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\u3c.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 \u3c6 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

Risk Factors for Tube Shunt Exposure: A Matched Case-Control Study

Purpose. To evaluate potential risk factors for developing tube shunt exposure in glaucoma patients. Patients and Methods. Forty-one cases from 41 patients that had tube shunt exposure from 1996 to 2005 were identified from the Robert Cizik Eye Clinic and Bascom Palmer Eye Institute. Each case was matched with 2 controls of the same gender and with tube shunts implanted within 6 months of the index case. Conditional logistic regression was used to determine risk factors. Results. The study cohort includes a total of 121 eyes from 121 patients. The mean age was 63.6 ± 19.7 years, ranging from 1 to 96 years. The average time to exposure was 19.29 ± 23.75 months (range 0.36–85.74 months). Risk factors associated with tube exposure were Hispanic ethnicity (; OR = 3.6; 95% CI, 1.3–9.7), neovascular glaucoma (; OR = 28.5; 95% CI, 2.6–316.9), previous trabeculectomy (; OR = 5.3; 95% CI, 1.6–17.7), and combined surgery (; OR = 3.7; 95% CI, 1.1–12.7). Conclusions. Hispanic ethnicity, neovascular glaucoma, previous trabeculectomy, and combined surgery were identified as potential risk factors for tube shunt exposure. These potential risk factors should be considered when determining the indication for performing tube shunt implantation and the frequency of long-term followup

Episcleral Venous Fluid Wave Correlates with Trabectome Outcomes: Intraoperative Evaluation of the Trabecular Outflow Pathway

To determine whether the characteristics of an intraoperative episcleral venous fluid wave (EVFW), a potential indicator of trabecular outflow patency, correlates with Trabectome (NeoMedix Corp, Tustin, CA) outcomes. Retrospective, observational study. A total of 68 eyes of 49 patients with glaucoma who underwent phaco-Trabectome (63 eyes) or Trabectome alone (5 eyes). The EVFW was evaluated in a masked fashion for wave degree (0-4) and clock hours (0-6). A diffuse EVFW (4, 5, 6 clock hours) was a near complete blanching of the episcleral vasculature, and a poorly defined wave was minimal change in the vasculature. Patients were grouped into wave categories to determine whether there was a correlation with postoperative intraocular pressure (IOP). Patients requiring further glaucoma surgery were considered failures. Degree and extent of EVFW, IOP, and glaucoma medications. For all eyes, there was a statistically significant correlation between wave clock hours and postoperative IOP at month 1 (P = 0.043) and month 3 (P = 0.002), but not a statistically significant correlation at month 6 (P = 0.12) or 1 year (P = 0.86). A strong correlation was found among IOP, medications, and EVFW in eyes with an extensive EVFW when compared with eyes with a poorly defined EVFW. At 12 months, the mean IOP in the extensive EVFW group was 13.3±2.7 mmHg on 1.4±1.2 medications compared with an IOP of 18.4±3.1 mmHg on 2.9±0.9 medications in the poorly defined group (both P = 0.001). Overall, 5 of 68 eyes (7%), required further glaucoma surgery. Eyes with a poorly defined EVFW had a higher likelihood of further glaucoma surgery (36%). The EVFW is an intraoperative gauge of patency through the trabecular outflow pathway. Absence of the EVFW implies obstruction in the collector channel-intrascleral aqueous outflow pathway, preventing flow to the visible episcleral veins. In contrast, eyes with a diffuse EVFW had sufficient flow through their collector channels, had a lower IOP, required fewer glaucoma medications, and had a lower requirement for further glaucoma surgery. The characteristics of an EFVW may be able to predict surgical outcomes after Trabectome surgery

Gonioscopy-assisted transluminal trabeculotomy, ab interno trabeculotomy: technique report and preliminary results

To introduce a minimally invasive, ab interno approach to a circumferential 360-degree trabeculotomy and to report the preliminary results. Retrospective, noncomparative cases series. Eighty-five eyes of 85 consecutive patients who sought treatment at Glaucoma Associates of Texas with uncontrolled open-angle glaucoma and underwent gonioscopy-assisted transluminal trabeculotomy (GATT) for whom there was at least 6 months of follow-up data. Retrospective chart review of patients who underwent GATT by 4 of the authors (D.S.G., D.G.G., O.S., R.L.F.) between October 2011 and October 2012. The surgery was performed in adults with various open-angle glaucomas. Intraocular pressure (IOP), glaucoma medications, visual acuity, and intraoperative as well as postoperative complications. Eighty-five patients with an age range of 24 to 88 years underwent GATT with at least 6 months of follow-up. In 57 patients with primary open-angle glaucoma, the IOP decreased by 7.7 mmHg (standard deviation [SD], 6.2 mm Hg; 30.0% [SD, 22.7%]) with an average decrease in glaucoma medications of 0.9 (SD, 1.3) at 6 months. In this group, the IOP decreased by 11.1 mmHg (SD, 6.1 mmHg; 39.8% [SD, 16.0%]) with 1.1 fewer glaucoma medications at 12 months. In the secondary glaucoma group of 28 patients, IOP decreased by 17.2 mmHg (SD, 10.8 mmHg; 52.7% [SD, 15.8%]) with an average of 2.2 fewer glaucoma medications at 6 months. In this group, the IOP decreased by 19.9 mmHg (SD, 10.2 mmHg; 56.8% [SD, 17.4%]) with an average of 1.9 fewer medications (SD, 2.1) at 12 months. Treatment was considered to have failed in 9% (8/85) of patients because of the need for further glaucoma surgery. The cumulative proportion of failure at 1 year ranged from 0.1 to 0.32, depending on the group. Lens status or concurrent cataract surgery did not have a statistically significant effect on IOP in eyes that underwent GATT at either 6 or 12 months (P > 0.35). The most common complication was transient hyphema, seen in 30% of patients at the 1-week visit. The preliminary results and safety profile for GATT, a minimally invasive circumferential trabeculotomy, are promising and at least equivalent to previously published results for ab externo trabeculotomy

Gonioscopy assisted transluminal trabeculotomy: an ab interno circumferential trabeculotomy for the treatment of primary congenital glaucoma and juvenile open angle glaucoma

Background/aimsTo introduce a novel ab interno 360° trabeculotomy for treating primary congenital glaucoma (PCG) and juvenile open angle glaucoma (JOAG) and report preliminary results.MethodsA retrospective chart review of patients who underwent a gonioscopy assisted transluminal trabeculotomy (GATT) procedure by four of the authors (DSG, OS, RLF and DGG) between October 2011 and October 2013. The surgery was performed in patients ≤30 years old with a dysgenic anterior segment angle and uncontrolled PCG and JOAG.ResultsFourteen eyes of 10 patients underwent GATT with follow-up >12 months (12–33 months; mean 20.4). Patients ranged in age from 17 months to 30 years (mean=18.4 years), and five (50%) were female patients. No complications occurred during or following surgery except for early postoperative hyphema in five (36%) of eyes, all cleared by 1 month. The mean intraocular pressure (IOP) decreased from 27.3 to 14.8 mm Hg and the mean number of medications required decreased from 2.6 to 0.86. Five eyes had a drop in IOP ≥15 mm Hg (range 15–39).ConclusionsThe preliminary results and safety for GATT, a minimally invasive conjunctival sparing circumferential trabeculotomy, are promising and at least equivalent to previous results for ab externo trabeculotomy for the treatment of PCG and JOAG. All eyes in the study were considered a clinical success

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 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. Ophthalmology 2021;128:1710-1721 (c) 2021 by the American Academy of Ophthalmology. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/)