Moderator
Sahar Bedrood, MD, PhD, ABO
Panelists
Emily M Schehlein, MD, ABO
Kendrick M Wang, MD
Viewing Papers
Expand a paper title to the right to view the paper abstract and authors. Use the video link to jump to that poster in the session.
Presenting Author
Haana McMurray, MD, BSc
Co-Authors
Sorana Raiciulescu MSc, Won Kim MD
Purpose
To report the long-term outcomes of performing cataract surgery (CS) with combined minimally invasive glaucoma surgeries (MIGS) for the treatment of glaucoma.
Methods
This is a nonrandomized retrospective study of 73 combined MIGS cases by a single glaucoma surgeon at the Walter Reed National Military Medical Center with 5 years of follow-up. All patients received two MIGS procedures within a single operation with or without CS. MIGS procedures in this study included ab interno canaloplasty, trabecular micro-bypass procedures, and cyclophotocoagulation and were combined at the discretion of the surgeon who took into account each patient�s therapy goals and ophthalmic history. Outcome measures included preoperative (preop) and postoperative (postop) intraocular pressures (IOP), glaucoma medication (med) use, complications, and need for additional surgery.
Results
There were no significant differences in preop and postop IOPs or med burden between the CS and non-CS groups. Both groups had significant IOP reductions out to year 5 (CS group: 22.2�7.6mmHg(n=48) preop to 13.2�3.3(n=15) and 12.0�1.2(n=5) at years 3 and 5; non-CS group: 24.8�8.1mmHg(n=25) preop to 12.3�2.2mmHg(n=4) and 12.0mmHg(n=1) at years 3 and 5). Reductions in meds were modest and significant out to year 1 for the CS group (3.1�1.4 meds(n=45) preop to 2.2�1.3 meds(n=28) at year 1) and out to month 8 for the non-CS group (3.6�1.1(n=25) preop to 2.5�1.4 meds(n=15) at month 8). There were no significant differences in eyes with complications between the CS(22.2%) and non-CS(40%) groups.
Conclusion
Concurrent CS with two MIGS procedures had no effect on postop IOPs or med burden compared to the non-CS group. Both groups showed significant postop IOP reductions from preop values out to 5 years. The non-CS group had a higher, but not statistically significant, rate of complications than the CS group.
Presenting Author
David M. Lubeck, MD, ABO
Co-Authors
Keith Barton MBBS, FRCOphth, Nathan Kerr MD, FRANZCO, Nir Shoham-Hazon MD, Shamil Patel MD
Purpose
The iTrack Global Data Registry (iTGDR) aims to collate efficacy and safety data for canaloplasty including: IOP reduction, number of medications, endothelial cell count, adverse events, and complications, in addition to canaloplasty-specific treatment parameters.
Methods
Prospective multicenter in America, Australia, and Europe, cloud-based database, real-world study including patients with primary and secondary open angle glaucoma undergoing canaloplasty. The iTGDR is a surgeon-led initiative conducted in collaboration with the International Glaucoma Surgery Registry (IGSR). It collects longitudinal data of efficacy (IOP, number of medications, RNFL analysis, and HVF), and safety (endothelial cell loss, adverse events, and complications). The iTGDR started in January 2022 in the USA, Canada, Europe, Asia, and Australia. The outcomes will be followed for at least 12 months and a minimum of 300 patients will be enrolled.
Results
424 eyes have been enrolled up to May 2024. Mean baseline IOP and number of medications were 18.1�6.10 and 2.04�1.18, respectively, and were reduced to 13.8�4.03 and 0.80�1.20, respectively, at 12 months (n=159; p<0.001) and to 12.7�3.09 and 1.26�1.43 at 24 months (n=43; p<0.001), respectively. Combined phaco-canaloplasty was performed in 89.9% and as a standalone procedure in 10.1% (baseline IOP was 17.8�5.99 and 20.9�6.39 vs 12.9�3.03 and 11.9�3.44 at 24 months postoperatively). 8.7% of the eyes were medication-free at baseline vs 51.2% at 24 months. Hyphema (>10% of the anterior chamber) occurred in 7 eyes (1.65%). No eye required further glaucoma surgery.
