Moderator
Deborah G Ristvedt, DO, ABO
Panelists
Michael S. Berlin, MD, MSc
Prasanna V Ramesh, MS, DNB
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
Thomas Khairy, None
Co-Authors
Ali Salimi MD, MSc, Paul Harasymowycz FRCSC, MSc, MD
Purpose
Bent Ab interno Needle Goniotomy (BANG) is an emerging, low-cost MIGS procedure proven effective in open-angle glaucoma. Little is known about the efficacy and safety of BANG in primary angle closure glaucoma (PACG). We compared 1-year outcomes of BANG with phacoemulsification (Phaco-BANG) versus phacoemulsification alone (Phaco-only) in PACG eyes.
Methods
A retrospective two-group matched single-center cohort study was conducted. A total of 86 PACG eyes were included with 43 eyes in the Phaco-BANG group (27 patients age 71.3�7.1 years, 48.1% female) and 43 eyes in the Phaco-only group (25 patients age 68.2�10.0, 72.0% female). The groups were matched 1:1 based on the preoperative IOP (�3 mmHg) and number of antiglaucoma medications (AGM) used. Primary efficacy outcomes were postoperative changes in mean IOP and AGM use at 1-year follow-up. Outcomes were assessed using generalized estimating equations that accounted for the non-independent data structure and corrected for baseline intergroup differences.
Results
At baseline, both average IOP and AGM use were comparable between the Phaco-BANG group (15.0�3.4 mmHg on 1.8�1.2 medications) and the Phaco-only group (15.6�2.9 mmHg on 1.6�1.0 medications). The reduction in IOP at 1-year was significantly greater in the Phaco-BANG group compared to the Phaco-only group (-2.3 mmHg versus -1.4 mmHg, P=0.003). Phaco-BANG likewise resulted in a greater reduction in mean AGM use at 1-year (-0.7 versus -0.3, P=0.018). No significant differences in adverse events were observed between the groups.
Conclusion
Phaco-BANG has a favorable safety profile and is more effective than phacoemulsification alone in PACG eyes, as evidenced by significantly larger reductions in IOP and AGM use.
Presenting Author
Zachary D. Vest, MD
Co-Authors
Jane Kuo OD, Guy Simpson PharmD, V Swetha Jeganathan MD
Purpose
The ENCORE registry aimed to collect 12 months of real-world performance and safety outcomes for the Hydrus microstent. It evaluated surgical proficiency among novice and experienced surgeons and assessed intraoperative procedural ease to understand factors influencing the adoption of this minimally invasive glaucoma surgeries (MIGS).
Methods
ENCORE was a prospective registry across 40 US sites, involving 936 eyes with open angle glaucoma. The registry included a diverse cohort of patients, in varied clinical settings. Surgeons documented Hydrus microstent implantation attempts, occurrences of repositioning, and their success rate of achieving accurate placement within Schlemm�s canal. Procedural ease was quantitatively assessed using a scale from 1 to 10, with 1 indicating difficult and 10 indicating easy.
Results
The ENCORE registry achieved first attempt Hydrus implantation success in 89.1% of cases. Repositioning was required in 9.2% of instances. Placement within Schlemm�s canal was successfully achieved in 99.9% of cases indicating confidence in proper placement. These results were similar to Hydrus implantation placement success in a large prospective RCT. Surgeons consistently rated procedural ease as ? 8 in 70.2% of cases, with a mean score of 8.1 and median score of 9, indicating the procedure was considered straightforward by most surgeons despite their varying prior experience. A single case was reported where placement was challenging due to patient movement and poor visualization.
Conclusion
The findings from the ENCORE registry reveal that the Hydrus procedure is well adopted by surgeons, even by those without prior experience. High success rates on initial attempts, coupled with minimal repositioning, and positive surgeons� ratings highlights confidence in placement and the short learning curve.
Presenting Author
Emily M Schehlein, MD, ABO
Co-Authors
Jane Kuo OD, Guy Simpson PharmD, V Swetha Jeganathan MD
Purpose
Simultaneous cataract and glaucoma surgery has long posed challenges for surgeons. This study reports refractive outcomes in patients undergoing cataract surgery with Hydrus microstent, comparing monofocal and multifocal IOLs (MFIOLs). It aims to provide insights for optimizing vision and reducing spectacle dependence in glaucoma patients.
