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.
CONCLUSIONS: 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.
BACKGROUND: 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.

UNASSIGNED: To evaluate outcomes of new adopters of the OMNI® Surgical System (Sight Sciences, Inc.) by prospectively evaluating intermediate-term outcomes of patients operated by trainees.
UNASSIGNED: This was a prospective study of surgeries performed by trainees on patients with open angle glaucoma undergoing simultaneous cataract surgery and ab interno canaloplasty and trabeculotomy using the OMNI Surgical System. Pre-operative intraocular pressure (IOP) and number of glaucoma medications were recorded. Only patients with a minimum of 6-month follow up were included. Baseline IOP was used to separate subjects into two groups: Group 1 (IOP ≥18 mmHg) and Group 2 (IOP <18 mmHg). Mean decrease in IOP and medications was calculated and compared with paired t-tests for the overall sample as well as the subgroups. Success was defined as those with a ≥20% reduction from pre-operative IOP or with an IOP ≤18 mmHg and ≥6 mmHg and on the same or fewer number of medications while not requiring additional surgery. Adverse events were also recorded.
UNASSIGNED: Forty-two eyes of 31 patients were included. Mean pre-operative IOP was 17.2 ± 4.8 mmHg and mean number of medications was 2.4 ± 1.2. The primary endpoint was reached in 83.3% of patients at 12 months. IOP was reduced by 22.3% to 13.4 ± 2.4 (p<0.001). Mean number of medications decreased to 1.7 ± 1.6 (p<0.001). Group 1 mean IOP decreased 35.4% from 22.2 ± 4.6 mmHg to 14.3 ± 2.8 mmHg (p<0.001). Group 2 mean number of medications decreased from 2.3 ± 1.1 to 1.6 ± 1.5 (p<0.001).
UNASSIGNED: When operated on by the novice MIGS surgeon, the OMNI device provides effective IOP and glaucoma medication reduction with minimal adverse events. Efficacy and safety of the device in the hands of trainees was comparable to experienced glaucoma surgeons suggesting its ease of adoption.

UNASSIGNED: To provide long-term intraocular pressure (IOP) and ocular hypotensive medication usage outcomes through 36 months for patients treated with canaloplasty and trabeculotomy (OMNI Surgical System) combined with cataract surgery as participants in the GEMINI study.
UNASSIGNED: Eleven ophthalmology practices in 10 US states.
UNASSIGNED: Non-interventional 36-month extension of the 12-month, prospective, multicenter, GEMINI study.
UNASSIGNED: GEMINI patients had visually significant cataract, mild-to-moderate glaucoma (ICD-10 guidelines), medicated IOP <33 mmHg, and unmedicated mean diurnal IOP (DIOP) (after washout) 21-36 mmHg. Patients from GEMINI were eligible for inclusion. Outcome measures were reduction in mean unmedicated DIOP, reduction in mean IOP-lowering medications, percent of eyes with ≥20% reduction in unmedicated DIOP, and percent of eyes with unmedicated DIOP ≥6 and ≤18 mmHg.
UNASSIGNED: A total of 66 patients provided consent and were enrolled. Mean (SD) unmedicated DIOP was 23.1 (2.7) mmHg at baseline, 16.7 (4.1), 16.3 (3.3) at 24 and 36 months; mean reductions of 6.2 (4.1) and 6.9 (3.4) mmHg. Twelve-month IOP at the end of GEMINI was 15.6 mmHg. The proportion of eyes with ≥20% reduction in IOP was 77% and 78% (months 24 and 36) compared to 87% at month 12 from GEMINI. About 68% of patients had an IOP between 6 and 18 mmHg at 24 months and 71% at 36 months. Mean IOP-lowering medications was 1.7 at baseline, which was reduced to 0.4 (24 months, -1.3) and 0.3 (36 months, -1.4). About 74% of patients (46 of 62) were medication free at 36 months.
UNASSIGNED: GEMINI demonstrated 12-month effectiveness of canaloplasty and trabeculotomy with OMNI combined with cataract surgery for IOP and medication reduction in mild-to-moderate glaucoma. However, longer-term data is key to the decision making in the selection of a surgical treatment. This GEMINI extension demonstrates that the 12-month outcomes from GEMINI were sustained through 36 months.

