Outcomes of gonioscopy-assisted transluminal trabeculotomy in advanced pigmentary glaucoma.

PURPOSE: To compare outcomes of gonioscopy-assisted transluminal trabeculotomy (GATT) over a 12-month period with trabeculectomy in patients with advanced pigmentary glaucoma (PG). METHODS: This was a pilot randomised controlled trial of patients with advanced PG (mean deviation worse than -12 dB), undergoing either GATT or a fornix-based trabeculectomy. Absolute success (criterion A) was defined as a postoperative intraocular pressure (IOP) between 6 and 18 mm Hg, with a drop of at least 30% from the treated preoperative value without need of any IOP-lowering medication. Success (criterion B) was also defined as per the target IOP, with an upper limit of 15 mm Hg for eyes with mean deviation (MD) between -12 and -24 dB, and 12 mm Hg or lower for MD values worse than -24 dB. Qualified success was a similar IOP standard on the same or fewer antiglaucoma medications. RESULTS: For GATT (n=10), mean preoperative IOP and number of glaucoma medications were 28.2±11.2 mm Hg and 4±0.8 that reduced to 11.8±2.5 mm Hg and 0.7 at 12 months postoperatively, while in the trabeculectomy (n=12) group, they were 27.3±5.5 mm Hg and 3.6±0.7 that reduced to 11.5±2.2 mm Hg and 0.5±0.9, respectively. All eyes (100%) achieved qualified success. Absolute success was 60% and 67.7% by criterion A and 50% and 58.3% by criterion B for GATT and trabeculectomy, respectively. Two eyes in the trabeculectomy group developed hypotony while none of the GATT group had any sight-threatening complications (p=0.4). CONCLUSIONS: GATT alone demonstrated a significant reduction in IOP and number of glaucoma medications in patients with advanced PG.

Bimatoprost SR for Glaucoma Therapy Implanted at the Slit-Lamp in a Real-World Setting.

Purpose: To characterize clinical outcomes following a single administration of bimatoprost SR in eyes with glaucoma in a real-world setting implanted at the slit-lamp. Setting: Tertiary care Glaucoma practice, Glaucoma Associates of Texas, Dallas, Texas. Design: Retrospective interventional case series. Methods: Data were analyzed from consecutive patients receiving a single bimatoprost SR implant from the time of its approval to the time of data collection. All eyes were implanted at the slit-lamp. Eyes with less than 1 month of follow-up were excluded. The primary outcome was median time to next intraocular pressure (IOP)-lowering intervention. Mean IOP and medication use, and changes from baseline, were also assessed through 12 months of follow-up. Results: Overall 129 eyes of 81 patients were analyzed. Following bimatoprost SR administration (replacing a topical prostaglandin analogue [PGA] in most eyes), the median survival time without any further IOP-lowering interventions was between 6-9 months. Mean IOP remained unchanged from baseline at month 1 (consistent with switch from topical to intracameral PGA therapy) and began to rise at month 3. At month 12, 40.5% of eyes (52 eyes) remained intervention-free, mean medication reduction was 0.5 medications per eye, and 27.8% of eyes (36 eyes) were medication-free. Adverse events were uncommon and most were transient and resolved with or without intervention. Conclusion: This real-world analysis of bimatoprost SR use for glaucoma therapy complements Phase 3 study findings and demonstrates that the implant can safely provide medication reduction through 6 months in most eyes and through 12 months in almost 40% of eyes.

Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: Two-Year Results from a Randomized, Multicenter Study.

