Included Intraocular Pressure Reduction Research Articles

Outcomes of Non-Penetrating versus Penetrating Deep Sclerectomy in Open-Angle Glaucoma.

In this retrospective study, Non-Penetrating-Deep-Sclerectomy and Penetrating-Deep-Sclerectomy interventions showed similar >90% complete success rates at one-year post-surgery. However, Non-Penetrating-Deep-Sclerectomy achieved a superior safety profile in terms of best-corrected visual acuity recovery and rates of post-surgical complications. Comparing the surgical outcomes of two surgical techniques: non-penetrating deep sclerectomy (NPDS) and penetrating deep sclerectomy (PDS). This was a retrospective, longitudinal, comparative study including 66 eyes from 57 patients aged 69±9 years who underwent either NPDS or PDS for medically uncontrolled open-angle glaucoma. Outcome measurements included intraocular pressure (IOP), best-corrected visual acuity (BCVA), rates of complications, post-operative corrective interventions and glaucoma medications at baseline and at all post-operative appointments up to 1 year. An exploratory mixed-effects model was used to assess the intergroup differences for IOP and BCVA. One-year post-surgery, similar significant IOP reduction from baseline were observed in NPDS (from 19,9±1.3 to 11.5±0.9mmHg, P<0.001) and PDS (from 19,5±1,1 to 10.7±0.6mmHg, P<0.001). A conservative complete success rate (defined as medicated IOP ≤16mmHg and ≥20% reduction in IOP) was of 87% for NPDS and 97% for PDS. No BCVA changes were observed between baseline and 1-year post-surgery in both groups, and glaucoma medications showed a similar 10-fold reduction in both groups (P<0.001 vs. baseline). However, a significant difference in the speed of post-operative BVCA recovery was observed between NPDS and PDS (P<0.01), NPDS showing a faster recovery. Moreover, lower numbers of post-surgical complication and post-operative interventions were observed following NPDS compared to PDS (NPDS n=30 and 34 vs. PDS n=80 and 48 (P<0.05), respectively). The present study confirmed that both NPDS and PDS are highly effective surgical interventions for the management of primary open angle glaucoma. However, NPDS had a superior safety profile, in terms of BCVA recovery, complication rates and post-operative interventions.

Short-Term Efficacy and Safety of Phacoemulsification Associated With iStent Inject W in Patients With Controlled Open Angle Glaucoma.

The iStent inject W implanted during phacoemulsification effectively reduces IOP. The purpose of this study was to evaluate the efficacy and safety of iStent inject W combined with phacoemulsification in patients with controlled open angle glaucoma undergoing cataract surgery. We conducted a retrospective, bicentric study of patients with controlled chronic open angle glaucoma who underwent phacoemulsification combined with the injection of 2 iStent inject Ws. Patient characteristics, including intraocular pressure (IOP) and the number of glaucoma medications, were evaluated preoperatively and 1 week, 1 month, and 6 months postoperatively. The primary end point was IOP reduction, and the secondary end point was the reduction in the number of glaucoma medications. In this study, 85 eyes were included. The majority of patients had primary open angle glaucoma (85% of eyes). Preoperative mean IOP was 16.1±2.0mmHg with a mean of 2.3±0.5 glaucoma medications. At 1 week postoperatively, the mean IOP was 16.7±3.1mmHg with a mean of 2.0±0.7 hypotensive medications. At 1 and 6 months, the mean IOP was 14.2±2.1 and 13.0±1.5mmHg, with a mean of 2.0±0.6 and 1.8±0.5 glaucoma medications, respectively. The percentage IOP reduction at 1 and 6 months was 11.6% ( P =0.001) and 19.3% ( P <0.0001), respectively. Regarding glaucoma medications, at 1 and 6 months, the reduction in the number of medications was 12.9% ( P =0.025) and 22.4% ( P =0.003), respectively. The most frequent significant postoperative adverse events were corneal edema in 7%, IOP spikes in 6%, and hyphema in 6% of eyes, which resolved spontaneously. The iStent inject W implanted during phacoemulsification effectively reduces IOP and the number of glaucoma medications needed at 6 months of follow-up, with a favorable safety profile in patients with controlled open angle glaucoma.

Comparative Effectiveness and Safety of Two Different Trabecular MIGS Devices With and Without Ab Interno Canaloplasty in Patients with Primary Open-Angle Glaucoma.