OBJECTIVE: To assess the safety and efficacy of combining phacoemulsification with gonioscopy-assisted transluminal trabeculotomy (GATT) compared to phacoemulsification alone in the management of primary angle closure glaucoma (PACG).
METHODS: Prospective, institutional study in which eyes requiring surgery for PACG were randomized to undergo phacoemulsification followed by GATT (phaco-GATT group) or phacoemulsification alone. Success was defined as having a final IOP of 6-20 mmHg with no subsequent glaucoma surgery or vision-threatening complications.
RESULTS: Thirty-six eyes underwent phaco-GATT with 360° angle incision and 38 eyes underwent phacoemulsification alone. IOP and glaucoma medications were significantly lower in the phaco-GATT group at 1, 3, 6, 9 and 12 months. The success rate in the phaco-GATT group was 94.4% after 12.16 ± 2.03 months, with 75% of eyes being off medications compared to 86.8% after 12.47 ± 4.27 months in the phaco group, with 42.1% off medications. (p = 0.008). Hyphema and fibrinous anterior chamber reaction were the most common complications in the phaco-GATT group and resolved with conservative treatment or required YAG capsulotomy. Although this delayed visual rehabilitation in the phaco-GATT group, it did not affect the final visual outcome with no significant difference in the final best-corrected visual acuity between both groups (p = 0.25).
CONCLUSIONS: Combining phacoemulsification with GATT in PACG yielded more favourable outcomes in terms of IOP, glaucoma medications and surgical success. Although the postoperative hyphema and fibrinous reaction may delay visual rehabilitation, GATT further lowers the IOP by breaking residual peripheral anterior synechiae and removing the dysfunctional trabeculum circumferentially, while avoiding the risks inherent in more invasive filtering procedures.

UNASSIGNED: To provide extended safety and effectiveness follow-up for eyes treated with circumferential canaloplasty and trabeculotomy (CP+TR) that were included in the 12-month ROMEO study.
UNASSIGNED: Seven multi-subspecialty ophthalmology practices located in 6 states (Arkansas, California, Kansas, Louisiana, Missouri, and New York).
UNASSIGNED: Retrospective, multicenter, IRB approved.
UNASSIGNED: Eligible eyes had mild-moderate glaucoma and were treated with CP+TR with cataract surgery or as a standalone intervention.
UNASSIGNED: Main outcome measures were mean IOP, mean number of ocular hypotensive medications, mean change in number of medications, proportion of patients with a ≥20% reduction in IOP or with IOP ≤18 mmHg, and proportion of patients medication free. Safety outcomes were adverse events and secondary surgical interventions (SSI).
UNASSIGNED: Eight surgeons at 7 centers contributed 72 patients stratified by pre-operative intraocular pressure (IOP); >18 mmHg (Grp1), ≤18 mmHg (Grp2). Mean follow-up of 2.1 years (min 1.4, max 3.5). 2-year IOP (SD) was 15.6 mmHg (-6.1 mmHg, -28% from baseline) on 1.4 medications (-0.9, -39%) for Grp1 with cataract surgery; 14.7 mmHg (-7.4 mmHg, -33% from baseline) on 1.6 medications (-0.7, -15%) for Grp1 standalone, 13.7 mmHg (-0.6 mmHg, -4.2%) on 1.2 medications (-0.8, -35%) for Grp2 with cataract surgery, 13.3 mmHg (-2.3 mmHg, -14.7%) on 1.2 medications (-1.0, -46%) for Grp2 standalone. The proportion of patients at 2 years with either a ≥20% IOP reduction or IOP between 6 and 18 mmHg and no increase in medication or SSI was 75% (54 of 72, 95% CI 69.9%, 80.1%). One-third of patients (24 of 72) were medication free whereas 9 of 72 were pre-surgical. No device-related adverse events during extended follow-up; 6 eyes (8.3%) required additional surgical or laser intervention for IOP control after 12 months.
UNASSIGNED: CP+TR provides effective IOP control that is sustained for 2 years or more.

UNASSIGNED: Twelve-month safety and effectiveness results for canaloplasty combined with trabeculotomy using the OMNI surgical system in pseudophakic eyes or combined with cataract surgery in mild-to-moderate open-angle glaucoma (OAG).
UNASSIGNED: Sixteen centers in 11 US states (AL, AR, CA, CT, KS, LA, MO, NY, SD, TN, TX).
UNASSIGNED: Retrospective, case series, open-label.
UNASSIGNED: A total of 136 eligible patients from 20 surgeons: mild-to-moderate OAG (visual field mean deviation (MD) not worse than -12 dB), 12-month follow-up, preoperative medicated IOP >18 mmHg and ≤36 mmHg on ≤5 medications. One eye per patient enrolled. Endpoints included proportion with ≥20% reduction in IOP or IOP between 6 and 18 mmHg (inclusive) and on the same or fewer medications without secondary surgical intervention (SSI) (primary success), mean IOP, change in IOP, ocular hypotensive medication use, and proportion of patients with a 20% or greater reduction in IOP at 12 months. Safety: adverse events (AE) and best corrected visual acuity (BCVA).
UNASSIGNED: Primary success was met by 71%. Mean IOP was reduced (22.3-15.9 mmHg, p < 0.0001). Medications went from 1.9 ± 1.3 to 1.3 ± 1.2 (p < 0.001). AE were mild and as expected for angle surgery. The most frequent AE were BCVA loss (6%), mild inflammation (4%), IOP elevation (3%), and clinically significant hyphema (3%). There were 4 (3%) SSI.
UNASSIGNED: The OMNI system provides effective IOP reduction, sustained IOP control, and meaningful medication reduction for up to 12 months postoperative. The present study confirms and extends the results from ROMEO.

UNASSIGNED: 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.
UNASSIGNED: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 US states.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.

