Ten-Year Effectiveness and Safety of Trabecular Micro-Bypass Stent Implantation with Cataract Surgery in Patients with Glaucoma or Ocular Hypertension.

INTRODUCTION: This study evaluated 10-year results of implanting one iStent trabecular micro-bypass stent during cataract surgery in eyes with open-angle glaucoma (OAG) or ocular hypertension. METHODS: This retrospective, non-randomized study examined 10-year outcomes of iStent trabecular micro-bypass stent implantation with cataract surgery by one surgeon in eyes with OAG [including primary OAG (POAG) and pseudoexfoliative glaucoma (PXG)] or ocular hypertension at a multi-specialty German ophthalmology center. Study visits were conducted preoperatively and at 2.5, 3, 5, and 10 years postoperatively; examinations included intraocular pressure (IOP), medications, corrected-distance visual acuity (CDVA), and adverse events. RESULTS: A total of 63 eyes of 45 patients with OAG (n = 60 eyes) or ocular hypertension (n = 3 eyes) and data through 10 years were analyzed. Mean preoperative IOP was 18.6 ± 4.4 mmHg on 1.83 ± 1.03 mean medications. At study visits through 10 years postoperative, mean IOP reduced by 12.9-19.0% (p < 0.005 at all points), and mean medication burden reduced by 37.8-51.4% (p ≤ 0.006 at all points). At 10 years postoperatively, 77.8% of eyes had IOP ≤ 18 mmHg and 47.6% had IOP ≤ 15 mmHg (vs. 50.8% and 25.4% preoperatively, respectively; p = 0.016). One-third (33.3%) of eyes were medication-free vs. 3.2% preoperatively (p < 0.001); 17.5% were on 2-5 medications (vs. 55.6% preoperatively, p = 0.005); and 93.7% of eyes were on the same or fewer medications vs. preoperative. Post-phacoemulsification CDVA improvement was maintained; no filtering surgeries were completed over 10-year follow-up. CONCLUSIONS: Significant and safe IOP and medication reductions were observed through 10 years after iStent implantation with cataract surgery in patients with OAG or ocular hypertension.

Rates of visual field change and functional progression in glaucoma following trabecular microbypass implantation of iStent technologies: a meta-analysis.

BACKGROUND/AIM: While intraocular pressure (IOP) remains the only modifiable risk factor for glaucoma progression, the ultimate goal of glaucoma management is to preserve patients' functional vision and quality of life. To this end, minimally invasive glaucoma surgeries (MIGSs) aim to reduce IOP with minimal eye trauma. Commonly used MIGS devices include iStent technologies, which have well-documented IOP-reducing potential and favourable safety profiles. However, no study concluded on their effect on the rates of visual field (VF) changes. The aim of this meta-analysis is to determine the long-term effect of iStent technology implantation on glaucoma functional progression. METHODS: Electronic medical literature databases were searched to identify studies reporting on iStent technologies. Reports with follow-up durations <12 months, retention rates <75% and missing VF data were excluded. Fifteen studies reporting on 1115 eyes were identified. The overall weighted mean VF mean deviation (MD) progression, IOP reduction and follow-up duration were calculated. RESULTS: Weighted mean IOP at baseline was 19.0±3.1 mm Hg. At the end of a 37.9-month mean follow-up (range 12-96 months), a weighted mean 26.6% IOP reduction was achieved (range 15.2%-42.3%). Over the same duration, the weighted mean VF MD progression rate was -0.02±0.34 dBs/year, from a mean baseline of -5.76±5.68 dBs. CONCLUSION: In this review, which examines functional stability of 1115 eyes, iStent technologies achieved a mean rate of progression of -0.024 dBs/year with serial standard automated perimetry, which is similar to that reported in non-glaucomatous eyes and slower than that reported in medically treated glaucoma.

Effectiveness and Safety of iStent Infinite Trabecular Micro-Bypass for Uncontrolled Glaucoma.

