Real-World Assessment of Second-Generation Trabecular Micro-Bypass Stents in Open-Angle Glaucoma Patients

Neovascular glaucoma (NVG) is a vision-threatening condition commonly associated with uncontrolled intraocular pressure (IOP). Ahmed glaucoma valve (AGV) implantation and Ex-PRESS shunt insertion are 2 frequently applied surgical techniques. This study aimed to compare the short-term and 1-year outcomes of these procedures when combined with intravitreal conbercept therapy. Forty-four patients diagnosed with NVG were randomly allocated to either the AGV group (n = 24) or the Ex-PRESS group (n = 20). All participants received adjunctive intravitreal conbercept injections. Postoperative assessments (including IOP, best-corrected visual acuity, iris neovascularization regression, use of antiglaucoma medication, and complication rates) were conducted on day 1, week 1, and at 1, 3, 6, and 12 months. No significant difference in IOP reduction was observed between the 2 groups up to 6 months after surgery. At the 12-month follow-up, mean IOP was significantly lower in the AGV group (18.17 ± 4.41 mm Hg) compared with the Ex-PRESS group (21.60 ± 5.25 mm Hg; P = .02). Improvements in best-corrected visual acuity, regression of iris neovascularization, and surgical success rates were comparable between the 2 groups during the early postoperative period. Nevertheless, AGV implantation showed a sustained advantage in long-term IOP control. Both AGV and Ex-PRESS implantation combined with conbercept provide effective and safe short-term management for NVG. Over a 1-year period, AGV implantation demonstrated better IOP control, indicating its potential benefit for long-term outcomes in NVG treatment.

PurposeTo analyse real-world outcomes in Asian eyes of iStent inject, a second-generation trabecular micro-bypass stent, combined with phacoemulsification.MethodsThis is a multi-centre, observational study of glaucomatous Asian eyes that have undergone iStent inject implantation combined with cataract surgery. Patient data were extracted from the Fight Glaucoma Blindness! Registry. Outcome measures included those of IOP reduction, glaucoma medication reduction, and adverse events including the need for secondary surgery.Results123 eyes of 86 patients with a mean age of 68.4 ± 9.3 years underwent iStent inject implantation with phacoemulsification. At baseline, the mean ± SD preoperative intraocular pressure (IOP) was 16.0 ± 4.4 mmHg, and the mean preoperative number of topical glaucoma medications was 1.9 ± 1.4. At 12 months 30.8% of eyes demonstrated a reduction in IOP greater than 20%, the mean IOP reduction was 12.5% with an additional reduction of 0.7 glaucoma medications. 40% of eyes were using no medications at 12 months compared to 16.3% preoperatively. 8.2% of eyes required a subsequent procedure within the 12-month follow-up window.ConclusioniStent inject implantation combined with phacoemulsification in Asian eyes showed a reduction of IOP and glaucoma medication use in a real-world clinical setting. The safety profile of the device is good with minimal adverse outcomes, however, a subset of patients required secondary procedures within the 12 month follow up.

Purpose:To compare the outcomes of iStent vs. iStent inject implantation combined with phacoemulsification.Methods:This single center retrospective comparative case series included subjects with open angle glaucoma who underwent iStent or iStent inject implantation combined with phacoemulsification with ≥1 year follow-up. The main outcome measures were in-group and between-group changes in intraocular pressure (IOP) and medication number, proportion of eyes that achieved IOP ≤15 mmHg, and surgical success defined as 20% IOP reduction from baseline at 6/12 months. Univariate/multivariate regression analyses were done to identify predictors of surgical failure.Results:One hundred ninety-seven eyes of 148 patients were included (122 iStent, 75 iStent inject). Both groups achieved significant IOP and medication reduction at months 6/12 (P < 0.05). At month 6, IOP was significantly lower in iStent inject vs. iStent eyes (P = 0.003), but the difference was insignificant by month 12 (P = 0.172). Medication number was comparable in both groups at months 6/12 (P > 0.05). More iStent inject eyes achieved IOP ≤15 mmHg at month 6 (P = 0.003) and 12 (P = 0.047). Surgical success was comparable in both groups at months 6/12 (P > 0.05). Kaplan–Meier survival analysis showed similar cumulative rate of surgical failure at year-1 in both groups (P = 0.644). The multivariate model identified older age (P = 0.017) and lower baseline IOP (P = 0.002) as the strongest predictors of surgical failure.Conclusion:Compared to iStent, iStent inject achieved lower IOP at month 6 and higher proportion of eyes achieved IOP ≤15 mmHg at month 6/12. However, surgical success was similar in both groups. Predictors of surgical failure were older age and lower baseline IOP rather than the stent type.

