Six-Month Outcomes of Goniotomy Performed with a Trapezoidal Dual Blade in Combination with Cataract Surgery.

Purpose: To assess the efficacy and safety of goniotomy using a uniquely shaped trapezoidal, serrated dual blade (TDB), designed to accommodate variability in patient anatomy, in reducing intraocular pressure (IOP) or anti-glaucoma medications (AGM) in adult glaucoma patients when combined with cataract surgery. Patients and Methods: Retrospective consecutive case series of patients with glaucoma who underwent phacoemulsification with TDB-goniotomy were included. Preoperative, intraoperative, and postoperative data were collected over 6 months. The primary outcome measure was surgical success, defined as IOP reduction ≥20% from baseline at 6 months, and/or reduction of at least 1 AGM. Postoperative adverse events were collected as a secondary outcome measure. Results: Sixty-five eyes of 46 patients were included with data available on 53 eyes at 6 months. Primary open-angle (38%), primary angle-closure (37%), and mixed-mechanism glaucoma (11%) were the most common diagnoses. Most cases were severe (48%) or moderate (32%) stage. At the 6-month mark, surgical success was achieved in 92% of eyes by either or both criteria. Mean preoperative IOP decreased from 18.4 mmHg (SE 0.83) to 13.0 mmHg (SE 0.37) (p<0.001) at postoperative month 6. Mean AGM decreased from 2.46 (SE 0.19) preoperatively to 1.45 (SE 0.17) (p<0.001). The most common postoperative complication was an IOP spike at postoperative week 1 (11%). No serious adverse events occurred related to the goniotomy. Conclusion: TDB-goniotomy in combination with cataract surgery safely and effectively lowered IOP and reduced AGM burden in adults with various types and severities of glaucoma over 6-months of follow-up.

There are many tools available to perform goniotomy, a popular minimally invasive glaucoma surgery, but data is lacking on many of these devices. This study sought to determine the safety and efficacy of excisional goniotomy using a uniquely shaped trapezoidal dual blade (TDB) in combination with cataract surgery for adult glaucoma patients. At 6 months, the primary outcome measure of intraocular pressure (IOP) reduction ≥20% from baseline and/or reduction of at least 1 anti-glaucoma medication was met by 92% of eyes. Six months postoperatively, there was a statistically significant decrease in mean IOP from 18.4 mmHg to 13.0 mmHg and mean antiglaucoma medications from 2.5 to 1.5. Therefore, TDB-goniotomy in combination with cataract surgery can safely decrease IOP and/or antiglaucoma medications in a mixed population of various glaucoma types and severities.

Comparison of Bent Ab-Interno Needle Goniectomy and Goniotomy in Primary Congenital Glaucoma: A Randomized Controlled Trial.

PURPOSE: Primary congenital glaucoma (PCG) is a potentially blinding disease, and the search for the best surgical option always remains. This study investigated the efficacy of Bent Ab-Interno Needle Goniectomy (BANG) compared to the established standard of traditional goniotomy. DESIGN: Parallel-group randomized controlled trial. PARTICIPANTS: Infants with PCG aged 1 month to 1 year with similar clinical features in both eyes. INTERVENTION: The 2 eyes of eligible patients were randomized to either goniotomy or BANG using a 25-gauge needle bent as a reverse cystitome, and the surgeries were done on the same day in both eyes. Postoperatively each infant was followed up for a minimum period of 1 year. MAIN OUTCOME MEASURES: The primary outcomes measured were intraocular pressure (IOP) control and the requirement for antiglaucoma medications (AGMs). The secondary outcome measures included corneal clarity enhancement, axial length stability, incidence of surgical complications, or the need for repeat surgery. RESULTS: Eight infants with both eyes eligible, were included. In each infant, 1 eye was randomized to BANG and the other to conventional goniotomy. The mean age was 7.6 ± 3.6 months. There was no significant difference in the mean preoperative IOP (16.8 ± 8.87 mm Hg vs. 17 ± 6.0 mm Hg; P = 0.48) in eyes randomized to goniotomy or BANG. The mean number of AGMs (1.7 ± 1.11 vs. 2 ± 0.81 respectively; P = 0.26) were similar in both groups. Postoperatively, the IOP at 6 months (14.05 ± 4.1 vs. 16.2 ± 4.07; P = 0.22) and 1 year (15.3 ± 3.4 vs. 17.1 ± 3.0; P = 0.15) were similar in eyes that underwent goniotomy or BANG respectively. Both procedures demonstrated significant improvements in corneal clarity and maintained normal axial length growth. However, the BANG group required slightly more AGMs than the goniotomy group. There were no serious complications in either group. Both eyes of 1 patient required repeat surgery for IOP control and underwent a combined trabeculotomy with trabeculectomy at 9 months and 1 year postoperatively, respectively. CONCLUSIONS: This study indicates that goniotomy remains an effective surgical treatment for PCG. The absence of discernible superiority in IOP control or overall outcomes implies that the added complexity of excising the trabecular meshwork in BANG may not confer additional benefits over the established approach. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Clinical Outcomes of Excisional Goniotomy with the Kahook Dual Blade: 6-Year Results.

