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.

Surgical Management of Intraocular Pressure With Ab Interno Canaloplasty in Postkeratoplasty Patients: 12-Month Results.

PURPOSE: The purpose of this study was to report clinical outcomes of ab interno canaloplasty (ABiC) with the iTrack microcatheter (Nova Eye Medical, Fremont, CA) for surgical management of intraocular pressure (IOP) in postkeratoplasty patients. METHODS: This study was a single-center retrospective case series of postkeratoplasty eyes undergoing ABiC. Efficacy was evaluated based on graft survivability and mean reduction in IOP at 12 months postoperatively. Secondary end points consisted of visual acuity outcomes, number of topical hypotensive medications, and rate of complications. RESULTS: ABiC was successfully performed in 17 eyes after keratoplasty (8 penetrating keratoplasty, 6 DSAEK, 2 penetrating keratoplasty + DSAEK, and 1 DMEK) with elevated IOP refractory to topical hypotensive medications. The baseline mean IOP was 26.2 ± 8.4 mm Hg and reduced significantly to 15.0 ± 4.21 mm Hg at 6 months and 13.0 ± 2.99 mm Hg at 12 months ( P < 0.005). The best-corrected visual acuity improved from 0.61 ± 0.55 logMAR at baseline to 0.47 ± 0.59 and 0.49 ± 0.64 at 6 and 12 months, respectively, following ABiC (not statistically significant: P = 0.6769). The baseline mean number of topical hypotensive medications was 3.7 ± 1.8 and reduced to 2.7 ± 1.4 and 2.9 ± 1.3 at 6 and 12 months, respectively ( P = 0.096). One patient developed a hyphema which required anterior chamber washout. One patient required additional glaucoma surgery 19 months after ABiC. No patients experienced graft failure. CONCLUSIONS: ABiC is a clinically safe and effective treatment that can be performed in postkeratoplasty patients to reduce IOP for at least 1 year without any significant complications.

Incidence and Clinical Characteristics of Postoperative Endophthalmitis After Ab-Interno Canaloplasty.

Introduction: Postoperative endophthalmitis (POE) is a rare but devastating complication of ophthalmic surgeries. Microinvasive glaucoma surgery (MIGS) procedures have become increasingly utilized for the surgical reduction of intraocular pressure (IOP). Ab-interno canaloplasty (ABiC) is a popular MIGS procedure, but POE rates and clinical effects following ABiC have not been studied. Methods: This study conducted a retrospective review of all consecutive cases of either standalone ABiC or combined ABiC with phacoemulsification performed at a tertiary care academic referral center from 2015 to 2021. Exclusion criteria included a history of incisional glaucoma surgery, retinal surgery, or additional concurrent microinvasive glaucoma surgery (MIGS) at the time of ABiC. The rates of POE after ABiC were calculated with 95% confidence intervals (CI) based on the Clopper-Pearson exact method. Results: Of 3256 cases of ABiC, one case (0.03%, 1/3256, 95% CI: 0.00-0.17%) of post-ABiC endophthalmitis was identified. The rate of POE in standalone ABiC was 0.00% (0/1332 cases, 95% CI: 0.00-0.28%), whereas the rate in combined ABiC with phacoemulsification was 0.05% (1/1924 cases, 95% CI: 0.00-0.29%). Additionally, the rate of POE following stand-alone cataract surgery, 0.10%, 11/11,470 cases, 95% CI: 0.05-0.17%), total cataract surgeries, 0.06% (17/28,013 cases, 95% CI: 0.04-0.10%), total MIGs, excluding ABiC, surgeries, 0.08%, (3/3845 cases, 95% CI: 0.02-0.23%) portray non-inferiority of ABiC in the risk of POE. The case of ABiC-POE presented four days after surgery and required a vitreous tap with intraocular injection of antibiotics and pars plana vitrectomy. No causative organism was identified. A final 1-year follow-up revealed a corrected distance visual acuity of 20/40 and stable glaucoma. Conclusion: The rate of POE after ABiC (1 per 3256 cases) is statistically non-inferior to the reported incidence of POE after other MIGS and incisional glaucoma surgeries.

Long-term medication reduction in controlled glaucoma with iTrack ab-interno canaloplasty as a standalone procedure and combined with cataract surgery.

