Consistency in Standalone Canaloplasty Outcomes Using the iTrack Microcatheter.

Purpose: To study the consistency in outcomes of standalone canaloplasty performed via an ab-interno surgical technique in reducing intraocular pressure (IOP) and number of medications in uncontrolled open-angle glaucoma (OAG) eyes over a 12-month period. Methods: This retrospective multicenter case series included patients who underwent standalone canaloplasty via an ab-interno surgical technique using the iTrack microcatheter (Nova Eye, Inc., Fremont, USA) and had preoperative uncontrolled OAG (IOP≥18mmHg) along with no previous glaucoma surgery. The iTrack microcatheter is used to circumnavigate 360° and viscodilate Schlemm's canal. Consistency of IOP and medications reduction on an eye-by-eye basis were evaluated to understand the outcomes in each single eye. Results: Sixty-four eyes of 60 patients (age 71.5±13.4 years) were included. Six eyes (9%) that underwent additional glaucoma surgery were considered a failure and were subsequently excluded from analysis. At 12 months, IOP was reduced in 57 of the 58 (89%) remaining eyes; one eye had the same IOP with a reduced number of medications. Of the 57/58 eyes with a reduced IOP: 44 eyes (69%) required fewer medications; 12 eyes (19%) required the same number of medications. Of these 58 eyes, 78% of eyes had a ≥20% reduction in IOP compared to baseline; 69% eyes had a postoperative IOP ≤15 mmHg, and 86% eyes ≤18 mmHg at 12 months. Forty percent of the eyes were medication-free at 12 months compared to none at baseline. Conclusion: Canaloplasty performed via an ab-interno surgical technique as a standalone procedure consistently reduced IOP and glaucoma medications in almost all eyes.

Efficacy and Safety of Pairing iStent Inject Trabecular Micro-Bypass and iAccess Precision Blade Goniotomy in Patients with Open-Angle Glaucoma.

INTRODUCTION: This study evaluated efficacy and safety of implanting two second-generation trabecular micro-bypass stents (iStent inject/iStent inject W) with phacoemulsification, either with or without iAccess Precision Blade goniotomy, in patients with mild-to-moderate open-angle glaucoma (OAG). METHODS: This retrospective, non-randomized, unmasked, dual-arm, single-site, multi-surgeon, consecutive case series evaluated all OAG eyes that underwent phacoemulsification and iStent inject implantation either as a dual procedure (group A) or paired with iAccess goniotomy (group B) from July 2020 to May 2022. Effectiveness outcomes analyzed from 1 month onward included intraocular pressure (IOP), proportions of eyes with IOP ≤ 12/≤ 15/≤ 18, proportion medication-free, and medication number. Safety outcomes at all timepoints included adverse events and secondary surgeries. RESULTS: In group A, mean IOP reduced from 14.9 ± 3.2 mmHg on 1.22 ± 1.31 mean medications preoperatively (n = 63) to 13.5 ± 2.5 mmHg on 0.24 ± 0.61 medications at month 3 (n = 34; p = 0.048 IOP, p < 0.001 medications). In group B, mean IOP reduced from 16.0 ± 4.2 mmHg on 1.12 ± 1.07 medications preoperatively (n = 93) to 12.2 ± 2.3 mmHg on 0.57 ± 1.27 medications at month 3 (n = 23; p < 0.001 IOP, p = 0.003 medications). From preoperative to 3 months, the percent of eyes with IOP ≤ 12 mmHg remained at 32.4% in group A (p = 1.0) and rose from 21.7% to 60.9% in group B (p = 0.0177); eyes with IOP ≤ 15 mmHg rose from 52.9% to 76.5% in group A (p = 0.0963) and from 43.5% to 91.3% in group B (p = 0.0034). Adjusting for baseline between-group differences, group B had significantly greater postoperative IOP reduction than group A (p = 0.043); medication reductions were similar. Safety was favorable in both groups. CONCLUSIONS: Phacoemulsification and iStent inject with or without iAccess Precision Blade goniotomy produced clinically meaningful and safe IOP and medication reductions. The paired iStent inject + iAccess + phacoemulsification procedure enabled greater IOP reduction and lower IOP thresholds than iStent inject + phacoemulsification. The study provides some of the first data on this paired approach and on the novel iAccess Precision Blade.

