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8 for the iStent inject Study Group* Purpose: Evaluate the safety and effectiveness of an ab interno implanted (iStent inject) Trabecular Micro-Bypass System (Glaukos Corporation, San Clemente, CA) in combination with cataract surgery in subjects with mild to moderate primary open-angle glaucoma (POAG). Design: Prospective, randomized, single-masked, concurrently controlled, multicenter clinical trial. Participants: Eyes with mild to moderate POAG and preoperative intraocular pressure (IOP) 24 mmHg on 1 to 3 medications, unmedicated diurnal IOP (DIOP) 21 to 36 mmHg, and cataract requiring surgery. Methods: After uncomplicated cataract surgery, eyes were randomized 3:1 intraoperatively to ab interno implantation of iStent inject (Model G2-M-IS; treatment group, n ¼ 387) or no stent implantation (control group, n ¼ 118). Subjects were followed through 2 years postoperatively. Annual washout of ocular hypotensive medication was performed. Main Outcome Measures: Effectiveness end points were !20% reduction from baseline in month 24 unmedicated DIOP and change in unmedicated month 24 DIOP from baseline. Safety measures included best spectacle-corrected visual acuity (BSCVA), slit-lamp and fundus examinations, gonioscopy, pachymetry, specular microscopy, visual fields, complications, and adverse events. Results: The groups were well balanced preoperatively, including medicated IOP (17.5 mmHg in both groups) and unmedicated DIOP (24.8AE3.3 mmHg vs. 24.5AE3.1 mmHg in the treatment and control groups, respectively, P ¼ 0.33). At 24 months, 75.8% of treatment eyes versus 61.9% of control eyes experienced !20% reduction from baseline in unmedicated DIOP (P ¼ 0.005), and mean reduction in unmedicated DIOP from baseline was greater in treatment eyes (7.0AE4.0 mmHg) than in control eyes (5.4AE3.7 mmHg; P < 0.001). Of the responders, 84% of treatment eyes and 67% of control eyes were not receiving ocular hypotensive medication at 23 months. Furthermore, 63.2% of treatment eyes versus 50.0% of control eyes had month 24 medication-free DIOP 18 mmHg (difference 13.2%; 95% confidence interval, 2.9e23.4). The overall safety profile of the treatment group was favorable and similar to that in the control group throughout the 2-year follow-up. Conclusions: Clinically and statistically greater reductions in IOP without medication were achieved after iStent inject implantation with cataract surgery versus cataract surgery alone, with excellent safety through 2 years.

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Purpose-To investigate the impact of an intervention program to improve adherence with topical, once daily therapy for glaucoma. Design-Randomized controlled clinical trial.Participants-Sixty-six patients with glaucoma being treated with a prostaglandin analog in one or both eyes at the Scheie or Wilmer Eye Institutes between November 2006 and June 2007.Methods-Participants in an observational study, who took 75% or fewer doses (as measured using the travoprost Dosing Aid [DA]) during an initial 3-month period, were randomized into two groups. The intervention group watched an educational video, reviewed current barriers to drop taking and possible solutions with a study coordinator, received regular phone call reminders, and had audible and visible reminders activated on their DA devices. The control group was told to take drops as prescribed and received no additional intervention.Main Outcome Measures-Change in drop usage adherence as determined by the DA device.Results-In the 3-month observation period prior to randomization, intervention group patients had used a mean of 54 ± 17% of scheduled doses and this increased to 73 ± 22% during the following 3-month period (p < 0.001, n = 35). The control mean adherence rate of 46 ± 23% at baseline was statistically unchanged during the follow up observation period (51 ± 30%, p = 0.16, n = 31). In a multivariate analysis, intervention, baseline compliance rate of less than 50%, and White ethnicity were predictors of improved adherence during the 3 months of intervention. The intraocular pressure (IOP) of intervention and control groups did not change between months 3 to 6 after intervention (p = 0.96, 0.34 respectively), and there was no correlation of IOP change with adherence rate change among both groups (Pearson Correlation r = 0.06, p = 0.51).Correspondence: Constance O. Okeke, Scheie Eye Institute, University of Pennsylvania, 51 North 39th Street, Philadelphia, PA, 19104. Email: constance.okeke@uphs.upenn.edu. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. NIH Public Access Author ManuscriptOphthalmology. Author manuscript; available in PMC 2010 December 1. Conclusion-A multifaceted intervention significantly increased adherence with glaucoma medications. Those with improved adherence were in the intervention group, had very low adherence rates at baseline and were White. IOP did not correlate with adherence. Further research is needed to determine which components of this intervention were most effective.