This study compared outcomes of the iStent inject trabecular micro-bypass system versus the Hydrus Microstent in patients with primary open-angle glaucoma (POAG). Forty subjects (80 eyes) with POAG were included in this single-center, retrospective, contralateral-eye analysis. All patients underwent phacoemulsification with either iStent inject or Hydrus implantation in one eye and the other device in the contralateral eye, with ≥ 3-month follow-up. In 58 eyes (27 iStent inject, 31 Hydrus) the surgery also included ab interno canaloplasty (ABiC). Twelve-month outcomes included intraocular pressure (IOP), medications, and adverse events. Subgroup analyses were completed for iStent inject versus Hydrus, and with versus without ABiC. At 12months versus baseline, mean IOP reduced from 16.8 ± 3.7 to 13.6 ± 2.9 (p = 0.003) in iStent inject eyes, and from 18.1 ± 4.5 to 14.9 ± 3.2mmHg (p = 0.003) in Hydrus eyes (between-group IOP reduction p = 0.582). Mean number of glaucoma medications reduced from 1.23 ± 0.97 to 0.30 ± 0.76 (p < 0.001) in iStent inject eyes and from 1.20 ± 1.02 to 0.39 ± 0.72 (p = 0.001) in Hydrus eyes (between-group medication reduction p = 0.943). At 12months, 82.6% of iStent inject eyes and 73.9% of Hydrus eyes were medication-free versus 20.0% preoperatively in both groups (p < 0.0001 both groups). There were no statistically significant IOP or medication differences between iStent inject and Hydrus pre- or postoperatively, both in the overall cohort and in the with/without ABiC subgroups. Outcomes also were similar between eyes with/without ABiC in the overall cohort and in the iStent inject/Hydrus subgroups. There were no adverse events in the iStent inject group; two eyes in the Hydrus group had device-related complications requiring five additional surgeries (one Hydrus repositioning, one Hydrus exchange, one Hydrus removal, two goniotomies). In this contralateral-eye comparison of iStent inject versus Hydrus, the groups had similar IOP and medication outcomes, regardless of stratification by ABiC completion. Eyes receiving Hydrus had more complications and subsequent surgeries.

Interim Analysis of Clinical Outcomes with Open versus Closed Conjunctival Implantation of the XEN45 Gel Stent

/Purpose: To examine the longitudinal postoperative outcomes of open versus closed conjunctiva implantation of the XEN45 gel stent. Retrospective multicenter study. 193 patients with glaucoma underwent XEN45 implantation via an open or closed conjunctiva approach. Patient demographics, diagnoses, preoperative and postoperative clinical data, outcome measures including intraocular pressure (IOP), use of glaucoma medications, visual acuity, and complications were collected. Statistical analyses were performed with P < 0.05 as significant. Failure was defined as less than 20% reduction of IOP from medicated baseline or IOP > 21 mmHg at 2 consecutive visits at postoperative month 1 and beyond, the need for subsequent operative intervention or additional glaucoma surgery, or a catastrophic event such as loss of light perception. Eyes that had not failed by these criteria and were not on glaucoma medications were considered complete successes. Overall success was defined as those who achieved success either with or without topical medications. Patients were followed for an average of 17 months. Complete success was achieved in 42.5% and 24.7% of the open and closed groups, respectively (P = 0.01). Overall success was achieved in 64.2% and 37.0% of the open and closed groups, respectively (P < 0.001) at the last follow up. Bleb needling was performed in 12.4% of eyes in the open group compared to 40% in the closed group. An IOP spike of 10 mmHg or greater was twice as likely to occur in the closed compared to the open group during the postoperative period (40% vs 18% P = 0.001). Implantation of the XEN45 with opening of the conjunctiva resulted in a lower IOP with greater success and lower needling rate compared with the closed conjunctiva technique. Similar rates of postoperative complications and vision loss were noted in each group. While both procedures provide substantial IOP reduction, the open technique appears to result in higher success rates and fewer postoperative interventions.

Ab-externo canaloplasty with and without suture in highly myopic eyes.

To evaluate the effectiveness of ab-externo canaloplasty using the iTrack canaloplasty microcatheter (Nova Eye Inc, Fremont, California), with or without suture, in glaucoma patients with high myopia. This was a prospective, single-center, single-surgeon, observational study comparing the outcomes of ab-externo canaloplasty performed with a tensioning suture (suture group) and without a tensioning suture (no-suture group) in mild to severe glaucoma patients with high myopia. Twenty-three eyes received canaloplasty as a standalone procedure, 5 in combination with phacoemulsification. Primary efficacy endpoints included intraocular pressure (IOP) and the number of glaucoma medications. Safety was assessed based on reported complications and adverse events. Twenty-nine eyes of 29 patients with a mean age of 61.2 ± 12.3years; 19 eyes in the no-suture group and 10 eyes in the suture group. All eyes demonstrated a significant reduction in IOP 24months postoperatively, from 21.9 ± 7.22 to 15.4 ± 4.86mmHg in the suture group and from 23.8 ± 7.58 to 19.7 ± 3.68mmHg in the no-suture group. The mean number of anti-glaucoma medications reduced from 3.1 ± 0.6 to 0.4 ± 0.7 in the suture group and 3.3 ± 0.9 to and 0.2 ± 0.6 in the no-suture group at 24months. IOP was not significantly different at baseline between the 2 groups, but it was statistically different at 12 and 24months. There was no statistically significant difference in the number of medications between the groups at baseline, 12 and 24months. No serious complications were reported. Ab-externo canaloplasty performed either with or without a tensioning suture demonstrated good effectiveness in highly myopic eyes with a significant reduction in IOP and number of anti-glaucoma medications. The suture group achieved a lower postoperative IOP. However, the no-suture modification provides a similar reduction in medications with reduced tissue handling.

