New Devices in Glaucoma.

Glaucoma remains a leading cause of blindness globally. Minimally invasive treatment techniques are rapidly expanding the availability of therapeutic options for glaucoma. These include devices aimed at enhancing outflow through the subconjunctival space, Schlemm's canal, and suprachoroidal space, sustained-release drug delivery devices, and extraocular devices aiming to reduce glaucomatous progression through other novel means. In this review, we provide an overview of several novel devices either newly available or in development for the medical and surgical management of glaucoma. Further studies are required to determine the long-term efficacy of these devices and how they will integrate into the current landscape of glaucoma management.

Intraocular Pressure and Medication Changes Associated with Xen Gel Stent: A Systematic Review of the Literature.

The Xen gel stent (Allergan Inc, an AbbVie company; Dublin, Ireland) was conceived as an option for patients requiring modest IOP reduction but for whom trabeculectomy was not yet indicated. As with any glaucoma surgery, establishing criteria for patient selection and identifying factors that contribute to a high likelihood of success are important. To help guide clinical decision-making, a systematic review of published studies on the gel stent was performed, with the goal of understanding postoperative outcomes based on clinical and patient factors. Results were organized around a series of pertinent clinical questions based on scenarios encountered in clinical practice. Criteria for including studies were intentionally broad, with the objective of simulating the diverse population of glaucoma patients encountered in real-world practice. Outcomes for IOP and medication reduction postoperatively were assessed in various analyses, including in eyes with various glaucoma types and severity; in eyes naïve to surgery as well as those with a history of prior incisional glaucoma surgery; and when surgery was performed as a standalone procedure or at the time of cataract surgery. The results of each of the various analyses were consistent in demonstrating that successful gel stent surgery achieved a postoperative IOP of approximately 14.0 mm Hg and reduction to fewer than 1 glaucoma medication. Additional data are shown on outcomes by method of implant (ab interno vs ab externo); intraoperative use of antifibrotics; and rates of needling in published studies.

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.

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.

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.

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.

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.

Economic and Clinical Burden Associated With Intensification of Glaucoma Topical Therapy: A US Claims-based Analysis.

PRECIS: Incremental addition of intraocular pressure-lowering topical drops is associated with shorter-lasting benefit and higher health-related costs with each additional agent, suggesting a need for new treatment options to improve disease control and reduce treatment burden. PURPOSE: The purpose of this study was to evaluate treatment intensification as a driver of clinical and economic burden in patients receiving topical glaucoma medications for open-angle glaucoma/ocular hypertension. METHODS: This retrospective analysis of administrative claims data (January 2011 to July 2017) from the IQVIA PharMetrics Plus database included diagnosed patients who initiated or intensified treatment with 1 to 4 topical glaucoma medications of a different drug class between January 2012 and July 2015 (index date being the first such event during this period). Patients with prior open-angle glaucoma surgery or an equal or greater number of topical glaucoma medication classes during the preindex period were excluded. Treatment intensification rates and eye-related outpatient costs were assessed over 24 months postindex. RESULTS: Of 48,402 patients (mean age: 61.4 y), 22,874 (47.3%), 16,214 (33.5%), 7137 (14.7%), and 2177 (4.5%) received a first, second, third, or fourth medication class, respectively, as their first observed initial or intensified regimen. Among cohorts receiving 1, 2, 3, or 4 medication classes, 7.8%, 12.2%, 17.2%, and 22.6% of patients and 12.6%, 18.5%, 25.9%, and 33.7% of patients had subsequent treatment augmentation (class addition or glaucoma procedure, laser or surgical) within 12 and 24 months postindex, respectively. Eye-related outpatient costs over 24 months increased with each additional topical glaucoma medication class at index [mean (SD): $1610 ($3460), $2418 ($4863), $2872 ($5110), and $3751 ($6608) in the 1, 2, 3, or 4 class cohorts, respectively]. CONCLUSION: Multiple-drop therapies yielded shorter-lasting benefits with each additional agent and were associated with the increased clinical and economic burden.

XEN Gel Stent in Pediatric Glaucoma.

PURPOSE: To report a series of 3 eyes of 3 children with congenital glaucoma receiving the XEN gel stent implant. PATIENTS AND METHODS: An interventional case series is reported. RESULTS: Three eyes underwent implantation of the gel stent. In 2 cases, the gel implant procedure was performed after failed trabeculotomy, while in the third eye, primary gel stent implantation was performed. One eye received 2 implants. Three procedures were performed via an ab interno approach while the fourth was performed ab externo. No device-related complications were observed. In all 3 eyes, intraocular pressure was controlled without the use of topical medications through 6 to 24 months of follow-up. CONCLUSIONS: The gel stent implant can be safely used in children with congenital glaucoma and effectively lowers intraocular pressure in these eyes. This procedure is a viable follow-up to, or replacement for, traditional angle surgery in eyes with congenital glaucoma.

Early Results of Goniotomy with the Kahook Dual Blade, a Novel Device for the Treatment of Glaucoma.

PURPOSE: To report the outcomes of patients who underwent goniotomy with the Kahook Dual Blade (KDB) either as a standalone procedure or in combination with cataract extraction. PATIENTS AND METHODS: This retrospective chart review included 111 eyes of 90 patients who underwent KDB goniotomy from January to November 2016 at Glaucoma Associates of Texas. KDB goniotomy was combined with cataract surgery in 100 eyes. The main outcome measures were postoperative intraocular pressure (IOP) and number of IOP lowering medications. RESULTS: Preoperatively, mean IOP was 17.1 ± 4.7 mmHg (range 8-34 mmHg) and mean number of IOP lowering medications was 2.4 ± 1.3 (range 0-6). Postoperatively, mean IOP was 14.9 mmHg, 13.9 mmHg, 14.1 mmHg, 14.4 mmHg, and 14.7 mmHg at 1, 3, 6, 9, and 12 months follow-up, respectively (all p <0.004). Mean numbers of IOP lowering medications were 0.8, 1.0, 1.0, 1.0, and 1.6 at 1, 3, 6, 9, and 12 months follow-up, respectively (all p <0.001). The cumulative reoperation rates for uncontrolled IOP after KDB were 0%, 1.0%, 2.1%, and 4.6% at 3, 6, 9, and 12 months, respectively. Eyes with a preoperative IOP >21 mmHg were significantly more likely to undergo reoperation (p = 0.038, log-rank test). There were no serious complications at any time point in the follow-up period. CONCLUSION: The Kahook Dual Blade results in a reduction in IOP and use of glaucoma medications after one year of follow-up. Further prospective studies are needed to fully characterize safety and efficacy.