Conclusion
The iTGDR will make a major contribution to understanding the clinical effectiveness of canaloplasty to guide evidence-based decision making for surgeons to achieve improved outcomes in the treatment of their glaucoma patients.
Presenting Author
Ahmad A. Aref, MD, MBA, ABO
Co-Authors
David Lubeck MD, Keith Barton MBBS, FRCOphth, Nathan Kerr MD, FRANZCO, Nir Shoham-Hazon MD
Purpose
To evaluate whether preoperative intraocular pressure (IOP) and medication burden can predict the 20% IOP reduction success rate.
Methods
Glaucoma eyes which underwent ab-interno canaloplasty with iTrack devices (Nova Eye Medical, Fremont, USA) were extracted from the International Glaucoma Surgery Registry�a prospective multicenter database of glaucoma surgeries that is globally available. Data was entered from the United States (n=257), Canada (n=61), Australia (n=101), and Europe (n=5). Endpoints were the identification of correlations between the preoperative IOP and medication burden and achievement of a glaucoma standard 20% reduction following canaloplasty. Eyes were grouped according to postop IOP reduction: �yes20%� and �no20%�, respectively, based on whether they achieved at least a 20% IOP reduction at 12M postop.
Results
424 eyes were included (mean age 72.3�10 years); 159 eyes reached 12M follow-up. IOP of eyes in the yes20% (n=86) and no20% (n=73) group was significantly different at baseline: 20.25�6.92 vs 15.30�3.75 (p<0.001). a="" significant="" but="" opposite="" result="" was="" observed="" at="" 12m="" postop:="" 12.25�3.28="" (yes20%)="" vs="" 15.73�4.04="" (no20%)=""><0.001). number="" of="" medications="" was="" significantly="" reduced="" in="" both="" groups:="" 1.88�1.22="" to="" 0.79�1.15=""><0.001) in="" the="" yes20%="" and="" 2.04�0.98="" to="" 0.81�1.27="" in="" the="" no20%="" group="" at="" baseline="" and="" 12m="" postop,="" respectively=""><0.001). preop="" iop="" was="" highly="" correlated="" with="" iop="" reduction="" (r="0.781;"><0.001). there="" was="" no="" significant="" difference="" between="" the="" groups="" based="" meds="" at="" preop="" and="">
Conclusion
Eyes with a higher preoperative IOP tend to more frequently achieve at least a 20% IOP reduction following ab-interno canaloplasty. Some eyes seem to respond particularly well to canaloplasty and achieve a lower preoperative IOP�a larger sample of eyes is necessary to stratify the groups and understand the baseline correlation factors.
Presenting Author
Gagan K Sawhney, MD
Co-Authors
Brittany Bowman MS, OD
Purpose
To determine the long term intraocular pressure (IOP) and medication reduction after combination cataract and Hydrus Microstent surgery.
Methods
This was a retrospective, single site, single surgeon study of patient outcomes with combination cataract and Hydrus Microstent surgery up to 5 years postoperatively. Eligible charts were from adults that had a diagnosis of mild to moderate primary open angle glaucoma or ocular hypertension and underwent combined cataract surgery with Hydrus Microstent with a minimum of six months of follow-up data available. Outcome measures included mean number of ocular hypotensive medication prescribed, intraocular pressure (IOP), number of glaucoma secondary surgical interventions (SSI), corrected distance visual acuity (CDVA), and visual field mean deviation.