PURPOSE: To evaluate the long-term effectiveness of iTrack (Nova Eye Medical, Fremont, USA) ab-interno canaloplasty performed as a standalone procedure, or combined with cataract surgery, in reducing antiglaucoma medication dependence and maintaining intraocular pressure within target range in patients with controlled primary open-angle glaucoma. METHODS: This is a retrospective, single-center, case series study of patients who underwent iTrack ab-interno canaloplasty as a standalone procedure (n = 34) or in combination with cataract surgery (n = 11). Eyes with controlled mild or moderate glaucoma (intraocular pressure ⩽17 mmHg) were included; those with prior glaucoma surgeries were excluded. The primary outcome was the mean reduction in glaucoma medication and the secondary outcome was the maintenance of controlled intraocular pressure postoperatively. RESULTS: A total of 35 patients (45 eyes) with a mean age of 73 ± 9.7 years were included in the study. For all eyes, a significant decrease (61%) in the mean number of medications was seen at 36 months (1.89 ± 0.93 versus 0.60 ± 0.82; p < 0.001), with 56% (14/25) of eyes medication free. No significant difference was observed in the reduction of medication use whether iTrack was performed with or without cataract surgery at 12 and 36 months. Mean baseline intraocular pressure of 14.42 ± 2.2 mmHg for all eyes was maintained at the 12-, 24-, and 36-month follow-up visits (14.6 ± 3.65, 15.06 ± 2.26, and 14.19 ± 2.91, respectively), with no significant difference between the two groups (p = 0.08). CONCLUSION: The iTrack ab-interno canaloplasty significantly reduced medication dependency and maintained intraocular pressure within target range in patients with controlled mild or moderate primary open-angle glaucoma, while showing a good safety profile, both as a standalone procedure or in combination with cataract surgery.

Evaluation of Spin in the Abstracts of Systematic Reviews and Meta-analyses of Treatments for Glaucoma.

PURPOSE: Spin - the misrepresentation of the study's actual findings - carries the ability to distort a reader's perception of a treatments' full benefits and risks. Recent studies have suggested that spin is common in abstracts of randomized controlled trials and systematic reviews focused on treatments for a variety of medical disorders. Therefore, our primary objective was to evaluate the prevalence of spin in the abstracts of systematic reviews and meta-analyses related to glaucoma treatments. We further assessed whether specific study characteristics were associated with spin, including the methodological quality of a study. PATIENTS AND METHODS: We used a cross-sectional study design searching MEDLINE and Embase databases all for systematic reviews and meta-analyses focused on glaucoma treatments. Each abstract was assessed for the nine most severe - severity determined by likelihood of distorting a reader's perception - types of spin that occur in systematic review abstracts. The screening and data extraction was performed in a duplicate, masked fashion. The methodological quality of each review was assessed using A MeaSurement Tool to Assess Systematic Reviews (AMSTAR-2) instrument. To evaluate relationships between spin, AMSTAR-2 appraisals, and other study characteristics, we used unadjusted odds ratios and Fisher's exact test. RESULTS: Only three of the 102 abstracts contained spin, with spin type 5 being the most prevalent. No abstracts contained spin types 1, 2, 3, 4, 6, or 8, and no association was found between the presence of spin in an abstract and any particular study characteristic. Using the AMSTAR-2 quality appraisal instrument, 35 (34.3%) of the studies received a methodological quality rating as high, 42 (41.2%) as moderate, 11 (10.8%) as low, and 14 (13.7%) as critically low. CONCLUSIONS: We found that's pin is present in only a small proportion of systematic reviews and meta-analyses covering the treatment of glaucoma. In comparison to studies in other fields of medicine, ophthalmology appears to be a leader in publishing systematic reviews and meta-analyses with low rates of spin occurring in the abstract.

A retrospective analysis of the use of loteprednol etabonate ophthalmic suspension 0.5% following canaloplasty.

BACKGROUND: While loteprednol etabonate (LE) suspension 0.5% is approved for the treatment of postoperative ocular inflammation, there have been no reported studies of its use in glaucoma patients undergoing canaloplasty. METHODS: This was a retrospective medical chart review conducted at a single US center. Data were collected on patients with glaucoma who underwent canaloplasty with or without cataract surgery, and were prescribed LE suspension 0.5% postoperatively. Outcomes evaluated included postsurgical inflammation (anterior chamber [AC] cells and flare), intraocular pressure (IOP), number of IOP-lowering medications, and postsurgical complications. RESULTS: Data were collected on 204 patients (262 eyes) with a mean (SD) age of 71.6 (11.3) years. The most frequent LE dosing regimens at day 1, week 1, and month 1 postsurgery were QID (92.3%; 241/261), TID (52.6%; 133/253), and QD (65.5%; 78/119), respectively. Inflammation (AC flare and cells), mostly mild, was noted in 33.2% (86/259) of eyes on postoperative day 1 and 8.6% (21/244) of eyes at month 1. Mean IOP and mean number of IOP-lowering medications were significantly reduced from baseline (P<0.001) at all time points postoperatively. Complete (no IOP-lowering medication) or qualified (use of ≤2 IOP-lowering medications) surgical success was achieved in 78.8% and 90.6% of eyes, respectively, at month 6 and 63.4% and 92.7% of eyes at month 36. The most frequently observed postoperative complication was hyphema in 48.7% (126/259) eyes at day 1, which decreased to 0.4% (1/244) of eyes by month 1. IOP ≥30 mmHg was noted in 13 (5.3%) eyes at postoperative week 1 and rarely thereafter, and no patient discontinued therapy because of an IOP increase. CONCLUSION: These real-world data suggest that canaloplasty with or without cataract surgery managed postoperatively with LE suspension 0.5% is effective and safe in the glaucoma patient.