Methods
ENCORE was a 12-month prospective, multi-center registry, conducted across 40 US sites, involving 936 patients. The study was non-randomized and open label. Patients were selected based on inclusion criteria of mild to moderate glaucoma and the need for cataract surgery. Monofocal or MFIOLs were used at the surgeon's discretion. Endpoints included mean manifest refraction spherical equivalent (MRSE), the percentage of patients achieving MRSE ? 0.5 D, and monocular best corrected distance visual acuity (BCDVA).
Results
IOL data was available for 931 patients (99.5%), with 86.5% receiving monofocal IOLs. At 1M, 69.1% of MFIOL patients and 63.9% of monofocal IOL patients achieved a refractive error of 0.5D or less. This level of MRSE was maintained at 71% vs 66.4% at 12M in the MFIOL and monofocal group, respectively. Mean MRSE at 1M was 0.5 D (SD 0.5) for MFIOLs and 0.6 D (SD 0.7D) for monofocal IOLs and remained stable to 12M. Visual acuity also saw substantial improvements. At 1M, 96.5% of MFIOL patients and 90.3% of monofocal IOL patients achieved BCDVA of 20/40 or better. 94.5% of MFIOL and 94.3% of monofocal IOL patients maintained this high level of visual acuity at 12M.
Conclusion
These results indicate that implantation of the Hydrus microstent during cataract surgery demonstrates a refractive-neutral procedure with excellent visual outcomes and long-term refractive stability with both monofocal and MFIOLs in real-world clinical settings.
Presenting Author
Nir Shoham-Hazon, MD
Co-Authors
David Lubeck MD, Keith Barton MBBS, FRCOphth, Nathan Kerr MD, FRANZCO
Purpose
Report the safety and efficacy of ab-interno canaloplasty using the iTrack� device (Nova Eye Medical, Fremont, USA) in patients with primary angle closure glaucoma (PACG).
Methods
Prospective multicenter (Australia, USA, Canada, United Kingdom) case series of 49 eyes in 41 patients with PACG undergoing canaloplasty via an ab-interno technique, with or without cataract extraction. Data was retrieved from the International Glaucoma Surgery Registry. Outcome measures included intraocular pressure (IOP), number of glaucoma medications and adverse events. 12-month results are presented.
Results
Mean IOP (mmHg) and number of medications decreased from 20.9�6.19 and 1.98�1.45 at baseline (n=49) to 13.3�3.35 (p<0.001) and 0.88�1.34 (p<0.001) at 6M (n=34), and to 12.8�3.19 (p<0.001) and 0.57�0.93 (p<0.001), respectively, at 12M (n=21). The 6 eyes operated with canaloplasty as a standalone procedure had baseline IOP of 21.0�5.93 and required 2.17�1.60 medications, which reduced to 14.0�2.53 (p=0.036) and 0.83�1.33 (p=0.054), respectively, at 6M postoperatively. 20% and 47% of the eyes had an IOP ?15mmHg and ?18mmHg at baseline, respectively, vs 68% and 94% at 6M postoperatively; 66.7% (14/21) of the eyes were medication-free at 12M from 16.3% (8/49) at baseline. One eye had a hyphema (>10% anterior chamber) that resolved without late sequela.
Conclusion
Canaloplasty, with or without phacoemulsification, performed on PACG eyes resulted in significant IOP and medication reductions, with most eyes medication-free at 12 months.
Presenting Author
Timothy Truong, MD, ABO
Co-Authors
Rachel Simpson MD, Abigail Jacketta BA
Purpose
iStent and Hydrus microstents have demonstrated IOP lowering when placed in conjunction with cataract surgery. Mispositioned microstents have been observed on post-operative evaluation. We hope to determine the incidence of mispositioned microstents using anterior segment optical coherence tomography and determine its impact on clinical outcomes.
Methods
This is an ambispective, single academic center observational study. 116 subjects who have undergone Hydrus or iStent Inject W placement between 2020-2022 at Moran Eye Center with at least 2-year follow-up will return for an anterior segment OCT imaging. OCT images were reviewed by two independent masked graders. The primary endpoint is percentage of mispositioned microstents between the two groups. Other endpoints include whether the stent dilated the canal, and stent efficacy as defined by change in IOP from baseline, the number of medication reduction, and the rate of secondary surgical intervention at 2 years.