PRCIS: The iStent Infinite Trabecular Micro-Bypass System implanted in patients with open angle glaucoma (OAG) (uncontrolled by prior surgical or medical therapy) was effective in reducing mean diurnal intraocular pressure with a favorable safety profile. PURPOSE: The purpose of this study is to evaluate safety and effectiveness of the iStent infinite Trabecular Micro-Bypass System in patients with OAG uncontrolled by prior surgical or medical therapy. DESIGN: Prospective, multicenter, single-arm, open-label clinical trial. METHODS: Implantation of iStent infinite (3 iStent inject W stents) was performed as a stand-alone surgical procedure in eyes with OAG uncontrolled by prior incisional or cilioablative surgeries or maximum tolerated medical therapy (MTMT). Prospectively declared effectiveness endpoints were proportion of eyes achieving ≥20% mean diurnal intraocular pressure (MDIOP) reduction from baseline at month 12 on the same or fewer intraocular pressure (IOP)-lowering medication classes (responder endpoint) and mean change in MDIOP from baseline at month 12. Safety parameters included visual acuity, slit-lamp and fundus examinations, gonioscopy, perimetry, surgical complications, and adverse events. RESULTS: Seventy-two eyes of 72 patients (mean age 71.9 y) with preoperative mean medicated MDIOP of 23.4±2.8 mm Hg on a mean of 3.1±0.9 IOP-lowering medication classes were enrolled: 61 eyes with failed prior surgery/ies (Failed-Surgery subgroup) and 11 eyes uncontrolled on MTMT (MTMT subgroup). A total of 76.1% of all enrolled patients met the responder endpoint (73.4% Failed-Surgery, 90.9% MTMT), with mean reduction (SE) in MDIOP at month 12 of 5.9(0.6) mm Hg [5.5(0.7) mm Hg Failed-Surgery subgroup, 8.1(0.9) mm Hg MTMT subgroup]. For patients on the same or fewer medication(s) as baseline, 53.0% achieved ≥30% MDIOP reduction without surgical interventions/other events. Safety was favorable, with no explants, infection, or device-related interventions or hypotony. CONCLUSIONS: iStent infinite stand-alone surgery achieved clinically significant IOP reduction and favorable safety in patients with OAG uncontrolled by prior therapy.

Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject ® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract.

PURPOSE: To examine effectiveness outcomes stratified by preoperative disease burden in the pivotal trial of iStent inject ® with cataract surgery (INJ) vs cataract surgery alone (CS). MATERIALS AND METHODS: Prospective, 3:1 randomized, single-masked, concurrently-controlled, multicenter trial enrolling 505 subjects with cataract and mild-to-moderate primary open-angle glaucoma who underwent iStent inject implantation with phacoemulsification or phacoemulsification alone, and were followed for 2 years including annual medication washouts. Post hoc stratification was completed for baseline mean diurnal intraocular pressure (BL DIOP; Low-DIOP <25mmHg, Mid-DIOP ≥25 to <30 mmHg, High-DIOP ≥30mmHg) and preoperative medication burden (Low-Med 1 medication, Mid-Med 2 medications, High-Med ≥3 medications). RESULTS: The 24-month primary and secondary effectiveness endpoints were met, with significant treatment-over-control differences in percent of eyes achieving ≥20% unmedicated DIOP reduction and in unmedicated DIOP reduction, respectively. In subgroup analyses, the proportions of INJ eyes achieving the primary endpoint remained steady across all BL DIOP (75.4%, 77.1%, 74.4% in Low/Mid/High-DIOP strata, respectively) and preoperative medication levels (76.8%, 70.8%, 79.7% in Low/Mid/High-Med strata, respectively); meanwhile, the proportions of CS eyes diminished with higher BL DIOP (64.5%, 63.6%, 33.3%, respectively) and more medications (69.0%, 63.3%, 29.4%, respectively). Regarding secondary effectiveness, postoperative DIOP reduction increased with higher BL DIOP in INJ eyes (6.2mmHg, 7.8mmHg, 9.8mmHg, respectively) but plateaued in CS eyes (5.2mmHg, 5.8mmHg, 5.4mmHg, respectively). INJ eyes also had consistent DIOP reduction regardless of preoperative medication burden (6.8mmHg, 6.7mmHg, 7.8mmHg, respectively), while DIOP reduction diminished with more medications in CS eyes (6.1mmHg, 5.0mmHg, 3.3mmHg, respectively). Safety was favorable, comparable to phacoemulsification alone. CONCLUSION: Significant IOP reductions occurred across all levels of BL DIOP and preoperative medication burden in iStent inject eyes. DIOP reductions increased with higher BL DIOP and remained stable across all levels of preoperative medication burden, suggesting the device's potential utility in more medically challenging cases.

Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract: Two-Year Results.

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 = 387) or no stent implantation (control group, n = 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 (24.8±3.3 mmHg vs. 24.5±3.1 mmHg in the treatment and control groups, respectively, P = 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 = 0.005), and mean reduction in unmedicated DIOP from baseline was greater in treatment eyes (7.0±4.0 mmHg) than in control eyes (5.4±3.7 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, 2.9-23.4). 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.