An Analysis of 3-Year Outcomes Following Canaloplasty for the Treatment of Open-Angle Glaucoma.

PURPOSE: To report 3-year results investigating the safety and efficacy of canaloplasty for open-angle glaucoma. SETTING: University of Oklahoma, Dean McGee Eye Institute, Oklahoma, United States of America. DESIGN: Nonrandomized single-center retrospective chart review. METHODS: Adult open-angle glaucoma eyes underwent canaloplasty or combined cataract-canaloplasty surgery. A tensioning suture was placed into Schlemm's canal in all eyes. Primary endpoints included the mean IOP and mean number of glaucoma medications at each follow-up visit. Secondary endpoints included visual acuity and surgical/postsurgical complications. RESULTS: The study cohort included 277 eyes (mean age, 72.8 years). Overall, the mean baseline IOP of 19.7 mmHg was reduced to 14.3 mmHg,14.0 mmHg, and 15.2 mmHg at 1, 2, and 3 years, respectively (p < 0.001). The average medicine use was reduced from 2.1 preoperatively to 0.4 at 12 months, and 0.5 and 0.6 at two and three years, respectively (p < 0.001). The frequency of surgical and postsurgical complications was low with no serious adverse events recorded. CONCLUSION: Canaloplasty was safe and effective in achieving long-term IOP reductions and reduced dependence on antiglaucoma medications.

Outcomes of Bleb Revision With Mitomycin C After Ex-PRESS Shunt Surgery.

PURPOSE: Investigate efficacy and safety of bleb revision using mitomycin C after Ex-PRESS shunt surgery. PATIENTS AND METHODS: We performed chart reviews of 36 consecutive eyes from 34 patients with previous Ex-PRESS shunt surgery who underwent subsequent bleb revision with mitomycin C. The mean follow-up time was 13.5 months. The primary outcome measure was surgical success. Secondary outcomes included visual acuity, intraocular pressure, number of medications, and complications. RESULTS: Twenty-four eyes had open-angle glaucoma (61.1%). Mean time from Ex-PRESS to bleb revision was 8.8 months. Complete success rate for the immediate 3-month postoperative period was 94.4% and qualified success rate was 97.2%. Complete and qualified success rates for the entire follow-up period were 40% and 65.7%, respectively. Visual acuity remained stable throughout the study period, and at 1 year, average intraocular pressure was 14.7 mm Hg on an average of 1.7 medications. No major complications were reported. CONCLUSIONS: Bleb revision in eyes with an Ex-PRESS shunt is a safe and efficacious procedure. The surgical outcomes are within the range of published outcomes for bleb needling after trabeculectomy. Further research with larger sample size and longer follow-up is needed to confirm these results.

Canaloplasty: A Minimally Invasive and Maximally Effective Glaucoma Treatment.

Canaloplasty is a highly effective, minimally invasive, surgical technique indicated for the treatment of open-angle glaucoma that works by restoring the function of the eye's natural outflow system. The procedure's excellent safety profile and long-term efficacy make it a viable option for the majority of glaucoma patient types. It can be used in conjunction with existing drug based glaucoma treatments, after laser or other types of incisional surgery, and does not preclude or affect the outcome of future surgery. Numerous scientific studies have shown Canaloplasty to be safe and effective in lowering IOP whilst reducing medication dependence. A recent refinement of Canaloplasty, known as ab-interno Canaloplasty (ABiC), maintains the IOP-lowering and safety benefits of traditional (ab-externo) Canaloplasty using a more efficient, simplified surgical approach. This paper presents a review of Canaloplasty indications, clinical data, and complications, as well as comparisons with traditional incisional glaucoma techniques. It also addresses the early clinical evidence for ABiC.