Results
A total of 262 eyes were identified that met the inclusion and exclusion criteria above. Mean medications improved from 2.3 � 1.1 at baseline to 1.6 � 1.3, 1.6 � 1.3, 1.7 � 1.3, and 1.8 � 1.4 at 12, 24, 36, and 48 months postoperatively, respectively. Intraocular pressure improved from 15.3 � 4.2 mmHg at baseline to 12.8 � 2.9, 13.0 � 3.2, 13.0 � 2.4, and 12.8 � 2.4 mmHg at 12, 24, 36, and 48 months postoperatively respectively. Mean postoperative mean deviation was -3.9 � 5.0, -3.9 � 4.2, -2.9 � 3.5, and -2.5 � 3.6 dB at 12, 24, 36, and 48 months, respectively, compared to -5.6 � 6.1 dB at baseline.
Conclusion
The results of this study suggest that after combination cataract and Hydrus Microstent surgery the number of glaucoma medications is reduced, IOP is improved, and visual fields are stable and these outcomes are sustained for 4 years postoperatively.
Presenting Author
Justin M Spaulding, DO
Co-Authors
David Lubeck MD, Keith Barton MBBS, FRCOphth, Nathan Kerr MD, FRANZCO, Nir Shoham-Hazon MD
Purpose
To evaluate the effectiveness of 360-degree canaloplasty using iTrack microcatheter (Nova Eye Medical., Fremont, USA) in glaucoma patients on 3+ medications.
Methods
A prospective multicenter case series of eyes undergoing canaloplasty either combined with cataract surgery or performed as a standalone procedure. Patients with glaucoma and on 3+ medications were included. Primary endpoints included intraocular pressure (IOP) and number of medications at 12 months.
Results
IOP (mmHg) and number of medications at baseline (n=139) were 17.55�5.70 and 3.44�0.58, which reduced to 13.92�4.76 (-20.7%; p<0.001) and="" 2.00�1.45="" (-41.8%;=""><0.001) at="" 12="" months="" (n="42)," respectively.="" eleven="" eyes="" (26.2%)="" were="" medication-free="" at="" 12="" months.="" there="" was="" a="" reduction="" in="" the="" number="" of="" medications="" in="" 25="" eyes="" (59.5%;="" mean="" reduction:="" 1.45="" meds);="" the="" other="" 17="" eyes="" (40.5%)="" had="" no="" change="" in="" medications;="" no="" eye="" had="" an="" increase="" in="" medications.="" twenty="" eyes="" (47.6%)="" still="" required="" the="" use="" of="" 3="" or="" more="">
Conclusion
Canaloplasty when combined with cataract surgery or performed as a standalone procedure reduced medication burden in eyes requiring 3 or more medications at baseline up to 12 months postoperatively.
Presenting Author
Fritz Hengerer, MD, PhD
Co-Authors
Gerd Auffarth MD, PhD, Ina Conrad-Hengerer MD, PhD
Purpose
Given Germany�s early adoption of 2nd-generation trabecular micro-bypass (iStent inject), German datasets provide some of the longest-term outcomes in the world to-date. This study evaluated 10-year (10Y) effectiveness & safety of iStent inject implantation w/ or w/o cataract surgery (Combined/Comb or Standalone/SA subgroups, respectively).
Methods
This prospective, non-randomized, unmasked, longitudinal study included 125 consecutive iStent inject cases of a single surgeon at a large German academic hospital. Patients had considerable preoperative (preop) disease burden, with mean intraocular pressure (IOP) of 23.5 mmHg, 85% of eyes on ?2 medications (meds), and 38% of eyes with prior glaucoma surgery. IOP, meds, adverse events, and secondary surgeries were assessed through 10Y in All Eyes and in Comb (n=81) and SA (n=44) subgroups.