Long-term effectiveness and safety of trabecular microbypass stent implantation with cataract surgery in patients with glaucoma or ocular hypertension: Five-year outcomes.

PURPOSE: To assess 5-year outcomes after implantation of 1 trabecular microbypass stent during cataract surgery in eyes with open-angle glaucoma (OAG) or ocular hypertension. SETTING: Private ophthalmology clinic (AaM Augenklinik am Marienplatz, Munich, Germany). DESIGN: Prospective nonrandomized consecutive case series. METHODS: One trabecular microbypass stent was implanted after phacoemulsification cataract surgery by one surgeon over 4 years. Evaluations included intraocular pressure (IOP), medications, corrected distance visual acuity, cup-to-disc ratio, complications, and adverse events. RESULTS: This case series included 65 eyes of 43 patients with OAG (including primary, n = 39; pseudoexfoliative, n = 14; secondary uveitic, n = 1; posttraumatic, n = 1) or ocular hypertension (n = 10). Thirty-eight percent of eyes had previous trabeculectomy and/or glaucoma laser procedures, and 68% were on 2 or more preoperative medications. Twenty-six eyes completed follow-up through 5 years, and follow-up is ongoing. Among eyes without additional glaucoma surgery, the mean year 5 IOP decreased by 38% to 14.7 mm Hg ± 3.0 (SD) versus 23.7 ± 7.4 mm Hg preoperatively; 92% of eyes had a mean year 5 IOP of 18 mm Hg or lower and 65% had an IOP of 15 mm Hg or lower. Medications were reduced by 75% to 0.5 ± 0.9 medications versus 2.0 ± 1.0 preoperatively, with 4% of eyes on 3 to 4 medications versus 28% preoperatively, and 69% medication-free versus 5% preoperatively. The mean IOP at all postoperative visits was 16.0 mm Hg or lower and the mean medication number was 0.5 or less. Safety was favorable throughout the follow-up. CONCLUSIONS: In a real-life cohort of eyes with OAG or ocular hypertension, substantial, durable, and safe IOP and medication reductions were achieved through 5 years after trabecular microbypass stent implantation with cataract surgery.

Long-term titrated IOP control with one, two, or three trabecular micro-bypass stents in open-angle glaucoma subjects on topical hypotensive medication: 42-month outcomes.

PURPOSE: Evaluate long-term outcomes after one, two, or three trabecular micro-bypass stents implanted in a standalone procedure in eyes with open-angle glaucoma taking ocular hypotensive medication. PATIENTS AND METHODS: Prospective randomized ongoing study of 119 subjects (109 with 42-month follow-up) with open-angle glaucoma, preoperative intraocular pressure (IOP) 18-30 mmHg on one to three glaucoma medications, and unmedicated (post-washout) IOP 22-38 mmHg. Subjects were randomized to receive one (n=38), two (n=41), or three (n=40) iStent trabecular micro-bypass stents in a standalone procedure. Postoperatively, IOP was measured with medication and annually following washout. Data included IOP, medications, gonioscopy, pachymetry, visual field, visual acuity, adverse events, and slit-lamp and fundus examinations. RESULTS: Preoperative mean medicated IOP was 19.8±1.3 mmHg on 1.71 medications in one-stent eyes, 20.1±1.6 mmHg on 1.76 medications in two-stent eyes, and 20.4±1.8 mmHg on 1.53 medications in three-stent eyes. Post-washout IOP prior to stent implantation was 25.0±1.2, 25.0±1.7, and 25.1±1.9 mmHg in the three groups, respectively. Postoperatively, Month 42 medicated IOP was 15.0±2.8, 15.7±1.0 and 14.8±1.3 mmHg in the three groups, and post-washout IOP (Months 36-37) was 17.4±0.9, 15.8±1.1 and 14.2±1.5 mmHg, respectively. IOP reduction ≥20% without medication was achieved in 89%, 90%, and 92% of one-, two-, and three-stent eyes, respectively, at Month 12; and in 61%, 91%, and 91% of eyes, respectively, at Month 42. The need for additional medication remained consistent at Months 12 and 42 in multi-stent eyes (four two-stent eyes and three three-stent eyes at both time points), whereas it increased in single-stent eyes (four eyes at Month 12 versus 18 eyes at Month 42). Safety parameters were favorable in all groups. CONCLUSION: The standalone implantation of either single or multiple iStent® device(s) produced safe, clinically meaningful IOP and medication reductions through 42 months postoperatively, with incrementally greater and more sustained reductions in multi-stent eyes.