Negative Pressure Application via a Multi-Pressure Dial to Lower IOP in Patients with Suspected Glaucoma or Open Angle Glaucoma.

PRCIS: The multi-pressure dial applies localized periocular negative pressure to safely and effectively lower IOP and represents the first non-invasive, non-pharmacologic device for IOP reduction. OBJECTIVE: To evaluate the safety and effectiveness of the Multi-Pressure Dial (MPD) system, a device that applies periocular negative pressure to lower intraocular pressure (IOP). SETTING: 6 investigational sites, United States. DESIGN: Prospective, assessor-masked, randomized controlled trial. METHODS: Subjects with suspected glaucoma, ocular hypertension (OHTN), and open angle glaucoma (OAG) with baseline IOP ≥13 mmHg and ≤32 mmHg were enrolled. One eye of each subject was randomized to receive negative pressure application; the fellow eye served as a control. The study eye negative pressure setting was programmed for 60% of the baseline IOP. The primary effectiveness endpoint was the proportion of study eyes versus control eyes achieving an IOP reduction ≥20% at Day 90. Secondary endpoints included the proportion of eyes achieving an IOP reduction ≥25% at Day 90 as well as the proportion of eyes achieving an IOP reduction ≥20% at Days 30 and 60. RESULTS: 116 eyes of 58 subjects completed the study. At the Day 90 visit, 89.7% ( n =52) of study eyes versus 3.4% ( n =2) of control eyes achieved an IOP reduction ≥20% ( P <0.001). At Day 90, 77.6% ( n =45) of study eyes achieved a ≥25% IOP reduction compared to 1.7% ( n =1) of control eyes ( P <0.001). The most commonly reported adverse events were lid (17.2% study eye, 7.8% control eye) and periorbital edema (14.1% study eye, 10.9% control eye). CONCLUSIONS: This trial demonstrates that the MPD safely and effectively lowers IOP in a group of patients that included glaucoma suspects, OHTN, and patients with OAG.

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.

Comparison of Clinical Outcomes Following Gel Stent Implantation via Ab-Externo and Ab-Interno Approaches in Patients with Refractory Glaucoma.

Purpose: To compare clinical outcomes following gel stent implantation via ab externo and ab interno approaches in patients with refractory glaucoma. Patients and Methods: This retrospective study included 203 eyes of 185 patients aged ≥45 years who underwent Xen gel stent implantation as a standalone procedure for medically uncontrolled glaucoma (intraocular pressure (IOP) ≥18 mmHg) despite maximum tolerable IOP-lowering medications. One hundred and five eyes underwent gel stent implantation via ab interno approach and 98 via ab externo. Patients with prior conjunctival-incisional glaucoma or cataract surgery were also included. Study parameters were reduction in IOP and number of IOP-lowering medications from baseline to 3, 6, 9 and 12 months postoperatively. Results: There were no statistically significant differences in the age, sex, preoperative IOP, number of IOP-lowering medications or cup-disc ratio between the ab interno and ab externo groups at baseline (p > 0.05). At all postoperative time points, mean IOP and percentage reduction from baseline were comparable in both groups (p > 0.05) except at postoperative 6 months when the outcomes were significantly better (p < 0.05) in the ab externo group. The rate of postoperative procedures (5-Fluorouracil injections and bleb needling), the incidence of numerical or clinical hypotony and adverse events were comparable in both groups (p > 0.05). The mean number of IOP-lowering medications was comparable in both groups at all time points. Conclusion: The Xen gel stent, whether implanted ab interno or ab externo, is effective in reducing IOP and dependence on topical medications in eyes with refractory glaucoma. The stent may be used in both phakic and pseudophakic patients and is a reasonable option for patients with prior failed trabeculectomy.

Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study.