This longitudinal case series provides valuable long-term data on the safety and efficacy of iStent inject with concomitant cataract surgery. Patients experienced significant and durable reductions in both intraocular pressure (IOP) and medication burden through 3 years postoperative. The purpose of this study was to examine the 3-year effectiveness and safety of iStent inject second-generation trabecular micro-bypass stent implantation with concomitant phacoemulsification cataract surgery in eyes with various glaucoma subtypes and severities. This was a single-center consecutive case series. Three-year outcomes included mean IOP and medications, the proportions of eyes with IOP ≤18, ≤15, and ≤12 mm Hg, and success (absence of secondary glaucoma interventions). Safety included best-corrected visual acuity (BCVA), cup-to-disc ratio, visual field (VF) mean deviation, retinal nerve fiber layer (RNFL), and ganglion cell-inner plexiform layer (GCIPL) thickness, and adverse events. A total of 124 eyes with different glaucoma subtypes and severities were included. At 3 years postoperative, mean IOP reduced from 16.90±3.85 mm Hg preoperatively to 13.17±2.83 mm Hg (22% reduction, P<0.001) and mean medication burden decreased from 2.38±1.29 medications preoperatively to 1.16±1.22 medications (51% reduction, P<0.001). At 3 years, 96% of eyes achieved IOP ≤18 mm Hg (vs. 69% preoperatively), 80% of eyes achieved IOP ≤15 mm Hg (vs. 40% preoperatively), and 42% of eyes achieved IOP ≤12 mm Hg (vs. 7% preoperatively) with 76% of eyes eliminating ≥1 medication and 37% of eyes eliminating ≥2 medications versus preoperative medication burden. The 3-year cumulative survival rate was 74%. Postphacoemulsification BCVA improvement was preserved, and cup-to-disc ratio, VF mean deviation, and RNFL and GCIPL thickness remained stable. A favorable safety profile included no intraoperative complications and few, transient, postoperative adverse events. Significant and sustained IOP and medication reductions were achieved through 3 years after iStent inject implantation with cataract surgery in a real-world clinical population with mild-to-severe glaucoma, along with favorable safety including stable BCVA, VF, and RNFL and GCIPL thickness.

Cataract Extraction and the Iris Configuration

PurposeTo evaluate the postoperative outcomes of cataract surgery and intraocular lens (IOL) implantation on visual outcomes and complications in pediatric patients with Juvenile Idiopathic Arthritis-Associated Uveitis.MethodsThis study included 25 patients (30 eyes) with uveitis and cataracts who underwent cataract surgery. The study was conducted as a retrospective study. Patients were divided into two groups based on their preoperative treatment: those who received immunomodulatory therapy (IMT) along with systemic corticosteroids and those who received IMT in combination with a biologic therapy. Best corrected visual acuity (BCVA), intraocular pressure (IOP), central macular thickness (CMT), macular volume (MV), and postoperative complications were assessed at various time points up to 12 months. All surgeries were performed by a single surgeon.ResultsSignificant improvement in BCVA were observed postoperatively in both study groups, with approximately 80% of eyes showing improvement. Mean BCVA improved from 0.89 ± 0.63 to 0.37 ± 0.33 in group 1and from 0.82 ± 0.68 to 0.35 ± 0.31 in group 2 after 12 months. Postoperatively, there was a decrease in mean IOP, with no significant variance observed between the two groups. Complications were observed in 73% of cases, including posterior capsular opacification (PCO), secondary glaucoma, and macular edema (ME), but did not significantly differ between groups.ConclusionCataract surgery in children with uveitis associated with JIA presents significant challenges due to the risk of postoperative complications, even with adequate preoperative and postoperative care. The similar improvement in BCVA observed in both groups suggests that different systemic therapies were sufficient for satisfactory control of inflammation before and after surgery.

To assess the efficacy of autologous platelet-rich plasma (PRP) injections in suprachoroidal space and subtenon space in cases of retinitis pigmentosa, which is a genetic disease, leading to gradual loss of vision. Till date, no treatment is available. Seventy-eight eyes of 39 patients of retinitis pigmentosa having visual acuity ranging from reading of Early Treatment Diabetic Retinopathy Study (ETDRS) chart from 1 m onward to patients who were not able to read the ETDRS chart but whose visual acuity ranged from finger count close to face to <1 m were included in the study. The left and right eyes of each patient were randomized as the intervention eye and control eye. 0.2 mL of autologous PRP was injected in suprachoroidal space and 0.5 mL of PRP was injected in subtenon space of the intervention eye taking aseptic precautions. Injections were repeated at 15-day intervals up to 3 injections. Majority of patients were in the age group of 18-30 years (20 cases) followed by 31-45 years (13 cases) and more than 45 years (6 cases). Intervention eyes showed a statistically significant improvement in visual acuity and multifocal electroretinography (mfERG). Improvement was noted in amplitude density latency and in ring ratio of mfERG. There was a significant improvement in best-corrected visual acuity (BCVA). However, no improvement in mfERG or BCVA was observed in the control group. Gene therapy may be the ultimate cure for retinitis pigmentosa, but it is unaffordable for many patients due to its high cost. PRP may be recognized as a modality to improve vision and stop further deterioration, especially in cases where functional vision is preserved. Negligible treatment costs and affordability will give power to economically disadvantaged patients.

