Project description:To determine the associations between medical, demographic, socioeconomic, and ocular factors and adherence to topical glaucoma ocular hypotensive therapy.One hundred sixteen patients with ocular hypertension or open-angle glaucoma from 2 tertiary glaucoma services participated in this prospective study. Adherence to ocular hypotensive therapy was measured using an electronic dose monitor (Travatan Dosing Aid, Alcon Laboratories Inc., Fort Worth, TX) and collected data at 3 months after enrollment. We used 3 different definitions of adherence: 1) Definition 1: the proportion of days taking the prescribed number of drops within 3 hours of the prescribed dosing time; 2) Definition 2: the proportion of days taking any drops within 3 hours of the prescribed dosing time; and 3) Definition 3: the proportion of days taking any drops within 6 hours of the prescribed dosing time. Univariate and multivariate models were used to determine the association between the 3 adherence definitions, medical, demographic, socioeconomic, and ocular factors at 3-month follow-up. The main outcome measures for this study were risk factors for poor objective medication adherence.Adherence, using Definition 1, Definition 2, and Definition 3, was 64%, 75%, and 80%, respectively. Age, total number of other eye diseases, and race were significantly associated with full treatment adherence (Definition 1), with race alone significantly predicting 11% of full treatment adherence. For Definition 2, age, income, level of education, and total number of eye diseases were significantly associated with partial adherence (3 h), again race alone significantly predicted 15% of partial adherence (any drops within 3 h). For Definition 3, race, income, level of education, and total number of other eye diseases significantly predicted partial adherence (any drops within 6 h), both race and income predicted 19% of partial treatment adherence. Significant differences for adherence rates between patients of European descent and those of African descent were found for all 3 definitions with those who were less adherent more likely to be of African descent.Electronic dose monitors provide important information regarding adherence to topical ocular hypotensive medications in glaucoma patients. Electronic dose monitors show low adherence in a significant number of participants. Future studies are needed to determine the reasons for these differences in health behaviors related to glaucoma treatment, which should guide treatment of poor adherence with glaucoma therapy.
Project description:Preservatives continue to be in widespread use in ophthalmic medications due to the convenience they provide, regulatory requirements and the higher cost of alternatives. Benzalkonium chloride (BAK) remains the most commonly used preservative but there is a trend towards the use of preservative-free (PF) drops for glaucoma, although at a higher price. An extensive body of literature explores BAK toxicity on ocular structures in animal and laboratory studies (in vitro and in vivo). Non-randomised controlled studies have provided some supporting evidence of its toxicity in patients, especially in those with pre-existing ocular surface disease (OSD) or on multiple medications. However, there have been very few randomised controlled trials that compare the same medication with and without BAK preservative. Several of these trials have never been published in any peer reviewed journals. Notwithstanding, those that have been published, have not demonstrated any clear benefits of the BAK-free formulations. Short duration and exclusion of those with OSD are limitations of these studies. There is a lack of evidence of clinically significant harm from a small number of BAK preserved drops in patients without OSD. This means that generally more expensive PF glaucoma medications should only be recommended for those on poly pharmacy or those with OSD but are not necessarily required for all patients.
Project description:Background and Objectives: A prospective, randomized clinical trial was conducted to evaluate the concentration of ofloxacin in the aqueous humour (AqH) of patients suffering from dry eye disease (DED) after topical instillation. Materials and Methods: Ninety-one (91) cataract patients scheduled for phacoemulsification were categorized into three groups according to DED severity. Group I (n = 17) was comprised of subjects without DED, patients in group II (n = 37) were evaluated as having non-severe DED, while group III (n = 37) consisted of patients suffering from severe DED. Preoperatively, patients received 4 drops of 0.3% of ofloxacin at 15 min intervals. One hour after the last instillation, aqueous samples were collected intraoperatively. Results: The median AqH concentration of ofloxacin in group I was 199.9 ng/mL (range 92.2−442.8 ng/mL), while in group II it was 530.5 ng/mL (range 283.7−1004.9 ng/mL), and 719.2 ng/mL (range 358.0−1512.4 ng/mL) in Group III, p < 0.001 (Kruskal-Wallis tests). Pairwise tests (two-tailed with Bonferroni corrections) between groups resulted in a p-value of 0.001 when group II was compared to group I and group III was compared to group I, and a p-value of 0.020 when group II was compared to group III. The severity of DED, across groups I, II, and III, and the levels of ofloxacin revealed a strong positive correlation (r = 0.639, p < 0.001). Conclusions: Ofloxacin concentration in the AqH after topical drop instillation may be affected by the degree of ocular surface inflammation in patients suffering from DED.