INTRODUCTION: This study aims to evaluate the long-term clinical outcomes of excisional goniotomy with the Kahook Dual Blade (KDB) in the management of various types of glaucoma. METHODS: This was a retrospective, noncomparative chart review of 90 eyes of 53 patients with glaucoma that underwent standalone KDB goniotomy (KDB-alone group) or KDB goniotomy with concomitant phacoemulsification (KDB-phaco group) between October 2015 and October 2017. Surgical success was defined as an intraocular pressure (IOP) reduction by ≥ 20% at the last follow-up with no surgical reinterventions required and a final IOP ≥ 4 mmHg and ≤ 21 mmHg. We also report on changes from baseline in IOP, number of glaucoma medications, best-corrected visual acuity (BCVA), and visual field parameters, for up to 72 months. RESULTS: At 72 months, mean (standard deviation [SD]) IOP was reduced from 17.5 (5.7) to 13.6 (3.0) mmHg (P < 0.0001) in the KDB-phaco group and from 23.3 (5.9) to 15.1 (6.2) mmHg (P = 0.0593) in the KDB-alone group. The mean (SD) number of glaucoma medications was reduced from 1.3 (1.0) to 0.8 (0.9) (P < 0.0001) in the KDB-phaco group and from 1.2 (1.0) to 0.7 (0.8) (P = 0.3409) in the KDB-alone group. During the 72-month follow-up, surgical success was achieved in 24 of the 52 available eyes (46.2%). Four eyes underwent a glaucoma surgical reintervention by 72 months. CONCLUSIONS: Excisional goniotomy with the KDB effectively lowered the IOP (by an average of 28.0% from baseline) and maintained or further reduced glaucoma medication burdens (by an average of 30.8% from baseline) under an excellent safety profile, independent of phacoemulsification status. The procedure exhibited favorable success for up to 6 years, providing valuable insights into its long-term efficacy as a glaucoma treatment.

Early cataract surgery and affordable Sinskey hook goniotomy in Black and Afro-Latino glaucoma patients: a 6-month retrospective study.

Aim: The purpose of this study was to determine the real-world efficacy of early phacoemulsification cataract surgery and goniotomy with a Sinskey hook in patients with glaucoma. Methods: This study was conducted at Advanced Eye Care of New York, a private practice located in Manhattan, NY. This was a single-center, retrospective study of predominantly Black and Afro-Latino patients with glaucoma. These patients underwent early phacoemulsification cataract surgery and goniotomy using an affordable and reusable straight Sinskey hook (Ambler 200-µm tip). Patients who underwent the aforementioned procedure with 6 months of follow-up were included in this study. Investigated parameters were intraocular pressure, number of medications, mean deviation on visual field test, visual acuity, adverse events, and pre/postoperative spherical refractive error. Results: Among all 38 eyes that were enrolled in the study and underwent surgery (goniotomy using a Sinskey hook with phacoemulsification), mean intraocular pressure was reduced from 16.45 mmHg at baseline to 13.24 mmHg at month 6, a 19.5% reduction. The mean number of topical intraocular pressure-lowering medications used was reduced from 1.81 at baseline to 0.52 at month 6, a 71% reduction in topical medications. Conclusion: Combined early cataract surgery and goniotomy performed with a Sinskey hook is an affordable microinvasive surgery and an effective way to reduce intraocular pressure and the number of ocular hypertensive medications used in Black and Afro-Latino patients with primary open-angle glaucoma.

Phacoemulsification combined with Kahook Dual Blade Goniotomy versus with Trabectome in the treatment of open angle glaucoma.