OCT biomarkers as predictors of visual improvement in diabetic macular edema eyes receiving dexamethasone implants

BackgroundSeveral optical coherence tomography (OCT) biomarkers have been proposed as predictors for functional and anatomical outcomes in Diabetic Macular Edema (DME). This study aims to examine the impact of these OCT features on the visual acuity improvement of patients with DME after long-acting Dexamethasone intravitreal implants (DEX-I) injection. Furthermore, the safety and impact of DEX-I on clinical parameters, including intraocular pressure (IOP) were assessed.MethodsIn this retrospective observational study, we reviewed the medical records of naïve and non-naïve eyes with DME who received at least one DEX-I. The primary endpoint was visual acuity improvement of ≥ 5 ETDRS letters at 1 month and 4 months after treatment. Secondary outcomes were the changes in OCT biomarkers and the impact of DEX-I on IOP at 1 and 4 months of follow-up. Linear panel regression analysis was used to test for differences in central subfield thickness (CST) over time and it was stratified according to biomarkers at baseline. Finally, a logistic regression analysis was used to identify factors predicting visual improvement at 1 and 4 months.ResultsWe included 33 eyes of which 63.6% were at an advanced stage of DME. Overall, CST, cube average thickness (CAT), cube volume (CV), and intraretinal cystoid spaces > 200 μm (ICS) decreased following DEX-I injection (p < 0.001). Additionally, a thicker CST at baseline was observed in eyes with better visual improvement at one month (p = 0.048). After logistic regression analysis, CST was retained as the only predictor for visual improvement at one month (p = 0.044). Furthermore, panel regression analysis identified a relation between subfoveal neuroretinal detachment (SND) at baseline and CST increase at four months. Lastly, only 15.2% of the eyes necessitated topical medication for IOP reduction, with no differences observed when stratifying between naïve and non-naïve eyes.ConclusionOur analyses suggest that a ticker baseline CST may serve as a positive predictor of early visual improvement and SND presence at baseline may be a negative prognostic factor for CST increase 4 months after DEX-I injection. Other well-known biomarkers, such as disorganization of the inner retinal layers (DRIL) and hyperreflective foci (HF), did not demonstrate prognostic value on visual outcomes, at least within the first four months following the injection.

Efficacy and Safety of Pairing iStent Inject Trabecular Micro-Bypass and iAccess Precision Blade Goniotomy in Patients with Open-Angle Glaucoma.

This study evaluated efficacy and safety of implanting two second-generation trabecular micro-bypass stents (iStent inject/iStent inject W) with phacoemulsification, either with or without iAccess Precision Blade goniotomy, in patients with mild-to-moderate open-angle glaucoma (OAG). This retrospective, non-randomized, unmasked, dual-arm, single-site, multi-surgeon, consecutive case series evaluated all OAG eyes that underwent phacoemulsification and iStent inject implantation either as a dual procedure (group A) or paired with iAccess goniotomy (group B) from July 2020 to May 2022. Effectiveness outcomes analyzed from 1month onward included intraocular pressure (IOP), proportions of eyes with IOP ≤ 12/≤ 15/≤ 18, proportion medication-free, and medication number. Safety outcomes at all timepoints included adverse events and secondary surgeries. In group A, mean IOP reduced from 14.9 ± 3.2mmHg on 1.22 ± 1.31 mean medications preoperatively (n = 63) to 13.5 ± 2.5mmHg on 0.24 ± 0.61 medications at month3 (n = 34; p = 0.048 IOP, p < 0.001 medications). In group B, mean IOP reduced from 16.0 ± 4.2mmHg on 1.12 ± 1.07 medications preoperatively (n = 93) to 12.2 ± 2.3mmHg on 0.57 ± 1.27 medications at month3 (n = 23; p < 0.001 IOP, p = 0.003 medications). From preoperative to 3months, the percent of eyes with IOP ≤ 12mmHg remained at 32.4% in group A (p = 1.0) and rose from 21.7% to 60.9% in group B (p = 0.0177); eyes with IOP ≤ 15mmHg rose from 52.9% to 76.5% in group A (p = 0.0963) and from 43.5% to 91.3% in group B (p = 0.0034). Adjusting for baseline between-group differences, group B had significantly greater postoperative IOP reduction than group A (p = 0.043); medication reductions were similar. Safety was favorable in both groups. Phacoemulsification and iStent inject with or without iAccess Precision Blade goniotomy produced clinically meaningful and safe IOP and medication reductions. The paired iStent inject + iAccess + phacoemulsification procedure enabled greater IOP reduction and lower IOP thresholds than iStent inject + phacoemulsification. The study provides some of the first data on this paired approach and on the novel iAccess Precision Blade.

Comparison of tube shunt implantation and trabeculectomy for glaucoma: a systematic review and meta-analysis

ObjectiveTo compare the efficacy and safety of tube shunt implantation with trabeculectomy in the treatment of patients with glaucoma.MethodsA systematic literature search was performed for studies comparing tube with trabeculectomy...