Project description:PURPOSE:To assess the safety and efficacy of one, two, or three trabecular microbypass stents in eyes with primary open-angle glaucoma (OAG) not controlled on ocular hypotensive medication. A total of 119 subjects were followed for 18 months postoperatively. MATERIALS AND METHODS:Subjects with medicated intraocular pressure (IOP) 18-30 mmHg and postmedication-washout baseline IOP 22-38 mmHg were randomized to implantation of one, two, or three stents. Ocular hypotensive medication was to be used if postoperative IOP exceeded 18 mmHg. RESULTS:A total of 38 subjects were implanted with one stent, 41 subjects with two stents, and 40 subjects with three stents. Both month 12 IOP reduction ?20% without ocular hypotensive medication vs baseline unmedicated IOP and month 12 unmedicated IOP ?18 mmHg were achieved by 89.2%, 90.2%, and 92.1% of one-, two-, and three-stent eyes, respectively. Furthermore, 64.9%, 85.4%, and 92.1% of the three respective groups achieved unmedicated IOP ?15 mmHg. Over the 18-month follow-up period, medication was required in seven one-stent subjects, four two-stent subjects, and three three-stent subjects. At 18 months, mean unmedicated IOP was 15.9±0.9 mmHg in one-stent subjects, 14.1±1.0 mmHg in two-stent subjects, and 12.2±1.1 mmHg in three-stent subjects. Month 18 IOP reduction was significantly greater (P<0.001) with implantation of each additional stent, with mean differences in reduction of 1.84 mmHg (95% confidence interval 0.96-2.73) for three-stent vs two-stent groups and 1.73 mmHg (95% confidence interval 0.83-2.64) for two-stent vs one-stent groups. Adverse events through 18 months were limited to cataract progression with best-corrected visual acuity loss and subsequent cataract surgery. CONCLUSION:In this series, implantation of each additional stent resulted in significantly greater IOP reduction with reduced medication use. Titratability of stents as a sole procedure was shown to be effective and safe, with sustained effect through 18 months postoperatively in OAG not controlled with medication.
Project description:PurposeTo assess long-time results of primary surgical treatment in children with glaucoma after congenital cataract surgery.MethodsA retrospective study of 37 eyes from 35 children with glaucoma after congenital cataract surgery, who underwent surgery between 2011 and 2021 at the Childhood Glaucoma Center, University Medical Center Mainz, Germany. Only children, who received a primary glaucoma surgery in our clinic within the given time (n = 25) and had at least one-year follow-up (n = 21), were included in the further analysis. The mean follow-up time was 40.4±35.1 months. The primary outcome was the mean reduction in IOP (in mmHg) from baseline to follow-up visits after the surgery, measured with Perkins tonometry.Results8 patients (38%) were treated with probe trabeculotomy (probe TO), 6 (29%) with 360° catheter-assisted trabeculotomy (360° TO) and 7 (33%) with cyclodestructive procedures. IOP was significantly reduced after probe TO and 360° TO after 2 years, from 26.9 mmHg to 17.4 mmHg (p<0.01) and 25.2 mmHg to 14.1 mmHg (p<0.02), respectively. There was no significant IOP reduction after cyclodestructive procedures after 2 years. Both, probe TO and 360° TO led descriptively to eye drops reduction after 2 years, from 2.0 to 0.7 and 3.2 to 1.1. The reduction was not significant.ConclusionsIn glaucoma after congenital cataract surgery, both trabeculotomy techniques, lead to good reduction of IOP after 2 years. There is a need for a prospective study with comparison to the use of glaucoma drainage implants.
Project description:We investigated the delivery of drugs to the posterior segment of the eye by non-invasive topical instillation using submicron-sized poly(D,L-lactide-co-glycolide) (PLGA) nanoparticles (NPs). Surface-modified PLGA NPs were developed to improve the drug delivery efficiency to the retina and were administered as topical eye drops to mice. Chitosan (CS) and glycol chitosan (GCS), which are mucoadhesive polymers, and polysorbate 80 (P80) were used as surface modifiers, and have been reported to increase the association of NPs with cells. Coumarin-6 was used as a model drug and fluorescent marker, and after ocular administration of PLGA NP eye drops, the fluorescence intensity of coumarin-6 was observed in the retina. The fluorescence image analysis indicated that there are several possible routes to the retina and fates of PLGA NPs in ocular tissue, and that these pathways involved the corneal, non-corneal, or uveal routes. Delivery to the mouse retina segments after topical administration was increased by surface modification with CS, GCS, or P80. Surface-modified PLGA NPs are a promising method for retinal drug delivery via topical instillation.
Project description:A clinical trial assessed the cutaneous immune response and short-term efficacy, safety, and tolerability in adults with mild to moderate AD who applied SB414 2% and 6% BID for 2 weeks.