Results
34 eyes of 22 patients were included in the study. 70.59% (24/34) eyes received iStent Inject W vs 29.41% (10/34) Hydrus. The incidence of misposition was 50.00% (12/24) for the iStent and 10.00% (1/10) for the Hydrus. At least some canal dilation was noted in 62.50% (15/24) in iStent eyes vs 70.00% (7/10) of Hydrus eyes. In iStent eyes, avg baseline IOP was 16.6mmHg on 1.6 meds decreased to 13.1mmHg on 1 med at 24m. In properly placed iStents, IOP reduction was -4.6mmHg while a mispositioned iStent led to an IOP diff of -2.3mmHg. The avg baseline IOP of 17.6mmHg on 2.3 meds decreased to 12.4mmHg on 1.7 meds at 24m in Hydrus. The mean diff in IOP was 5.2mmHg regardless of Hydrus placement.
Conclusion
These interim data indicate a higher incidence of mispositioned iStent Inject W as compared to Hydrus. Although Hydrus led to more IOP reduction, both microstents led to IOP and med reduction at 24months. Correct stent positioning appears to affect the IOP reduction potential for iStent Inject W but not for Hydrus.
Presenting Author
Shamil Patel, MD
Co-Authors
David Lubeck MD, Keith Barton MBBS, FRCOphth, Nathan Kerr MD, FRANZCO, Nir Shoham-Hazon MD
Purpose
To investigate the effectiveness and correlation of pressurized ophthalmic viscoelastic device (OVD) volume delivered during ab-interno canaloplasty to reduce IOP in glaucomatous eyes.
Methods
Eyes with glaucoma diagnosis and with ?270� microcatheter circumnavigation of Schlemm�s canal were collated from multicenter cloud-based database (iTGDR, part of the International Glaucoma Surgery Registry). All patients underwent ab-interno canaloplasty via iTrack or iTrack Advance (Nova Eye Inc). Outcomes were defined as complete success: lower IOP, less meds; qualified success: lower IOP, same meds or same IOP, less meds; failure: final IOP or meds increased. Eyes were stratified based on OVD used (Healon; Healon Pro; Healon GV) and by amount of microboluses delivered (25-39; 40-59; 60-80). All eyes were included for safety data; for success results, only eyes with at least 12M follow-up.
Results
376 eyes have been enrolled at baseline, 157 had at least 12-month follow up. Mean OVD volume delivered was 116.7�26.7�l or 46.7�10.7 microboluses (range: 25-175 �l or 10-70 microboluses). Complete success was 39.3%, 63% and 50% in the groups 25-39, 40-59 and 60-80 microboluses respectively. Qualified success was 26.8%, 16% and 35% and failure was 33.9%, 21% and 15% respectively. When stratified by OVD type, the group 40-59 microboluses returned the highest percentage of complete success in each OVD used. IOP spikes at day 1 were 9.1% for Healon, 10.5% for Healon Pro and 13.3% for Healon GV.
Conclusion
Findings suggest that 40-59 microboluses or 100-148 �l of OVD delivered in Schlemm�s canal result in the best outcomes for lowering IOP and medications.
Presenting Author
John P. Berdahl, MD
Co-Authors
Steven Sarkisian MD, George Reiss MS, MD, Tomas Navratil PhD, Mitchell Shultz MD, L. Jay Katz MD
Purpose
Trabecular bypass implant technology has been shown to provide intraocular pressure (IOP) reduction in patients with open-angle glaucoma (OAG). We aimed to compare IOP and safety outcomes following standalone implantation of 2 types of current generation trabecular bypass stent technologies in OAG patients 35-85 years of age.
Methods
In a prospective, randomized, controlled multicenter study, 180 OAG eyes with mean IOP ?24 mmHg on 0-3 IOP-lowering medications and baseline mean diurnal IOP (MDIOP) 21-36 mmHg after medication washout were randomized to standalone implantation of iStent infinite or Hydrus microstent. The pre-specified primary analysis was a comparison of the proportion of iStent infinite eyes versus Hydrus eyes without surgical complications achieving an unmedicated MDIOP reduction ?20% from baseline at Month 12. Safety parameters included intraoperative and postoperative complications, best corrected visual acuity, slit-lamp exam, fundus exam, gonioscopy, perimetry and adverse events (AEs).