Gonioscopy-assisted transluminal trabeculotomy for open-angle glaucoma with failed incisional glaucoma surgery: two-year results

BackgroundTo evaluate the safety and efficacy of gonioscopy-assisted transluminal trabeculotomy (GATT) in treating patients with open-angle glaucoma (OAG) who had failed prior incisional glaucoma surgery.MethodsA consecutive case series of OAG patients aged ≥ 18 who underwent GATT with previous failed glaucoma incision surgery was retrospectively analyzed. Main outcome measures included intraocular pressure (IOP), the number of glaucoma medications, surgical success rate, and occurrence of complications. Success was defined as an IOP of ≤ 21 mmHg and a reduction of IOP by 20% or more from baseline with (qualified success) or without (complete success) glaucoma medications. For eyes with preoperative IOP of < 21 mmHg on 3 or 4 glaucoma medications, postoperative IOP of ≤ 18 mmHg without any glaucoma medications was also defined as complete success.ResultsForty-four eyes of 35 patients (21 with juvenile-onset open-angle glaucoma and 14 with adult-onset primary open-angle glaucoma) with a median age of 38 years were included in this study. The proportion of eyes with 1 prior incisional glaucoma surgery was 79.5%, and the others had 2 prior surgeries. IOP decreased from 27.4 ± 8.8 mm Hg on 3.6 ± 0.7 medications preoperatively to 15.3 ± 2.7 mm Hg on 0.5 ± 0.9 medications at the 24-month visit (P < 0.001). The mean IOP and the number of glaucoma medications at each follow-up visit were lower than the baseline (all P < 0.001). At 24 months postoperatively, 82.1% of the eyes had IOP ≤ 18 mmHg (versus 15.9% preoperatively, P < 0.001), 56.4% reached IOP ≤ 15 mmHg (versus 4.6% preoperatively, P < 0.001), and 15.4% achieved IOP ≤ 12 mmHg (compared to none preoperatively, P = 0.009). While 95.5% of eyes took 3 or more medications preoperatively, 66.7% did not take glaucoma medication 24 months after GATT. Thirty-four (77.3%) eyes achieved IOP reduction greater than 20% on fewer medications. The complete and qualified success rates were 60.9% and 84.1%, respectively. No vision-threatening complications occurred.ConclusionsGATT was safe and effective in treating refractory OAG patients who failed prior incisional glaucoma surgery.

Comparison of Outcomes of Phacoemulsification Combined with Endoscopic Cyclophotocoagulation, iStent, or Both in the Management of Open-Angle Glaucoma.

To compare outcomes of phacoemulsification combined with endoscopic cyclophotocoagulation (phaco/ECP), first generation iStent implantation (phaco/iStent), or both (phaco/iStent/ECP) in patients with open-angle glaucoma. A retrospective chart review was performed on patients at the University of Colorado Department of Ophthalmology. Outcomes included intraocular pressure (IOP), medication use, best corrected visual acuity (BCVA), and surgical complications were analyzed. Success was defined as IOP reduction of≥20% and/or reduction by at least one glaucoma medication. A total of 394 eyes were included in the study. There were 170 eyes (43.1%) in the phaco/ECP group, 175 eyes (44.4%) in the phaco/iStent group, and 49 eyes (12.4%) in the phaco/iStent/ECP group. The mean pre-operative IOP was 15.9mmHg for phaco/ECP, 15.8mmHg for phaco/iStent, and 15.2mmHg for phaco/iStent/ECP. At 24months, the mean IOP was 13.7mmHg (p<0.0001), 14.2mmHg (p=0.0001), and 13.0mmHg (p=0.0007), respectively. The mean pre-operative number of glaucoma medications was 2.0 for phaco/ECP, 1.4 for phaco/iStent, and 2.2 for phaco/iStent/ECP and at 24months post-surgery decreased to, 1.8 (p=0.011), 0.9 (p<0.0001), and 1.7 (p=0.01), respectively. The success rate at 24months was 54.4% for phaco/ECP, 75.3% for phaco/iStent, and 55.6% for phaco/iStent/ECP. Phacoemulsification when combined with ECP, iStent, or both, lowered IOP and glaucoma medication reliance at 24months. The success rate for phaco/iStent was significantly higher than phaco/ECP. When iStent was added to phaco/ECP, the success rate was higher at earlier postoperative visits compared to the phaco/ECP alone.

Multicenter Effectiveness and Disease Stability Through 3 Years After iStentTrabecular Micro-Bypass with Phacoemulsification in Glaucoma and Ocular Hypertension.