Prospective Evaluation of Two iStent® Trabecular Stents, One iStent Supra® Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes.

INTRODUCTION: This study evaluates long-term outcomes of two trabecular micro-bypass stents, one suprachoroidal stent, and postoperative prostaglandin in eyes with refractory open angle glaucoma (OAG). METHODS: Prospective ongoing 5-year study of 80 eligible subjects (70 with 4-year follow-up) with OAG and IOP ≥ 18 mmHg after prior trabeculectomy and while taking 1-3 glaucoma medications. Subjects received two iStent® trabecular micro-bypass stents, one iStent Supra® suprachoroidal stent, and postoperative travoprost. Postoperative IOP was measured with medication and annually following medication washouts. Performance was measured by the proportion of eyes with ≥ 20% IOP reduction on one medication (the protocol-specified prostaglandin) versus preoperative medicated IOP (primary outcome); and the proportion of eyes with postoperative IOP ≤ 15 and ≤ 18 mmHg on one medication (secondary outcome). Additional clinical and safety data included medications, visual field, pachymetry, gonioscopy, adverse events, visual acuity, and slit-lamp and fundus examinations. RESULTS: Preoperatively, mean medicated IOP was 22.0 ± 3.1 mmHg on 1.2 ± 0.4 medications, and mean unmedicated IOP was 26.4 ± 2.4 mmHg. Postoperatively, among eyes without later cataract surgery, mean medicated IOP at all visits through 48 months was ≤ 13.7 mmHg (≥ 37% reduction), and annual unmedicated IOP was ≤ 18.4 mmHg (reductions of ≥ 30% vs. preoperative unmedicated IOP and ≥ 16% vs. preoperative medicated IOP). At all postoperative visits among eyes without additional surgery or medication, ≥ 91% of eyes had ≥ 20% IOP reduction on one medication versus preoperative medicated IOP. At month 48, 97 and 98% of eyes achieved IOP ≤ 15 and ≤ 18 mmHg, respectively, on one medication. Six eyes required additional medication, no eyes required additional glaucoma surgery, and safety measurements were favorable throughout follow-up. CONCLUSION: IOP control was achieved safely with two trabecular micro-bypass stents, one suprachoroidal stent, and postoperative prostaglandin. This microinvasive, ab interno approach introduces a possible new treatment option for refractory disease. TRIAL REGISTRATION: NCT01456390. FUNDING: Glaukos Corporation.

Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up.

IMPORTANCE: Additional data are sought regarding treatment options for glaucoma, a major cause of global blindness. BACKGROUND: The study assessed outcomes following standalone implantation of two second-generation trabecular micro-bypass stents and postoperative topical prostaglandin in eyes with open-angle glaucoma not controlled on two preoperative medications. DESIGN: The study design is a prospective, nonrandomized, open-label study at a tertiary-care ophthalmology centre. PARTICIPANTS: Subjects had open-angle glaucoma with preoperative intraocular pressure of 18-30 mmHg on two medications, a medication washout phase, and post-washout intraocular pressure of 22-38 mmHg. All subjects (N = 53) have been followed for 18 months. METHODS: One day following implantation of two second-generation trabecular micro-bypass stents, subjects started topical travoprost. Medication washout was repeated at month 12. MAIN OUTCOME MEASURES: The main outcome measure was the proportion of eyes with intraocular pressure reduction ≥ 20% versus medicated baseline intraocular pressure with reduction of one medication at 12 months. RESULTS: At 12 months, 91% of eyes achieved intraocular pressure reduction ≥ 20% with reduction of one medication. All eyes had intraocular pressure ≤ 18 mmHg with reduction of one medication, and 87% had intraocular pressure ≤ 15 mmHg. Mean intraocular pressure on one medication was ≤ 13.0 mmHg (≥ 34% reduction) through 18 months. Mean post-washout intraocular pressure at month 13 was 33% lower than preoperative unmedicated intraocular pressure. No adverse events occurred through 18 months. CONCLUSIONS AND RELEVANCE: In open-angle glaucoma eyes on two preoperative medications, treatment with two second-generation trabecular stents and one postoperative prostaglandin resulted in mean intraocular pressure ≤ 13 mmHg with reduction of one medication, with favourable safety. These findings show the utility of second-generation trabecular bypass with postoperative prostaglandin in patients with open-angle glaucoma.

Efficacy of two trabecular micro-bypass stents combined with topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 3-year follow-up.