PURPOSE: To compare the effectiveness and safety of the MicroShunt (Santen Inc) versus trabeculectomy in patients with primary open-angle glaucoma (POAG). DESIGN: Prospective, randomized, multicenter trial conducted in the United States and Europe. PARTICIPANTS: Adult patients (aged 40-85 years) with mild to severe POAG inadequately controlled on maximum tolerated medical therapy and intraocular pressure (IOP) ≥ 15 mmHg and ≤ 40 mmHg. METHODS: Patients were randomized 3:1 to stand-alone MicroShunt implantation (n = 395) or trabeculectomy (n = 132), both augmented with mitomycin C (MMC) 0.2 mg/ml for 2 minutes. MAIN OUTCOME MEASURES: The primary effectiveness end point was surgical success, defined as ≥ 20% reduction in mean diurnal IOP from baseline with no increase in glaucoma medications. Secondary end points included changes in mean IOP and medication use from baseline and the need for postoperative interventions. RESULTS: At 2 years, the rate of surgical success was lower in the MicroShunt group than in the trabeculectomy group (50.6% vs. 64.4%, P = 0.005). Mean diurnal IOP was reduced from 21.1 ± 4.9 mmHg at baseline to 13.9 ± 3.9 mmHg at 24 months in the MicroShunt group and from 21.1 ± 5.0 mmHg at baseline to 10.7 ± 3.7 mmHg at 24 months in the trabeculectomy group (P < 0.001 compared with baseline in both groups). Mean medication use decreased from 3.1 to 0.9 in the MicroShunt group and from 2.9 to 0.4 in the trabeculectomy group (P < 0.001 compared with baseline in both groups). Adverse events at 2 years were generally similar in the 2 groups, except that hypotony was more common in eyes undergoing trabeculectomy (51.1% vs. 30.9%, P < 0.001). Repositioning or explantation of the implant occurred in 6.8% of MicroShunt patients. The majority of these patients had device removal at the time of subsequent glaucoma surgery. Vision-threatening complications were uncommon in both groups. CONCLUSION: At 2 years, both the MicroShunt and trabeculectomy provided significant reductions in IOP and medication use, with trabeculectomy continuing to have greater surgical success. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Early Outcomes of Combined Phacoemulsification and Ab Interno Tanito Microhook Trabeculotomy in Open-Angle Glaucoma.

PURPOSE: To study the early postoperative efficacy and safety of an Ab Interno microhook trabeculotomy (microLOT) combined with cataract surgery in patients with open-angle glaucoma. METHODS: This prospective, randomized, interventional study was conducted on consecutive patients with visually significant cataract and mild-moderate open-angle glaucoma. One hundred fourteen patients were included for analysis. The patients were randomized to undergo microhook trabeculotomy with phacoemulsification (group 1) or phacoemulsification alone (group 2). All patients were evaluated on postoperative day 1, 15, and 30, as well as 3, 6, and 12 months postoperatively. A P value < 0.05 was considered statistically significant. Baseline and follow-up visits were compared to determine significant differences in the number of antiglaucoma medications (AGMs), intraocular pressure (IOP), and best-corrected visual acuity. RESULTS: There were 57 patients in each group. The baseline characteristics were similar between the 2 groups, except the number of AGMs, which was greater in group 2. The mean preoperative IOP for group 1 (phaco-microLOT) was 26.5 mmHg ± 5.2 and group 2 (phaco-alone group) was 25.3 mmHg ± 3.1 which decreased to 12.5 mmHg ±3.6 (P < 0.001) and 20.0 mmHg ± 2.7(P < 0.001) at 12 months, respectively. Logarithm of the minimum angle of resolution visual acuity improved from 0.48 (interquartile range [IQR], 0.30-0.60) preoperatively to 0.00 (0.00-0.18) postoperatively (P < 0001) in group 1 and improved from 0.30 (IQR, 0.30-0.48) to 0.00 (0.00-0.00) in group 2 (P < 0.001). In group 1, the mean (standard deviation [SD]) AGM used preoperatively was 0.6 (0.9) which was significantly reduced to 0.2 (0.5) at 12 months postoperatively, whereas in group 2, at 12 months, the mean (SD) AGM used was reduced from 1.4 (0.6) to 1.1 (0.9). In group 1, 90.3% of eyes achieved complete success at the end of 1 year. The most common complication was hyphema, noted in 4 patients with 1 eye requiring an anterior chamber washout. CONCLUSION: Ab interno microhook trabeculotomy (microLOT) combined with phacoemulsification in patients with open-angle glaucoma is an efficacious procedure with relatively minimal complications. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Difficult decisions, filtration surgery, and the heartbreak of the numerator.