Purpose: To report 12-month efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI surgical system in combination with phacoemulsification in patients with mild-moderate open-angle glaucoma (OAG) and visually significant cataract. Setting: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 US states. Design: Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications. Unmedicated post-washout mean diurnal IOP (DIOP) ≥21 and ≤36 mmHg. Methods: Medication washout preoperatively and prior to month 12 DIOP. Effectiveness outcomes were IOP and IOP lowering medication use. Safety outcomes included adverse events and secondary surgical interventions (SSIs). Evaluations at 1, 3, 6, and 12 months. Results: A total of 149 subjects underwent surgery and 120 were included in the final effectiveness analysis. Mean (standard deviation) unmedicated diurnal IOP was reduced from 23.8 (3.1) mmHg at baseline to 15.6 (4.0) at month 12 (-35%) and medications (before washout) were reduced from 1.8 (0.9) at baseline to 0.4 (0.9) at month 12 (-80%). At month 12, 84.2% of eyes achieved IOP reductions >20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6-18 mmHg inclusive. Adverse events were uncommon. Most were mild and self-limited including transient hyphema (9 of 149; 6%) and transient IOP elevations (3 of 149; 2.0%). No eyes required SSIs or experienced loss of VA that was attributable to the device or procedure. Conclusion: Canaloplasty and trabeculotomy performed with the OMNI surgical system at the time of phacoemulsification significantly reduces unmedicated mean diurnal IOP and medication use 12 months postoperatively, with an excellent safety profile. This procedure should be considered for eyes with mild-moderate OAG to reduce IOP, medication burden, or both.

A novel use of the endoscopic cyclophotocoagulative probe for the management of excisional goniotomy induced chronic recurrent hyphema.

Purpose: To describe the management of a case of chronic, recurrent hyphema following excisional goniotomy with the Kahook Dual Blade. Observations: One week following uncomplicated surgery, the patient presented with eye pain, elevated intraocular pressure, and layered hyphema. The hyphema resolved with conservative measures but recurred several times with similar symptoms over the next several months. An attempt to stenose the "oozing" collector channel using the argon laser was unsuccessful. Treatment of the angle with an endoscopic semi-conductor diode laser (endoscopic cyclophotocoagulative or ECP) probe successfully altered the angle preventing further episodes of recurrent hyphema. The primary glaucoma procedure failed necessitating a filtering procedure. Conclusions and importance: Clinician should be aware of this potential complication, its treatment options, and outcomes.

36-Month Effectiveness of Ab-Interno Canaloplasty Standalone versus Combined with Cataract Surgery for the Treatment of Open-Angle Glaucoma.

PURPOSE: To report the 36-month effectiveness of ab-interno canaloplasty performed with the iTrack microcatheter (Nova Eye Medical) as a standalone procedure or combined with cataract surgery. DESIGN: A single-center, retrospective case series. PARTICIPANTS: Eyes diagnosed with primary open-angle glaucoma (POAG). METHODS: Eyes with POAG were treated with either ab-interno canaloplasty as a standalone procedure (iTrack alone) or in conjunction with phacoemulsification (iTrack+phaco). MAIN OUTCOME MEASURES: The main outcomes were mean reductions in intraocular pressure (IOP) and numbers of glaucoma medications at 12, 24, and 36 months postoperatively. The secondary endpoints consisted of visual acuity and the rate of complications. RESULTS: Forty-four eyes of 44 patients with open-angle glaucoma were included: 23 eyes in the iTrack-alone group and 21 eyes in the iTrack+phaco group. When both groups were analyzed together, both the IOPs and numbers of medications were significantly reduced at 12 months (P < 0.0001) and remained stable at 24 and 36 months. IOPs decreased from 20.5 ± 5.1 mmHg preoperatively to 13.3 ± 2.1, 13.1 ± 2.4, and 13.3 ± 2.1 mmHg at 12, 24, and 36 months, respectively; the numbers of medications were reduced from 2.8 ± 0.9 preoperatively to 1.1 ± 1.1, 1.0 ± 1.1, and 1.3 ± 1.3 at 12, 24, and 36 months postoperatively, respectively. Comparable IOP results were observed in the iTrack-alone and iTrack+phaco groups, from baseline values 20.9 ± 6.1 and 20.0 ± 3.9 mmHg, respectively, to 13.2 ± 2.1 and 13.5 ± 2.2 mmHg at 36 months, respectively. At 36 months, 95.5% of eyes had an IOP of ≤ 17 mmHg and 68.2% of eyes were on ≤ 1 medication. No serious intraoperative or postoperative complications were reported. CONCLUSIONS: Ab-interno canaloplasty performed with the iTrack microcatheter was found to be effective in reducing IOP and medication dependence. Comparable results were observed when employed as a standalone procedure or when combined with cataract surgery.