BackgroundThis study was conducted to evaluate the safety and efficacy of adding a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin analog (PGA) monotherapy in patients with primary open-angle glaucoma, pigment dispersion glaucoma, or ocular hypertension who require additional intraocular pressure (IOP) reduction.MethodsThis was a prospective, multicenter (n = 5), open-label, single-arm, Phase IV clinical trial in which patients currently being treated with a PGA but requiring additional IOP reduction were administered brinzolamide 1%/timolol 0.5% twice daily as adjunctive therapy to their current PGA monotherapy regimen. The primary objective was to examine the IOP-lowering efficacy of brinzolamide-timolol when used as adjunctive therapy.ResultsForty-seven patients enrolled in and completed the study. After 12 weeks of adjunctive brinzolamide-timolol therapy, the mean IOP of the total patient population decreased from 22.1 mmHg at baseline to 16.7 mmHg. The mean IOP reduction of 5.4 mmHg (24.4%) was both clinically and statistically significant (P < 0.001). This significant decrease in mean IOP at week 12 was maintained across all PGA groups (P < 0.05). No significant differences were observed in symptom frequency between baseline and week 12 for any of the six solicited symptoms. A total of 17 adverse events from six patients was reported, of which ten were drug-related. Most (n = 7) of the drug-related adverse events were mild or moderate in intensity. None of the adverse events required any treatment or resulted in treatment interruption or discontinuation. Of the 90 eligible eyes, 85.6% had a decrease in IOP of at least 3 mmHg from baseline and 98% of patients had a decrease in IOP of ≥1 mmHg.ConclusionThis study suggests that a fixed combination of brinzolamide 1%/timolol 0.5% can provide additional IOP reduction effectively and safely when used as adjunctive therapy for patients receiving insufficient IOP reduction from PGA monotherapy.

BackgroundTo assess the efficacy and safety of supra-choroidal (SC) Iluvien in the management of chronic diabetic macular edema (DME).MethodsA retrospective interventional non-comparative consecutive case series including patients with chronic DME who received an SC Iluvien implant. All patients had persistent central macular thickness (CMT) ≥ 300µ after previous treatment with anti-vascular endothelial growth factor (VEGF) agents or laser photocoagulation. The main outcome measures were improvement of best-corrected visual acuity (BCVA), reduction of CMT, and detection of ocular hypertension/glaucoma or cataract formation. Friedman’s two-way ANOVA was used to analyze BCVA, intraocular pressure (IOP), and DME across different time points. P-value = 0.05.ResultsThe study included 12 eyes of 12 patients. Six patients (50%) were males. The median age was 58 years (range 52–76 years). The median duration of DM was 13 years (range 8–20 years). Ten patients (83.3%) were phakic and 2 patients (17%) were pseudophakic. The median pre-operative BCVA was 0.07 (range 0.05–0.8). The median pre-operative CMT was 544µ (range 354–745µ). The median pre-operative IOP was 17 mmHg (range 14-21mmHg). The median follow-up period was 12 months, range (12–42). Post-operatively, the median final BCVA was 0.15 (range 0.03-1), p 0.02, the median CMT was 404µ (range 213–747), p 0.4 and the median IOP was 19.5 mmHg (range 15–22), p 1. Two out of 10 phakic patients (20%) developed nuclear sclerosis grade I by 12 months. Six patients (50%) developed a transient rise in IOP < 10 mmHg from the baseline that resolved within 3 weeks with antiglaucoma drops.ConclusionSC Iluvien is potentially effective in improving visual function, reducing macular edema, and reducing the incidence of steroid-induced cataracts and glaucoma.

