localized to any part of the visual field of the deviated eye. In our study, we utilized a dichoptic presentation in which the optokinetic stimulus is presented only to the deviated eye (never binocularly) and the fixating eye sees only a stationary target. Moreover, the optokinetic stimulation is restricted to a 108 patch, and we observed optokinetic nystagmus (OKN) only when the patch occupied the central 108 of the deviated eye that included the fovea. We also made quantitative evaluations of the strength of the OKN response and its gradation with spatial location and contrast of the OKN stimulus, whereas the Brodsky and Klaehn study was essentially a qualitative evaluation of the OKN response. Therefore, in our view, the two studies are not directly comparable. However, our results do agree with one of the conclusions that they reached, which was that information is being processed via both eyes. In his letter, Brodsky does not question our results but perhaps suggests two additional discussion points with regard to our study: (1) The OKN responses that we observed are driven by a subcortical optokinetic circuit, that is, no cortical involvement, and (2) cortical suppression of the fovea of the deviating eye might still have been present because the OKN leaked through via the subcortical pathway. In response to his two points, we make the following arguments. (1) In strabismus, nasotemporal asymmetry is observed in motion detection, visually evoked potential (VEP) response, smooth pursuit, and OKN. Neurophysiological investigation in strabismic monkeys has shown loss of binocularity in cortical areas V1, MT, MST, and also in brainstem area nucleus of the optic tract (NOT). Therefore, as proposed by models in the literature, the loss of binocular connections in the pathway from V1 MT MST NOT could lead to asymmetric visual or oculomotor response to monocular motion stimuli. Subcortical projections (direct retina–NOT projections) may also play a role, but it is not clear that they play an exclusive or primary role in generating nasalward OKN in strabismus. (2) Our study was focused on identifying areas of retinal suppression in strabismus, and OKN was simply used as a readout to identify suppressed versus unsuppressed retina. Our data and conclusions fit in nicely with the previous work in the literature. For instance, Economides, Adams, and Horton used a visual psychophysical paradigm, and showed that the fovea of the deviated eye was not suppressed. In addition, other work from our lab in which we used a saccade paradigm to examine spatial patterns of fixation switch behavior (presumably driven by suppression) also revealed similar results. Taken together with these other studies, our current study does indeed support the idea of lack of suppression of the fovea of the deviated eye in exotropia. Finally, we would like to point out that the discussion points above are fundamentally speculative because neither Brodsky’s previous work nor our current study directly examined neural responses, and therefore cannot ascribe the optokinetic responses to cortical/subcortical pathways. As always in science, the best way to settle the issue would be to design and perform an appropriate experiment and quantitatively evaluate the data.

Evaluation of the conjuntival blebs using spectral domain optical coherence tomography after glaucoma surgery

Objective: Analyze the application of the spectral domain optical coherence tomography (SD-OCT), Optovue iVue, on morphofunctional assessment of filtering blebs after different types of glaucoma surgery and point out the correlation between of morphologic features of blebs (bleb-wall thickness, scleral flap profile, and presence of hyporeflective spaces and internal cavity) and intraocular pressure (IOP). Methods: Thirty-eight eyes of thirty-two primarly open angle glaucoma patients, following three different types of glaucoma surgery (trabeculectomy with MMC 0.3%; with the implant of the Ex-PRESS device; with the insertion of Ologen [OLO]) were recruited. Patients attended a 6-month follow-up with intermediate checks at 1 week, 1 month and 3 months. Each visit include the evaluation of bleb using both slit lamp biomicroscopy and OCT. Results: In all patients, regardless of the type of surgery, a very significant reduction of IOP is observed after surgery. The bleb-wall thickness and the scleral flap profile are not shown to be sensitive parameters to identify the functionality of the bleb. The presence of hyporeflective spaces and of a cavity over the sclera is an important sign of bleb functionality. Among the different types of surgery, a higher percentage of blebs provided with hyporeflective spaces is in the Ex-PRESS group. In regards to the presence of a cavity over the sclera, there are no differences between the different groups. Comparing the blebs with filtering aspect at the OCT in the different groups, in the Ex-PRESS group there is a higher percentage of blebs with a filtering aspect compared to the other groups. Conclusions: Optovue iVue, is able to show detailed superficial features of the bleb which significantly correlate with the functionality of the bleb itself.