PURPOSE: To evaluate the long-term intraocular pressure (IOP)-lowering effect and safety parameters following treatment with two trabecular micro-bypass stents and topical prostaglandin in phakic eyes with open-angle glaucoma (OAG) not controlled on two preoperative medications. METHODS: This prospective, single-arm, unmasked study enrolled 39 qualified phakic eyes with OAG not controlled on 2 medications, preoperative medicated IOP of 18-30 mmHg, and IOP following medication washout of 22-38 mmHg. Two trabecular micro-bypass stents were implanted as a standalone procedure, and travoprost was started on postoperative day 1. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit-lamp examinations, visual field, cup:disc ratio, central corneal thickness, and ocular complications. Data through 18 months were summarized previously. Thirty-seven of the original 39 subjects have been followed for 3 years postoperatively; follow-up is continuing for 5 years. RESULTS: At 3 years postoperative, 97% of eyes had achieved an IOP reduction of ≥20% from baseline with a reduction of 1 medication. Eighty-six percent of eyes had IOP of ≤18 mmHg with a reduction of 1 medication. Mean medicated IOP decreased to 14.0±2.6 mmHg on 1 medication versus 22.4±2.3 mmHg on 2 medications preoperatively. The mean unmedicated IOP decreased to 17.7±1.7 mmHg at 37 months from 25.3±1.9 mmHg preoperatively. Long-term postoperative adverse events included cataract surgery in 3 eyes due to cataract progression, and trabeculectomy in 1 eye due to uncontrolled IOP of 23 mmHg. No intraoperative or device-related adverse events occurred. CONCLUSION: Significant and sustained reduction in IOP and medications with a favorable safety profile was shown through 3 years after implantation of 2 trabecular micro-bypass stents combined with postoperative travoprost in phakic OAG eyes uncontrolled on 2 preoperative medications. These findings demonstrate the long-term performance and safety of trabecular bypass stents in combination with topical prostaglandin for OAG patients.

Occurrence of and Risk Factors for Ocular Hypertension and Secondary Glaucoma in Juvenile Idiopathic Arthritis-associated Uveitis.

PURPOSE: To describe the incidence of ocular hypertension (OHT) and secondary glaucoma (SG) in JIA-associated uveitis, identify risk factors for development of these complications, and describe their effect on visual outcomes. METHODS: A retrospective cohort of 108 patients (196 eyes) with JIA-associated uveitis seen over 30 years at an academic practice. RESULTS: Of examined eyes, 40% had OHT or SG at presentation. These eyes had a nearly three-fold higher incidence of legal blindness during follow-up, compared with eyes without OHT or SG. An additional 41 eyes developed OHT or SG during follow-up. Presenting with anterior uveitis, active inflammation, and using systemic corticosteroids were risk factors for developing OHT, while use of immunosuppressive medication at presentation reduced this risk. Risk factors for developing SG included anterior uveitis and use of systemic corticosteroids. CONCLUSIONS: OHT and SG were common in patients with JIA-associated uveitis. Use of immunosuppressive drugs may decrease the risk of developing OHT.

Outcomes of combined trabecular micro-bypass and phacoemulsification in a predominantly Hispanic patient population.

PURPOSE: The purpose of this study was to evaluate intraocular pressure (IOP) and topical ocular hypotensive medication burden at 12 months postoperatively in a predominantly Hispanic patient population with primary open-angle glaucoma each implanted with one trabecular micro-bypass stent during cataract surgery. METHODS: This was a retrospective, consecutive case series. The main objective was to assess reduction of IOP and/or medication burden in all eyes at the 12-month postoperative exam. A secondary objective was to assess outcomes in 3 subgroups, distinguished preoperatively by IOP control and by medication burden (suboptimal or maximum therapy) and with different treatment goals. Group 1 had medication-controlled IOP and goal to reduce medications while maintaining IOP control (n=65); Group 2 had uncontrolled IOP on ≤2 medications and goal to reduce IOP and maintain/reduce medication burden (n=31); and Group 3 had uncontrolled IOP on ≥3 medications and goal to reduce IOP and avoid filtering surgery (n=38). Evaluations included IOP, medication use, cup-to-disc ratio, visual fields, complications, and interventions. One hundred subjects (134 eyes) have been followed for 12 months. RESULTS: Most patients (80%) were Hispanic and had moderate or severe glaucoma (87%). At 12 months, mean IOP reduced to 12.9 mmHg vs 16.5 mmHg preoperatively; 92% had an IOP ≤15 mmHg at 12 months (99% had ≤18 mmHg). Mean medication burden had decreased to 0.9 vs 2.3 preoperatively. At the 12-month time point, 94% of all eyes achieved their predefined treatment goal of reduced IOP and/or medications. Reductions in medication burden for Group 1, and in IOP for Groups 2 and 3, were highly statistically significant (P<0.001). Two eyes in Group 3 had filtering surgery; the remaining 95% avoided such treatment. No other complications were reported. CONCLUSION: This mainly Hispanic population with predominantly moderate or severe glaucoma had substantial reduction of IOP and medication and favorable safety for 12 months following stent implantation during cataract surgery, with treatment success achieved in all 3 subgroups. These data show this stent technology to be effective in Hispanic eyes with more advanced disease.

Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up.

INTRODUCTION: The study objective was to evaluate the intraocular pressure (IOP) and medication-lowering effect of 2 second-generation trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) on one preoperative medication. METHODS: Fifty-seven qualified phakic eyes with OAG on 1 medication, preoperative medicated IOP of 18-30 mmHg, and preoperative unmedicated (post-washout) IOP of 22-38 mmHg underwent implantation of 2 second-generation trabecular micro-bypass stents in a standalone procedure. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit lamp examinations, visual field, cup to disc ratio, pachymetry, and complications and interventions. Subjects have been followed for 18 months, and follow-up is ongoing. RESULTS: At Month 12 postoperative, 100% of eyes had achieved an IOP reduction ≥20% (100% had IOP ≤18 mmHg and 67% had IOP ≤15 mmHg) without medication versus preoperative unmedicated IOP, and 75% had IOP reduction ≥20% without medication versus preoperative medicated IOP. The Month 12 mean unmedicated IOP had decreased by 42%, to 14.2 ± 1.9 mmHg vs 24.4 ± 1.3 mmHg preoperatively, and this reduction was maintained through 18 months (14.4 ± 2.1 mmHg). A high safety profile was observed. CONCLUSION: In this prospective, open-label, single-arm study, the standalone implantation of two second-generation trabecular micro-bypass stents in OAG patients on 1 preoperative medication resulted in IOP reduction to ≤15 mmHg and elimination of medication through 18 months, with favorable safety. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02868190. FUNDING: Glaukos Corporation, San Clemente, CA.

Risk of Hypotony in Juvenile Idiopathic Arthritis-Associated Uveitis.

OBJECTIVE: To describe risk factors for hypotony in patients with juvenile idiopathic arthritis (JIA)-associated uveitis. DESIGN: Retrospective cohort study. METHODS: All patients with JIA-associated uveitis (N = 108; affected eyes = 196) evaluated and followed at the Wilmer Eye Institute from July 1984 through June 2014 were included in this study. Prevalence and incidence of hypotony (intraocular pressure [IOP] <5 mm Hg) and low IOP (5 mm Hg ≤ IOP < 8 mm Hg) and risk factors for developing hypotony were analyzed. RESULTS: At presentation, 9.3% of patients (7.1% of affected eyes) had hypotony. During a median follow-up of 5.3 years, the rate of developing hypotony and low IOP were 0.04 per eye-year (/EY; 95% confidence interval [CI]: 0.02/EY, 0.05/EY) and 0.06/EY (95% CI: 0.04/EY, 0.08/EY), respectively. Risk factors for development of hypotony during follow-up appeared to be associated with more severe uveitic disease, such as the presence of panuveitis (adjusted hazard ratio [aHR], 43.1; P = .004), anterior chamber cells or flare ≥ 3+ (aHR, 25.6, P < .001), posterior synechiae (aHR, 5.9, P = .02), and the use of oral corticosteroid (aHR 28.9; P = .003) at the presenting examination. Receiving immunosuppressive drug therapy at the time of presentation was associated with a lower risk of development of hypotony (aHR, 0.02; P = .002). CONCLUSIONS: Hypotony affects a small but significant proportion of patients with JIA-associated uveitis and is associated with signs of active and severe uveitis. Immunosuppression was associated with significantly lower risk of hypotony, suggesting that aggressive control of the inflammation may reduce risk of hypotony in JIA-associated uveitis.

Treatment Options for Juvenile Idiopathic Arthritis (JIA) Associated Uveitis.