Our objective is to investigate which factors and patient characteristics are associated with success in Trabectome surgery.A total of 658 phakic cases with at least of 12 months follow-up were included in the analysis. Baseline demographics and medical data were collected. The main outcome measure was intraocular pressure (IOP), glaucoma medication (Rx), and secondary glaucoma surgery if any. Success was defined as IOP reduction of 20% or more from preoperative IOP and IOP < 21 mm Hg with no secondary surgery throughout the follow-up period. Risk factors for failure were determined by using univariate and multivariate cox regression.At baseline, the average IOP was 23.6 ± 7.8 mm Hg and the average number of medications was 2.6 ± 1.3 for all cases. At 12 months, the average IOP was 16.0 ± 3.6 mm Hg (P < .01∗) and the average number of medications was 1.8 ± 1.3 (P < .01∗). Based on the result of multivariate cox regression model, we found that the Trabectome + Phaco (TP) and Trabectome alone (TA) group had a 94% and 79% survival rate at 12 months, respectively. TP cases had 78% lower risk of failure than TA (95% confidence interval [CI]: 54–89), diagnosis of pseudoexfoliation glaucoma had a 54% lower risk of failure than primary open angle glaucoma patients (95% CI: 1–78). Hispanics had an estimated hazard ratio that is 60% lower than Caucasians (95% CI: 18–80); 20% of TA cases and 3% of TP cases were required to undergo additional secondary surgery (P < .01).Trabectome surgery, whether in combination with phacoemulsification cataract removal or stand alone, is associated with a significant reduction of IOP and glaucoma medication. Patients having a higher baseline IOP are expected to have a higher IOP reduction after Trabectome. Pseudoexfoliation glaucoma, combination with phacoemulsification cataract surgery and Hispanic race are factors associated with enhanced Trabectome survival.

Rationale:Bilateral acute iris transillumination (BAIT) is a poorly-understood ocular syndrome in which patients present with acute iridocyclitis and pigmentary dispersion with or without ocular hypertension. The etiology of the disease remains unknown, though recent reports suggest an antecedent upper respiratory tract infection or systemic antibiotic administration may trigger the clinical syndrome.Patient concerns:A 55-year-old female was referred for a second opinion regarding her bilateral ocular pain, photophobia, and ocular hypertension. Her medical history was notable for a diagnosis of pneumonia managed with oral moxifloxacin several weeks prior to her initial presentation.Diagnoses:Visual acuity was 20/40 with an intraocular pressure (IOP) of 30 mmHg in the affected eye despite maximal tolerated medical therapy. The patient had severe bilateral iris transillumination defects with posterior synechiae formation and 3+ pigment with rare cell in the anterior chamber. This constellation of findings was consistent with a diagnosis of BAIT.Interventions:A peripheral iridotomy was placed, which mildly relieved the iris bowing, but did not affect the IOP or inflammatory reaction. The patient then underwent cataract extraction with posterior synechiolysis and ab interno trabeculotomy of the left eye with the Trabectome.Outcomes:The patient's IOP on the first post-operative day was 13 mmHg, and anterior chamber inflammation was noted to be significantly reduced at post-operative week 2. The patient was recently seen at a 1-year post-operative visit and her IOP remains in the low teens on a low-dose combination topical agent.Lessons:Ophthalmologists should remain aware of the association between systemic fluoroquinolones and acute pigmentary dispersion that can progress to glaucoma. The Trabectome remains a viable option for management of pigmentary and uveitic glaucoma resistant to medical treatment.

Introduction: The objective of this study was to evaluate real-world effectiveness of latanoprostene bunod (LBN) ophthalmic solution 0.024% in treatment-naïve patients newly diagnosed with open-angle glaucoma (OAG) or ocular hypertension.

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