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.

Interim Analysis of Clinical Outcomes with Open versus Closed Conjunctival Implantation of the XEN45 Gel Stent.

OBJECTIVE: To examine the longitudinal postoperative outcomes of open versus closed conjunctiva implantation of the XEN45 gel stent. DESIGN: Retrospective multicenter study. SUBJECTS: One hundred ninety-three patients with glaucoma underwent XEN45 implantation via an open or closed conjunctiva approach. METHODS: Data on 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: Failure was defined as < 20% reduction in IOP from the medicated baseline or a IOP of > 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. Overall success was defined as those who achieved success either with or without topical medications. RESULTS: Patients were followed for an average of 17 months. Complete success was achieved in 42.5% and 24.7% of the open and closed groups, respectively (P = 0.01). Overall success was achieved in 64.2% and 37.0% of the open and closed groups, respectively (P < 0.001) at the last follow-up. Bleb needling was performed in 12.4% of eyes in the open group compared with 40% of eyes in the closed group. An IOP spike of ≥ 10 mmHg was twice as likely to occur in the closed group compared with the open group during the postoperative period (40% vs. 18%; P = 0.001). CONCLUSIONS: Implantation of XEN45 with opening of the conjunctiva resulted in a lower IOP with greater success and lower needling rate compared with those achieved with the closed conjunctiva technique. Similar rates of postoperative complications and vision loss were noted in each group. Although both procedures provide substantial IOP reduction, the open technique appears to result in higher success rates and fewer postoperative interventions. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study.

PRCIS: This study demonstrates the efficacy and safety of once-daily 0.002% omidenepag isopropyl (OMDI) in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) who do not respond or respond poorly to latanoprost. PURPOSE: The purpose of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of OMDI in latanoprost low/nonresponders with POAG or OHT. MATERIALS AND METHODS: Phase 3, nonrandomized, 2-phase, open-label, multicenter study (NCT03697811) in the United States. Key inclusion criteria included individuals aged 18 years or above, POAG or OHT diagnosis in both eyes, IOP ≥22 mm Hg in ≥1 eye, and ≤34 mm Hg in both eyes at all time points. Overall, 107 patients were enrolled; 104 completed treatment. Included a screening period (≤35-day washout period and 8-week latanoprost run-in period) and a 3-month treatment period comprising one drop of OMDI 0.002% once daily in both eyes. The primary study endpoint was changed from baseline in the mean diurnal (MD) IOP at month 3. Safety endpoints included incidence of adverse events, serious adverse events, and adverse drug reactions. RESULTS: At baseline (visit 4), 75 (70.1%) patients had POAG, 32 (29.9%) had OHT, and 68 (63.6%) had prior use of prostaglandin/prostaglandin analogs (37.4% of whom used latanoprost). The mean (SD) baseline MD IOP was 23.34 mm Hg (2.12). The mean (SD) 3-month (visit 7) MD IOP change from baseline (following latanoprost run-in period and OMDI treatment period) was an additional decrease of 2.96 mm Hg (2.83) ( P <0.0001). No significant safety issues were reported during OMDI treatment. CONCLUSIONS: These data demonstrate OMDI efficacy and safety in latanoprost low/nonresponders with POAG or OHT, suggesting OMDI is a treatment option in the patient population in this study.

Neuro-Ophthalmologic Variability in Presentation of Genetically Confirmed Wolfram Syndrome: A Case Series and Review.

Wolfram syndrome is a neurodegenerative disorder caused by pathogenic variants in the genes WFS1 or CISD2. Clinically, the classic phenotype is composed of optic atrophy, diabetes mellitus type 1, diabetes insipidus, and deafness. Wolfram syndrome, however, is phenotypically heterogenous with variable clinical manifestations and age of onset. We describe four cases of genetically confirmed Wolfram syndrome with variable presentations, including acute-on-chronic vision loss, dyschromatopsia, and tonic pupils. All patients had optic atrophy, only three had diabetes, and none exhibited the classic Wolfram phenotype. MRI revealed a varying degree of the classical features associated with the syndrome, including optic nerve, cerebellar, and brainstem atrophy. The cohort's genotype and presentation supported the reported phenotype-genotype correlations for Wolfram, where missense variants lead to milder, later-onset presentation of the Wolfram syndrome spectrum. When early onset optic atrophy and/or diabetes mellitus are present in a patient, a diagnosis of Wolfram syndrome should be considered, as early diagnosis is crucial for the appropriate referrals and management of the associated conditions. Nevertheless, the condition should also be considered in otherwise unexplained, later-onset optic atrophy, given the phenotypic spectrum.