PURPOSE: To summarize the available published data regarding the treatment of JIA-associated chronic uveitis. METHODS: Available peer-reviewed publications regarding the treatments of JIA-associated uveitis were read by multiple authors (RMA, EM, JET, and DH) and the data from these reports were synthesized for this review. RESULTS: Juvenile idiopathic arthritis (JIA)-associated chronic uveitis is a significant cause of ocular morbidity and visual impairment in children, often resulting in more frequent complications and worse visual outcomes than other types of pediatric uveitis. Since not all patients respond to the first medication introduced, it is useful to have a wide range of available treatment modalities to address recalcitrant disease. Treatment options for JIA-associated uveitis have increased substantially over the past decade, particularly with the availability of newer biological agents in addition to established medication classes such as anti-inflammatories (including topical and systemic corticosteroids) and antimetabolites. CONCLUSIONS: Although data are increasing regarding biologic agents, definitive randomized prospective clinical trials would be helpful to determine their optimal dose, frequency, treatment duration, and long-term safety in children.

Immunosuppressive therapy for eye diseases: Effectiveness, safety, side effects and their prevention.

Ocular inflammation is a significant cause of ocular morbidity and visual impairment. Topical, periocular, intraocular, and systemic corticosteroids are highly effective for treating appropriate forms of ocular inflammation. However, their use may be constrained by local and/or systemic side effects, especially if long-term therapy is required. As a result, immunosuppressive agents increasingly have been used to manage ocular inflammation alongside or in place of corticosteroids. The four categories of agents used today are antimetabolites [primarily methotrexate, mycophenolate mofetil (MMF), and azathioprine]; T-cell inhibitors (usually cyclosporine, less often tacrolimus or sirolimus); alkylating agents (cyclophos-phamide and chlorambucil); and biologic agents [tumor necrosis factor (TNF) inhibitors, lymphocyte inhibitors, and interleukin inhibitors]. The primary goals of immunosuppressive therapy are (1) to control inflammation when corticosteroids fail to do so; (2) to prevent corticosteroid-induced toxicity when the necessary corticosteroid dosage exceeds the desired or safe level (corticosteroid sparing); and (3) to treat specific high-risk uveitis syndromes known to respond poorly to corticosteroids alone. Growing evidence shows the effectiveness of immunosuppressive drugs in achieving these goals, as well as improved visual function, prevention of ocular complications, and in some cases even disease remission. However, these agents also have side effects, which must be considered in each patient's management. In this report, we summarize the effectiveness and safety of immunosuppressive drug therapy utilized in the treatment of ocular inflammatory diseases.

Interobserver agreement in clinical grading of vitreous haze using alternative grading scales.

PURPOSE: To evaluate the reliability of clinical grading of vitreous haze using a new 9-step ordinal scale versus the existing 6-step ordinal scale. DESIGN: Evaluation of diagnostic test (interobserver agreement study). PARTICIPANTS: A total of 119 consecutive patients (204 uveitic eyes) presenting for uveitis subspecialty care on the study day at 1 of 3 large uveitis centers. METHODS: Five pairs of uveitis specialists clinically graded vitreous haze in the same eyes, one after the other using the same equipment, using the 6- and 9-step scales. MAIN OUTCOME MEASURES: Agreement in vitreous haze grade between each pair of specialists was evaluated by the κ statistic (exact agreement and agreement within 1 or 2 grades). RESULTS: The scales correlated well (Spearman's ρ = 0.84). Exact agreement was modest using both the 6-step and 9-step scales: average κ = 0.46 (range, 0.28-0.81) and κ = 0.40 (range, 0.15-0.63), respectively. Within 1-grade agreement was slightly more favorable for the scale with fewer steps, but values were excellent for both scales: κ = 0.75 (range, 0.66-0.96) and κ = 0.62 (range, 0.38-0.87), respectively. Within 2-grade agreement for the 9-step scale also was excellent (κ = 0.85; range, 0.79-0.92). Two-fold more cases were potentially clinical trial eligible on the basis of the 9-step than the 6-step scale (P<0.001). CONCLUSIONS: Both scales are sufficiently reproducible using clinical grading for clinical and research use with the appropriate threshold (≥ 2- and ≥ 3-step differences for the 6- and 9-step scales, respectively). The results suggest that more eyes are likely to meet eligibility criteria for trials using the 9-step scale. The 9-step scale appears to have higher reproducibility with Reading Center grading than clinical grading, suggesting that Reading Center grading may be preferable for clinical trials.

No light perception vision from compressive thyroid orbitopathy.

