Background/Objectives: In glaucoma patients, the fluctuation in intraocular pressure during the day seems to have an influence on the progression of the disease. The contact lens sensor (CLS) Triggerfish^® from the company SENSIMED records ocular dimensional changes for 24 h. The aim was to determine the amplitude of the measurements with a contact lens sensor before and after trabeculectomy (TE) in glaucoma patients. Methods: Twelve patients with glaucoma were included in this prospective, single-arm, single-center, interventional study. All patients received a CLS measurement for 24 h 8 ± 2 days before and 12 weeks (±1 week) after surgery. The raw data of the measurements were modeled using a double-harmonic cosine function. Fluctuation in the raw CLS data, amplitude, and the MESOR (midline estimating statistic of rhythm, rhythm-adjusted mean) of the modeled data were investigated. The safety and feasibility of the CLS measurements were evaluated. Results: Nine patients underwent the complete 24-h wearing period before and after surgery. Whereas the MESOR changed significantly before and after surgery (p = 0.04), the amplitude of the modeled data did not change significantly and the daytime fluctuation and circadian rhythm also did not vary significantly. The CLS could be safely removed from all study eyes after surgery. Conclusions: The non-significant change in amplitude suggests that diurnal fluctuations persist after TE. This contrasts with reports in the literature that show that TE reduces diurnal fluctuations. It can be assumed that the significant reduction in the MESOR represents the reduction in the average intraocular pressure over 24 h. The CLS can be used safely three months after TE.

Background: Age-related macular degeneration (AMD) is a multifactorial disorder, and there is growing evidence of immunological involvement in its pathogenesis. To address this, we aimed to identify biomarker candidates related to retinal antigens in patients with neovascular AMD treated with ranibizumab and healthy subjects. Materials and Methods: This study was designed as a prospective, open, parallel-group, interventional, single-center phase IV trial. Fifty subjects with neovascular AMD and twenty healthy volunteers were enrolled. The primary objective was to assess the efficacy of intravitreally (IVT) administered ranibizumab in terms of the change in best-corrected visual acuity in subjects with all subtypes of neovascular AMD and in a subgroup of pretreated AMD subjects. A secondary objective was to assess the efficacy of the same in terms of the change in central retinal thickness (CRT) in the same subjects. Another secondary objective was to identify antibodies against retinal antigens in patients with neovascular AMD treated with ranibizumab and healthy subjects. The last secondary objective was to correlate functional and structural parameters with the identified biomarker candidates to differentiate between initial and deferred responders to IVT administered ranibizumab. Serum was analyzed using customized antigen microarrays containing 58 antigens. Results: After 12 weeks of ranibizumab treatment, treated patients gained 4.02 letters on average. The central retinal thickness (CRT) measured in the complete AMD study population was significantly (p < 0.001) decreased at Week 24 compared to the baseline measurement, and the mean CRT dropped from 393.4 to 296.8 µm. A significant increase in the following autoantibodies was detected between the control group and AMD group at Week 24, as well as in the AMD group between baseline and Week 24: antibodies targeting the proteins serotransferrin, opioid growth factor receptor, 60 kDa chaperonin 2, neurotrophin-4, dermcidin, clusterin and vascular endothelial growth factor. Conclusions: The present trial was able to confirm the efficacy of ranibizumab treatment in neovascular AMD, and treatment-naïve patients benefitted the most. Up- and downregulations of antibodies were observed over the course of treatment with ranibizumab. Some antibodies seemed to have a fair correlation with the classification of initial and deferred responders.