Automated 360-degree goniophotography with the NIDEK Gonioscope GS-1 for glaucoma.

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.

Subconjunctival filtration in evolution: current evidence on MicroShunt implantation for treating patients with glaucoma.

BACKGROUND: Although traditional surgical procedures for glaucoma (such as trabeculectomy and tube-shunt implantation) can significantly reduce intraocular pressure (IOP), they are associated with numerous complications, some of which are vision-threatening, or involve prolonged recovery or a highly intensive postoperative course. Micro-invasive glaucoma surgery (MIGS) procedures have shown better safety but reduced efficacy in achieving target IOP. Combinations of these methods have led to the development of subconjunctival micro-invasive procedures with safety comparable to traditional surgery and greater efficacy than minimally invasive methods. This review describes the use of one of these devices, the poly(styrene-block-isobutylene-block-styrene) (SIBS)-based PreserFlo MicroShunt (Santen, Emeryville, CA), in the surgical treatment of patients with glaucoma. MAIN TEXT: The MicroShunt is an 8.5-mm tube made of an inert polymer with no endplate, an internal diameter of 70 µm, and fins intended to prevent peritubular flow and anchor the device within the sclera to prevent proximal migration into the eye. Following ab externo implantation, the tube provides a conduit for flow of aqueous humor from the anterior chamber into the subconjunctival/sub-Tenon space. Clinical trials to date have shown that, when paired with mitomycin C (MMC) treatment, MicroShunt implantation significantly reduced both IOP and the number of glaucoma medications. These IOP-lowering results were found both when surgery was performed alone and with phacoemulsification. The MicroShunt also showed a safety profile comparable to that of traditional filtering surgery. CONCLUSIONS: The MicroShunt and other novel subconjunctival procedures have shown substantial IOP reductions while mitigating hypotony-related complications. MMC, which modulates fibrosis and scarring postoperatively, is essential to surgical success. Randomized, long-term clinical trials will further clarify the role of controlled micro-incisional device-assisted ab externo glaucoma filtering surgery in long-term glaucoma management.

Choroidal Effusions after Glaucoma Drainage Implant Surgery: Risk Factors and Surgical Management.

OBJECTIVE: To report the incidence of patients who developed choroidal effusions after glaucoma drainage implant (GDI) surgery and determine risk factors for and outcomes of surgical intervention. DESIGN: Retrospective case series. SUBJECTS: Medical records of 605 patients who underwent GDI surgery from January 1, 2017 to June 7, 2021 at New York University Langone Health and New York Eye and Ear Infirmary of Mount Sinai were reviewed. METHODS: Preoperative, intraoperative, and postoperative clinical data were obtained. Multivariate logistic regression evaluated the factors associated with the need for surgical intervention. Patient records were analyzed for effusion resolution, intraocular pressure (IOP), visual acuity (VA), and complications across treatment modalities. MAIN OUTCOME MEASURES: Incidence of choroidal effusion development and need for surgical intervention. RESULTS: Choroidal effusions developed in 110 (18%) patients (110 eyes). Surgical intervention to drain the effusion or ligate the implant tube was performed in 19 (17%) patients. The average time to surgical intervention was 47.6 days. Among patients who developed postoperative effusions, risk factors for requiring surgical intervention included history of selective laser trabeculoplasty (SLT) (P = 0.004; odds ratio [OR], 14.4), prior GDI surgery (P = 0.04; OR 8.7), 350-mm2 Baerveldt glaucoma implant placement (P = 0.05; OR, 4.8), and anterior chamber shallowing (AC; P < 0.001; OR, 25.1) in the presence of effusions. The subgroup that required multiple surgeries for effusion resolution had a significantly lower mean IOP at the most recent follow-up compared with those who received medical management only (P < 0.001). A higher percentage of patients who required surgical intervention lost VA at the most recent follow-up compared with patients whose effusions resolved with conservative management (i.e., medical management, AC viscoelastic injection). CONCLUSIONS: Choroidal effusions after GDI surgery resolved with conservative management in most patients. A history of SLT or GDI placement, implantation of a BGI-350, and the presence of a shallow chamber were risk factors for surgical intervention. Although interventions, such as surgical drainage are at times necessary, a better understanding of their impacts can help guide postoperative decisions. The risks and benefits of these procedures must be carefully considered in these high-risk eyes. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Risk factors and management of choroidal effusions.