Results
Preoperatively (n=125), mean IOP in All Eyes was 23.5�6.2mmHg on 2.68�1.02 mean meds, reducing to 12.6�1.3mmHg on 1.07�0.54 meds at 10Y (n=28)(46% and 60% reductions, respectively; both p<0.001). in="" comb="" eyes="" (n="81" preop,="" n="17" at="" 10y),="" mean="" iop="" decreased="" by="" 45%="" (22.6="" to="" 12.5mmhg,=""><0.001) and="" meds="" by="" 60%="" (2.52="" to="" 1.00,=""><0.001). in="" sa="" eyes="" (n="44" preop,="" n="11" at="" 10y),="" mean="" iop="" reduced="" by="" 49%="" (25.3="" to="" 12.8mmhg,=""><0.001) and="" meds="" by="" 60%="" (2.98="" to="" 1.18,=""><0.001). at="" last="" follow-up,="" 100%="" of="" eyes="" had="" the="" same="" or="" lower="" iop="" vs="" preop,="" and="" 100%="" maintained="" or="" reduced="" meds="" vs="" preop.="" favorable="" safety="" included="" no="" filtration="" surgeries="" over="" 10="" years="" of="">
Conclusion
iStent inject implantation with or without phacoemulsification produced significant and durable 10-year reductions in IOP and meds in this prospective cohort of patients with relatively high preoperative disease burden. Comb and SA cases had similarly favorable effectiveness and safety.
Presenting Author
Mary Qiu, MD, ABO
Co-Authors
David Lubeck MD, Keith Barton MBBS, FRCOphth, Nathan Kerr MD, FRANZCO, Nir Shoham-Hazon MD
Purpose
To evaluate the clinical outcomes and safety profile of standalone ab-interno canaloplasty performed using the iTrack microcatheter (Nova Eye Medical) compared to ab-interno canaloplasty combined with cataract surgery
Methods
Data were collected from the prospective multicenter cloud-based database (iTGDR, part of the International Glaucoma Surgery Registry � IGSR), including eyes with glaucoma diagnosis and 12 months of follow-up. Patients underwent canaloplasty using the ab-interno technique with the iTrack or iTrack Advance (Nova Eye Inc., Fremont, USA), either as a standalone procedure (standalone group) or combined with cataract surgery (+phaco group). All glaucoma types were included except for angle closure glaucoma
Results
In the standalone canaloplasty group (37 eyes; n=28 phakic, n=9 pseudophakic) baseline IOP (mmHg) and medications significantly decreased from 20.8�6.5 and 2.32�0.88 to 15.6�7.20 (-25.3%; p=0.015) and 1.19�1.38 (-48.9%; p=0.008) at 12 months (n=16). In the canaloplasty +phaco group (338 eyes) IOP and number of medications significantly decreased from 17.4�5.8 and 2.01�1.17 to 13.81�3.54 (-20.7%; p<0.001) and="" 0.79�1.21="" (-60.9%;=""><0.001) at="" 12="" months="" (n="122)." in="" the="" phakic="" eyes="" standalone="" group="" the="" reduction="" in="" iop="" and="" medications="" was="" significant="" (p="0.022;" p="0.02);" there="" were="" not="" enough="" standalone="" pseudophakic="" eyes="" to="" return="" a="" meaningful="" p="" value.="" no="" serious="" adverse="" events="" were="">
Conclusion
Both standalone canaloplasty and canaloplasty combined with cataract surgery using the iTrack microcatheter significantly reduced intraocular pressure and the number of medications over a 12-month period, with no serious adverse events observed
Presenting Author
Zachary D. Vest, MD
Co-Authors
Christy Benson MD, Ronald Caronia MD, Steven Sarkisian MD, Valerie Trubnik MD, Deborah Ristvedt DO, Mitchell Shultz MD
Purpose
The current study assessed cases of iStent infinite implantation conducted at 6 U.S. sites by 7 surgeons in patients with open-angle glaucoma.
Methods
This multicenter, retrospective, real-world case series included 64 eyes with open-angle glaucoma who underwent implantation of the third-generation trabecular micro-bypass stent (iStent infinite, containing three stents) with or without cataract surgery. No preoperative medication washout was conducted. In the consistent cohort of eyes with 12-month data, intraocular pressure (IOP) and topical IOP-lowering medications prior to iStent infinite implantation were compared to IOP and topical IOP-lowering medications 12 months postoperatively. Safety parameters and incidence of secondary procedures were also recorded. Additional patients will be added by the time of the conference.