A 70-year-old man had progressive and severe glaucoma in each eye. He was intolerant to dorzolamide, brimonidine, and netarsudil. Each eye had prior selective laser trabeculoplasty (SLT) as well as phacoemulsification plus minimally invasive glaucoma surgery (MIGS) 6 years before current presentation (iStent [Glaukos Corp.] in the right eye and Cypass [Alcon Laboratories, Inc.] in the left eye). Postoperative acuities were 20/20 and 20/25 in the right and left eyes, respectively. When his left eye progressed with loss of central acuity despite peak intraocular pressures (IOPs) in the middle to upper teens, neuro-ophthalmology consultation was obtained (Figure 1JOURNAL/jcrs/04.03/02158034-202401000-00017/figure1/v/2023-12-22T124801Z/r/image-tiff). That workup included magnetic resonance imaging scan and hematologic screening, but all results were negative, and the neuro-ophthalmic consultant concluded that the vision loss was likely on the basis of glaucoma. Accordingly, a trabeculectomy was performed in the left eye achieving consistent IOPs in the range of 7 to 10 mm Hg without medications, rending the left eye stable since the filtration surgery nearly 2 years previously. The right eye continued to progress both subjectively and objectively, and on recent examination, the IOP measured 20 mm Hg and 09 mm Hg in the right and left eyes, respectively (Figure 2JOURNAL/jcrs/04.03/02158034-202401000-00017/figure2/v/2023-12-22T124801Z/r/image-tiff). Medications included timolol and latanoprostene bunod in the right eye only. Central corneal thickness was 526 µm and 527 µm in the right and left eyes, respectively. The visual acuity now measured 20/25 in the right eye and 20/250 in the left eye. The vertical cup-to-disc ratio was 0.9 in the right eye and 1.0 in the left eye. Gonioscopy revealed a wide open angle in each eye with a patent sclerostomy superiorly in the left eye. The conjunctiva and sclera were healthy and without scarring in the right eye. The bleb in the left eye was diffuse, lightly vascularized, and seidel negative. Axial length (AL) was 26.88 µm in the right eye and 26.77 µm in the left eye. The patient was in good health and was not anticoagulated. An extensive discussion ensued about the best course of action for the right eye. How would you proceed in managing definite progression in this individual's right eye, knowing that he had lost fixation in his left eye at similar pressures?

Gel Stent Versus Trabeculectomy: The Randomized, Multicenter, Gold-Standard Pathway Study (GPS) of Effectiveness and Safety at 12 Months.

PURPOSE: To compare effectiveness and safety of the gel stent to trabeculectomy in open-angle glaucoma (OAG). DESIGN: Prospective, randomized, multicenter, noninferiority study. METHODS: Patients with OAG and intraocular pressure (IOP) 15 to 44 mm Hg on topical IOP-lowering medication were randomized 2:1 to gel stent implantation or trabeculectomy. Primary end point (surgical success): percentage of patients at month 12 achieving ≥20% IOP reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or secondary surgical intervention (SSI) in a noninferiority test with 24% margins. Secondary end points (month 12) included mean IOP and medication count, postoperative intervention rate, visual recovery, and patient-reported outcomes (PROs). Safety end points included adverse events (AEs). RESULTS: At month 12, the gel stent was statistically noninferior to trabeculectomy (between-treatment difference [Δ], -6.1%; 95% CI, -22.9%, 10.8%); 62.1% and 68.2% achieved the primary end point, respectively (P=.487); mean IOP and medication count reductions from baseline were significant (P<.001); and the IOP change-related Δ (2.8 mm Hg) favored trabeculectomy (P=.024). The gel stent resulted in fewer eyes requiring in-office postoperative interventions (P=.024 after excluding laser suture lysis), faster visual recovery (P≤.048), and greater 6-month improvements in visual function problems (ie, PROs; P≤.022). The most common AEs were reduced visual acuity at any time (gel stent, 38.9%; trabeculectomy, 54.5%) and hypotony (IOP <6 mm Hg at any time) (gel stent, 23.2%; trabeculectomy, 50.0%). CONCLUSIONS: At month 12, the gel stent was statistically noninferior to trabeculectomy, per the percentage of patients achieving ≥20% IOP reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or SSI. Trabeculectomy achieved a statistically lower mean IOP, numerically lower failure rate, and numerically lower need for supplemental medications. The gel stent resulted in fewer postoperative interventions, better visual recovery, and fewer AEs.