Purpose: To analyze the intraocular pressure (IOP) lowering effect, prognostic factors, and complications that occurred after iStent inject® or XEN® implantation in South Korea.Methods: We retrospectively analyzed 83 eyes with glaucoma who were followed-up for more than 6 months after iStent inject® or XEN® implantation alone or combination with cataract surgery. The success of surgery was defined as an IOP ≤21 mmHg and IOP reduction ≥20% from preoperative IOP.Results: The average IOP drop rate for 6 months after surgery was 33.80% for iStent inject® (group A, 24 eyes), 24.91% for XEN® (group B, 15 eyes), 20.47% for combined iStent inject® and cataract surgery (group A-1, 32 eyes), and 30.39% for combined XEN® and cataract surgery. The cumulative success rate of 6 months after surgery was 45.5% ± 11.2% for group A, 52.8% ± 15.4% for group B, 51.9% ± 9.0% for group A-1, and 83.3% ± 10.8% for group B-1. The difference in success rates between groups A and B was not statistically significant (p = 0.574), and also between groups A-1 and B-1 (p = 0.079).Conclusions: iStent inject® and XEN® both have a significant effect on lowering IOP, regardless of combining cataract surgery. XEN® implantation led to a statistically significant reduction in IOP lowering medications.

To evaluate: (i) the relationship between intraocular pressure (IOP) reduction attained with a fixed treatment protocol and the untreated IOP level; (ii) the consistency of IOP reduction over time; and (iii) whether there is a threshold pretreatment IOP level below which IOP reduction might be less effective. Results are based on 128 patients with glaucoma with field defects, who were randomized to the treatment arm of the Early Manifest Glaucoma Trial (EMGT). The EMGT fixed treatment protocol consisted of 360° laser trabeculoplasty and topical betaxolol eye drops B.I.D. Treatment was unchanged as long as progression did not occur. Analyses assessed the initial IOP reduction after 3 months and also the mean reduction based on all follow-up values; IOP changes over time were evaluated with linear regression analysis. Factors influencing initial and mean IOP reduction were also explored using linear models. Mean age at baseline was 68 years, and untreated baseline IOP ranged from 13 to 30.5 mmHg. On average, eyes with higher baseline IOP experienced larger pressure reductions than eyes with lower baseline IOP, whether expressed in mmHg or as percentages. Each mmHg of higher baseline IOP was associated with approximately 0.6 mmHg larger IOP reduction. IOP changed little over time, with 66% of patients changing less than 0.5 mmHg/year, and only 13% (17/128) changing >1.0 mmHg/year. The treatment protocol did not achieve any average IOP reduction in eyes with baseline pressures ≤ 15 mmHg. Factors related to more IOP reduction at 3 months were higher baseline IOP and positive refractive error, while higher baseline IOP and male gender (more reduction) and cardiovascular disease history (less reduction) were associated with mean IOP on treatment. With a fixed treatment protocol, the IOP reduction achieved depended very strongly on baseline untreated IOP levels. There seemed to be a lower threshold around 15 mmHg, where therapy did not result in any reduction of IOP. Our results suggest that when effects of IOP-lowering treatment are reported, whether expressed in mmHg or as a percentage of untreated pressure levels, the baseline IOP levels should be specified as well.

To evaluate the efficacy of intravitreal injection of bevacizumab (IVB) followed by modified grid laser photocoagulation (MGP) versus each alone as a primary treatment of diffuse diabetic macular edema. A randomized 3-arm clinical trial in which 62 eyes of 48 patients with diffuse diabetic macular edema were enrolled. Eyes were randomly distributed to 1 of 3 study groups: 19 eyes underwent MGP (MGP group), 21 eyes received 1.25 mg of IVB (IVB group), and 22 eyes received IVB followed by MGP (combined group). All eyes underwent a complete ophthalmic examination including fluorescein angiography and optical coherence tomography at baseline and at 1, 3, and 6 months, after treatment. Fluorescein angiography was performed at the 3 and 6 months follow up visits. The outcome measures were the change compared with baseline in central macular thickness (CMT), changes in best-corrected visual acuity (BCVA), changes in fluorescein angiography leakage, and any reported complication. A P value less than 0.05 was considered statistically significant. One month after treatment, the reduction in the mean CMT versus baseline was 49.88 μm (10.45%) in MGP group, 150.92 μm (31.30%) in IVB group, and 110.30 μm (23.77%) in the combined group, with a corresponding improvement in the mean BCVA. At 1 month, the improvement in CMT was better than baseline in all groups, yet only significant in the IVB group (P < 0.05) and the combined group (P < 0.05). The improvement in mean BCVA was significant in the IVB (P < 0.05) and the combined groups at 1 month (P < 0.05). At 3 months, the mean CMT was still better than baseline in all groups but this improvement was significant only in the combined group (P < 0.05). The improvement in the mean BCVA was significant only in the IVB and the combined groups (P < 0.05). Six months after treatment, the reduction in the mean CMT was significant in the combined group only (P < 0.05) and there was no significant improvement in the mean BCVA in all groups (P > 0.05). The BCVA did not deteriorate below baseline in all eyes included in the study, except three eyes in the MGP group. No complication related to the intravitreal injection was reported in the injected eyes. Combined therapy with IVB and sequential MGP 3 weeks later appeared to be superior to MGP or IVB alone in reducing macular thickening and improving visual acuity. However, no significant improvement in BCVA occurs 6 months after treatment. A combination of IVB and sequential MGP could be used as an initial treatment of diffuse diabetic macular edema.