Results
All patients underwent successful implantation of three iStent infinite stents. In the consistent cohort of eyes with 12 month data (n=64 eyes), mean IOP reduced from 18.1+3.7 mmHg preoperatively to 13.8+3.2 mmHg at month 12 (23% reduction, P=0.001). Mean number of medications reduced from 1.31+0.87 preoperatively to 0.64+1.00 at month 12 (51% reduction, P=0.001). 43/64 eyes (67%) achieved an IOP <14mmhg at="" month="" 12,="" and="" 23/64="" eyes="" (36%)="" achieved="" an="" iop=""><12mmhg at="" month="" 12.="" twelve="" months="" following="" implantation,="" 39/64="" eyes="" (61%)="" were="" free="" of="" topical="" iop="" lowering="" medications="" versus="" 5/64="" eyes="" (8%)="" pre-implantation.="" no="" intraoperative="" complications="" were="" reported.="" aes="" were="" mild="" and="">
Conclusion
Implantation of iStent infinite in patients with open-angle glaucoma yielded statistically significant and clinically meaningful IOP and topical medication reductions in this multicenter, U.S. based, retrospective, real-world case series.
Presenting Author
Mahmoud A. Khaimi, MD
Co-Authors
Juliana Bryant MD, BA
Purpose
To investigate the clinical outcomes of ab-interno canaloplasty (ABiC) with the iTrack microcatheter (Nova Eye Medical) performed as a standalone procedure (ABiC) and in combination with phacoemulsification (ABiC+phaco) over a 36-month period.
Methods
Non-randomized, single center, retrospective case series of eyes undergoing either ABiC or ABiC+phaco. Adult patients with controlled and uncontrolled open-angle glaucoma and no prior glaucoma surgery were eligible for inclusion. Outcome measures include intraocular pressure (IOP) and number of glaucoma medications.
Results
1013 eyes (335 ABiC and 678 ABiC+phaco) were included. Mean baseline IOP was 21.7�7.1mmHg (ABiC) and 18.5�7.3mmHg (ABiC+phaco) while the number of glaucoma medications was 2.11�1.17 (ABiC) and 1.72�1.13 (ABiC+phaco). There was a statistically significant difference among the groups at baseline (p<0.001). at="" 36="" months,="" mean="" iop="" was="" reduced="" to="" 17.0�4.0="" mmhg="" (n="10)" and="" 14.4�3.3="" mmhg="" (n="41)," respectively,="" and="" the="" mean="" number="" of="" medications="" was="" reduced="" to="" 1.42�0.90="" (n="12)" and="" 0.88�1.13="" (n="42)," respectively,="" with="" no="" significant="" statistical="" difference="" between="" groups="" (p="0.18;" p="0.44)." ninety-nine="" eyes="" experienced="" adverse="" events="" such="" as="" postoperatively="" iop="" spikes;="" 7="" eyes="" had="">
Conclusion
ABiC results in a sustained reduction in mean IOP and glaucoma medications when used as a standalone procedure or in combination with phacoemulsification.