Results
Preoperatively, 91 iStent infinite eyes had mean (�standard deviation, SD) baseline unmedicated MDIOP of 23.7�2.9 mmHg; 89 Hydrus eyes had mean baseline unmedicated MDIOP of 23.5�2.7 mmHg. At Month 12, 76.7% of iStent infinite vs 62.7% of Hydrus eyes had unmedicated MDIOP reduction ?20% from baseline with no surgical complications (difference 14.0%; 95% CI 4.0%, 23.9%; p=0.0059). In an analysis of all eyes (regardless of surgical complications or IOP medication use), 81.2% of iStent infinite eyes vs 75.3%of Hydrus eyes had MDIOP reduction ?20% from baseline (difference 6.0%; 95% CI -3.1%, 15.0%; p=0.1937). AEs occurred in 34.1% and 48.3% of iStent infinite and Hydrus groups, respectively.
Conclusion
In this head-to-head study of 2 current trabecular stent technologies implanted in a standalone procedure in eyes with OAG, a statistically significantly greater proportion of iStent infinite eyes compared to Hydrus eyes achieved an unmedicated MDIOP reduction of ?20% with no surgical complications.
Presenting Author
Billy Pan, MD
Co-Authors
Antonio Fea MD, Philippe Denis MD, PhD, Ike Ahmed FRCSC, MD
Purpose
Describe the safety and efficacy profile 2 years after implantation of a novel, supraciliary, minimally-invasive glaucoma surgery drainage device, MINIject� (iSTAR Medical, Belgium) in patients with medically-uncontrolled, primary open-angle glaucoma.
Methods
The STAR-I,II,III,IV trials are 4 prospective, multi-center, single-arm, completed studies. Across these trials, patients were treated at 11 sites in Germany, France, Spain, Colombia, India and Panama. The MINIject implant is a 5mm long network of hollow spheres made of soft, flexible silicone. It was implanted standalone and ab-interno into the supraciliary space. Patients were seen at a preoperative baseline visit and at intervals until 2 years post-implantation. Safety and efficacy in reducing intraocular pressure and hypotensive medication use was assessed at each timepoint. Preliminary results from 83 patients who received the implant and completed 2-year follow-up have been pooled.
Results
At 2-year follow-up in 83 patients, mean diurnal IOP was 14.4�4.4 mmHg, representing a 39.7% mean reduction (p<0.0001) from="" preoperative="" baseline="" (23.9�3.3mmhg,="" n="100)." similarly,="" medications="" were="" reduced="" from="" preoperative="" mean="" of="" 2.4�1.0="" (n="100)" to="" 1.3�1.4=""><0.0001) at="" 2-year="" follow-up,="" with="" 39%="" of="" patients="" being="" medication-free.="" iop="" 8="" mmhg="" was="" achieved="" in="" 85.5%="" of="" patients="" and="" 90.4%="" patients="" achieved="" an="" iop="" reduction="" of="" at="" least="" 20%.="" the="" most="" frequently="" reported="" adverse="" events="" included="" anterior="" chamber="" inflammation="" (30.1%),="" hyphema="" (11.7%),="" pupillary="" deformity="" (7.8%)="" and="" vision="" blurred="" (7.8%).="" the="" per-protocol="" mean="" reduction="" in="" central="" endothelial="" cell="" density="" was="" 4.3%="" at="" 2="">
Conclusion
This meta-analysis strengthens the evidence for this supraciliary drainage device implanted in a standalone ab-interno procedure. The implant achieved meaningful efficacy and a reduction of hypotensive medications until 2-year follow-up, and may offer a valuable bleb-free treatment option for patients with glaucoma requiring low target pressures.
Presenting Author
Damien Goldberg, MD
Co-Authors
Claudio Orlich MD, Brian Flowers MD, Inder Singh MD, Sydney Tyson MD, MPH, Leonard Seibold MD, Mohammed ElMallah MD, Malik Kahook MD
Purpose
To report 12-month outcomes in the ongoing VENICE study, a multi-center randomized controlled trial comparing the safety and efficacy of minimally invasive STREAMLINE Surgical System canaloplasty vs iStent inject W implantation in patients with mild to moderate open-angle glaucoma (OAG) undergoing uncomplicated cataract extraction.