PurposeTo evaluate 3-year safety and efficacy of two second-generation trabecular micro-bypass stents. (iStent inject®) with phacoemulsification.Materials and MethodsThis multicenter retrospective study of iStent inject implantation with phacoemulsification included data from eight surgeons across Australia. Eyes with cataract and mild to advanced glaucoma [predominantly primary open-angle (POAG), primary angle closure (PAC), or normal-tension (NTG) glaucoma] or ocular hypertension (OHT) were included. Study assessments included intraocular pressure (IOP); number of ocular hypotensive medications; proportions of eyes with 0, 1, 2, or ≥3 IOP-lowering medications; IOP ≤15 mmHg or ≤18 mmHg; visual fields (VF); retinal nerve fiber layer thickness (RNFL); central corneal thickness (CCT); intraoperative complications; adverse events; and secondary surgeries.ResultsA total of 273 eyes underwent surgery and had 36-month follow-up. At 36 months versus preoperative, mean IOP decreased by 15.5% (16.4±4.6 mmHg to 13.9±3.5 mmHg; p<0.001), and 70.3% of eyes achieved IOP of ≤15 mmHg (versus 49.1% preoperatively; p<0.001). The mean medication burden decreased by 68.5% (from 1.51±1.17 to 0.48±0.89 medications; p<0.001); 71.4% of eyes were medication-free (versus 21.6% preoperatively; p<0.001), while 6.2% of eyes were on ≥3 medications (versus 22.3% preoperatively; p<0.001); 96.3% of eyes maintained or reduced medications vs preoperative. Significant IOP and medication reductions occurred across glaucoma subtypes (POAG, PAC, NTG, OHT): 13–22% for IOP (p<0.05 for all) and 42–94% for medication (p<0.05 for all). Favorable safety included few adverse events; stable VF, RNFL, and CCT; and filtering surgery in only 8 eyes (2.9%) over 3 years.ConclusionIn this multicenter cohort from 8 surgeons across Australia, significant IOP and medication reductions were sustained through 3 years after iStent inject implantation with phacoemulsification. Results were favorable across different glaucoma subtypes (including POAG, PAC, NTG, OHT), severities, and surgeons, thereby underscoring the real-world relevance and efficacy of iStent inject implantation for glaucoma treatment.

The efficacy of XEN gel stent implantation in glaucoma: a systematic review and meta-analysis

BackgroundXen is a device for minimally invasive glaucoma surgery, and is used to treat POAG, pseudoexfoliative or pigmentary glaucoma, as well as refractory glaucoma. The efficacy of XEN in treating glaucoma remains to be confirmed and clarified. Hence, we conducted a systematic review and meta-analysis to examine the efficacy and associated complication of XEN implantations.MethodsWe conducted a literature search in PubMed, EMBASE, the Cochrane Library of Systematic Reviews, Web of Science, China National Knowledge Infrastructure, WanFang and SinoMed databases to identify studies, published before May 15, 2021, which evaluated XEN in glaucoma, and parameters for measurements included intra-ocular pressure (IOP), number of anti-glaucoma medications (NOAM), and bleb needling rate. We compared the measurements of XEN-only procedure between phaco-XEN and trabeculectomy, and we also did sub-analysis based on time points, glaucoma types, ethnics, etc. Sensitivity analyses and publication bias were conducted for evaluating bias.This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA 2020) reporting guideline.ResultsWe identified 78 eligible studies, analysis revealed obvious IOP reduction after XEN stent implantation (SMD: 1.69, 95% CI 1.52 to 1.86, p value < 0.001) and NOAM reduction (SMD: 2.11, 95% CI 1.84 to 2.38, p value < 0.001). Sub-analysis showed no significant difference with respect to time points, ethnicities, and economic status. No significant difference was found between XEN treatment effect on POAG and PEXG eyes and between pseudo-phakic and phakic eyes. Also no significant difference was found between XEN and phaco-XEN surgery in terms of IOP after surgery (SMD: -0.01, 95% CI -0.09 to 0.08, p value 0.894). However, NOAM (after publication bias correction) and bleb needling rate (RR: 1.45, 95% CI 1.06to 1.99, p value 0.019) were lower in phaco-XEN group compared to XEN only group. Compared to trabeculectomy, XEN implantation had similar after-surgery IOP, however bleb needling rate (RR: 2.42, 95% CI 1.33 to 4.43, p value 0.004) was higher.ConclusionOur results confirmed that XEN is effective in lowering both IOP and NOAM till 48 months after surgery. It is noteworthy that XEN implantation leads to higher needling rate, compared to phaco-XEN or trabeculectomy. Further research, studying complications of XEN on non-European ethnicities, especially on Asian, are in urgent need before XEN is widely applied.

12-Month Outcomes of Combined Phacoemulsification and iStent Inject in Asian Eyes with Normal Tension Glaucoma: A Single-Centre Experience.