Presenting Author
Nimrita Nagdev, MS, MBBS
Co-Authors
Devendra Maheshwari MD, Madhavi Pillai MBBS, DNB, Shivam Gupta MS
Purpose
To study the efficacy and safety of gonioscopy-assisted transluminal trabeculotomy combined with phacoemulsification in mild-moderate and severe primary open-angle glaucoma
Methods
This was prospective, interventional study. Based on mean deviation by Humphery visual field; patients were divided into mild-moderate (144) & severe (121) glaucoma. 265 eyes underwent combined gonioscopy assisted transluminal trabeculotomy with phacoemulsification. All patients were evaluated for IOP, BCVA, and number of AGMs at 2 weeks, 1, 3, 6 months & 1 year from baseline. Other outcome measures included complications, secondary interventions, & surgical success. Success was defined as at least 20%/25%/30% IOP reduction &IOP <21,><18, or=""><15 mmhg="" (criteria="" 1,="" 2,="" or="" 3).="" risk="" factors="" for="" surgical="" failure="" were="" analyzed.="" a="" p="" value="" of=""><0.05 was="" considered="" statistically="">
Results
265 eyes Phaco-GATT.Mild-moderate grp,Mean IOP reduced 20.40(4.47)mmHg to12.44 (2.88)mmHg(37.1%reduction)&severe grp,21.46(6.45)mmHg to12.49(2.90)mmHg(38.5% reduction) by 1 yr(p<0.001),no significant="" difference="" between="" grps(p="0.625).AGM" reduced="" 1.35(0.56)to0.08(0.30)mild-moderate="" grp="" &2.00(0.90)to0.13(0.38)severe="" grp=""><0.001),no significant="" difference="" between="" grps(p="0.468).Cumulative" probability="" of="" overall="" success="" was88.8%,83.9%,and72.1%mild-moderate="" grp&91.6%,85.8%="" and72.4%="" severe="" grp,="" with="" no="" significant="" difference="" between="" grps(p="0.459,p=0.695" &p="0.950).Higher" baseline="" iop="" associated;reduced="" likelihood="" of=""><0.001).macrohyphema;40pts(mild-moderate)&35 pts(severe),15required="">
Conclusion
GATT combined with phacoemulsification is a safe and efficacious option of open-angle glaucoma irrespective of its severity prior to surgery.
Presenting Author
Devendra Maheshwari, MD
Co-Authors
Madhavi Pillai MBBS, DNB, Nimrita Nagdev MS, MBBS, Rengappa Ramakrishnan MS
Purpose
To compare the efficacy and safety of Tanito Microhook Ab Interno Trabeculotomy with phacoemulsification (Phaco-�LOT) versus Bent ab interno needle goniectomy with phacoemulsification (Phaco-BANG) in mild to moderate open-angle glaucoma.
Methods
Prospective, Randomized, interventional study.94 patients with mild-moderate open-angle glaucoma and visually significant cataracts were randomized into Group 1 who underwent Phaco-�LOT, and Group 2 Phaco-BANG.Outcome measures included changes in intraocular pressure (IOP), antiglaucoma medications (AGM), best-corrected visual acuity (BCVA), complications, and interventions. Success was defined as IOP ?21/?18/?15 mm Hg or 20%/25%/30% IOP reduction (Criteria 1, 2, 3).
Results
Mean IOP decreased from 24.69 � 7.09 mmHg and 23.20 � 7.90 mmHg to 11.97 � 2.82 mmHg and 11.74 � 2.65 mmHg at 6 months for groups 1 and 2, respectively(P < 0.001).AGM reduced from 1.57 � 1.07 and 1.46 � 0.85 to 0.11 � 0.40 and 0.11 � 0.32, P < 0.001 in Group 1 and Group 2 respectively.No significant difference in IOP and AGM was found between the groups. The cumulative probability of complete success was 91.4%,88.6%,88.6% in Group 1, and 88.6%,88.6%, and 82.9% in Group 2 (Criteria 1, 2,3) without significant difference between the groups.Microhyphema was seen in 10 eyes in Group 1 and seven eyes in Group 2. Two eyes in Group 1 had macrohyphema and underwent anterior chamber wash.
Conclusion
Tanito Ab interno microhook trabeculotomy and Bent ab interno needle goniectomy,combined with phacoemulsification demonstrated equivalent efficacy in mild to moderate glaucoma.Both procedures provide significant IOP control and decrease the burden of topical medications with a good safety profile and favorable success rates.