Methods
Eyes with OAG entering the study were required to have an intraocular pressure (IOP) of 22 to 34 mmHg post washout out of topical medications. Qualified patients had one eye randomized 1:1 to STREAMLINE canaloplasty or iStent inject W implantation following cataract surgery. Patients were evaluated on post-operative Day 1, Week 1, and Months 1, 3, 6, 9, and 12. Assessments included measurement of diurnal IOP, number of IOP-lowering medications and occurrence of adverse events.
Results
Seventy-two eyes were enrolled in the study, 35 eyes received STREAMLINE canaloplasty and 37 eyes received iStent inject W. Baseline unmedicated diurnal IOP (DIOP; [Mean (SD) mmHg] was 24.50 (3.02) for STREAMLINE and 25.00 (3.23) for iStent Inject W. Currently, 12-month data are available for post-washout DIOP in 31 eyes for STREAMLINE and 30 eyes for iStent inject W. Mean DIOP was 16.8 (3.03) for STREAMLINE and 16.9 (3.25) for iStent inject W. Five eyes post STREAMLINE canaloplasty and 11 eyes post iStent Inject W were back on topical therapy at the 12-month visit prior to consideration for washout. Adverse events were limited and unrelated to study devices.
Conclusion
Both STREAMLINE Surgical System canaloplasty and iStent Inject W implantation in combination with cataract surgery demonstrated significant reduction in DIOP after 12 months. Further data collection is ongoing and will be reported when available.
Presenting Author
Inder P. Singh, MD
Purpose
Minimally invasive micro sclerostomy (MIMS�) is an ab interno, stent-less procedure that creates a ~100-?m sclerostomy drainage channel at the sclero-corneal junction to reduce intraocular pressure (IOP). This study aims to characterise the experience of a group of US physicians receiving training on the MIMS procedure and initial patient outcomes
Methods
One instructing physician provided 13 US physicians with training on the MIMS procedure at the Ophthalmologic Center after S.V. Malayan, Yerevan, Armenia. MIMS procedures were performed in September 2023, January 2024, and April 2024. Patients with moderate open-angle glaucoma were treated with MIMS if their physician determined a need for further IOP lowering despite tolerated ocular hypotensive medication. IOP, best-corrected visual acuity, lens status, and medication use were recorded at baseline. IOP was assessed 2 hours post-treatment and on Days 1, 7, and 14, and Months 1 and 3, for all patient groups, and Month 6 post-treatment for the September 2023 patient group only.
Results
The MIMS procedure was performed on 23, 14, and 10 eyes in September 2023, January 2024, and April 2024, respectively (one eye per patient). At baseline, 89% (42/47) of patients required ocular hypotensive medication. At 6 months (n=19), the mean � SD IOP was reduced by 36% from 21.8 � 3.4 mmHg at baseline to 13.9 � 3.3 mmHg, and the mean � SD number of ocular hypotensive medications was reduced by 86% from 1.5 � 0.75 at baseline to 0.2 � 0.7. All AEs were reversible and non-serious. Over the 6-month follow-up period there were 19 cases (18/47) of elevated IOP; removal of viscoelastic agent resolved all cases.
Conclusion
The results of this study suggest that the MIMS device achieves successful IOP-lowering with a reduction in ocular hypotensive medication and minimal complications. Longer-term data are needed to confirm efficacy and assess the learning processes associated with the MIMS device.
Presenting Author
Anam Akhlaq, MBBS
Co-Authors
Natalie Hamilton PhD, Yulia Nam MD, Elyse McGlumphy MD, Thomas Johnson PhD, MD
Purpose
While in-office tonometry offers a snapshot into intraocular pressure (IOP), remote tonometry gauges daily and hourly IOP fluctuation, a likely independent risk factor for glaucoma progression. We used remote tonometry to study changes in IOP fluctuation after cataract extraction with Hydrus Microstent implantation in open-angle glaucoma patients.