Thyroid eye disease (TED) is an autoimmune inflammatory disorder that affects the extraocular soft tissues and causes eyelid retraction, proptosis and restrictive extraocular myopathy. Compressive optic neuropathy from extraocular muscle enlargement occurs in less than 5% of patients, in the majority of whom it develops within 18 months of the diagnosis of hyperthyroidism. Vision loss from compressive optic neuropathy in patients with thyroid eye disease is usually bilateral and insidious in onset and progression and is associated with diplopia and elevated intraocular pressure. To our knowledge, there have been no reported cases of acute vision loss to the level of no light perception secondary to thyroid orbitopathy. The authors report a 66-year-old Caucasian male with history of long-standing thyroid eye disease and massive proptosis who progressed from mild compressive symptoms to no light perception within days, despite being clinically stable for over 10 years.

Emerging trends in breastfeeding practices in Singaporean Chinese women: findings from a population-based study.

INTRODUCTION: This study records the prevalence and patterns of breastfeeding in Singaporean Chinese mothers who gave birth between 2000 and 2008. MATERIALS AND METHODS: The Strabismus, Amblyopia and Refractive Error in Singaporean Children (STARS) study is a population-based survey conducted in South-Western Singapore. Disproportionate random sampling by 6-month age groups of Chinese children born from 2000 to 2008 was performed. The mothers (n = 3009) completed a standard questionnaire which recorded the initiation, content, method and duration of breastfeeding. World Health Organization (WHO) definitions for feeding content were used: Replacement (exclusive commercial formula or any liquid or solid/semi-solid food, excluding breast milk), Complementary (breast milk, solid/semi-solid foods, and any non-human liquid), and Exclusive (breast milk only, without additional food, drink or water). STARS-specific definitions for feeding method were used: Expressed (breast milk only fed via bottle, with no additional food or non-human liquid), Combination (breast milk and non-breast milk, fed via bottle and breast), and Direct (breast milk only fed via breast). RESULTS: Breastfeeding initiation (overall prevalence 77.0%) and duration increased over time, and were independently associated with higher maternal education: in 2000 and 2001, 68.6% of mothers initiated breastfeeding and 12.9% breast fed for or=6 months, vs 90.9% and 35.3%, respectively, of university-educated women (P <0.001). Expressed, Combination and Complementary feeding also increased, while Replacement feeding decreased (P <0.001). There was no difference in breastfeeding patterns by the child's gender. CONCLUSIONS: In a population-based sample of Singaporean Chinese mothers giving birth from 2000 to 2008, breastfeeding initiation and duration increased over time and were independently associated with higher maternal education. This increase was associated with increased milk expression and complementary feeding. Thus awareness of breastfeeding benefits is rising in Singapore, but future health policies may need to target less-educated mothers.

Prevalence of refractive error in Singaporean Chinese children: the strabismus, amblyopia, and refractive error in young Singaporean Children (STARS) study.

PURPOSE: To determine the prevalence of refractive error types in Singaporean Chinese children aged 6 to 72 months. METHODS: The Strabismus, Amblyopia and Refractive Error in Singaporean Children (STARS) is a population-based study in southwest Singapore. Door-to-door recruitment of participants was used, with disproportionate random sampling in 6-month increments. Parental questionnaires were administered. Participant eye examinations included logMAR visual acuity, cycloplegic autorefraction, and ocular biometry. Overall and age-specific prevalences of myopia (spherical equivalence [SE] or= +3.00 D), astigmatism (cylinder >or= +1.50 D), and anisometropia (SE difference between each eye >or=2.00 D) were calculated. RESULTS: A total of 3009 children were examined (participation rate, 72.3%). Right eye (OD) cycloplegia data were available for 1375 boys and 1264 girls (mean age, 41 months). Mean OD SE was +0.69 D (SD 1.15). Overall myopia prevalence was 11.0% with no variance between the sexes (P = 0.91). The prevalence of high myopia (at least -6.00 D) was 0.2%. The prevalences of hyperopia, astigmatism, and anisometropia were 1.4%, 8.6%, and 0.6%, respectively. Most astigmatism (>95%) was with-the-rule (cylinder axes between 1 degrees and 15 degrees or 165 degrees and 180 degrees ). Myopia was present in 15.8%, 14.9%, 20.2%, 8.6%, 7.6%, and 6.4% of children aged 6 to 11, 12 to 23, 24 to 35, 36 to 47, 48 to 59, and 60 to 72 months, respectively. Prevalence increased with age for astigmatism (P < 0.001), but not for hyperopia or anisometropia (P = 0.55 and P = 0.37), respectively. CONCLUSIONS: The prevalences of myopia and astigmatism in young Singaporean Chinese children are high, but that of hyperopia is low. Age effects were observed for each refractive error category, but differences between the sexes were not significant. Age-related variation in myopia prevalence may be influenced by ocular development, environment, and/or testability.