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

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

A Review of Excisional Goniotomy Performed with the Kahook Dual Blade for Glaucoma Management.

Aim: To review the published literature describing clinical outcomes of excisional goniotomy using the Kahook Dual Blade (KDB) for the management of glaucoma. Background: A family of less invasive glaucoma procedures-including excisional goniotomy with the KDB-has been developed to provide moderate reductions in intraocular pressure and/or medication burden in eyes with therapeutic needs that may not warrant the risks associated with more traditional procedures such as trabeculectomy and tube-shunt implantation. This review's goal is to synthesize the existing literature into a compendium of excisional goniotomy's indications, technique, efficacy and safety outcomes, and optimal place in glaucoma management. Review results: Excisional goniotomy with the KDB effectively lowers IOP and reduces the medication burden in eyes with POAG and other forms of glaucoma across the spectrum of both baseline IOP and disease severity. The procedure exhibits a safety profile that is on par with other angle-based surgical interventions and enhanced safety compared to filtration procedures. It can be performed by comprehensive ophthalmologists as well as glaucoma specialists. This procedure as a standalone operation delivers IOP reductions consistent with filtration surgery, and in combination with cataract surgery delivers both IOP and medication reductions at least as great as other minimally invasive procedures. Conclusion: Given the broad base of evidence supporting its use in a wide variety of clinical scenarios, excisional goniotomy with the KDB can play a meaningful role in the achievement of patient-specific glaucoma therapy goals. Clinical significance: These aggregate findings support the efficacy and safety of excisional goniotomy with the KDB and clarify the patient profiles best suited for this procedure. How to cite this article: Dorairaj S, Radcliffe NM, Grover DS, et al. A Review of Excisional Goniotomy Performed with the Kahook Dual Blade for Glaucoma Management. J Curr Glaucoma Pract 2022;16(1):59-64.

iSTAT (Intraluminal Suture Transfixed and Titratable) technique for ligature-free Reversal of long-term drainage implant hypotony.

Purpose: To describe the iSTAT (Intraluminal Suture Transfixed and Titratable) technique, an improvement on prior tube occlusion methods, allowing for variable flow. Observations: A 76-year-old woman who underwent an uncomplicated glaucoma drainage device (GDD) placement for uncontrolled mixed mechanism glaucoma presented with hypotony 4 years post-operatively. The iSTAT technique was performed to adjust the flow in the GDD tube: a 4-0 polypropylene suture tip was blunted with a low-temperature cautery, creating a bulbed end that would occlude the tube. The suture was introduced into the tube bulb-first intracamerally, extending to the plate. If partial occlusion of the tube is desired, the suture can be secured in place by piercing the side wall of the tube tip with the distal end of the suture. After complete occlusion of the GDD tube with a large bulb, the patient had intraocular pressures (IOPs) > 40 mmHg on post-operative day 1, which remained in the 25-30 mmHg range 2-3 weeks post-operatively on maximally tolerated medications. Patient underwent a second revision with a smaller-bulbed stent (with a 3-0 polypropylene suture), which stabilized her IOP at 8 mmHg. Conclusion and Importance: The iSTAT technique allows for an ab interno revision, titration of flow, and stabilization of the stent in the wall of the tube. The ab interno approach precludes the need for conjunctival incisions, thus maintaining bleb integrity and permitting surgery under topical anesthesia. The intracameral stabilization of the stent in the tube allows for smaller bulbs to titrate the flow without external ligatures.

Clinical Outcomes of Ahmed ClearPath Implantation in Glaucomatous Eyes: A Novel Valveless Glaucoma Drainage Device.

