Histopathological findings of failed blebs after microinvasive bleb surgery with the XEN Gel Stent and Preserflo MicroShunt.

PURPOSE: The success of XEN Gel Stent (XEN) and Preserflo MicroShunt (Preserflo) implantation depends mainly on the development of bleb fibrosis. This study aimed to describe the histological findings of bleb fibrosis after XEN and Preserflo surgery. METHODS: This retrospective study included patients with different types of glaucoma who underwent revision surgery after XEN or Preserflo implantation. The available clinical information and histological samples of removed fibrotic tissue were analyzed. RESULTS: Thirty-six patients were included. Revision surgery was performed at a median of 195 (range = 31-1264) days after primary surgery. The mean intraocular pressure changed from 29.1 (± 10.3) mmHg at baseline to 18.3 (± 8.7) mmHg (- 37%; p < 0.0001) and 16.2 (± 4.2) mmHg (- 45%; p < 0.0001) after 6 and 12 months, respectively. Histological analysis revealed an increase in activated fibroblasts and macrophages in all specimens and a parallel orientation of fibroblasts in a minor part of the probe in 60% of the specimens. No pronounced inflammatory reaction in the form of lymphocytic or granulocytic infiltration was observed. The comparison of specimens from uveitic glaucoma and primary open-angle glaucoma patients revealed no significant differences. CONCLUSIONS: The histological analysis of fibrotic blebs from the XEN and Preserflo implants did not show any pronounced immune or foreign-body reaction and revealed a similar histological pattern of failed blebs after trabeculectomy.

Effectiveness of Microinvasive Glaucoma Surgery in the United States: Intelligent Research in Sight Registry Analysis 2013-2019.

PURPOSE: To evaluate the effectiveness of microinvasive glaucoma surgery (MIGS) with and without concurrent phacoemulsification. DESIGN: Multicenter, retrospective cohort study. PARTICIPANTS: Patients in the Intelligent Research in Sight (IRIS®) Registry who underwent Xen gel stent (ab interno) implantation, endoscopic cyclophotocoagulation (ECP), or goniotomy or canaloplasty from 2013 through 2019. METHODS: Kaplan-Meier survival analysis was used to assess reoperation rates. We defined reoperation as any subsequent glaucoma surgery occurring 1 month to 3 years after the initial procedure. Multivariable Cox proportional hazard models were used to determine factors predictive of reoperation. MAIN OUTCOME MEASURES: Reoperation rate, mean intraocular pressure (IOP) and visual acuity (VA), postoperative complications, predictors of reoperation, and reoperation procedure type. RESULTS: A total of 79 363 eyes from 57 561 patients were included, with 15 118 eyes (19%) receiving stand-alone MIGS and 64 245 eyes (81%) receiving MIGS concurrent with phacoemulsification. Overall, patients who underwent MIGS concurrently with phacoemulsification showed lower reoperation rates compared with stand-alone MIGS, most pronounced in ECP and goniotomy or canaloplasty. At postoperative year 2, the cumulative reoperation rate for stand-alone procedures was 15% for ECP, 24% for Xen implantation, and 24% for goniotomy or canaloplasty compared with 3% for ECP, 19% for Xen implantation, and 6% for goniotomy or canaloplasty concurrent with phacoemulsification (P < 0.001 for each stand-alone MIGS vs. MIGS with phacoemulsification). Black race, older age, moderate and severe glaucoma, higher baseline IOP, and glaucoma subtype were associated with higher reoperation risk. Although IOP decreased in all groups, stand-alone MIGS showed a more substantial decrease in mean IOP. Complication rates from MIGS were low overall: 1% for ECP, 1% for Xen implantation, and 2% for goniotomy or canaloplasty. CONCLUSIONS: In current United States clinical practice, MIGS has substantially lower reoperation rates when performed with phacoemulsification, especially for ECP and goniotomy or canaloplasty. Approximately one-sixth of patients undergoing stand-alone ECP and one-quarter of patients undergoing stand-alone Xen implantation or goniotomy or canaloplasty require reoperation by 2 years. Black race, diagnosis coding of moderate to severe glaucoma, and higher baseline IOP were associated with higher risk of reoperation after MIGS procedures. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Long-term Outcomes from the HORIZON Randomized Trial for a Schlemm's Canal Microstent in Combination Cataract and Glaucoma Surgery.