PURPOSE OF REVIEW: Choroidal effusions are recognized as a common early postoperative complication of glaucoma surgery, and although often benign, they may cause significant ocular morbidity. This article aims to summarize current research on the risk factors and management of choroidal effusions. RECENT FINDINGS: Glaucoma drainage device (GDD) implantation and trabeculectomy are the most commonly performed surgeries for the management of moderate to severe glaucoma. Common postoperative complications of these procedures include hypotony and the development of choroidal effusions. Choroidal effusions have recently been associated with the oral administration of certain drugs, including select monoclonal antibody, antiseizure and bisphosphonate medications. Risk factors for effusion development include specific patient characteristics such as pseudoexfoliative glaucoma, older age and hypertension. Although choroidal effusions typically resolve with medical therapy alone, surgical intervention may be required. Various methods of surgical intervention, such as surgical drainage or GDD tube ligation, can be utilized to treat choroidal effusions when conservative management with medical treatment fails, but themselves carry alternative risks that must be considered. SUMMARY: Minimizing the incidence and duration of hypotony following ophthalmic surgery and careful monitoring of patients starting certain oral medications are important in limiting the occurrence of choroidal effusions. Risk factors for choroidal effusions have been recently identified in the literature. A better understanding of these risk factors, as well as the outcomes of choroidal effusion management, can help to reduce the occurrence of effusions overall and minimize ocular morbidity.

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.

Extreme intraocular pressure and steroid-dependent iritis.

A 50-year-old ophthalmic technician was referred by her retina specialist for urgent consultation due to markedly elevated intraocular pressure (IOP) unresponsive to medical therapy. Her history included chronic polyarticular juvenile rheumatoid arthritis and chronic uveitis requiring ongoing topical steroid therapy. She had a sub-Tenon injection of Kenalog (triamcinolone) 18 months prior to referral. Chronic topical anti-inflammatory therapy included nepafenac (Ilevro) and prednisolone acetate 2 times a day. Attempts to discontinue topical steroid resulted in worsening inflammation. The patient was referred when the IOP measured 44 mm Hg in the left eye despite aggressive medical therapy, including acetazolamide. The IOP improved slightly when loteprednol was substituted for prednisolone acetate. Current medications in the left eye include brimonidine 3 times a day, loteprednol 2 times a day, nepafenac 2 times a day, and fixed combination latanoprost + netarsudil at bedtime. Her only medication in the right eye was travoprost. She is intolerant to dorzolamide. She was also taking acetazolamide 500 mg 2 times a day. She was not taking any anticoagulants. Past surgical history included cataract surgery in each eye. She has not had laser trabeculoplasty in either eye. Examination revealed uncorrected visual acuity of J1+ in the right eye (near) and 20/30 in the left eye (mini-monovision). There was no afferent pupillary defect. There was mild band keratopathy in each eye while the central cornea was clear in both eyes without keratic precipitates. Here angles were open to gonioscopy without peripheral anterior synechia. There was mild to moderate flare in each eye with trace cells. The IOP was 17 mm Hg in the right eye and 31 mm Hg in the left. Central corneal thickness measured 560 µm and 559 µm in the right and left eye respectively. There was a well-positioned intraocular lens within each capsule with a patent posterior capsulotomy. There was mild vitreous syneresis but no vitreous cell. The cup to disc ratio was 0.5 in each eye with a symmetrical neural rim. The retina was flat without macular edema. Visual field was normal in both eyes (Figures 1 and 2). Optical coherence tomography of retinal nerve fiber layer (RNFL) is shown in Figure 3 and retinal ganglion cell layer is shown in Supplemental Figure 1 (http://links.lww.com/JRS/A756).JOURNAL/jcrs/04.03/02158034-202301000-00020/figure1/v/2022-12-26T045736Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202301000-00020/figure2/v/2022-12-26T045736Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202301000-00020/figure3/v/2022-12-26T045736Z/r/image-tiff Please comment on your management of this patient's left eye.