PRCIS: Designed with novel features to facilitate implantation and improve safety, the Ahmed ClearPath (ACP) glaucoma drainage device (GDD) provided intraocular pressure (IOP) reduction comparable with other GDDs in eyes with refractory glaucoma in a multicenter retrospective study. PURPOSE: To present clinical outcomes with a novel valveless GDD (ACP, New World Medical). The 250 and 350 mm2 models feature a contoured plate for optimal globe apposition, anteriorized suture points to facilitate suturing to the globe, and a prethreaded 4-0 polypropylene ripcord suture. METHODS: This was a multicenter retrospective analysis of eyes with medically and/or surgically uncontrolled glaucoma implanted with the 250 or 350 mm2 ACP either as a standalone procedure or in combination with other procedures. Pre-, intra-, and postoperative data through 6 months were collected. RESULTS: A total of 104 eyes (100 subjects) received the ACP by 10 US surgeons, 63.5% of which had primary open-angle glaucoma and 62.5% had severe glaucoma. Mean baseline IOP was 26.3 (9.0) mm Hg and mean medication use was 3.9 (1.3). Through 6 months' follow-up, mean IOP ranged from 13.6 to 16.7 mm Hg and mean medication use from 0.9 to 1.9 medications (P<0.0001 at all timepoints for each outcome measure). At 6 months, mean IOP was 13.7 mm Hg (-13.0 mm Hg, 43.0%, P<0.0001) and mean medication use was 1.9 medications per eye (-2.1, 47.7%, P<0.0001). Common adverse events included anterior chamber inflammation (16.3%), hyphema (15.4%), and hypotony (6.7%). CONCLUSION: The new ACP appears to be safe and efficacious as a standalone procedure or in combination with other procedures for uncontrolled glaucoma, and may be considered as a GDD option for patients in whom its unique design may facilitate the implantation process.

Outcomes of bleb revision with ologen following filtering glaucoma surgery.

PURPOSE: This study reports long-term outcomes of bleb revision with ologen™ Collagen Matrix (Aeon Astron Europe BV, the Netherlands) for the surgical management of various bleb-related issues including persistent bleb leaks with or without associated hypotony, bleb dysesthesia, overhanging blebs, or hypotony after filtering glaucoma surgery. MATERIALS AND METHODS: A retrospective chart review was performed for patients who underwent ologen bleb revision from 2012 to 2019 at Glaucoma Associates of Texas. RESULTS: The study included 23 eyes of 22 patients undergoing bleb revision with the ologen implant. Mean age was 74.0 ± 11.3 years, 16 (69.6%) were female, and 13 (56.5%) were White. Indications for bleb revision included bleb leak (78.3%), dysesthesia (13.0%), and hypotony from an overfiltering bleb (8.7%). Mean preoperative intraocular pressure was 6.8 ± 4.1 mmHg and the number of medications was 0.3 ± 0.9. Median follow-up was 24 months (range: 12-84 months); all patients had at least 12 months of follow-up. At 1 year, mean intraocular pressure was 10.9 ± 4.6 mmHg on 0.2 ± 0.5 medications, and at last follow-up, mean intraocular pressure was 10.4 ± 3.6 mmHg on 0.3 ± 0.7 medications. Bleb morphology remained low, diffuse, and posterior. One patient developed kissing choroidal effusions requiring surgical drainage with subsequent stabilization of intraocular pressure and bleb function, and three patients required additional surgery due to persistent leaks or bleb failure; there were no other vision-threatening complications. CONCLUSIONS: Use of the ologen implant during surgical bleb revision is a useful surgical technique that confers long-term improvements in bleb morphology and stability of function.

Twenty-Four-Month Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy (GATT) in Eyes With Prior Corneal Transplant Surgery.