Long-term efficacy of the Baerveldt 250 mm2 compared with the Baerveldt 350 mm2 implant.

PURPOSE: To investigate the long-term surgical outcomes of the Baerveldt 250 mm2 versus Baerveldt 350 mm2 glaucoma drainage implants (GDIs) (Abbott Laboratories Inc., Abbott Park, IL) in the treatment of refractory glaucoma. DESIGN: Comparative case study. PARTICIPANTS: A total of 89 consecutive eyes in 86 patients treated at Dean McGee Eye Institute between January 2006 and December 2008. METHODS: We retrospectively reviewed patient data from the following postoperative visits: 1 week, 1 month, 2 months, 3 months, 6 months, and every 3 months thereafter. Postoperative complications were also recorded. The mean follow-up time was 40 months (range, 2-78 months) for the Baerveldt 250 mm2 group and 31 months (range, 3-75 months) for the Baerveldt 350 mm2 group. MAIN OUTCOME MEASURES: The primary outcome measure was surgical success. Secondary outcome measures included visual acuity (VA), intraocular pressure (IOP), and number of medications. RESULTS: There was no difference in surgical success (P=0.98). No significant differences were observed in VA measured using the logarithm of the minimum angle of resolution (logMAR) scale, IOP, and number of medications at the last visit (P=0.09, 0.23, and 0.82, respectively). Complication and failure rates were comparable (P=0.82 and 0.64, respectively). CONCLUSIONS: With a mean follow-up of 40 and 31 months, no differences in surgical success, VA, IOP, number of medications at the last visit, and complication/failure rates were noted between the Baerveldt 250 mm2 and 350 mm2 GDIs, respectively. The size of the GDI may not be associated with surgical outcomes.

Intermediate term safety and efficacy of transscleral cyclophotocoagulation after tube shunt failure.

PURPOSE: To determine the efficacy and safety of diode transscleral cyclophotocoagulation (TSCPC) after tube shunt failure. PATIENTS AND METHODS: The patient population consisted of 32 eyes of 31 patients with uncontrolled glaucoma. Each eye had a previously implanted aqueous tube shunt and was currently on maximally tolerated medication. Each eye also underwent TSCPC treatment using the Iridex (Mountain View, CA) diode laser with a maximum of 360 degrees of treatment. All 31 charts were reviewed for data pertaining to demographics, treatment, ocular history, and follow-up clinical examinations. Safety was evaluated by complication data. Efficacy was evaluated in terms of TSCPC treatment parameters (number of laser applications, laser power, application duration, and degrees of ciliary body treated), intraocular pressure, number of hypotensive medications, and any further treatment required. RESULTS: With a mean (SD) follow-up of 17.1 (16.3) (median=11.7) months from the last treatment, the mean intraocular pressure decreased from 28.6 (10.2) mm Hg to 16.8 (7.5) mm Hg (35% reduction) at 3 months (n=30, P<0.0001) and to 14.7 (7.9) mm Hg (43% reduction) at 1 year (n=13, P<0.0001). Complications included hypotony (n=4), hyphema (n=2), failed corneal transplant (n=1), and loss of light perception (n=5). CONCLUSIONS: TSCPC has a significant ocular hypotensive effect on glaucoma refractory to both tube shunt and medical therapy. The safety of this intervention remains unclear in this high risk patient population and warrants further study.

A review of canaloplasty.

Canaloplasty is a method of lowering intraocular pressure (IOP) by which a flexible, beacon-tipped microcatheter equipped with an ophthalmic viscosurgical device (OVD) delivery system is used to catheterize and introduce a suture into Schlemm's canal. Ligation of this suture provides tension on the canal and facilitates aqueous outflow. Canaloplasty is designed to be a blebless procedure that requires no antifibrotic agents and has been shown to safely and effectively lower IOP in patients with open-angle glaucoma (OAG) with minimal complications. Most importantly, no bleb-related adverse events are associated with this procedure. When contemplating surgical management of OAG, canaloplasty may be considered.

Canaloplasty using iTrack 250 Microcatheter with Suture Tensioning on Schlemm's Canal.

Open angle glaucoma (OAG) necessitating surgery has traditionally been treated with filtering procedures using antifibrotics. Unfortunately, such filtering procedures are not without the risk of postsurgical complications. Increasing interest in blebless surgery has led to innovative surgical procedures aimed at rejuvenating the natural trabeculo canalicular outflow pathway. Circumferential catheterization with suture tensioning of Schlemm's canal has emerged as a safe and effective way to surgically treat OAG.