To evaluate efficacy and safety of the iStent inject combined with phacoemulsification in Asian eyes with normal-tension glaucoma (NTG) up to 12months after surgery. Retrospective case series. Retrospective case series of eyes undergoing surgery from April 2017 to August 2019. Outcome measures included intraocular pressure (IOP), number of topical glaucoma medications and adverse outcomes. Data were retrieved from the post-operative day 1 (POD1), week 1 (POW1), month 1 (POM1), month 3 (POM3), month 6 (POM6) and month 12 (POM12) timepoints. Data were analysed at each timepoint for eyes with available clinical data at that visit. Subgroup analysis was performed for a consistent cohort which included only eyes with data at all six follow-up timepoints. Data from 91 eyes in the collective subject group was analysed. Majority of subjects were male (53, 58.2%) and Chinese (79, 86.8%). Mean age was 73.2 ± 7.2years. Pre-operatively, mean IOP was 14.3 ± 3.0mmHg and mean number of medications was 1.5 ± 0.8. Significant IOP reduction was observed at all timepoints except POW1 and POM12. The number of medications was reduced at all timepoints (p < 0.001). By POM12, there was reduction of 1.2 ± 1.0 medications (p < 0.001). Both the collective and consistent cohorts demonstrated a trend towards decreasing surgical efficacy with time, in IOP reduction and decrease in medications. None of the eyes experienced sight-threatening complications. Asian eyes with NTG undergoing combined phacoemulsification and iStent inject surgery demonstrated significant and sustained reduction in number of glaucoma medications up to 12months post-operatively.

Safety and Effectiveness of the PRESERFLO® MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study

To assess the safety and effectiveness of the PRESERFLO® MicroShunt (formerly InnFocus MicroShunt) in patients with primary open-angle glaucoma (POAG). The MicroShunt, a controlled ab externo glaucoma filtration surgery device, was investigated in a 2-year, multicenter, single-arm study. Eligible patients were aged 18-85 years with POAG inadequately controlled on maximal tolerated medical therapy with intraocular pressure (IOP) ≥18 and ≤35 mmHg or when glaucoma progression warranted surgery. The MicroShunt was implanted as a stand-alone procedure with adjunctive use of topical mitomycin C (MMC; 0.2-0.4 mg/ml) for 2-3 minutes. The primary effectiveness outcome was IOP reduction and success (not requiring reoperation or pressure failures [IOP > 21 mmHg and < 20% reduction in IOP]) at year 1. Additional end points at year 2 included IOP reduction, success, glaucoma medications, adverse events (AEs), and reoperations. Results are reported in the overall population and subgroups of patients receiving 0.2 or 0.4 mg/ml MMC. In 81 patients, mean (± standard deviation [SD]) IOP decreased from 21.7 ± 3.4 mmHg at baseline to 14.5 ± 4.6 mmHg at year 1 and 14.1 ± 3.2 mmHg at year 2 (P < 0.0001). Overall success (with and without supplemental glaucoma medication use) at year 1 was 74.1%. Mean (± SD) number of medications decreased from2.1 ± 1.3 at baseline to 0.5 ± 0.9 at year 2 (P < 0.0001), and 73.8% of patients were medication free. Most common nonserious AEs were increased IOP requiring medication or selective laser trabeculoplasty (25.9%) andmild-to-moderate keratitis (11.1%). There were 6 (7.4%) reoperations and 5 (6.2%) needlings by year 2. Inananalysis (post hoc) according to MMC concentration, overall success was 78.1% (0.2 mg/ml) and 74.4% (0.4 mg/ml; P=0.710). In the 0.2 and 0.4 mg/ml MMC groups, 51.9% and 90.3% of patients were medication free, respectively (P= 0.001). There was a trend toward lower IOP and higher medication reduction in the 0.4mg/ml MMC subgroup. In this study, mean IOP and glaucoma medication reductions were significant and sustained over2 years postsurgery. No long-term, sight-threatening AEs were reported. Further studies may confirm potential risk/benefits of higher MMC concentration.

Comparison of Surgical Outcomes of Sponge Application versus Subconjunctival Injection of Mitomycin-C during Combined Phacoemulsification and Trabeculectomy Surgery in Asian Eyes.

Purpose:To compare the outcomes of combined phacoemulsification–trabeculectomy surgery with intraoperative sponge-applied versus subconjunctival injection of mitomycin-C (MMC) in Asian eyes.Methods:This was a retrospective review of 95 eyes that consecutively underwent combined phacoemulsification–trabeculectomy surgery in a tertiary eye center in Singapore from January 2013 to June 2014. Data collected included intraocular pressure (IOP), best corrected visual acuity, and number of glaucoma medications. Outcome measures included postoperative IOP and complications at various timepoints up to 12 months after surgery.Results:Twenty eyes (21.1%) received 0.2 mg/ml subconjunctival MMC injection (“Group 1”) and 75 (78.9%) received 0.4 mg/ml sponge-applied MMC (“Group 2”). There was no difference between groups in demographics, IOP, and number of glaucoma medications preoperatively. There was a reduction in IOP at postoperative month (POM) 1, 6, and 12 in both the groups (POM12: Group 1, −2.8 ± 5.36 mmHg, P < 0.001; Group 2, −5.8 ± 6.29 mmHg, P = 0.054). At POM1, Group 2 showed a trend toward greater IOP reduction (−5.89 ± 7.67 mmHg vs. −1.55 ± 5.68 mmHg, P = 0.061). However, at both POM6 and POM12, there was no statistically significant difference in IOP reduction between the two groups. At POM12, complete success, defined as achieving an IOP of between 6 and 15 mmHg without the use of antiglaucoma medications, was achieved in 11 (55%) eyes in Group 1 and 48 (64%) in Group 2 (P = 0.9). There was a lower rate of postoperative hypotony in the Group 1 (0%) compared to Group 2 (8%) (P = 0.34).Conclusion:Combined phacoemulsification–trabeculectomy with subconjunctival MMC injection has comparable outcomes to that with sponge-applied MMC, with a similar reduction in IOP at 1, 6, and 12 months postoperatively and a lower postoperative complication rate.