PURPOSE: Glaucoma is a well-known sequelae of corneal transplant surgery and is a leading cause of visual loss in this patient group. We evaluated the performance and safety of gonioscopy-assisted transluminal trabeculotomy (GATT) in this population. DESIGN: Noncomparative retrospective case series. PARTICIPANTS: Consecutive eyes of patients receiving the GATT procedure for uncontrolled intraocular pressure (IOP) following corneal transplant surgery from 2016 to 2019. METHODS: Retrospective analysis of eyes with a history of prior corneal transplant undergoing GATT at Glaucoma Associates of Texas between 2016 and 2019 was performed. Data included IOP, patient demographics, preoperative and postoperative medications, preoperative and postoperative corneal procedures, complications, and need for reoperation for IOP control. MAIN OUTCOME MEASURES: IOP reduction and medication use following the procedure. RESULTS: Thirty-nine eyes of 32 patients with prior corneal transplant surgery underwent a GATT procedure. Prior corneal surgery included penetrating keratoplasty (59.0%), Descemet's stripping endothelial keratoplasty (35.9%), Descemet's membrane endothelial keratoplasty (2.6%), and deep anterior lamellar keratoplasty (2.6%). Patient age ranged from 24 to 94 years (mean 68.0 y) with 44% female and 81% Caucasian. The majority of patients had secondary open angle glaucoma (64.1%). There was a significant reduction in IOP and number of medications at all postoperative time points after censoring patients requiring reoperation to control IOP (P<0.001). At 24 months the pressure decreased from baseline of 30.9±11.5 to 13.9±4.7 mm Hg. Medications decreased from 4.2±1.0 medications at baseline to 0.6±1.0 at 24 months. Visual acuities decreased significantly over the first postsurgical month (all P<0.05), but these recovered at subsequent follow-up visits with 2-Snellen line improvements exceeding losses from month 3 to 36. Seven eyes required reoperation for uncontrolled glaucoma at a median of 8.5 months (range: 1.6 to 16.2 mo) after GATT. The cumulative proportion of eyes undergoing repeat cornea surgery was 2.6%, 2.6%, and 14.3% at 12, 24, and 36 months post-GATT, respectively. CONCLUSIONS: This case series describes a group of glaucoma patients, with a history of prior corneal surgery, that were safely and successfully treated with GATT. While classically traditional glaucoma surgeries are considered the standard of care for eyes following corneal transplant surgery, GATT should be considered as a reasonable, safe and effective alternative for surgically lowering IOP.

Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study.

PURPOSE: To compare the effectiveness and safety of the MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG). DESIGN: One-year results from a 2-year, prospective, randomized, multicenter, noninferiority study (NCT01881425) conducted in the United States and Europe. PARTICIPANTS: Eligible patients were aged 40-85 years with intraocular pressure (IOP) ≥15 and ≤40 mmHg and mild-to-severe POAG inadequately controlled on maximum tolerated medical therapy. METHODS: Patients were randomized 3:1 to undergo stand-alone MicroShunt implantation or trabeculectomy, both performed with adjunctive mitomycin C (0.2 mg/ml for 2 minutes). MAIN OUTCOME MEASURES: The primary effectiveness end point was surgical success, defined as ≥20% reduction in mean diurnal IOP from baseline (no medication washout) at year 1 without increasing the number of glaucoma medications. Secondary effectiveness end points at year 1 were the mean IOP change from baseline and requirement for postoperative intervention. Additional end points included glaucoma medication use and adverse events. RESULTS: Overall, 395 (MicroShunt) and 132 (trabeculectomy) patients were randomized (mean Humphrey visual field mean deviation, -12.34 decibels [dB]). At year 1, probability of success was lower in the MicroShunt group compared with the trabeculectomy group (53.9% vs. 72.7%, respectively; P < 0.01). In the MicroShunt group, mean IOP ± standard deviation decreased from 21.1 ± 4.9 mmHg at baseline to 14.3 ± 4.3 mmHg (-29.1%; P < 0.01) at year 1, with a mean of 0.6 ± 1.1 glaucoma medications (baseline 3.1 ± 1.0; P < 0.01). In the trabeculectomy group, mean IOP decreased from 21.1 ± 5.0 mmHg to 11.1 ± 4.3 mmHg (-45.4%; P < 0.01), with a mean of 0.3 ± 0.9 glaucoma medications (baseline 3.0 ± 0.9; P < 0.01). Postoperative interventions, including laser suture lysis, were reported in 40.8% (MicroShunt) versus 67.4% (trabeculectomy) of patients (P < 0.01). Reported incidence of transient hypotony was higher in the trabeculectomy group versus the MicroShunt group (49.6% vs. 28.9%; P < 0.01). Vision-threatening complications were uncommon and reported in 1.0% of MicroShunt versus 0.8% of trabeculectomy patients. CONCLUSIONS: Probability of success was lower with MicroShunt compared with trabeculectomy. Although reductions in IOP and glaucoma medications over 1 year were observed in both groups, the trabeculectomy group had a lower mean IOP on fewer medications.