PURPOSE: To compare the surgical effectiveness and safety of phacoemulsification combined with KDB (Phaco-KDB) and with Trabectome (Phaco-Trabectome) at 6 months follow-up in patients with open-angle glaucoma (OAG) METHODS: This comparative case series was conducted at Beijing Tongren Hospital, including patients diagnosed with OAG who underwent Phaco-KDB from November 2021 to April 2022 and Phaco-Trabectome from April 2017 to December 2017. Surgical success was defined as an IOP reduction ≥ 20% or a postoperative IOP ≤ 21 mmHg. Kaplan-Meier methods were used to calculate cumulative rates of success among groups RESULTS: A total of 35 eyes from 29 patients were included in the analysis. At 6-month, Both groups exhibited a significant reduction in IOP and the number of IOP-lowering medications compared to preoperative (P=0.01 and P<0.01, respectively). There were no significant differences among groups in terms of reducing IOP and the number of IOP-lowering medications (all P values<0.05). In the Phaco-KDB and Phaco-Trabectome groups, 53.8% and 45.0% of patients achieved an IOP reduction of ≥ 20%, while 92.3% and 85% achieved a mean IOP ≤ 21 mmHg 6 months after surgery. The incidence of IOP spike was 20%, and 3 eyes (8.6%) needed further surgery to control the IOP CONCLUSIONS: Both Phaco-KDB and Phaco-Trabectome demonstrate a significant reduction in IOP and the number of IOP-lowering medications. Phaco-Trabectome appears to provide a more predictable postoperative course in the early postoperative period compared to Phaco-KDB, and the postoperative mean IOP is lower in Phaco-KDB compared to Phaco-Trabectome, despite not being statistically significant.

Refractive Outcomes Following Combined Cataract and Microinvasive Glaucoma Surgery.

PURPOSE: To compare refractive outcomes in eyes undergoing cataract extraction (CE) alone, CE with goniotomy (CE/goniotomy), and CE with Schlemm's canal stent (CE/SCS) insertion. DESIGN: Retrospective cohort study. PARTICIPANTS: Eyes from the Bascom Palmer Glaucoma Repository undergoing CE/goniotomy, CE/SCS insertion, or uncomplicated CE alone between July 2014 and February 2022 were identified. METHODS: Refraction data were analyzed at postoperative month (POM) 1 and 6 with Kruskal-Wallis and Dunn's tests. Anisometropia was defined as a spherical equivalent (SE) difference of ≥2D. MAIN OUTCOME MEASURES: The primary outcome was mean refraction at POM1 and POM6 across the 3 surgical groups. Secondary outcomes were comparisons of refraction and visual acuity (VA) among different goniotomy and Schlemm's canal stent (SCS) devices, as well as incidence of anisometropia. RESULTS: A total of 8360 eyes (150 CE/goniotomy, 395 CE/SCS, and 7815 CE alone) from 6059 patients were analyzed. At POM1, mean SE in the CE/goniotomy, CE/SCS, and CE alone groups was -0.36 ± 0.91D, -0.31 ± 0.85D, and -0.39 ± 0.88D respectively (P = 0.019). Mean logarithm of the minimum angle of resolution VA was 0.10 ± 0.20, 0.08 ± 0.19, and 0.14 ± 0.26 respectively (P = 0.002, CE/SCS vs. CE alone). No statistically significant differences were noted at POM6. Anisometropia occurred at POM1 in 2 patients (13.3%) in the CE/goniotomy-CE group, 1 patient (3.2%) in the CE/SCS-CE group, and 184 patients (4.9%) in the CE-CE group (P = 0.217). At POM6, mean SEs were -0.38 ± 0.97D (CE/goniotomy), -0.35 ± 0.81D (CE/SCS), and -0.40 ± 0.91D (CE alone; P = 0.473). No significant differences in overall refractive outcomes were observed with different SCS or goniotomy devices. Among primary open-angle glaucoma/normal-tension glaucoma eyes, mean SE at POM1 was -0.36 ± 0.73D (CE/goniotomy), -0.24 ± 0.84D (CE/SCS), and -0.45 ± 0.81D (CE alone; P < 0.001). CONCLUSIONS: Concurrent SCS insertion or goniotomy with CE was associated with some statistically significant differences in postoperative refraction and VA, although these small magnitude differences were unlikely to be clinically meaningful. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references in the Footnotes and Disclosures at the end of this article.

Influence of Laser Trabeculoplasty on Combined Phacoemulsification/Kahook Dual Blade Goniotomy.