OBJECTIVE: To clarify recent trends in glaucoma surgery in Japan, including minimally invasive glaucoma surgery.
METHODS: Retrospective cohort study.
METHODS: We used the Diagnostic Procedure Combination database, a nationwide administrative database in Japan. Patients who underwent glaucoma-related procedures were included. We calculated the number of surgeries stratified by procedures and age categories. We also investigated the number of glaucoma-related procedures in combination with cataract surgery.
RESULTS: From fiscal years 2011 to 2019, we identified 134,331 glaucoma-related procedures at 720 hospitals. The total number of glaucoma-related procedures increased by 215% from 6516 in 2011 to 20,569 in 2019. The numbers of filtering surgeries, trabeculotomies, and glaucoma drainage devices with plates [GDD(p +)] procedures significantly increased (P = 0.002, 0.002, and 0.006, respectively), whereas the number of cyclocryotherapy procedures significantly decreased (P = 0.002). The number of iStent procedures increased by 49% from 371 in 2018 to 551 in 2019. The ≥ 65 year age group accounted for > 80% of the iStent procedures. In the 0 to 14 year age group, trabeculotomy accounted for about 70% of the procedures, and the GDD(p +) procedure became the second most common procedure after trabeculotomy because of the decrease in filtering surgeries. Among combination surgeries, trabeculotomy was most frequently performed. The proportion of combination surgery increased, especially in trabeculotomy.
CONCLUSIONS: The total number of glaucoma-related procedures increased throughout the observation period. Before 2017 filtering surgery was the most common procedure, whereas trabeculotomy was most common after 2018. The proportion of trabeculotomies performed in combination with cataract surgery continuously increased.

OBJECTIVE: This study analyzes diurnal IOP data (9AM, 12PM, 4PM) from a prospective 12-month trial of the OMNI Surgical System in open-angle glaucoma (OAG) patients with the aim of evaluating effect of MIGS surgery on the amplitude of the diurnal IOP profile pre- and postoperatively.
METHODS: Fifteen ophthalmology practices and surgery centers located in 14 states in the United States.
METHODS: Prospective, multicenter, IRB approved study. Patients treated with canaloplasty (360°) and trabeculotomy (180°). Patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on zero to four hypotensive medications.
METHODS: Post-hoc analysis of diurnal IOP data from the multicenter GEMINI study. Analysis includes comparison of IOP preoperatively and at month 12 for each of the diurnal time points, 9AM, 12PM, 4PM, change in magnitude of spread between the maximum IOP and minimum IOP for each patient and the proportions of patients preoperatively and at month 12 with IOPs at or below 25, 21, 18, and 15 mmHg, average variability (standard deviation of the 9AM, 12PM, and 4PM IOP) preoperatively and at month 12.
RESULTS: A total of 128 patients included in this analysis. IOP at each diurnal timepoint was significantly lower postoperatively (p<0.0001). The difference between highest and lowest IOP measurement for each patient averaged 2.8 mmHg preoperatively (SD 2.4, MAX 14, MIN 0) and 1.8 mmHg (SD 1.7, MAX 10, MIN 0) month 12 (P<0.00001). The proportion with IOP ≤ to 25, 21, 18, and 15 mmHg increased; 75%-97%, 27%-88%, 1%-79%, and <1%-56%, respectively. The average variability was greater at all time points preoperatively (P<0.0001).
CONCLUSIONS: This study demonstrates that eyes with OAG can benefit from an overall decreased IOP and degree of IOP fluctuations for as long as 12 months after surgical treatment with canaloplasty and trabeculotomy.

UNASSIGNED: To characterize clinical outcomes of combined viscodilation of Schlemm\'s canal and collector channels and 360° trabeculotomy as a standalone procedure or combined with cataract surgery in eyes with mild to moderate open-angle glaucoma (OAG).
UNASSIGNED: In this prospective case series, the OMNI glaucoma surgical platform (Sight Sciences, Menlo Park, CA) was utilized to perform the procedure either combined with phacoemulsification or as a standalone procedure. Changes from baseline in intraocular pressure (IOP) and IOP-lowering medications were evaluated through the first 12 months of a planned 24-month follow-up period.
UNASSIGNED: Among 17 eyes of 15 subjects, mean IOP was reduced from 20.4 mmHg to 12.7-13.7 mmHg through 12 months of follow-up (p < 0.001 at every time point) and mean medications reduced from 2.5 to 0.1-0.6 (p < 0.001 at every time point). IOP reductions in eyes undergoing standalone surgery were approximately 2-4 mmHg greater at each time point compared to eyes undergoing surgery combined with phacoemulsification; this may be related to a higher baseline IOP in the former eyes (22.1 vs 18.5 mmHg). Six eyes developed hyphema, of which three required washout for elevated IOP on the first postoperative day; six additional eyes had IOP elevations that resolved with medical management.
UNASSIGNED: Viscodilation of Schlemm\'s canal and collector channels paired with ab interno trabeculotomy performed with a single integrated instrument (OMNI), whether as standalone or combined with phacoemulsification, effectively lowers both IOP and the need for IOP-lowering medications through 12 months of follow-up.