24-Month Efficacy of Viscodilation of Schlemm's Canal and the Distal Outflow System with iTrack Ab-Interno Canaloplasty for the Treatment of Primary Open-Angle Glaucoma.

PURPOSE: This study aimed to evaluate the 24-month efficacy of viscodilation of Schlemm's canal and the distal outflow system with iTrack ab-interno canaloplasty in reducing intraocular pressure (IOP) and antiglaucoma medication use in patients with primary open-angle glaucoma (POAG). PATIENTS AND METHODS: This retrospective, comparative, and consecutive case series assessed the 24-month outcomes of iTrack as a standalone procedure (iTrack-alone) or in conjunction with cataract surgery (iTrack+phaco), in cases of mild, moderate or severe POAG. Data were collected at baseline and the 12- and 24-month follow-up visits. RESULTS: The study included 53 patients (60 eyes) with a mean age of 73.6±9 years. For all eyes, a significant reduction in mean IOP was seen at 12 and 24 months, reducing from 20±4.9 mmHg at baseline to 13.6±1.9 mmHg and 13.5±2.6 mmHg, respectively (P<0.001). The reduction in medications was also significant, reducing to 1.12±1.09 and 1.7±1.29 medications at 12 months and 24 months, respectively, from a baseline of 2.77±0.91 (P<0.001). Similar results were achieved whether iTrack was performed as a standalone procedure, or in conjunction with cataract surgery. While the iTrack-alone group started with a higher IOP at baseline, both groups experienced similar and stable IOP reduction of more than 30% from baseline. The reduction in medication use was also significant in both groups, decreasing from 3±0.7 for iTrack-alone and 2.5±1.1 for iTrack+phaco at baseline to 2.1±1.3 and 1.3±1.2 at 24 months, respectively (P<0.001). The 24-month efficacy outcomes were similar in cases of mild-moderate versus severe glaucoma. No serious adverse events were recorded. CONCLUSION: Twenty-four-month follow-up data demonstrate that iTrack ab-interno canaloplasty can effectively reduce IOP and medication dependence, with a good safety profile. These results also demonstrate that iTrack can be effectively performed as a standalone procedure or in combination with cataract surgery, and in all grades of glaucoma severity.

Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study.

PURPOSE: To report interim 6-month safety and efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI® Surgical System concomitantly with phacoemulsification in patients with open-angle glaucoma (OAG). SETTING: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 states (Alabama, Arizona, Arkansas, Florida, Georgia, Iowa, Kansas, Montana, Nebraska, North Dakota, Oklahoma, Pennsylvania, Texas, and Wisconsin). DESIGN: Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications. METHODS: Medication washout prior to baseline diurnal IOP (Goldmann). Effectiveness outcomes included mean IOP and medications. Safety outcomes included adverse events (AE), best corrected visual acuity (BCVA) and secondary surgical interventions (SSI). Analysis includes descriptive statistics and t-tests evaluating change from baseline. RESULTS: A total of 137 patients were enrolled and treated. Mean diurnal IOP after washout was 23.8 ± 3.1 mmHg at baseline. At month 6, 78% (104/134) were medication free with IOP of 14.2 mmHg, a mean reduction of 9.0 mmHg (38%). 100% (104/104) had a ≥ 20% reduction in IOP and 86% (89/104) had IOP ≥6 and ≤18 mmHg. The mean number of medications at screening was 1.8 ± 0.9 and 0.6 ± 1.0 at month 6. AE included transient hyphema (4.6%) and IOP elevation ≥10 mmHg (2%). There were no AE for loss of BCVA or recurring hyphema. There were no SSI. CONCLUSION: Canaloplasty followed with trabeculotomy and performed concomitantly with phacoemulsification has favorable intra and perioperative safety, significantly reduces IOP and anti-glaucoma medications through 6 months in eyes with mild-moderate OAG.

Proliferative Anterior Optic Membranes in Hydrophobic Acrylic Intraocular Lenses.