Presenting Author
Devendra Maheshwari, MD
Co-Authors
Nimrita Nagdev MS, MBBS, Madhavi Pillai MBBS, DNB, Shivam Gupta MS
Purpose
To study the efficacy and safety of gonioscopy-assisted transluminal trabeculotomy combined with phacoemulsification in primary open angle and primary angle closure glaucoma
Methods
This was Prospective, comparative, interventional study.180 eyes (90 POAG & 90 PACG) underwent combined gonioscopy assisted transluminal trabeculotomy with phacoemulsification. All patients were evaluated for IOP, BCVA and number of AGMs at 2weeks, 1,3,6 and 12months from baseline. Other outcome measures included complications, secondary interventions, & surgical success. Success was at least 20%/25%/30% IOP reduction & IOP <21,18, or15="" mmhg="" (criteria="" 1,2,="" or="" 3).="" risk="" factors="" for="" surgical="" failure="" were="" analyzed.="" a="" p="" value="" of=""><0.05 was="" considered="" statistically="">
Results
In POAG group, mean (SD) IOP decreased from 20.97(4.23) to 12.60(2.72)mmHg(38.4% reduction) & PACG group, mean(SD) IOP reduced from 21.02(60.13)mmHg to 13.10 (3.39) mmHg (35.4% reduction) by end of 1 yr(p<0.001),no significant="" difference="" between="" grps(p="0.685).AGM" reduced="" 1.66(0.80)to0.09(0.36)="" poag="" grp="" &="" pacggrp="" 1.87(0.93)="" to="" 0.11(0.39)="" by=""><0.001),no significant="" difference="" between="" grps(p="0.940)." cumulative="" probability="" of="" overall="" success="" was="" 91.1%,="" 84.4%="" &="" 72.1%="" in="" poag="" grp.in="" pacg="" ,85.2%="" ,81.9%="" &67%="" at12mth="" (p="0.22,0.616" &0.422).="" higher="" baseline="" iop="" associated;reduced="" likelihood="" of=""><0.001).14 pts="" (poag)&16="" pts="" (pacg)="" had="" microhyphema.4="" pts(pacg)="" had="" ac="">
Conclusion
Combined gonioscopy assisted transluminal trabeculotomy with phacoemulsification can be safe & efficacious with comparable surgical outcomes in both POAG & PACG.
Presenting Author
Nathan M. Radcliffe, MD, ABO
Co-Authors
Jennifer Harris PharmD, PhD, Kristian Garcia MPH, BA, Jaime Dickerson PhD, Erin Zwick PhD, Michael Mbagwu MD, Robert Chang MD
Purpose
To characterize long-term real-world clinical outcomes of standalone canaloplasty and trabeculotomy using the OMNI� Surgical System (Sight Sciences) in patients with primary open-angle glaucoma (POAG).
Methods
This was a retrospective, observational cohort study utilizing the American Academy of Ophthalmology IRIS� Registry (Intelligent Research in Sight). Eyes with POAG undergoing standalone canaloplasty and trabeculotomy using the OMNI Surgical System with at least 6 months and up to 36 months of postoperative follow-up were included. Outcomes included intraocular pressure (IOP) and medication changes postoperatively compared to baseline tested for statistical significance using a paired t-test. The nature and timing of any secondary procedures (SSI) for glaucoma during follow-up were captured; SSI were not censoring events for this study.
Results
230 eyes of 196 patients were analyzed. Most had moderate (40.0%) or severe (41.3%) POAG. 44.4% of procedures performed by glaucoma specialists. Mean (SD) baseline IOP was 22.1 (6.4) mmHg; over 36 months ranged from 15.1-16.7 mmHg (all p<0.0001), reductions of 5.6-7.1 mmHg. Mean baseline medications was 2.1 (1.5) and over 36 months ranged from 1.1-1.8; significant reductions through 18 months postoperatively (p<0.0011) and insignificant at months 24 and 36. Eyes with lower baseline IOP (<18 mmHg) had medication reductions through 36 months; eyes with higher baseline IOP (>18 mmHg) had significant IOP reductions through 36 months. The rate of secondary surgical interventions was 40.0%.
