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Introduction: A non-interventional, multicenter, European, prospective evaluation of the effectiveness, tolerability, and safety of a topical preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in adults with open-angle glaucoma (OAG) and ocular hypertension (OHT) demonstrating insufficient response to topical beta-receptor blockers or prostaglandin analogue (PGA) monotherapy. Methods: Mean intraocular pressure (IOP) change from baseline was measured at study visits following a switch to PF tafluprost/timolol FC. Primary endpoint was absolute mean IOP change at month 6. Change from baseline concerning ocular signs and symptoms was also explored.Results: Analyses included 577 patients (59.6% female). Mean age (SD) was 67.8 (11.67) years. Mean (SD) IOP reduction from baseline was significant at all study visits; 5.4 (3.76) mmHg (23.7%) at week 4, 5.9 (3.90) mmHg (25.6%) at week 12, and 5.7 (4.11) mmHg (24.9%) at month 6 (p \ 0.0001 for all visits). At month 6, 69.2%, 53.6%, 40.0%, and 25.8% were responders based on C 20%, C 25%, C 30%, and C 35% cutoff values for mean IOP, respectively. Significant reductions were observed concerning corneal fluorescein staining (p \ 0.0001), dry eye symptoms, irritation, itching, and foreign body sensation (p \ 0.001 for each parameter). Conjunctival hyperemia was significantly reduced at all study visits (p \ 0.0001 at each visit). Overall, 69 treatment-related adverse events (AEs) were reported, one of which was serious (status asthmaticus). Most AEs were mild to moderate in severity, and the majority had resolved or were resolving at the end of the study period. Conclusion: In clinical practice, PF tafluprost/timolol FC provided statistically and clinically significant IOP reductions in patients with OAG and OHT insufficiently controlled on or intolerant to PGA or beta-receptor blocker monotherapy. The full IOP reduction appeared at week 4 and was maintained over the 6-month study period. Key symptoms of ocular surface health improved. Trial Registration: European Union electronic Register of Post-Authorisation Studies (EU PAS) register number, EUPAS22204.The members of The VISIONARY Study Group are listed in Acknowledgements. Key Summary PointsWhy carry out this study?Prostaglandin analogue (PGA) and betareceptor blocker combination therapies are among the most extensively used intraocular pressure (IOP)-lowering treatments in glaucoma care. Fixed-dose combinations simplify the treatment regimen and reduce the number of daily instillations, compared with administration of the corresponding concomitant medications, and preservative-free formulations are generally considered to offer improved tolerability.The VISIONARY study aimed to provide real-world data concerning the treatment effectiveness of the preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in people with open-angle glaucoma (OAG) and ocular hypertension (OHT) who demonstrated an insufficient response ...

Our results suggest that the current CLS technique cannot be clinically used to monitor IOP decrease induced by topical medication in glaucoma, and has limited value in identification of transient IOP elevation periods.

In this white screening population with relatively high risk for mild glaucomatous damage, a combination of different GDx-VCC criteria was useful for glaucoma screening; but combinations of HRT criteria or combinations of GDx-VCC criteria with HRT criteria were less good for this purpose.

The accuracy of referrals was poor in the UK and the other countries. Requiring a combination of criteria and raising the IOP threshold for IOP-only referrals are needed to cut waste in clinical care.

Although no eyes showed mean diurnal IOP reduction of 20% or more, selective laser trabeculoplasty resulted in a significant decrease in the amplitude of diurnal IOP fluctuation.

Background/aim: Retinal nerve fibre layer thickness (RNFLT), as measured with scanning laser polarimetry using the fixed angle corneal polarisation compensator (SLP-F), has been found to be reduced after uncomplicated laser assisted in situ keratomileusis (LASIK) compared to the pre-LASIK measurement. Since this virtual RNFLT thinning is attributed to the corneal changes induced by the LASIK, the authors investigated whether customised corneal polarisation compensation (SLP-C), which compensates for the actual corneal polarisation during each measurement, can avoid the LASIK induced, virtual changes of the polarimetric RNFLT values. Methods: Scanning laser polarimetry using both the SLP-F and SLP-C methods (GDx-Access, software version 5.0) was performed on 15 consecutive healthy subjects with no eye disease who underwent LASIK for ametropia correction. The SLP measurements were performed before the surgery, then on day 1 and day 6 after LASIK. Thickness data from images of one randomly selected eye per subject were analysed using the ANOVA and Scheffe multiple comparison tests. Results: Superior maximum, inferior maximum, normalised superior area, and normalised inferior area (SLP parameters representing the RNFLT at the superior and inferior poles of the optic nerve head) remained unchanged with SLP-C (ANOVA, p.0.05) but decreased (superior maximum, normalised superior area, Scheffe test, p,0.05) or tended to decrease (inferior maximum) after LASIK, when measured using SLP-F. In contrast, certain other parameters-namely, superior ratio and inferior ratio (representing the ratios between the superior or the inferior sector and the temporal sector), maximal modulation, and ellipse modulation decreased with SLP-C (Scheffe test, p,0.05), but remained stable with SLP-F (ANOVA, p.0.05) after LASIK. Superior to nasal ratio, symmetry of the superior and inferior RNFLT as well as the parameter showing the probability of having glaucoma (called ''the number'') remained unchanged with both types of corneal compensation (ANOVA, p.0.05). With SLP-C the parameter ellipse average thickness increased after LASIK (Scheffe test, p = 0.021). No parameter value altered between day 1 and day 6 after LASIK, for either method. Conclusion:The results suggest that the LASIK induced decrease of the polarimetric RNFLT, which is consistently detected with polarimeters when using the fixed angle corneal polarisation compensator, is due to alterations of the corneal polarisation. The use of customised corneal polarisation compensation avoids this virtual decrease of the polarimetric RNFLT. However, our results suggest an increase of the measured retardation in the temporal quadrant of the SLP-C image after LASIK. Since ratios of parameters using the temporal RNFLT in the denominator are important in the polarimetric glaucoma diagnosis algorithm, their decrease as a consequence of using SLP-C needs further investigation.

Objectively measured adherence to once-daily prostaglandin analog medication was good, and not influenced by treatment characteristics or patient factors including mild-to-moderate depression. The elevated social desirability suggests that self-reported adherence is not a reliable measure of adherence in glaucoma.