Rescue of Failed XEN-45 Gel Implant by Nd:YAG Shock Wave to Anterior Chamber Tip to Dislodge Hidden Intraluminal Occlusion.

PURPOSE: The purpose of this study was to inform ophthalmic surgeons in a timely manner of the hidden problem of clear intraluminal cellular debris as a cause for XEN-45 failure and to describe low energy neodymium-doped yttrium aluminum garnet (Nd:YAG) laser revision with periluminal anterior chamber tip shockwave treatment to improve flow to the bleb. PATIENTS AND METHODS: Six patients with visibly patent stent lumen post XEN-45 surgery. These eyes developed rising intraocular pressure (IOP) with a history of excellent prior bleb formation and were treated successfully with Nd:YAG laser shockwave therapy to disperse assumed intraluminal cellular debris. The laser was aimed just anterior and axial to the intracameral tip of the gel stent through a gonioscopy lens. RESULTS: Six patients with an average age of 75 years (60 to 90 y), preoperative IOP of 30 mm Hg (16 to 52 mm Hg) on an average of 2 antiglaucoma medications (0 to 4) underwent periluminal anterior chamber tip shock wave at an average of 12 months (1 to 38 mo) from XEN-45 surgery. The IOP was immediately reduced to an average of 15 mm Hg (8 to 23 mm Hg) and last IOP averaged 15 mm Hg (10 to 23 mm Hg) on 1.5 medications (0 to 4) at 4 months post periluminal anterior chamber tip shock wave. CONCLUSION: Nd:YAG laser revision of hidden blockage of a XEN-45 gel implant with periluminal anterior chamber tip shockwave treatment can disperse invisible intraluminal cellular debris and improve flow in a failing XEN-45 microstent, especially when distal fibrosis is not excessive.

The Canonical Wnt Signaling Pathway Inhibits the Glucocorticoid Receptor Signaling Pathway in the Trabecular Meshwork.

Glucocorticoid-induced glaucoma is a secondary open-angle glaucoma. About 40% of the general population may develop elevated intraocular pressure on prolonged glucocorticoid treatment secondary to damages in the trabecular meshwork (TM), a tissue that regulates intraocular pressure. Therefore, identifying the key molecules responsible for glucocorticoid-induced ocular hypertension is crucial. In this study, Dickkopf-related protein 1 (Dkk1), a canonical Wnt signaling inhibitor, was found to be elevated in the aqueous humor and TM of glaucoma patients. At the signaling level, Dkk1 enhanced glucocorticoid receptor (GR) signaling, whereas Dkk1 knockdown or Wnt signaling activators decreased GR signaling in human TM cells as indicated by luciferase assays. Similarly, activation of the GR signaling inhibited Wnt signaling. At the protein level, glucocorticoid-induced extracellular matrix was inhibited by Wnt activation using Wnt activators or Dkk1 knockdown in primary human TM cells. In contrast, inhibition of canonical Wnt signaling by ß-catenin knockdown increased glucocorticoid-induced extracellular matrix proteins. At the physiological level, adenovirus-mediated Wnt3a expression decreased glucocorticoid-induced ocular hypertension in mouse eyes. In summary, Wnt and GR signaling inhibit each other in the TM, and canonical Wnt signaling activators may prevent the adverse effect of glucocorticoids in the eye.