Faculty Bibliography

This study was registered with ClinicalTrials.gov (ID: NCT03715231). A total of 20 participants (37 eyes) who were 18 or older and had glaucoma or were glaucoma suspects were enrolled from the NYU Langone Eye Center and Bellevue Hospital. During their usual ophthalmology visit, they were consented for the study and underwent 360-degree goniophotography using the NIDEK Gonioscope GS-1. Afterwards, the three ophthalmologists separately examined the images obtained and determined the status of the iridocorneal angle in four quadrants using the Shaffer grading system. Physicians were masked to patient names and diagnoses. Inter-observer reproducibility was determined using Fleiss' kappa statistics. The interobserver reliability using Fleiss' statistics was shown to be significant between three glaucoma specialists with fair overall agreement (Fleiss' kappa: 0.266, p < .0001) in the interpretation of 360-degree goniophotos. Automated 360-degree goniophotography using the NIDEK Gonioscope GS-1 have quality such that they are interpreted similarly by independent expert observers. This indicates that angle investigation may be performed using this automated device and that interpretation by expert observers is likely to be similar. Images produced from automated 360-degree goniophotography using the NIDEK Gonioscope GS-1 are similarly interpreted amongst glaucoma specialists, thus supporting use of this technique to document and assess the anterior chamber angle in patients with, or suspected of, glaucoma and iridocorneal angle abnormalities.

While treatment options available to patients with glaucoma are expanding, trabeculectomy and glaucoma drainage device implantation (GDI) remain a mainstay in glaucoma surgical care. This article reviews key aspects of bleb management following trabeculectomy and GDI surgery. Basics of postoperative management of trabeculectomy and GDIs are reviewed, as well as how to manage complications such as early and late bleb leaks, fibrosis, bleb dysesthesia and the hypertensive phase. In general, careful surgical technique, close postoperative monitoring and appropriate intervention can help patients achieve safe outcomes and long-term control of intraocular pressure
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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.

PRECIS/CONCLUSIONS:Sub-Tenon's implantation of the Xen® Gel stent resulted in significant intraocular pressure lowering along with a low rate of postoperative bleb needling, and a favorable bleb morphology on anterior segment optical coherence tomography. PURPOSE/OBJECTIVE:To assess clinical outcomes and bleb morphology following sub-Tenon's implantation of the Xen® Gel Stent (Allergan Inc., Dublin, Ireland). METHODS:The medical records of patients who underwent sub-Tenon's Xen® Gel Stent implantation with intraoperative mitomycin-C via an open conjunctival approach were reviewed. Postoperative intraocular pressure (IOP) and number of glaucoma medications at 1,3,6,9 and 12 months were assessed. Bleb morphology was analyzed at various timepoints using anterior segment optical coherence tomography (AS-OCT, Topcon DRI OCT version 1.1.1). RESULTS:Twenty-six eyes were included in the study. Mean age was 69.4±8.0 years. Mean preoperative IOP was 28.1±7.8▒mm Hg on an average of 3.5±0.9 glaucoma medications. Mean IOP at postoperative month 12 (n=23 eyes) was 12.9±4.0▒mm Hg (P<0.01) on an average of 0.3±0.6 (P<0.01) glaucoma medications. Three eyes (12%) required postoperative needle revision. Bleb morphology in the early postoperative period (≤ 3▒mo) was characterized by multiple small subconjunctival microcysts on AS-OCT. At the intermediate (6-12▒mo) and long-term (>12▒mo) time points, reduction in microcysts with multiple internal parallel layers of aqueous flow and a uniform pattern were more frequently noted. All functional blebs were characterized by the presence of a posterior episcleral fluid lake. Failed blebs showed absence of aqueous humor around the distal end of the microshunt. CONCLUSION/CONCLUSIONS:Following an open conjunctival approach, sub-Tenon's placement of the Xen® Gel Stent with significant IOP lowering was achieved. In eyes with good shunt function, bleb morphology by AS-OCT showed a posterior episcleral fluid lake similar to findings following trabeculectomy.