PURPOSE: To present the 5-year results of the HORIZON trial comparing cataract surgery (CS) combined with an intracanalicular microstent with CS alone. DESIGN: Prospective, multicenter, controlled randomized clinical trial. PARTICIPANTS: Patients with cataract and primary open-angle glaucoma treated with 1 or more glaucoma medications, washed-out diurnal intraocular pressure (DIOP) of 22 to 34 mmHg, and no prior incisional glaucoma surgery. METHODS: Eyes were randomized 2:1 to receive a Hydrus Microstent (HMS; Ivantis, Inc) or no stent after successful CS. MAIN OUTCOME MEASURES: Intraocular pressure (IOP), glaucoma medication use, repeat glaucoma surgery, visual acuity, visual field, procedure-related adverse events, and corneal endothelial cell counts. RESULTS: Three hundred sixty-nine eyes were randomized to HMS treatment, and 187 eyes were randomized to CS only. Study groups were well matched for preoperative IOP, medication use, washed-out DIOP, and glaucoma severity. Five-year follow-up was completed in 80% of patients. At 5 years, the HMS group included a higher proportion of eyes with IOP of 18 mmHg or less without medications than the CS group (49.5% vs. 33.8%; P = 0.003), as well as a greater likelihood of IOP reduction of 20% or more without medications than the CS group (54.2% vs. 32.8%; P < 0.001). The number of glaucoma medications was 0.5 ± 0.9 in the HMS group and 0.9 ± 0.9 in the CS group (P < 0.001), and 66% of eyes in the HMS group were medication free compared with 46% in the CS group (P < 0.001). The cumulative risk of incisional glaucoma surgery was lower in the HMS group (2.4% vs. 6.2%; P = 0.027, log-rank test). No clinical or statistically significant differences were found in the rate of endothelial cell loss from 3 to 60 months between the HMS and CS alone groups (P = 0.261). CONCLUSIONS: The addition of a Schlemm's canal microstent in conjunction with CS was safe, resulted in lowered IOP and medication use, and reduced the need for postoperative incisional glaucoma filtration surgery compared with CS after 5 years. Long-term presence of the implant did not affect the corneal endothelium adversely.

Predictability of success and open conjunctival revision rates in the subsequent eye after XEN45 Gel Stent implantation according to lens status.

PURPOSE: To determine the predictability of success and the risk of open conjunctival revision in the subsequent eye after XEN45 Gel Stent implantation according to lens status. METHODS: This was a retrospective single-centre study involving 132 eyes of 66 participants who had undergone intraocular pressure (IOP)-lowering XEN45 Gel Stent implantation, either as a standalone procedure in phakic and pseudophakic eyes or in combination with phacoemulsification. Successful surgery was defined by three scores: IOP at follow-up < 21 mmHg (score A) or < 18 mmHg (score B) and an IOP reduction > 20% or IOP ≤ 15 mmHg and an IOP reduction ≥ 40% (score C). In all scores, one open conjunctival revision was allowed, and additional repeat surgery was considered a failure. The predictability of success and revision rate depending on the outcome of the first eye were calculated using Bayes' theorem. RESULTS: IOP-lowering did not differ significantly between the first and second eyes. Success rates of standalone surgery in the second eye after successful surgery in the first eye significantly exceed rates after prior failure. For the combined procedure, the rates did not differ significantly. For score A, we determined a 76.6% chance of success following a prior success and a 57.9% chance, if prior surgery failed. The corresponding probabilities were 75% and 59.1% for score B, while 66.7% and 15.7% for score C, respectively. We calculated a 60% risk for revision surgery in the standalone phakic group. If the first eye was not revised, the risk of revision in the subsequent eye was 20%. The corresponding risks were 72.7% and 5% for the standalone procedure in pseudophakic patients and 38.4% and 41.7% for the combined procedure, respectively. CONCLUSION: The results of our study offer a tool to predict the outcome of subsequent eye surgeries based on either the outcome in the initial eye and the type of surgery performed, owing to the high predictive potential.

Demographic and Clinical Characteristics Associated with Minimally Invasive Glaucoma Surgery Use: An Intelligent Research in Sight (IRIS®) Registry Retrospective Cohort Analysis.