To investigate the safety, tolerability, and signals of effect of MyopiaX, a smartphone app that selectively delivers blue light to the optic nerve head to control myopia progression in children and adolescents. Multicenter, randomized, active-controlled, examiner-masked proof-of-concept clinical trial (ClinicalTrials.gov identifier NCT04967287). Eligible children aged 6 to 12 years, with myopia of cycloplegic spherical equivalent refraction (SER) between –0.75 and –5.00 diopters (D) at baseline. Children were screened and enrolled between November 2021 and September 2023. Children were randomly assigned in a 2:1 ratio to MyopiaX or active control. Participants were instructed to use MyopiaX for 10 minutes twice daily for the first 6 months and, during the second 6 months of the trial, also wear defocus incorporated multiple segments (DIMS) myopia control spectacles. The active control group wore DIMS spectacles for the entire 12-month trial. The primary outcome was change in axial length (AL) and change in SER at month 6. Clinical safety examinations and the frequency and severity of device-related adverse events (AEs) were analyzed for all participants who began treatment. Of the 124 randomized participants, 101 were enrolled under the 12-month active-control study design (MyopiaX: n = 66, DIMS: n = 35). After 6 months, the mean AL change from baseline in the MyopiaX (n = 50) and DIMS (n = 34) groups, respectively, was 0.14 ± 0.11 mm and 0.08 ± 0.09 mm. The 6-month change in SER was –0.18 ± 0.39 D in the MyopiaX group and –0.16 ± 0.41 D in DIMS participants. Among the 73 participants who used MyopiaX, including those randomized under the original study design (prior to introduction of an active control), there were 23 related AEs among the 16 participants (22%), including transient ocular discomfort and headache, all of which resolved without any need for treatment. MyopiaX was safe and well tolerated over 12 months in treatment-naive children with myopia. This exploratory study provides the first clinical data on the impact of MyopiaX’s selective blue light stimulation on myopia progression and ocular growth. This novel approach may offer a complementary therapeutic solution for the clinical management of progressive myopia. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Background/Objectives: To investigate the non-inferiority of preservative-free (PF) tafluprost eye drops (Taflotan sine^®) compared to latanoprost eye drops (Xalatan^®) in reducing mean 24 h intraocular pressure (IOP) on the second day of a diurnal IOP measurement. Methods: In this retrospective monocentric cohort study, patients suffering from primary open-angle glaucoma, ocular hypertension, normal tension glaucoma, pigment dispersion glaucoma, or pseudoexfoliation glaucoma who had undergone inpatient diurnal IOP measurement were included. Patients of cohort 1 used latanoprost eye drops as monotherapy; patients of cohort 2 used preservative-free tafluprost eye drops. Data from 7 January 2005 to 9 July 2019, inclusive, were analyzed. Results: Ninety-three eyes were included (n = 59 latanoprost group, n = 34 PF tafluprost group). Mean 24 h IOP on day 2 was 14.1 mmHg (SD 2.3) in the latanoprost group and 14.5 mmHg (SD 3.4) in the PF tafluprost group. The non-inferiority of PF tafluprost eye drops to latanoprost eye drops in efficacy on mean 24 h IOP could not be confirmed (95% CI −1.5, ∞, p = 0.235). The average difference in mean IOP at the individual measurement times between both cohorts was 0.24 mmHg (SD 0.17) on day 1 and 0.44 mmHg (SD 0.6) on day 2. The non-inferiority of PF tafluprost compared to latanoprost regarding fluctuation range could not be demonstrated for both days. Conclusions: The data suggests slight inferiority of PF tafluprost to latanoprost eye drops. There were similar mean 24 h IOP values in both cohorts. PF tafluprost eye drops remain a useful treatment option as long as the patient’s individual target pressure is achieved. Furthermore, according to the literature, it is also a treatment option for patients with symptoms of ocular surface disease and other side effects affecting the ocular surface while receiving preservative-containing topical therapy.

Background: Patients affected by neovascular age-related macular degeneration (nAMD) require long-term anti-vascular endothelial growth factor (VEGF) therapy to maintain visual function. This study assessed 10-year functional outcomes as well as the cumulative incidence and progression of complete retinal pigment epithelium and outer retinal atrophy (cRORA) in a real-world cohort. Methods: Treatment-naïve eyes of nAMD patients receiving intravitreal anti-VEGF therapy under a pro re nata regimen over 10 years were retrospectively analyzed. Demographics, visual acuity (VA) (LogMAR), number of injections, macular neovascularization (MNV) subtype, and treatment agents were collected. cRORA incidence was assessed according to the Classification of Atrophy Meeting (CAM) group, and the progression rate was quantified. Factors associated with final VA and cRORA progression rate were further investigated. Results: 35 eyes from 30 patients (63.3% female; mean age 74.9 ± 6.6 years) were analyzed. The median number of injections over 10 years was 69. VA declined by +0.016 logMAR/year, with a significant change compared to baseline only at the 10-year visit ( p < 0.05). Baseline and 5-year VA correlated strongly with final VA ( p < 0.001). cRORA developed in 48.6% of eyes, with a mean progression rate of 0.26 ± 0.11 mm/year. Conclusion: Over 10 years, nAMD-affected eyes receiving anti-VEGF therapy demonstrated only a modest decline in visual function. While cRORA developed in nearly half of the eyes, no association with treatment intensity or MNV type was observed in this cohort. Early VA was significantly associated with long-term functional outcomes.

Background. The aim of this study was to demonstrate the equivalence of generic dorzolamide 2 eye drops solution versus the innovator formulation (Trusopt® eye drops solution) in patients with open-angle glaucoma or ocular hypertension. Methods. This prospective, monocentric, double-masked, active-controlled crossover phase III study included 32 patients. After washout, patients were randomized to reference product (Trusopt®) or test product (dorzolamide 2 eye drops, Rompharm Company SRL) for a 4-week period. Subsequent washout and crossover were performed. Drops were applied t.i.d. The primary efficacy endpoint was the difference in mean diurnal IOP. Goldmann applanation tonometry was performed at 8 am, 12 pm, and 4 pm at each visit, and safety was assessed by documentation of adverse events (AEs). Therapy adherence was documented by self-reporting and eye drop bottle weighing. An ANOVA with treatment, sequence, study period, and patient within the sequence as effects was performed and an additional post hoc ANCOVA including the baseline IOP was also performed. Results. 34 patients were randomized and analyzed in the safety population. The per-protocol population included 32 patients. According to the self-report, all patients were >80 compliant. Under the ANCOVA model, the 90 confidence interval for the average change of the IOP 0.27mmHg (1.17mmHg0.64mmHg) is included by the acceptance range 1.5mmHg to +1.5mmHg after excluding 2 patients, which had falsely reported high therapy adherence. No clinically relevant difference was observed in frequency or severity of the AEs between both treatments. Conclusions. This study showed the equivalence of the tested generic dorzolamide 2 eye drops solution to the reference product Trusopt® eye drops solution. Trial Registration. This trial is registered with (ClinicalTrials.gov (identifier: NCT00878917) on April 9, 2009).