Purpose/UNASSIGNED:Immune checkpoint inhibitors (ICIs) are associated with a range of immune-related adverse ophthalmic events. To date, there are scant reports of ocular hypertension coupled with ICI-associated uveitis. However, in instances of ocular hypertension in the context of only mild uveitic reaction and absence of synechiae, trabeculitis is considered. This series describes our observations of presumed trabeculitis in the setting of ICI therapy and investigates the clinical findings, treatment and outcome of these patients. Observations/UNASSIGNED:Two eyes of 2 patients (both male aged 65 and 43) developed a mild anterior uveitis and elevated intraocular pressure (IOP) with open angles and no evidence of peripheral anterior synechiae in association with ICI treatment for their malignancy; and were considered to have presumed unilateral trabeculitis. The patients underwent 10 cycles (6.53 months) and 2 cycles (3.33 months) respectively of ICI therapy before developing ophthalmic symptoms. Neither patient was on systemic or topical steroid treatment at time of diagnosis and there was no suspicion of a viral etiology for the inflammation. Following management, the anterior uveitis resolved and IOP rapidly returned to normal in both eyes: ICI therapy was discontinued in both patients (and uneventfully re-challenged at a lower dose in one patient) and both eyes were treated with a combination of topical and/or oral glaucoma medications and topical steroids. Conclusions and Importance/UNASSIGNED:Uveitic ocular hypertension has been described with ICI. However, another immune-related mechanism for ocular hypertension with unique clinical characteristics, includes trabeculitis. We describe two cases of trabeculitis in the setting of ICI-therapy. The intraocular inflammation and elevated intraocular pressure which characterizes trabeculitis often responds rapidly to conservative treatment. In both patients checkpoint inhibitor therapy was discontinued and, in one patient, was re-challenged at a lower dose without recurrence. Immunotherapy is now more widely used for cancer treatment and its potential ocular manifestations should be shared with the ophthalmic community.

Purpose : Repetitive transorbital alternating current stimulation (rtACS) is an application of weak electric current near the eyes used in vision rehabilitation of optic neuropathies (ON). Conceptually rtACS entrains neuronal oscillations, augmenting neuronal function. In subjects with ON we evaluated whether rtACS influenced visual structure and function. Methods : 34 subjects with ON enrolled in a prospective trial underwent comprehensive ophthalmic evaluation, visual field (VF) 24-2 and 10-2 tests (Humphrey Field Analyzer) and OCT (Cirrus HD-OCT) retinal nerve fiber layer (RNFL) and ganglion cell inner plexiform layer (GCIPL) thicknesses at baseline and follow-up (FU) visits. Subjects received rtACS 30-to 45-minutes daily for 10 days. Sham subjects (n=4) underwent the same procedures but received no current. Point-by-point analyses of VF total deviation (TD) values were conducted between rtACS and sham groups. Regression analyses determined rate of change for each TD point per eye (significant points with positive rate of change defined as improved, negative rate of change as progressed; insignificant rate of change as no change) and the association between RNFL and GCIPL between groups. Results : The number of FU visits with VF tests ranged 2 to 7, with no significant differences detected between rtACS vs sham groups' FU duration. No significant differences were detected between groups' baseline VF 24-2 and 10-2 mean deviation (MD) values (Table 1). The average numbers of improved points (VF 10-2) and progressed points (VF 24-2) were greater for rtACS while the average number of no change points was greater for sham (VF 24-2, p0.05, Table 1). Further analysis of FU duration determined a significant interaction with rtACS; number of improved points (VF 10-2) and progressed points (VF 24-2, p<0.02) were not sustained over time. No significant differences were detected in average RNFL and GCIPL thicknesses between groups. Conclusions : Preliminary analyses of the effect of rtACS in ON indicate initial improvement but not a clear benefit over time. Detection of differences between rtACS vs sham groups may be biased due to the small sham sample and range of FU duration as VF test-to-test variability is known to increase with worsening VF MD. Future analyses will assess interim effect at early vs late FU time points to evaluate the role of rtACS in vision rehabilitation