PURPOSE: Minimally invasive glaucoma surgery (MIGS) is increasingly performed at the time of cataract extraction. Understanding the demographic and clinical characteristics of patients undergoing MIGS procedures may provide insight into patient selection. This study evaluates racial-ethnic and other differences in the use of MIGS in persons with cataract and open-angle glaucoma (OAG). DESIGN: Retrospective cohort study using Intelligent Research in Sight (IRIS) Registry data. PARTICIPANTS: Patients aged ≥ 40 years with a diagnosis of OAG and no history of MIGS or cataract surgery who were undergoing cataract extraction, with or without MIGS, during 2013 to 2017 in the United States. METHODS: Multivariable logistic regression models were used to calculate odds ratios (ORs) and 95% confidence intervals (CIs). MAIN OUTCOME MEASURES: Variables assessed include age, sex, race-ethnicity, disease severity, insurance type, census region, comorbidity, and cup-to-disc ratio (CDR). RESULTS: The odds of MIGS use was greater among patients who were aged ≥ 60 years (OR, 1.10 [95% CI, 1.05-1.16]); Black (OR, 1.11 [CI, 1.07-1.15]) compared with White; a Medicare recipient (OR, 1.12 [CI, 1.10-1.15]) versus privately insured; or in the Midwest (OR, 1.32 [CI, 1.28-1.36]) or Northeast (OR, 1.26 [CI, 1.22-1.30]) compared with the South. Having moderate rather than mild glaucoma (OR, 1.07 [CI, 1.04-1.11]) and a higher CDR (OR for 0.5 to 0.8 vs. <0.5, 1.24 [CI, 1.21-1.26]; OR for >0.8 to 1.0 vs. <0.5, 1.27 [CI, 1.23-1.32]) were also each associated with increased odds of MIGS use. Use of MIGS was less likely in women (OR, 0.96 [CI, 0.94-0.98]); patients taking 5 to 7 glaucoma medications (OR, 0.94 [CI, 0.90-0.99]) compared with 1 to 2 medications; and patients with severe, compared with mild, glaucoma (OR, 0.64 [CI, 0.61-0.67]). CONCLUSIONS: This analysis highlights the importance of capturing race-ethnicity data and other pertinent patient characteristics in electronic health records to provide insight into practice patterns. Such data can be used to assess the long-term performance of MIGS and other procedures in various patient populations.

The association between corneal hysteresis and surgical outcomes from trabecular meshwork microinvasive glaucoma surgery.

PURPOSE: To assess whether an association exists between pretreatment corneal hysteresis (CH) and the magnitude of intraocular pressure (IOP) and medication burden reduction following microinvasive glaucoma surgery (MIGS). METHODS: Retrospective chart review of 84 eyes from 57 patients with CH measurements who underwent trabecular meshwork MIGS in a glaucoma practice in New York City with follow-up visits at 3-6 and 9-12 months. MIGS included canaloplasty, goniotomy, microbypass stents, or a combination thereof. RESULTS: The lowest and middle CH tertiles experienced significantly reduced mean IOP at 3-6-month follow-ups (p = .007, < .001), whereas the highest tertile did not (p = .06). At 9-12-month follow-ups, a significant mean IOP reduction only persisted in the middle tertile (p = .001). For medication burden reduction, only the highest CH tertile experienced significant mean reductions at both 3-6- and 9-12-month follow-ups (p = .015, .028). Notably, 7 patients in the lowest CH tertile failed MIGS and required an additional surgical or laser procedure within 24 months of MIGS, whereas only 3 patients failed in the other tertiles (likelihood ratio < .05). Multivariate analysis excluding MIGS failures demonstrated an inverse association between CH and the magnitude of post-operative IOP reduction at both 3-6- and 9-12-month follow-ups when controlling for baseline IOP and medication changes (p = .002, .026). CONCLUSION: There was an inverse association between pretreatment CH and the magnitude of IOP reduction following surgery. There is also evidence of an increased need for repeat surgery or other intervention in patients with lower CH who undergo MIGS.

Effectiveness of iStent Trabecular Microbypass System Combined with Phacoemulsification versus Phacoemulsification Alone in Patients with Glaucoma and Cataract Depending on the Initial Intraocular Pressure.

INTRODUCTION: To assess the effect of iStent trabecular microbypass implantation combined with phacoemulsification on intraocular pressure (IOP) and glaucoma medications and to compare this to outcomes of phacoemulsification alone in patients with mild to moderate primary open-angle glaucoma (POAG) depending on initial IOP. MATERIALS AND METHODS: Eighty subjects with cataract and POAG were randomized 1:1 into either iStent implantation and cataract surgery (iStent group) (n = 44) or cataract surgery alone (control group) (n = 36). Groups were divided according to initial IOP (after washout period) into IOP <26 mm Hg and IOP ≥26 mm Hg. Patients were assessed preoperatively and at postoperative day 1, week 1, and months 1, 3, 6, 12, and 24. Outcome measures included best-corrected visual acuity, IOP, and glaucoma medications. RESULTS: Postoperatively at 24 months, mean IOP decreased from 20.93 ± 1.28 to 17.79 ± 2.50 mm Hg in the IOP subgroup <26 mm Hg and from 26.00 ± 0.00 to 19.86 ± 2.19 in the subgroup ≥26 mm Hg in the control group. In the iStent group <26 mm Hg, IOP decreased from 22.04 ± 1.64 to 15.57 ± 2.13 mm Hg and from 26.6 ± 1.09 to 17.06 ± 2.43 mm Hg in the iStent group ≥26 mm Hg. CONCLUSION: In patients with open-angle glaucoma and cataract, iStent implantation combined with cataract surgery reduced IOP significantly through 2 years, with greater reductions achieved versus phacoemulsification alone. In patients with baseline IOP <26 mm Hg, surgery reduced IOP and medication use significantly declined through 2 years, with greater reductions achieved versus patients with baseline IOP ≥26 mm Hg. The study was registered at ClinicalTrials.gov under the number NCT03807869.