Comparison of Clinical Outcomes with Open Versus Closed Conjunctiva Implantation of the XEN45 Gel Stent

Purpose:To describe the efficacy and safety of open versus closed conjunctival implantation of the XEN45 Gel Stent (Allergan Inc).Design:Retrospective, multicenter study.Participants:A total of 137 patients with glaucoma who underwent XEN45 implantation via open or closed conjunctival methods. The XEN45 was implanted as a stand-alone procedure or at the time of cataract surgery by 5 surgeons.Methods:Patient demographics, diagnoses, preoperative and postoperative clinical data, outcome measures including intraocular pressure (IOP), use of glaucoma medications, visual acuity, and complications were collected. Statistical analyses were performed with P < 0.05 as significant.Main Outcome Measures:Failure was defined as less than 20% reduction of IOP from medicated baseline or IOP >21 mmHg at 2 consecutive visits at postoperative month 1 and beyond, the need for subsequent operative intervention or additional glaucoma surgery, or a catastrophic event such as loss of light perception. Eyes that had not failed by these criteria and were not on glaucoma medications were considered complete successes. Eyes that had not failed but required glaucoma medications were defined as qualified successes.Results:Complete success was achieved in 31% and 56% of the closed and open groups, respectively (P = 0.01). Qualified success was achieved in 53% and 71% of the closed and open groups, respectively (P = 0.06). At postoperative month 12, the open conjunctiva group was using fewer glaucoma medications than the closed group (0.9 vs. 1.8, respectively; P = 0.02). At postoperative month 12, the open group had a significantly greater percentage of IOP reduction compared with the closed group (43.1% vs. 24.8%, respectively; P = 0.02). Postoperative needling rates were higher in the closed group compared with the open group (36.1% vs. 11.8%, P = 0.001).Conclusions:Implantation of the XEN45 with opening of the conjunctiva is a safe and efficacious procedure to lower IOP with comparable success rate and lower needling rate compared with the closed conjunctiva technique. Prospective evaluation of the various methods for XEN45 implantation will allow for further comparison.

Two-Year Multicenter Outcomes of iStent inject Trabecular Micro-Bypass Stents Combined with Phacoemulsification in Various Types of Glaucoma and Ocular Hypertension.

PurposeThis multicenter study evaluated 2-year effectiveness and safety following implantation of two second-generation trabecular micro-bypass stents (iStent inject®) with phacoemulsification.Materials and MethodsThis was a retrospective study of iStent inject implantation with phacoemulsification by nine surgeons across Australia. Eyes had mild to advanced glaucoma (predominantly primary open-angle/POAG, appositional angle-closure/ACG, or normal-tension/NTG) or ocular hypertension (OHT), and cataract. Evaluations included intraocular pressure (IOP); medications; proportions of eyes with 0 or ≥2 medications, reduced/stable medications versus preoperative, and IOP ≤15 mmHg; visual acuity; cup-to-disc ratio (CDR); visual fields (VF); adverse events; and secondary surgery.ResultsA total of 340 eyes underwent surgery and had 24-month follow-up data. At 24 months, mean IOP decreased by 16% from 16.4±4.7 mmHg preoperatively to 13.7±3.1 mmHg (p<0.001), and 77% of eyes achieved IOP of ≤15 mmHg versus 49% preoperatively (p<0.001). Mean number of medications decreased by 67% to 0.49±0.95 versus 1.49±1.20 preoperatively (p<0.001), with 74% of eyes medication-free versus 25% preoperatively (p<0.001), and 14% of eyes on ≥2 medications versus 46% preoperatively (p<0.001). Medication burden was reduced or stable in 98% of eyes versus preoperative. Stratified analyses showed significant IOP and medication reductions across glaucoma subtypes (POAG, ACG, NTG, OHT): 13–22% for IOP (p<0.01 for all) and 62–100% for medication (p<0.001 for all). Favorable safety included few adverse events; stable CDR, VF, and visual acuity; and filtering surgery in only 8 eyes (2.4%) over 2 years.ConclusionThis 340-eye multicenter dataset provides robust evidence of the safety and efficacy of iStent inject implantation with phacoemulsification, with significant and sustained IOP and medication reductions through 2 years. Results were similarly favorable across glaucoma subtypes (including POAG, ACG, NTG, OHT) and were attained across various glaucoma severities, clinical sites, and surgeons, highlighting the real-world versatility and utility of this treatment modality.

IStent Trabecular Micro-Bypass Stent Implantation with Cataract Surgery in a Japanese Glaucoma Population.