Purpose: To investigate the influence of laser trabeculoplasty (LTP) on subsequent surgery with combined phacoemulsification/Kahook Dual Blade goniotomy (phaco-KDB) in patients with open-angle glaucoma or intraocular hypertension. Patients and Methods: Patients undergoing phaco-KDB between 2019 and 2021 were divided into previously LTP treated and previously non-LTP treated, and LTP-treatment included argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT). The primary goal was to investigate if previous LTP influenced later surgical outcome of phaco-KDB. The secondary goal was to investigate if the outcome of LTP could be predictive of the outcome of subsequent phaco-KDB. We also compared IOP- and medication reductions between LTP and non-LTP treated patients. Results: A total of 111 LTP treated patients were compared to 139 non-LTP treated patients. In LTP treated patients, surgical success of phaco-KDB was 82.9%, compared to 88.5% in non-LTP treated patients (P=0.20). Reductions in IOP and medications were similar between groups. Furthermore, within the LTP group, patients with successful LTP-treatment had a subsequent surgical success of phaco-KDB in 80.7%, compared to 83.0% in patients with unsuccessful LTP-treatment (P=0.765). Conclusion: Previous LTP treatment does not predict the outcome of phaco-KDB. Furthermore, no correlation was found between the LTP effect and a later surgical success of phaco-KDB.

Comparison of Superior versus Inferior Canaloplasty and Trabeculotomy Using the OMNI Surgical System.

Purpose: To compare outcomes of ab-interno canaloplasty and trabeculotomy of the superior versus inferior angle. Patients and methods: This was a prospective, non-randomized, interventional comparison study done at the Veteran Affairs Hospital in Long Beach, California. All patients underwent cataract surgery with intraocular lens implantation combined with ab-interno canaloplasty and trabeculotomy with the OMNI Surgical System (SightSciences, Menlo Park, CA, USA), either superiorly or inferiorly. Pre- and post-operative intraocular pressure using Goldmann applanation tonometry and best corrected visual acuity were obtained and compared using paired t-tests. Patients were excluded if they had any prior intraocular surgery or prior laser trabeculoplasty procedures. Results: 38 eyes from 29 patients were analyzed. 19 eyes were included in the superior group and 19 eyes in the inferior group. Mean pre-operative IOP in the superior group was 17.6 ± 5.2 mmHg and in the inferior group was 17.6 ± 4.6 mmHg (p > 0.99). At 12 months, mean postoperative IOP for the superior group decreased 24% to 13.3 ± 2.8 mmHg while the inferior group decreased 26% to 13.1 ± 2.2 mmHg (p = 0.92). Mean preoperative medications in the superior group were 2.2 ± 1.3 and in the inferior group was 2.4 ± 1.3 (p = 0.88). At 12 months, this decreased to 1.3 ± 1.5 post-operatively in the superior group and 2.2 ± 1.6 post-operatively in the inferior group (p = 0.64). Conclusion: There was no statistical difference in efficacy between superior versus inferior canaloplasty/trabeculotomy with OMNI. Therefore, surgeons can perform the procedure in the direction that is most comfortable for them without affecting outcomes.

Bent ab interno needle goniotomy versus gonioscopy-assisted transluminal trabeculotomy in primary open-angle glaucoma: study protocol of a randomized clinical trial.

BACKGROUND: Minimally invasive glaucoma surgery (MIGS) is a new class of surgeries, which combines moderate to high success rates and a high safety profile. Bent Ab interno Needle Goniotomy (BANG) and Gonioscopy-Assisted Transluminal Trabeculotomy (GATT) are two low-cost MIGS procedures that communicate the anterior chamber to Schlemm's canal. Most of the available publications on MIGS are either case series or retrospective studies, with different study protocols. The aim of this manuscript is to describe a randomized clinical trial (RCT) protocol to compare the long-term intraocular pressure (IOP) control and the safety of both procedures in eyes with primary open-angle glaucoma. METHODS: This is a parallel, double-arm, single-masked RCT that includes pseudophakic primary open-angle glaucoma (POAG) eyes. After inclusion criteria, medications will be washed out to verify baseline IOP before surgery. Patients will be randomized to BANG or GATT using a sealed envelope. Follow-up visits will be 1, 7, 15, 30, 60, 90, 180, 330 and 360 days after surgery. On PO330, a new medication washout will be done. The main outcome is the IOP reduction following the procedures. Complimentary evaluation of functional and structural parameters, safety, and quality of life will be done after 30, 90, 180, and 360 days. DISCUSSION: Our study was designed to compare the long-term efficacy and safety of two low-cost MIGS. Most of the published studies on this subject are case series or retrospective cohorts, with different study protocols, which included different types and severities of glaucomas, combined with cataract extraction. Our study only included mild to moderate POAG eyes, with previous successful cataract extraction. Moreover, it provides a standardized protocol that could be replicated in future studies investigating various types of MIGS. This would allow comparison between different techniques in terms of efficacy, safety, and patients' quality of life. TRIAL REGISTRATION: Retrospectively registered at the Registro Brasileiro de Ensaios Clínicos (ReBEC) platform RBR-268ms5y . Registered on July 29, 2023. The study was approved by the Ethics Committee of the University of Campinas, Brazil.