Cataract and glaucoma combined surgery: XEN® gel stent versus nonpenetrating deep sclerectomy, a pilot study.

BACKGROUND: To compare the efficacy of phacoemulsification (PKE) combined with nonpenetrating deep sclerectomy (NPDS) with mitomycin C (MMC) versus XEN® gel stent with MMC. METHODS: In this nonrandomized, retrospective, comparative, single-center pilot study, 105 consecutive eyes of 75 patients with uncontrolled primary open-angle glaucoma (POAG) and cataract who underwent PKE combined with either XEN implantation (n = 47) or NPDS (n = 58) between May 2013 and November 2018 were included. The primary outcome was complete success at 9 months, which was defined as intraocular pressure (IOP) ≤18, 15 or 12 mmHg without treatment; qualified success was IOP ≤18, 15 or 12 mmHg with antiglaucoma medications. Secondary outcome measures included the number of antiglaucoma medications, visual acuity (VA), and postoperative adverse events. RESULTS: Using the 18 mmHg threshold, complete or qualified success was achieved in 69.6 and 89.1% in the PKE + XEN group, and 63.8 and 89.7% in the PKE + NPDS group (p = .54 and p = .93), respectively, at 9 months. The mean IOP decreased from 20.8 ± 6.8 mmHg to 16.2 ± 2.8 mmHg in the PKE + XEN group (p < .001, 18.9% mean drop), and from 21.5 ± 8.9 mmHg to 14.9 ± 3.9 mmHg in the PKE + NPDS group (p < .001, 25.6% mean drop). Best-corrected VA significantly improved (p < .001) in both groups. The mean number of antiglaucoma medications was significantly reduced from 2.66 ± 1.1 to 0.49 ± 1.0 in the PKE + XEN group (p < .001) and from 2.93 ± 0.9 to 0.69 ± 1.2 in the PKE + NPDS group (p < .001). CONCLUSIONS: The XEN stent combined with PKE seemed to be as effective and safe as PKE + NPDS at 9 months in this pilot study.

Ab interno gel implant in patients with primary open angle glaucoma and pseudoexfoliation glaucoma.

PURPOSE: To compare efficacy and safety results of an ab interno gel implant in patients with pseudoexfoliation glaucoma (PXG) and primary open angle glaucoma (POAG). METHODS: Retrospective analysis of the medical records of 110 consecutive eyes with open angle glaucoma who had received a XEN45 gel implant between March 2014 and June 2015. Intraocular pressure course, number of glaucoma medications, the need for additional intervention (including needling) and complications were evaluated until 12 months postoperatively. RESULTS: Data of 67 eyes with POAG and 43 eyes with PXG were analyzed. At 12 months postoperatively, the mean IOP had significantly decreased by 54.0% from preoperatively 31.85 ± 8.5 mmHg to 13.99 ± 2.6 mmHg in the POAG group, (p = 0.000; Wilcoxon test), and by 55.2% from 31.63 ± 9.0 mmHg to 13.28 ± 3.1 mmHg in the PXG group (p = 0.000; Wilcoxon test). The mean number of anti-glaucoma medications had significantly decreased from 3.25 ± 0.8 at baseline to 0.3 ± 0.7 medications at 12 months postoperatively in POAG eyes (p = 0.000; Wilcoxon test), and from 3.05 ± 1.0 to 0.3 ± 0.6 medications in PXG eyes (p = 0.000; Wilcoxon test). Hypotony (IOP ≤ 6 mmHg) was observed in 2 POAG eyes (3.0%) and in 5 PXG eyes (11.7%) at 1 month but normalized in all eyes at 12 months postoperatively. Severe complications were not observed. No statistically significant differences were found between PXG eyes and POAG eyes. CONCLUSION: Our data indicate that the XEN45 gel implant provides significant and comparable reduction in IOP and anti-glaucoma medication during the one-year follow-up period in POAG as well as PXG eyes. This suggests that it may be a noteworthy alternative to traditional filtering procedures in patients with POAG and PXG respectively.

[XEN-45 Gel Stent implant in glaucoma treatment]. / Mikroshunt XEN-45 dlia lecheniia glaukomy.

The XEN-45 drainage implant is a hypotensive device made of hydrophilic gelatin and stabilized by glutaraldehyde. The implant is designed for modern Microinvasive Glaucoma Surgery (MIGS). Being installed ab interno, the stent drains aqueous fluid from the anterior chamber into the subconjunctival space. According to indications, XEN-45 can be used in treatment of primary open angle glaucoma, pseudoexfoliation or pigment glaucoma with uncompensated intraocular pressure amid maximum tolerated hypotensive therapy, and refractory glaucoma including cases with history of unsuccessful surgery. The implant can also be effectively used in combination with phacoemulsification. The article describes the structure and implantation process of the XEN drainage and reviews existing clinical trials on its effectiveness. The article also presents results on hypotensive efficacy of the implant, as well as characteristics and complications of postoperative management.

iStent insertion orientation and impact on trabecular meshwork motion resolved by optical coherence tomography imaging.