PURPOSE: To describe the observed stages of development and management of proliferative anterior optic membranes (AOM) seen on a popularly implanted single-piece hydrophobic intraocular lens (IOL). METHODS: This is an observational series of patients with AOMs managed by three surgeons in different geographical areas in the USA. RESULTS: AOMs may clinically present in one of the four distinct stages. Most patients were visually asymptomatic, but those with decreased visual acuity (Stage 4) required Nd:YAG laser treatment to remove the AOM. These patients had improved visual acuity without recurrence of the AOM during the one-year follow-up period. CONCLUSION: AOMs can present and progress in four distinct stages with variable visual significance. AOMs may be safely and effectively treated with Nd:Yag laser. Occurrence of the membrane may be related to many factors, including high fibronectin content of this IOL. Additional studies are needed to identify incidence, etiology, and best management strategies.

Twelve-Month Outcomes of Stand-Alone Excisional Goniotomy in Mild to Severe Glaucoma.

PURPOSE: To describe 12-month intraocular pressure (IOP) and medication use outcomes following excisional goniotomy (EG) as a stand-alone procedure in eyes with medically uncontrolled glaucoma. METHODS: This was a retrospective analysis of data from surgeons at 8 centers (6 US, 2 Mexico). Eyes with glaucoma undergoing standalone EG with a specialized instrument (Kahook Dual Blade, New World Medical, Rancho Cucamonga, CA) for IOP reduction and followed for 12 months postoperatively were included. Data were collected preoperatively, intraoperatively, and 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. The primary outcome was reduction from baseline in IOP, and key secondary outcomes included IOP-lowering medication reduction as well as adverse events. RESULTS: A total of 42 eyes were analyzed, of which 36 (85.7%) had mild to severe primary open-angle glaucoma (POAG). Mean (standard error) IOP at baseline was 21.6 (0.8) mmHg, and mean number of medications used at baseline was 2.6 (0.2). At 3, 6, and 12 months postoperatively, mean IOP reductions from baseline were 4.6 mmHg (22.3%), 5.6 mmHg (27.7%), and 3.9 mmHg (19.3%) (p≤0.001 at each time point). At the same time points, mean medications reductions of 0.7 (25.8%), 0.9 (32.6%), and 0.3 (12.5%) medications were seen (p<0.05 at months 3 and 6, not significant at month 12). Six eyes (14.3%) underwent additional glaucoma surgery during the 12-month follow-up period. DISCUSSION: Standalone EG with KDB can reduce IOP, and in many cases reduce medication use, through up to 12 months in eyes with mild to severe glaucoma. Statistically significant and clinically relevant reductions in IOP were seen at every time point. While the goal of surgery was not to reduce medication burden, mean medication use was significantly reduced at all but the last time point. In the majority of eyes, the need for a bleb-based glaucoma procedure was delayed or prevented for at least 12 months.

Gonioscopy-assisted Transluminal Trabeculotomy in a Pediatric Patient With Steroid-induced Glaucoma.

PURPOSE: To report a case of successful intraocular pressure (IOP) reduction after a 360-degree gonioscopy-assisted transluminal trabeculotomy (GATT) using the iTrack catheter in a patient with steroid-induced glaucoma as a result of treatment of vernal keratoconjunctivitis (VKC). MATERIALS AND METHODS: Case report. RESULTS: An 8-year-old male individual with a long-standing history of VKC, treated with topical steroids, developed elevated IOP and glaucoma in the right eye despite maximum topical glaucoma therapy. Reducing the steroid was not a viable option given the severity of VKC. A 360-degree GATT was successfully performed and IOP has been maintained off all glaucoma drops. CONCLUSIONS: GATT is a viable option for steroid-induced glaucoma in the pediatric population. This obviates the need for riskier, more invasive conjunctival-based procedures.

Three-year outcomes of combined trabecular micro-bypass and phacoemulsification in a predominantly Hispanic population with primary open-angle glaucoma.