Project description:PurposeTo assess the accuracy of 5 subjective self-assessment tools (3 adherence measures and 2 psychometric scales) and pharmacy refill data in predicting objective electronically monitored nonadherence.DesignProspective cohort study.ParticipantsGlaucoma patients (> 40 years old, >1 medication with poor self-reported adherence) were recruited from University of Michigan Kellogg Eye Center for a study assessing the impact of a personalized glaucoma coaching program on medication adherence.MethodsParticipants completed an initial assessment including 5 self-assessment tools and a 3-month period of electronic monitoring of glaucoma medication adherence (AdhereTech); pharmacy refill data were obtained. Electronically monitored adherence was calculated monthly as the percentage of doses taken on time. The median of these adherence rates was designated as baseline adherence. Patients with adherence of ≤80% by electronic monitoring were considered nonadherent. Self-assessment tools were scored, and pharmacy refill data were summarized as the proportion of days covered. Correlation between measures of adherence was estimated with Pearson and Spearman correlation coefficients. Receiver operating characteristic curves, including estimation of area under the curve (AUC), sensitivity, specificity, and accuracy were used to compare measures of adherence with respect to predicting electronically monitored nonadherence.Main outcome measuresAccuracy of self-reported and pharmacy refill data adherence measures in predicting electronically monitored nonadherence.ResultsNinety-five patients completed 3 months of electronic monitoring with a median monthly adherence of 74 (± 21%); 53 patients (56%) were nonadherent. Pharmacy refill data were not correlated significantly with electronically monitored medication adherence (r = 0.12; P = 0.2). Of all the measures, a single-item adherence question ("Over the past month, what percentage of your drops do you think you took correctly?") showed the largest correlation with median electronically monitored adherence (r = 0.47; P < 0.0001), largest AUC for predicting nonadherence (AUC = 0.76 [95% confidence interval [CI], 0.66-0.87]), best accuracy (71% [95% CI, 61%-82%]), and good sensitivity (84% [95% CI, 73%-96%]).ConclusionsThe single-item question was the most accurate in predicting electronically monitored nonadherence among participants with poor self-reported adherence. In clinical practice, where alternatives are too resource intensive, this free single-item screening question can help to identify glaucoma patients at risk of poor medication adherence with reasonable accuracy.
Project description:ObjectivesWe evaluated early medication persistence with new topical antiglaucoma eyedrops, omidenepag isopropyl 0.002% (a selective prostaglandin EP2 agonist).Design and settingRetrospective two-institute study in Himeji and Akashi in Japan.ParticipantsWe analysed patients with glaucoma who were prescribed topical omidenepag isopropyl from November 2018 to December 2019. From the last outpatient visit of patients until February 2020, 235 patients were prescribed a new solution of omidenepag isopropyl (129 patients in the initial monotherapy group, 85 in the switching group (switched from another topical antiglaucoma eyedrops), 19 added to another topical antiglaucoma eyedrops group, and 2 were lost to follow-up)). Additionally, we recruited 98 patients (3 were lost to follow-up) who received initial latanoprost 0.005% monotherapy during the same period as a control group.OutcomesMedication persistence failure was defined as drug discontinuation due to any adverse effects or change of therapy. Kaplan-Meier survival analysis was performed with a Cox regression analysis.ResultsAmong 233 patients, 48 (20%) showed failure of treatment; the median persistence time of all patients was 165 days, and the median time until discontinuation of omidenepag isopropyl was 45 days. The total persistence rates were 85%, 80% and 70% at 3, 6 and 12 months, respectively. Risk factors for failure were male gender (HR: 1.45, p=0.023) and monotherapy/switching (HR: 1.715, p=0.002). Comparison between latanoprost and omidenepag isopropyl monotherapy, only male gender (HR: 1.43, p=0.016) was a significant risk factor. Failures associated with omidenepag isopropyl were due to insufficient intraocular pressure-lowering efficiency (n=26, observed during all the period), followed by conjunctival hyperaemia (n=10) and visual acuity disturbance (n=5) in patients who were observed until 3 months.ConclusionMedication persistence with omidenepag isopropyl is mostly positive; however, clinicians should also be cautious of early failure.
Project description:PurposeTo describe two surgical techniques for removing Baerveldt-350 Glaucoma Implants (BGI-350).Observations and planA 91-year-old female with history of bilateral BGI-350s and prior history of tube associated endophthalmitis in the left eye requiring tube removal and resultant phthisis was referred for tube erosion and hypopyon in the right only-seeing eye, and we recommended tube removal. On exam, the left phthisical eye still had a BGI-350 plate attached under the lateral rectus muscle by one anchoring stalk, as it had not been fully removed previously, and the patient recalled severe pain during attempted tube removal in the left eye. We performed concurrent removal of both BGI-350s under general anesthesia. We describe a surgical technique for removing a BGI-350 when the conjunctiva does not need to be spared for future surgery. We also present a second case of BGI-350 removal with a different technique that aims to spare the conjunctiva for future surgery.Conclusions and importanceBGI-350s can develop complications requiring repositioning, revision, or removal. Improper removal of BGI-350s can lead to patient discomfort and future complications. We highlight two different techniques to remove a BGI-350, depending on whether the conjunctiva is intended to be spared for future surgery or not. With either technique, we advocate for general anesthesia and a posterior scleral traction suture to provide patient comfort and optimal exposure of the surgical field.