Significance: The iStent is a popular device designed for glaucoma treatment, functioning by creating an artificial fluid pathway in the trabecular meshwork (TM) to drain aqueous humor. The assessment of iStent implantation surgery is clinically important. However, current tools offer limited information. Aim: We aim to develop innovative assessment strategies for iStent implantation using optical coherence tomography (OCT) to evaluate the position and orientation of the iStent and its biomechanical impact on outflow system dynamics. Approach: We examined four iStents in the two eyes of a glaucoma patient. Three-dimensional (3D) OCT structural imaging was conducted for each iStent, and a semi-automated algorithm was developed for iStent segmentation and visualization, allowing precise measurement of position and orientation. In addition, phase-sensitive OCT (PhS-OCT) imaging was introduced to measure the biomechanical impact of the iStent on the outflow system quantified by cumulative displacement (CDisp) of pulse-dependent trabecular TM motion. Results: The 3D structural image processed by our algorithm definitively resolved the position and orientation of the iStent in the anterior segment, revealing substantial variations in relevant parameters. PhS-OCT imaging demonstrated significantly higher CDisp in the regions between two iStents compared to locations distant from the iStents in both OD ( p = 0.0075 ) and OS ( p = 0.0437 ). Conclusions: Our proposed structural imaging technique improved the characterization of the iStent's placement. The imaging results revealed inherent challenges in achieving precise control of iStent insertion. Furthermore, PhS-OCT imaging unveiled potential biomechanical alterations induced by the iStent. This unique methodology shows potential as a valuable clinical tool for evaluating iStent implantation.

Urrets-Zavalia Syndrome of Unresolving Mydriasis Following Endocyclophotocoagulation Combined with Phacoemulsification.

Aim and background: Combined endocyclophotocoagulation and phacoemulsification (ECP/Phaco) are uncommonly associated with complications. We present the first case of a rare complication following ECP/Phaco. Case description: A 72-year-old patient with dense nuclear sclerotic cataracts and primary open-angle glaucoma (POAG) underwent bilateral surgery uneventfully. He experienced a brief episode of postoperative elevated intraocular pressure (IOP), but only one eye with a lower baseline IOP developed a dilated pupil. No pupillary response was observed after applying 4% pilocarpine. The fixed mydriasis persisted without reaction to light or near stimulus, and the best-corrected vision (BCVA) was 20/30 in the affected eye. Conclusion: This case reports a possible rare complication when undergoing ECP/Phaco therapy. The pathogenesis of Urrets-Zavalia syndrome is unknown, but we hypothesized that eyes with more pronounced increases in IOP from baseline may be more susceptible to ischemic injury to the pupillary sphincter, resulting in a chronically dilated pupil. Clinical significance: Even a modest transient rise in postoperative IOP in a glaucomatous eye with normal baseline IOP could result in a chronically dilated pupil. How to cite this article: Cheng AMS, Vedula GG, Kubal AA, et al. Urrets-Zavalia Syndrome of Unresolving Mydriasis Following Endocyclophotocoagulation Combined with Phacoemulsification. J Curr Glaucoma Pract 2024;18(1):28-30.

7-Year Efficacy and Safety of iStent inject Trabecular Micro-Bypass in Combined and Standalone Usage.

INTRODUCTION: This study evaluated 7-year effectiveness and safety of second-generation trabecular micro-bypass implantation (iStent inject) either in combination with cataract surgery or as a standalone procedure (Combined or Standalone subgroups, respectively) in eyes with open-angle glaucoma. METHODS: This prospective, non-randomized, unmasked, longitudinal study included 125 consecutive iStent inject cases of a single surgeon at a large German academic hospital. Patients had considerable preoperative disease burden, with mean intraocular pressure (IOP) of 23.5 mmHg, 84.8% of eyes on ≥ 2 medications, and 38.4% of eyes with prior glaucoma surgery. IOP, medications, adverse events, and secondary surgeries were assessed through 7 years in the Overall cohort and in Combined (n = 81) and Standalone (n = 44) subgroups. RESULTS: Over 7-year follow-up, mean IOP decreased by 36.2-40.0% in Overall eyes, 34.1-38.9% in Combined eyes, and 39.5-43.5% in Standalone eyes (p < 0.001 at all timepoints for all groups). Meanwhile, mean medications decreased by 59.3-71.3% in Overall eyes, 57.9-69.0% in Combined eyes, and 62.1-76.2% in Standalone eyes (p < 0.001 at all timepoints in all groups). At last follow-up (mean 77.4 months; 92.8% of patients with last visit at 6 or 7 years), 83.7% of Overall eyes, 82.3% of Combined eyes, and 86.4% of Standalone eyes had achieved ≥ 20% IOP reduction vs preoperative. At last follow-up vs preoperative, 100% of eyes in all groups had the same or lower IOP and 100% had the same or lower medication regimen. Safety outcomes were favorable, with no filtration surgeries and only 4.84% of eyes experiencing clinically significant visual field loss over 7 years of follow-up. CONCLUSION: iStent inject implantation with or without phacoemulsification produced significant and durable 7-year reductions in IOP (~ 34-44% reduction) and medications (~ 58-76% reduction) while preventing filtering surgery in this cohort of patients with relatively high preoperative disease burden. Combined and Standalone cases had similarly favorable effectiveness and safety.