Methods
Twenty-four eyes of 20 patients, who underwent combined cataract surgery with Hydrus Microstent implantation, were studied. Patients were asked to measure IOP using an at-home tonometer (iCare HOME 2, iCare USA, Raleigh, NC) ?4 times a day for one week immediately before surgery (baseline) and at 6 months postoperatively. Mean, standard deviation, and range of daily IOP measurements were calculated to assess change in IOP fluctuation; median and interquartile ranges (IQR) were calculated for cumulative data. The normality of data was assessed; paired t-tests and non-parametric tests were used for analysis. A p-value of <0.05 was="" considered="" statistically="">
Results
Of the 20 patients, 12 (60%) were female and 16 (80%) were White. Before surgery, median (IQR) IOP was 16.5 (6.6) mmHg, which reduced to 14.2 (5.6) mmHg at 6-months (p=0.002, n=24 eyes). The median (IQR) number of glaucoma drops used by patients was 1.0 (1.0) at baseline and dropped to 0.0 (1.0) at 6 months (p=0.001). Compared to pre-operative baseline, a decrease in IOP fluctuation was observed at 6 months (median daily standard deviation: 2.2 versus 1.8 mmHg, p=0.001; daily maximum IOP: 21.0 versus 18.5 mmHg, p=0.001; daily minimum IOP: 12.0 versus 10.0 mmHg, p=0.034; daily IOP range 9.0 versus 7.5 mmHg respectively, p=0.001).
Conclusion
Remote tonometry identified not only a reduction in mean IOP, but also several metrics of IOP fluctuation in glaucoma patients who underwent cataract extraction with Hydrus Microstent implantation. Further follow-up is warranted to assess these IOP changes over longer periods.
Presenting Author
Devendra Maheshwari, MD
Co-Authors
Madhavi Pillai MBBS, DNB, Nimrita Nagdev MS, MBBS
Purpose
To compare the early outcomes of 5-0 prolene gonioscopy-assisted transluminal trabeculotomy combined with phacoemulsification(Phaco-GATT) and Tanito microhook Trabeculotomy combined with phacoemulsification(Phaco-TMH) in Open-angle glaucoma
Methods
Prospective, comparative, interventional study of 60 patients who underwent Phaco-GATT(Group 1-N=30) and Phaco-TMH(Group 2-N=30). Outcome measures included changes in intraocular pressure (IOP), antiglaucoma medications (AGM), and best-corrected visual acuity (BCVA). Success was defined as at least 30%/40% IOP reduction and IOP <18 5="" mm="" hg(criteria="" 1,="" 2).="" additionally,="" interventions="" and="" complications="" were="" compared="" between="" the="">
Results
In Group 1,IOP reduced from 23.63�7mmHg to 10.93�2.15mmHg,in Group 2 from 24.27� 2.30mmHg to 11.20�3.87 mmHg at 6 months(p<0.001),with no="" significant="" difference="" between="" the="" groups(p="0.802).The" %="" reduction="" of="" iop="" in="" group="" 1="" was="" 53.45%&="" group="" 2="" was="" 57.42="" %.agm="" reduced="" from="" 1.33�0.88="" to="" 0.14�0.35&="" 1.27�0.64="" to="" 0.31�0.62="" in="" group=""><0.001), with="" no="" significant="" difference="" between="" the="" groups(p="0.301).The" cumulative="" probability="" of="" complete="" success="" was="" 95.2%,81.8%="" in="" group="" 1,="" and="" 88.9%,77.8%="" in="" group="" 2(criteria="" 1,2),="" with="" a="" significant="" difference="" between=""><0.001).hyphema was="" seen="" in="" 7="" patients="" in="" group="" 1,="" patient="" in="" group="" 2,="" and="" two="" patients="" in="" group="" 1="" required="" anterior="" chamber="">
Conclusion
Gonioscopy-assisted transluminal trabeculotomy is as efficacious as Tanito microhook Trabeculotomy when combined with phacoemulsification in terms of IOP reduction and antiglaucoma medication lowering open-angle glaucoma. The 360-degree suture GATT achieved better surgical success when compared to the Tanito Microhook trabeculotomy.
Presenting Author
Moncef Berkache, MD
Co-Authors
Georges Durr FRCSC, MD, Andrea Dahoud MD, Younes Agoumi FRCSC, MD, Wissam Nassrallah MD, PhD
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