IntroductionThis study assesses two-year efficacy and safety following implantation of a single trabecular micro-bypass stent (iStent®) with concomitant phacoemulsification cataract surgery in Japanese patients with open-angle glaucoma (OAG).Materials and MethodsThis retrospective, consecutive case series included eyes that underwent iStent implantation with phacoemulsification and were followed for 24 months postoperative. Efficacy and safety measures included intraocular pressure (IOP), number of glaucoma medications, adverse events, secondary surgeries, visual fields, and endothelial cell counts.ResultsOf 73 operated eyes, 53 eyes had 24 months of follow-up and are analyzed. Diagnoses included primary open-angle glaucoma (POAG, n=25), normal-tension glaucoma (NTG, n=16), and pseudoexfoliative glaucoma (PXG, n=12). At 24 months, mean IOP reduced by 18% to 13.6±3.0 mmHg versus 16.5±3.4 mmHg preoperatively (p<0.0001), and mean medication number reduced by 81% to 0.37±0.74 versus 1.96±0.98 preoperatively (p<0.0001). The percentage of medication-free eyes was 77% versus 0% preoperatively, and 81% of eyes had IOP ≤15 mmHg versus 42% preoperatively. Results were similarly favorable across glaucoma subtypes (POAG, NTG, PXG). Notably, mean IOP in NTG eyes decreased to 12.8±1.4 mmHg from 14.4±3.0 mmHg preoperatively (p=0.03), and medications decreased by 87% to 0.31±0.70 versus 2.38±0.72 preoperatively (p<0.0001). At 24 months, 81% of NTG eyes were medication-free (versus 0% preoperatively); 2 NTG eyes (13%) were on ≥2 medications (versus 100% preoperatively). Throughout the follow-up, visual fields and endothelial cell counts remained stable; 1 eye (1.9%) underwent filtration surgery.DiscussionFavorable safety and significant IOP and mediation reductions were achieved through two years following iStent implantation with phacoemulsification in a Japanese population. These gains were achieved across all glaucoma subtypes (including POAG, NTG, PXG).ConclusionThis real-world study supports the viability of iStent implantation to treat Japanese patients with glaucoma and shows that the benefits extend to those with NTG or PXG in addition to POAG.

Evaluation of Blood-filling Patterns in Schlemm Canal for Trabectome Surgery.

The purpose of this study was to evaluate the association between trabectome surgery outcomes and the blood filling patterns in SC before TM ablation. This retrospective cohort study included 105 eyes of 84 Japanese primary open-angle glaucoma patients who had undergone trabectome surgery in combination with cataract surgery. Provocative gonioscopy was performed before TM ablation to classify the blood filling patterns in SC into 3 groups: no filling (group 1); patchy/irregular filling (group 2); and complete filling (group 3). The subjects were divided into 3 groups according to the blood filling patterns and the trabectome surgery outcomes were compared, including intraocular pressure (IOP), the percentage reduction in IOP, surgical success rate, and the number of glaucoma medications. Success was defined by IOP ≤15 mm Hg and a >20% reduction in IOP with/without glaucoma medication, and without additional glaucoma surgery after trabectome surgery combined with cataract surgery. Twenty-four eyes were assigned to group 1, 48 to group 2, and 33 to group 3. Between-group analyses showed no significant intergroup differences in age (P=0.213), preoperative mean deviation (P=0.505), preoperative and postoperative IOP (P=0.941 and 0.458, respectively), preoperative and postoperative number of glaucoma medications (P=0.805 and 0.077, respectively), percentage IOP reduction (P=0.256), and success rates (P=0.540). Trabectome surgery is effective for mild to moderate primary open-angle glaucoma patients, independent of the blood-filling patterns in SC before the TM ablation.

Surgical Outcomes of a Second Ahmed Glaucoma Valve Implant for the Treatment of Refractory Glaucoma.

To evaluate the surgical outcomes of a second AGV implant in Hispanic patients with refractory glaucoma. The medical records of patients who underwent a second AGV implant were reviewed retrospectively. Clinical outcome measures including intraocular pressure (IOP), visual acuity, and glaucoma medication use were collected from the preoperative visit and all follow-up visits up to 18 months after surgery. Failure was defined as one of the following: loss of light perception, sustained IOP >21 or <6 mm Hg, an IOP reduction of <20% from baseline, need for additional glaucoma surgery, including needling revision with subconjunctival adjuvant therapy, or valve extrusion. A total of 48 patients were included. In all cases, an S-2 model was implanted in the superonasal quadrant. Mean preoperative IOP was 24.3±7.9 mm Hg and was significantly reduced to 13.9±4.8 at 6 months (P<0.05), 15.4±7.2 at 12 months (P<0.05), and 12.9±2.0 at 18 months (P<0.05). Mean glaucoma medications were reduced from 2.8±1.1 preoperatively to 1.9±1.2 at 6 months (P<0.05), 2.4±1.2 at 12 months, and 2.2±1.1 at 18 months; however, the difference was no longer statistically significant after 6 months, and the success rate was 60% at the mean for survival time of 15 months (13.7 to 16.5). The findings of this study demonstrate that a second AGV can achieve a significant reduction in IOP for up to 18 months postoperatively.