MIGS in Severe Glaucoma: 12-Month Retrospective Efficacy and Safety of Microinvasive Glaucoma Surgery with Cataract Extraction.

Purpose: Despite holding promise, reports of using MIGS in severe glaucoma are scarce, and none has described combining multiple MIGS in this population. To the best of our knowledge, this is the largest study to report outcomes of phacoemulsification and MIGS (Phaco/MIGS) in patients with severe glaucoma. Methods: This retrospective review comprised 327 clinical visits of 71 patients with severe glaucoma who underwent Phaco/MIGS with iStent, endocyclodestruction, Kahook Dual Blade, Hydrus Microstent, or a combination of these MIGS (cMIGS) performed between 2016 and 2021. Primary outcomes included intraocular pressure (IOP) and medication burden evaluated by Generalized Estimating Equations, as well as Kaplan-Meier Estimates. Further analyses compared the efficacy of cMIGS and single Phaco/MIGS (sMIGS), procedure duration, visual acuity, and complications. Results: Mean preoperative IOP was 16.7 mmHg ± 5.8 (SD) on 2.3 ± 1.9 medications overall (N = 71), 16.9 ± 6.3 mmHg on 1.7 ± 1.9 medications in the sMIGS group (N = 37), and 16.4 ± 5.3 mmHg on 2.9 ± 1.6 medications in the cMIGS group (N = 34). Throughout 12 months, Phaco/MIGS led to significant reduction patterns in IOP (p < 0.001) and medications (p = 0.03). At 12 months, 47.5%, 87.5%, and 64.7% of the patients achieved IOP ≤ 12 mmHg, 17 mmHg, or predetermined goal IOP, respectively, without additional medication or procedure. Mean 12-month IOP was 13.5 ± 3.1 mmHg on 1.8 ± 1.7 medications. After adjusting for baseline medication burden, the reduction pattern in IOP (p < 0.05) was different between cMIGS and sMIGS, favoring cMIGS, and the groups had similar reduction patterns in medications (p = 0.75). Conclusion: The use of Phaco/MIGS in patients with cataract and severe glaucoma may significantly reduce IOP and medication burden throughout 12 months and, thus, may serve as a stepping stone in severe glaucoma patients with visually significant cataract before proceeding with more invasive glaucoma surgery. This effect may be potentiated by the combination effect of cMIGS.

Many patients with cataract and mild or moderate glaucoma who undergo cataract surgery also benefit from microinvasive glaucoma surgery (MIGS) performed at the same time, but the role of MIGS in patients with severe glaucoma and cataract is not clear. We report that combined cataract surgery and MIGS were associated with significant reductions in eye pressure in patients with severe glaucoma for more than 12 months.

Comparing Outcomes of 45 µm Gelatin Stent Placed ab Externo with Open Conjunctiva to ab Externo with Closed Conjunctiva.