Glaucoma is a chronic, progressive disease of the optic nerve which if left untreated can lead to blindness at end stages. A decrease of intraocular pressure (IOP) has proven to slow down the progression of the disease. IOP decrease can be achieved by medical, laser and surgical treatment. The aim of this study was to evaluate the response of patients with medically uncontrolled primary open angle glaucoma to selective laser trabeculoplasty (SLT). The study involved baseline characteristics recorded for each of 35 patients (48 eyes) in whom, despite being under full medication we could not achieve a satisfactory IOP. Patients, who had pressure above 25 mmHg under the maximal medication therapy, were not included into the study and were referred for surgical treatment. IOP was measured on admission, 1 hour, 7 days, 1, 3, 6 and 12 months after SLT. We considered satisfactory surgical result if IOP was decreased more than 20% of the initial value. Also, we investigated the influence of baseline IOP on SLT outcome after 12 months. Patient inclusion criteria were inability to reach target IOP with maximal medical therapy. Exclusion criteria were congenital glaucoma, any type of angle closure glaucoma, advanced-stage glaucoma, eyes with previous laser or surgical glaucoma applications and patients with baseline IOP > 25 while fully medicated. Patients who could not be followed for at least 12 months were also excluded. The mean age of our patients was 73 ± 12 years. The mean baseline IOP was 20.48 mmHg (SD = 1.91), and the mean change in IOP from baseline of the treated eye after one year was 4.47 mmHg (SD = 2.12). In eyes with a higher baseline IOP the reduction of pressure at the end of the study was significantly higher. Satisfactory effect of IOP reduction after one year was achieved in 64.58% of eyes. The IOP reduction did not show to be dependent as regarding age and gender. SLT effectively lowers IOP in patients with primary open-angle glaucoma, and the intervention is not followed by significant complications. Our results confirm that the IOP reduction is more significant if the initial value is higher. Our first reliable results of IOP reduction were confirmed one month after the procedure so that the procedure should not be repeated before one month has elapsed.The study is limited by a small number of eyes, which is insufficient to make a complete case analysis.

To evaluate 1-year clinical outcomes and response markers after implantation of a trabecular micro-bypass stent (iStent inject® W) in patients with moderate-to-severe open-angle glaucoma (OAG). This retrospective cohort study included 22 eyes of 22 patients with moderate-to-severe OAG who underwent standalone iStent inject® W implantation (n = 4) or combined phacoemulsification with iStent inject® W (n = 18). Qualified surgical success was defined as intraocular pressure (IOP) ≤15 mmHg with glaucoma medications and either ≥25% IOP reduction or final IOP ≤12 mmHg if baseline IOP was ≤15 mmHg. Kaplan-Meier analysis was used for cumulative probability of success; Cox proportional hazards regression analysis was used to identify response markers of surgical failure. Based on 19 eyes after censoring 3 eyes requiring additional surgery, IOP reduced from 22.09 ± 5.62 mmHg preoperatively to 12.37 ± 2.43 mmHg at 1 year (p < 0.001). Cumulative qualified success rates were 90.9% at 6 months and 72.7% at 12 months. No statistically significant changes were observed in the number of IOP-lowering medications. Higher postoperative IOP at 1 week and 1 month were independently associated with a higher surgical failure rate (1 week: hazard ratio [HR], 1.118; p = 0.007, 1 month: HR, 1.341; p = 0.031). Transient hyphema occurred in 7 eyes and resolved within 1 week; iStent iris plugging occurred in 2 eyes; and 3 eyes required subsequent trabeculectomy. iStent inject® W appeared to provide meaningful IOP reduction and may serve as an intermediate option in patients with moderate-to-severe OAG. Early higher postoperative IOP may be an early response marker associated with surgical failure.

IntroductionThe 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.MethodsFifty-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.ResultsAt 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.ConclusionIn 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 RegistrationClinicalTrials.gov identifier, NCT02868190.FundingGlaukos Corporation, San Clemente, CA.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-016-0420-8) contains supplementary material, which is available to authorized users.