Purpose: To present long-term, real-world outcomes after implanting one trabecular micro-bypass stent with cataract surgery for primary open-angle glaucoma (POAG) in a predominantly Hispanic patient population. Patients and methods: This retrospective, consecutive case series evaluated intraocular pressure (IOP), medications, and safety through 36 months after implanting one iStent® during phacoemulsification cataract surgery. Eyes were stratified into 2 subgroups classified by preoperative IOP and surgical goal. The Controlled Group had IOP <18 mmHg on ≥1 medications, and goal to reduce medications. The Uncontrolled Group had IOP ≥18 mmHg and/or maximum tolerated medication load, and goal to reduce IOP. Assessments included IOP, medications, visual fields (VF), retinal nerve fiber layer thickness (RNFL), adverse events, and secondary surgeries. Results: Of 168 total operated eyes, 87 eyes (49 Controlled, 38 Uncontrolled) completed 36 months of follow-up and comprise the Consistent Cohort in this report. At baseline, 79.6% (39/49) of Controlled eyes and 71.1% (27/38) of Uncontrolled eyes were from Hispanic patients. In the Controlled Group desiring medication reduction, mean medications were reduced by 77.3% (2.6 medications preoperatively vs 0.6 at 36 months; p<0.001. All Controlled eyes maintained or reduced medications versus preoperative; no eyes were on ≥3 medications (vs 61.2% preoperatively); and 58.3% were medication-free (vs 0% preoperatively). In the Uncontrolled Group desiring IOP reduction, mean IOP decreased by 31.2% (19.4 mmHg preoperatively vs 13.4 mmHg at 36 months; p<0.001), 91.7% of eyes achieved IOP ≤18 mmHg, 69.4% reached IOP ≤15 mmHg, and 77.8% decreased IOP ≥20% vs baseline. Uncontrolled eyes also experienced a 45.3% medication reduction (2.2 medications preoperatively vs 1.2 at 36 months; p<0.001). Favorable safety included no intraoperative complications, and stable VF and RNFL through 36 months. Conclusion: In this predominantly Hispanic patient cohort, significant IOP and medication reductions were sustained safely through 36 months after iStent implantation during cataract surgery.

Circumferential viscodilation of Schlemm's canal for open-angle glaucoma: ab-interno vs ab-externo canaloplasty with tensioning suture.

PURPOSE: To compare the efficacy of minimally invasive ab-interno canaloplasty (ABiC) vs ab-externo canaloplasty (CP) in reducing intraocular pressure (IOP) and glaucoma medication dependence. PATIENTS AND METHODS: This nonrandomized, retrospective, single-center, paired eye study assessed the 12-month outcomes of 12 patients with primary open-angle glaucoma who underwent ABiC in one eye and CP in the other eye, either as stand-alone procedures or combined with cataract extraction. Primary endpoints included mean IOP and number of glaucoma medications at 12 months postoperative. Secondary endpoints included surgical complications and secondary interventions. RESULTS: Four males and eight females with a mean age of 73.8±12.6 years were included. In the CP group, the mean preoperative IOP was 18.1±3.9 mmHg on 2.4±0.5 medications, which reduced to 13.5±2.2 mmHg (P<0.05) on 0.9±0.9 medications (P<0.001). In the ABiC group, the mean preoperative IOP was 18.5±3.4 mmHg on 2.4±0.5 medications and postoperative IOP was 13.8±2.2 mmHg (P<0.05) on 0.8±0.8 medications (P<0.05). There was no significant difference in IOP and medication use between treatment groups at 12 months postoperative. No serious adverse events were recorded in either group, though two patients in the CP group developed pressure spikes 10 mmHg beyond preoperative IOP. CONCLUSION: This paired eye study found ABiC to have comparable IOP lowering and glaucoma medication reduction to CP in open-angle glaucoma. This suggests ABiC may be a suitable method for improving aqueous outflow via the trabecular pathway. Further large-scale investigation is needed.

Viscodilation of Schlemm's canal for the reduction of IOP via an ab-interno approach.