PURPOSE: Compare outcomes of a gelatin stent (XEN45 Gel Stent [XGS]) placed either ab externo with open conjunctiva (AEO) or ab externo with closed conjunctiva (AEC) with or without cataract surgery in patients with glaucoma. DESIGN: Retrospective nonrandomized comparative study. PARTICIPANTS: A total of 86 eyes from 86 glaucoma patients who received XGS placed either AEO (N = 49) or AEC (N = 37) with or without cataract surgery between May 2019 and April 2022 at Massachusetts Eye and Ear. METHODS: Reviewed and analyzed 809 visits from patient charts from a level 3 triage center. MAIN OUTCOME MEASURES: Intraocular pressure (IOP), medication burden, Kaplan-Meier (KM) success rates, 5-fluorouracil (5-FU) impact, and complications. RESULTS: Baseline demographics were similar between both groups, except for baseline IOP and glaucoma type. Both AEO and AEC procedures resulted in significant patterns of IOP and medication reduction from baseline up to 1 year. The AEO procedure had significantly higher KM qualified success (QS) rates than the AEC procedure, but similar complete success (CS) rates. Under QS, the cumulative probability of survival was 73% in the AEO group and 51% in the AEC group at month 6 and 62% in the AEO group and 20% in the AEC group at year 1. Under CS, the cumulative probability of survival was 41% in the AEO group and 37% in the AEC group at month 6 and 29% in the AEO group and 14% in the AEC group at year 1. The AEO procedure had significantly more IOP reduction than the AEC procedure at all postoperative time points beyond week 2, but similar medication burden reduction. At postoperative year 1 (POY1), the mean IOP was reduced to 10.72 ± 5.71 mmHg on 1.16 ± 1.68 medications after AEO and 17.03 ± 2.37 mmHg on 1.59 ± 1.21 medications after AEC. Phacoemulsification (phaco) was not a significant factor while 5-FU usage trended toward significance. Procedure time was longer for standalone XGS AEO. CONCLUSIONS: We demonstrate that both placements reduce medication and IOP from baseline, with AEO placement having more favorable XGS success rates and IOP control at the expense of longer procedure time and greater 5-FU usage. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Comparison of Safety and Efficacy of Hydrus and iStent Combined with Phacoemulsyfication in Open Angle Glaucoma Patients: 24-Month Follow-Up.

The paper presents the results of a 24-month-long observation comparing the effectiveness and safety of two micro-invasive glaucoma surgery (MIGS) devices: Hydrus Microstent and iStent Trabecular Bypass in combination with cataract phacoemulsification in the treatment of open-angle glaucoma. We also analyzed the impact of preoperative factors on achieving surgical success in both surgical methods. The prospective, comparative, non-randomized study included 65 glaucoma surgeries. In 35 patients (53.8%), an iStent implant procedure was performed, while 30 patients (46.2%) underwent a Hydrus implant procedure. The demographic data was similar in both treatment groups. At 24 months after surgery, the mean IOP in the iStent group was 15.9 ± 3.0 mmHg and in the Hydrus group 16.2 ± 1.8 mmHg. The difference between the mean iStent vs Hydrus after two years of treatment was -0.3 (p = 0.683). At the 24 month follow-up, the average change in the number of antiglaucoma medications used was 71.7% in the iStent group and 79.6% in the Hydrus group. The difference in mean percentage change between groups was 7.9% in favor of Hydrus. Patients under the age of 70 may benefit from a greater risk reduction in the Hydrus group (HR = 0.81), while those over the age of 70 may benefit from a risk reduction in the iStent group (HR = 1.33). IOP cases with >18 mmHg before the surgery have a better chance of surgical success with the Hydrus method (HR = 0.28), and with IOP < 18 mmHg in the iStent group (HR = 1.93). Cases with more drugs (≥3 drugs) are more favorable in the Hydrus group (HR = 0.23), while those with a maximum of two drugs have a better prognosis in the iStent group (HR = 2.23). The most common postoperative complication was the presence of erythrocytes in the anterior chamber (AC), found in 40.0% of operated eyes in the Hydrus group. The profile of observed complications and significant improvement in visual acuity allows us to consider both implants as a safe way of treating patients with early or moderate glaucoma and co-existing cataracts.

Surgical Augmentation of the Suprachoroidal Space: A Novel Material and Implant.

Microinvasive glaucoma surgery (MIGS) has emerged as a safer method to lower IOP with minimal impact on patient quality of life compared to traditional glaucoma surgeries. With the advent of MIGS, there has been a renewed interest in exploring the suprachoroidal route. MIGS targeting the suprachoroidal space allow for a safe reduction in IOP while sparing conjunctiva and allowing "blebless" surgery, thus avoiding bleb-related complications. This article aims to review the rationale behind the suprachoroidal MIGS procedures and the literature surrounding the efficacy and safety of a novel suprachoroidal device, the MINIject. The available literature has shown promising IOP lowering results with the MINIject implant with a potentially safer and less invasive approach than traditional glaucoma surgeries.

Management of Steroid-Induced Glaucoma in a Patient with Pyoderma Gangrenosum.

Pyoderma gangrenosum (PG) is an uncommon inflammatory skin disorder typically presenting as painful skin ulcers, which may also exhibit extracutaneous findings. PG can occur at the site of trauma or surgery, which is known as the pathergic phenomenon. A 36-year-old man developed bilateral steroid-induced glaucoma after prolonged systemic immunosuppressive treatment for cutaneous pyoderma gangrenosum. After successful Ahmed glaucoma valve implantation surgery with donor scleral patch graft in the right eye, the same surgery failed repeatedly in the left eye and complicated with the prolonged conjunctival necrosis and the exposure of the donor scleral patch graft. Under the impression of ocular involvement of PG, microinvasive glaucoma surgery (MIGS) with XEN® Gel Stent was performed in the left eye; the conjunctival bleb was successfully formed without conjunctival necrosis, and intraocular pressure was well maintained. Ophthalmic surgery can be complicated in patients with PG, and the surgical option should be selected prudently to minimize surgical trauma. MIGS, as a minimally invasive surgical technique, could offer an advantage for patients with PG.