Conclusion
Standalone canaloplasty and trabeculotomy provides clinically and statistically significant reductions in IOP and medication use through up to 36 months postoperatively. Standalone OMNI surgery is a reasonable MIGS option for patients with POAG seeking IOP reduction, medication reduction, or both.
Presenting Author
Ticiana De Francesco, MD
Co-Authors
Ike Ahmed FRCSC, MD, Shienal Patel BSc
Purpose
Evaluate the intraocular pressure (IOP) lowering and adverse event profile of adjusting postoperative outflow resistance in a novel aqueous shunt using a green laser to titrate nitinol valves.
Methods
The early clinical outcomes of the Calibreye System (Myra Vision, Campbell, CA) were assessed in 25 eyes with open-angle glaucoma that underwent Calibreye implantation with Mitomycin- C (MMC). The device communicates the anterior chamber with the subconjunctival space with three flow channels, two of which are controlled by nitinol valves that can be opened or closed using a slit lamp mounted green laser. Following implantation, the investigators opened and closed the valves to titrate device resistance as needed. Postoperative study visits were scheduled on days 1 and 3, weeks 1, 2, and 3, and months 1 and 3. Additional follow-ups visits are ongoing and will be reported as available.
Results
By month three, 18 out of 24 eyes had undergone postoperative titration to maximal flow, resulting in an average IOP reduction of 46% from baseline, with a mean IOP of 11.4 mmHg. IOP reduction of ?20% from baseline was achieved in 92% of the eyes. The average IOP reduction when titration was performed to lowest device resistance was 3 mmHg. Additionally, 75% of the eyes were medication-free. The device demonstrated a favorable safety profile comparable to other glaucoma drainage devices, with no intraoperative adverse events and all postoperative laser titrations being successfully performed. One patient with high myopia developed hypotony maculopathy and explantation was performed.
Conclusion
The early clinical outcomes of the titratable aqueous shunt demonstrated a significant IOP reduction and an encouraging safety profile. The ability to adjust outflow resistance postoperatively offers a promising approach to personalized patient care in postoperative glaucoma management.
Presenting Author
Shivani S. Kamat, MD, ABO
Co-Authors
David Lubeck MD, Keith Barton MBBS, FRCOphth, Nathan Kerr MD, FRANZCO, Nir Shoham-Hazon MD
Purpose
To evaluate intraocular pressure (IOP) control and medication reduction in uncontrolled glaucoma eyes.
Methods
Eyes which received canaloplasty performed with an ab-interno approach with the iTrack microcatheter (Nova Eye Medical) with a preoperative IOP above 18mmHg (defined as uncontrolled IOP) were collated from the International Glaucoma Surgery Registry - IGSR. Primary endpoints were IOP reduction, control of IOP equal or below 18mmHg, and medication reduction.
Results
168 eyes with a mean preoperative IOP (mmHg) of 23.9�5.5 and on 1.82�1.2 medications were recruited. IOP and medications were reduced to 15.1�4.9 and 15.4�4.6 and 1.12�1.4 and 0.74�1.1 at the 6- (n=91) and 12-month (n=58) follow-ups (p<0.001), respectively. 81.0% of the eyes were controlled (equal or below 18 mmHg) at the 12-month follow up. Mean IOP decreased in 96.6% of the eyes, while the number of medications decreased in 62.1% of the eyes, stayed the same in 29.3%, and increased in 8.6% of the eyes. Potentially related adverse events were: cystoid macular edema (2/168); hyphema >10% anterior chamber (3/168), and intraocular inflammation/uveitis (1/168).
Conclusion
Canaloplasty performed via an ab-interno technique resulted in a generic decrease of IOP in uncontrolled glaucoma eyes. The majority of baseline uncontrolled glaucoma eyes were IOP controlled following the canaloplasty procedure.
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