Purpose : Prevalence and severity of glaucoma varies between ethnicities. It has been previously shown that ocular vessel density (VD) varies among healthy subjects of different ethnicities. To further elucidate the potential role of VD in glaucoma we examined ocular VD in Caucasian, African American (AA), and Latin at similar stages of glaucoma severity. Methods : 150 glaucoma eyes of which 46 eyes (30 subjects) were Caucasian, 71 eyes (43 subjects) African American, and 33 eyes (19 subjects) Latin were included in the analysis. Comorbidities known to affect the systemic or local micro-or macro-vasculature and medications that are known to modify vessel diameter were excluded. Disease severity distribution was similar across ethnicity groups. All eyes had comprehensive ophthalmic examination, Cirrus HD-OCT (Zeiss, Dublin, CA) and OCT angiography (OCTA; Angioplex, Zeiss) qualified scans of the macula and optic nerve head regions (200x200 OCT cube scans and 3x3mm / 6x6mm OCTA scans). VD as provided by the device's native software in the inner vascular plexus was used for the analysis. Statistical analysis was performed using mixed-effects models accounting for ethnicity, age, axial length, visual field mean deviation (MD), OCT signal strength (SS), disc area and intra-subject correlation. Tukeyadjusted p-values for pairwise ethnicity comparisons were obtained.Results : No significant difference was detected in age and MD among ethnicities (Table 1). Caucasian subjects had the longest AL and thinnest RNFL, and Latin subjects had the largest disc area and cup-to-disc ratio (CDR; Table 1). No significant differences were detected among ethnicities in ONH VD in any of the scan types and regions. In the macula, Caucasians had significantly higher VD in the center of both scan sizes in comparison with both AA and Latin (Table 2). Caucasian eyes also had significantly higher VD in the full 3x3 scan in comparison with AA eyes. There were no significant differences in the rest of the macular VD measurements among the 3 groups. Conclusions : Macular VD in glaucoma subjects varies among ethnicities and might play a role in the varying disease behavior among ethnicities. Differences in foveal avascular zone size might explain our findings but further investigation is warranted

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

PURPOSE/OBJECTIVE:To study the effect of phacoemulsification on intraocular pressure (IOP) control in patients with preexisting glaucoma drainage implants (GDIs). DESIGN/METHODS:Retrospective, observational case series. PARTICIPANTS/METHODS:A total of 45 patients (51 eyes) with previously placed GDIs who underwent phacoemulsification between January 2013 and March 2018. METHODS:The list of patients was obtained from billing records. Clinical data were retrieved from the corresponding electronic medical records. MAIN OUTCOME MEASURES/METHODS:Intraocular pressure, number of glaucoma medications before and after phacoemulsification (postoperative day 1, week 1, months 1, 3, 6, 12, 18, and 24), rate of failure (failure defined as IOP >18 mmHg and IOP increase >20% at 2 consecutive visits after month 1, need for additional glaucoma surgery, or loss of light perception vision), and postoperative complications. RESULTS:Mean follow-up was 23.0 ± 11.1 months. The average interval between GDI surgery and phacoemulsification was 9.4 ± 6.7 months. An Ahmed glaucoma valve (AGV; New World Medical) was implanted in 12 eyes, a Baerveldt glaucoma implant (BGI; Johnson & Johnson Surgical Vision) was implanted in 36 eyes, and a Molteno (Molteno Ophthalmic Limited) glaucoma implant was implanted in 3 eyes. Before phacoemulsification, the mean IOP was 14.4 ± 4.4 mmHg on 2.1 ± 1.3 glaucoma medications. At postoperative month 24, the mean IOP was 12.6 ± 4.4 mmHg (n = 29, P = 0.519) on 2.0 ± 1.6 (P = 0.457) glaucoma medications. The reduction in IOP was significant only at postoperative week 1 (P = 0.031). The cumulative failure rate was 3.9% at 1 year and 11.8% at 2 years. The AGV group had a significantly higher mean IOP before phacoemulsification than the BGI group (P = 0.016). Analysis of covariance, taking the baseline IOP as a covariate, revealed no differences in postoperative IOP and number of glaucoma medications between groups, except for month 18 (1 patient in the BGI group had uncontrolled IOP requiring surgery). Postoperative complications included cystoid macular edema (10%), corneal decompensation (6%), and choroidal effusion (4%). CONCLUSIONS:Phacoemulsification after GDI surgery resulted in a transient reduction in IOP at postoperative week 1. Patients with previously placed AGVs had similar postoperative outcomes compared with those with BGIs.