Open Conjunctival Approach for Sub-Tenon's Xen Gel Stent Placement and Bleb Morphology by Anterior Segment Optical Coherence Tomography.

PRCIS: Sub-Tenon's implantation of the Xen Gel stent resulted in significant intraocular pressure (IOP) lowering along with a low rate of postoperative bleb needling, and a favorable bleb morphology on anterior segment optical coherence tomography (AS-OCT). PURPOSE: The aim was to assess clinical outcomes and bleb morphology following sub-Tenon's implantation of the Xen Gel Stent. METHODS: The medical records of patients who underwent sub-Tenon's Xen Gel Stent implantation with intraoperative mitomycin-C through an open conjunctival approach were reviewed. Postoperative IOP and number of glaucoma medications at 1, 3, 6, 9, and 12 months were assessed. Bleb morphology was analyzed at various timepoints using 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 to 12 mo) and long-term (>12 mo) timepoints, 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: 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.

Immune checkpoint inhibitor associated ocular hypertension (from presumed trabeculitis).

PURPOSE: 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: 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: 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.

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.

Comparison of Safety and Efficacy Between Ab Interno and Ab Externo Approaches to XEN Gel Stent Placement.

PURPOSE: To compare the safety and efficacy of two different techniques for implantation of the XEN Gel Stent, a minimally invasive surgical device for the treatment of refractory glaucoma. METHODS: A retrospective chart review of eyes that received ab interno or ab externo XEN Gel Stent placement from February 2017 to October 2019 was conducted. A single surgeon (NMR) performed all operations. Eyes that received the XEN implant concomitant with a glaucoma drainage device insertion or that were lost to 6-month follow-up were excluded. Intraocular pressure (IOP) change, change in glaucoma medications, frequency of slit lamp revision procedures, and frequency of secondary glaucoma surgeries were the primary outcomes compared between groups. RESULTS: Fifty eyes that underwent ab interno placement and 30 eyes that underwent ab externo placement were studied. The ab interno cohort demonstrated a mean IOP reduction of 8.4 ± 1.7 mmHg (28.6% decrease) by 12 months, compared to a mean reduction of 12.8 ± 3.0 mmHg (40.1% decrease) in the ab externo group (p = 0.208). Mean reduction in medication use was 1.81 ± 0.29 medications in the ab interno group and 1.86 ± 0.37 in the ab externo group (p = 0.913). By 12 months, 58% of ab interno eyes had required 5-fluorouracil injection compared to 36.7% of ab externos (p = 0.105). Bleb needling was applied to 42% and 26.7% of the eyes, respectively (p = 0.231). A second glaucoma surgery was necessary for 20% of the ab interno cohort and 10% of the ab externo cohort (p = 0.351). CONCLUSION: There were no differences in outcomes between ab interno and ab externo placement of the XEN Gel Stent. Both approaches are safe and effective for lowering IOP.

The Effect of Phacoemulsification on Intraocular Pressure in Eyes with Preexisting Glaucoma Drainage Implants.

PURPOSE: To study the effect of phacoemulsification on intraocular pressure (IOP) control in patients with preexisting glaucoma drainage implants (GDIs). DESIGN: Retrospective, observational case series. PARTICIPANTS: 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: 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.