PURPOSE: The aim of this study was to compare the 1-year efficacy and safety profile of ab-interno canaloplasty (ABiC) when performed as a stand-alone procedure or as an adjunct to cataract extraction in reducing IOP and glaucoma medication dependence. PATIENTS AND METHODS: This retrospective, comparative, consecutive case series included patients with uncontrolled primary open-angle glaucoma (POAG) who underwent ABiC as a stand-alone procedure or in conjunction with cataract extraction. Data were collected over a 12-month period. Primary outcome measures were mean lower IOP and mean number of glaucoma medications. Secondary endpoints included surgical and postsurgical complications and secondary interventions. RESULTS: The study included 75 eyes of 68 patients (mean age: 73.7±9.9 years) with a mean baseline IOP of 20.4±4.7 mmHg on 2.8±0.9 medications, which reduced to 13.3±1.9 mmHg (n=73) on 1.1±1.1 medications at 12 months postoperative (both P<0.0001). At 12 months, 40% of eyes were medication free. In the ABiC/phacoemulsification subgroup (n=34 eyes), the mean IOP and medication use decreased from 19.4±3.7 mmHg on 2.6±1.0 medications preoperatively to 13.0±1.8 mmHg on 0.8±0.2 medications at 12 months (both P<0.001). In the stand-alone ABiC subgroup (n=41), the mean IOP and medication use decreased from 21.2±5.3 mmHg on 3.0±0.7 medications preoperatively to 13.7±1.9 mmHg on 1.3±1.1 medications at 12 months (P=0.001 and <0.001, respectively). No serious adverse events were recorded. CONCLUSION: These data demonstrate that ABiC was effective at reducing IOP and medication use in eyes with uncontrolled POAG with or without cataract surgery.

Six-Month Outcomes of Goniotomy Performed with the Kahook Dual Blade as a Stand-Alone Glaucoma Procedure.

INTRODUCTION: To characterize the reduction in intraocular pressure (IOP) and IOP-lowering medication use following goniotomy via trabecular meshwork excision performed using the Kahook Dual Blade as a stand-alone procedure in adult eyes with glaucoma uncontrolled on a regimen of 1-3 topical IOP-lowering medications. METHODS: In this retrospective analysis, data from consecutive patients undergoing goniotomy with the Kahook Dual Blade by 11 surgeons were analyzed. Preoperative, intraoperative, and postoperative follow-up data through 6 months of follow-up were collected. The primary efficacy endpoint was IOP reduction from preoperative baseline; reduction in IOP-lowering medication use was a secondary endpoint. RESULTS: Data were collected from 53 eyes of 42 subjects. Mean (± SE) preoperative IOP was 23.5 ± 1.1 mmHg, and from day 1 through 6 months of postoperative follow-up mean IOP reductions of 7.0-10.3 mmHg (29.8-43.8%; p < 0.001 at each time point) were observed. Mean preoperative medication use was 2.5 ± 0.2 medications per eye and was reduced by month 6 to 1.5 ± 0.2 (a 40.0% reduction; p < 0.05). Eyes with higher baseline IOP experienced mean IOP reductions of 13.7 mmHg (- 46.4%) at month 6, while eyes with lower baseline IOP experienced mean IOP reductions of 3.8 mmHg (- 21.0%) at month 6. Mean medications were reduced by 1.3 medications in high-IOP eyes and by 0.9 in low-IOP eyes at month 6. No significant sight-threatening adverse events were observed. CONCLUSIONS: Goniotomy via trabecular meshwork excision performed using the Kahook Dual Blade effectively and safely lowered IOP when performed as a stand-alone procedure in eyes with glaucoma. The significant drop in IOP met or exceeded the recommended targets for these glaucoma patients. FUNDING: New World Medical, Inc.

Cypass Supraciliary Stent in Eye With Chronic Angle Closure and Postvitrectomy With Silicone Oil.

PURPOSE: To report a case of successful intraocular pressure (IOP) reduction following Cypass supraciliary stent implantation in a postvitrectomized eye filled with silicone oil and chronic angle-closure glaucoma. MATERIALS AND METHODS: This is a case report. RESULTS: A 19-year-old female with chronic angle-closure glaucoma underwent combined cataract extraction, goniosynechiolysis and Cypass supraciliary shunt implantation. Patient had a history of proliferative diabetic retinopathy and a tractional retinal detachment, which required pars plana vitretomy and silicone oil implantation, and was subsequently complicated by neovascular glaucoma requiring implantation of an inferior glaucoma drainage device. Approximately 6 months later, the patient's IOP increased to 36 mm Hg on maximum tolerable medical therapy. The patient underwent combined cataract extraction and Cypass implantation and is now controlled with an IOP of 16 mm Hg on 3 classes of medications 6 months postoperatively. CONCLUSIONS: Implantation of a Cypass supraciliary shunt can be an effective means for controlling IOP in patients with chronic angle-closure glaucoma in a postvitrectomized eye with silicone oil implantation and failed glaucoma drainage device.