Real-world efficacy of the intrascleral ciliary sulcus suprachoroidal microtube technique in Black and Afro-Latinx patients with glaucoma: a 1-year retrospective study.

Background: Suprachoroidal surgery can lower intraocular pressure and medication use. There is currently no commercial suprachoroidal product on the market. Here, we report our 1 year results of a novel ciliary sulcus suprachoroidal microtube technique. Purpose: To determine the real-world efficacy of intrascleral ciliary sulcus suprachoroidal microtube technique in Black and Afro-Latinx patients with glaucoma refractory to topical ocular hypertensive medications. Methods: A retrospective non-comparative single center study of 36 Black and Afro-Latinx patients with glaucoma and pseudophakia who underwent intrascleral ciliary sulcus suprachoroidal microtube surgery for glaucoma as a stand-alone procedure at a single practice. Investigated parameters were number of medications, visual acuity (VA), intraocular pressure (IOP), mean deviation on visual field (VF) test. Success was defined as (a) IOP ⩽ 15 mmHg and or ⩾ 20% reduction in IOP and (b) a reduction in number of medications. We used paired t-test to compare baseline and follow-up parameters. Results: We reviewed a total of 36 patients who had undergone the procedure. Twenty had success with 12-month follow-up in the study. The mean number of medications decreased significantly from 4.2 ± 1.0 preoperatively to 2.4 ± 1.7 in 12 months (p = 0.021) with five patients being medication free. In addition, the IOP decreased significantly from 21 ± 8.2 to 13.5 ± 4.4 mmHg (p = 0.032). In the 20 patients who had 12-month follow-up, the VA remained stable from Log Mar 0.62 ± 0.6-0.46 ± 0.6 (p = 0.052). VF in patients with successful procedure (no further interventions) remained stable from baseline mean deviation of -16.53 ± 10.04 to -16.82 ± 9.80 dB at 6-12 months. Adverse effects were transient and included IOP spike, hypotony, hyphema, and cornea edema that were treated and resolved. Conclusions: This 12-month retrospective study demonstrated that intrascleral ciliary sulcus suprachoroidal microtube surgery can reduce IOP and medication burden in pseudophakic patients with glaucoma. However, despite several successes, surveillance should take place for IOP spikes, possible tube obstruction, and need for additional glaucoma surgery.

[Bleb morphology using optical coherence tomography : After primary implantation of XEN gel stent and open conjunctival revision]. / Morphologie des Sickerkissens mittels optischer Kohärenztomographie : Nach primärer Implantation von XEN-Gel-Stent und offener Bindehautrevision.

BACKGROUND: The implantation of a XEN gel stent is an innovative method for filtration surgery using an ab interno approach. The morphological evaluation of the resulting bleb is decisive for surgical success. Bleb revision is frequently needed after XEN implantation and might affect the bleb morphology. Aim of this study was to examine bleb morphology using anterior segment OCT (AS-OCT) and analyze the morphological differences of blebs after primary XEN implantation and after bleb revision. MATERIAL AND METHODS: Included were eyes that underwent XEN implantation (Pr-X) or bleb revision after XEN (Re­X group). An AS-OCT of blebs was performed and images were classified using a novel classification system (the Jenaer bleb grading system, JBGS). Frequency of different tomographic patterns (M) and their correlation with intraocular pressure (IOP) were analyzed. RESULTS AND DISCUSSION: A total of 69 eyes (40 in the Pr­X and 29 in the Re­X groups) were included. At the conjunctival level, the most common M in both groups was subconjunctival spaces (M-C2) followed by intraconjunctival cysts (C1) and no conjunctival changes (C0). No differences of frequencies between the two groups or of IOP between the three Ms were seen. At the tenon level, the most commonly seen Ms in the Pr­X group were hyporeflective and cavernous changes (M-T2, T3) followed by no changes (M0) and hyperflective changes (T1). In the Re­X group, the M­T1 and T2 were most commonly seen followed by T3 and T0. The M­T2 and T3 in the Pr­X group and the M­T1 and T2 in the Re­X group correlated with lower IOP. An episcleral lake (M-ES1) was seen significantly less frequently in the Pr­X group compared with Re­X group where it correlated with lower IOP CONCLUSION: The hyperreflective changes at the tenon level and the presence of an episcleral lake were seen more frequently following bleb revision compared with primary XEN implantation and correlated with lower IOP. The interpretation of bleb morphology using AS-OCT should only be done considering the surgical approach used.