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Moderator
Nir Shoham-Hazon, MD
Panelists
Gabriel Ayub, MD, PhD; Marc G. Bodman, MD, ABO
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
Douglas J. Rhee, MD
Purpose
To evaluate the one-year safety and effectiveness outcomes of bio-reinforced cyclodialysis in patients with open-angle glaucoma as a standalone procedure without concomitant cataract surgery in a real-world setting.
Methods
Patients were included in this interim analysis from the CREST study— a prospective, multicenter, real-world evidence study—who received one or more scleral allograft spacer implants following ab interno cyclodialysis without concomitant cataract surgery and completed 12- month (12M) postoperative follow-up. Intraocular pressure (IOP), ocular hypotensive medication use (meds), and adverse events were analyzed up to 12M post-op.
Results
A total of 41 eyes were analyzed. 28 eyes (68%) had prior cataract surgery, and 15 eyes (37%) had a prior minimally invasive glaucoma surgery targeting the trabecular meshwork. At baseline, the medicated mean ± SD IOP was 21.6 ± 5.1 mmHg and the mean ± SD meds was 2.8 ± 1.4. At 12M, the medicated IOP reduced to 14.7 ± 5.4 mmHg (a 31% paired reduction, p<0.001) on 1.9 ± 1.6 meds. There were 2 cases of transient hypotony and 3 cases of elevated IOP (≥ 10 mmHg higher than preoperative, noted > 30 days postoperatively). For optimal IOP control, 3 eyes (7.3%) underwent subsequent incisional glaucoma surgery.
Conclusion
Scleral allograft reinforcement following cyclodialysis has demonstrated promising 12-month IOP-lowering results with a positive safety profile in a standalone setting.
Presenting Author
Jumanah Qedair, MBBS
Purpose
Although trabeculectomy is invasive, it remains the gold standard for refractory glaucoma. The XEN45 Gel Stent provides a minimally invasive alternative; however, comprehensive data comparing its efficacy and safety to trabeculectomy remain limited. This meta-analysis evaluates outcomes between XEN45 and trabeculectomy.
Methods
We conducted a systematic review and meta-analysis, following PRISMA guidelines. A search of PubMed, Web of Science, and CENTRAL was performed from inception to July 2025. We pooled weighted mean differences (WMDs), proportions, and odds ratios (ORs) using random-effects models. Primary outcomes included intraocular pressure (IOP) reduction; complete success, qualified success, and failure rates; and risk of hyphema and hypotony.
Results
12 studies (2,381 eyes [XEN45: 1,106; trabeculectomy: 1,275]) were included. Open-angle glaucoma was the predominant diagnosis (XEN45:78.7%; trabeculectomy:74.7%). Trabeculectomy showed greater IOP reduction rates (WMD:11.9mmHg [95%CI: 10.2-13.7]) compared to the XEN45 Gel Stent (WMD: 9.1mmHg [95%CI: 7.4-10.8],p=0.02). Trabeculectomy achieved higher complete success rates (63.0%[95%CI: 56.0-70.0]) than XEN45 (47.0%[95%CI:40.0-55.0],p=0.004), with no significant difference in qualified success (67.0% vs. 58.0%,p=0.44). XEN45 demonstrated significantly reduced risks of hyphema (OR:0.34,p=0.04), hypotony (OR:0.31,p=0.01), bleb fibrosis (OR:0.68,p=0.01), and bleb leak (OR:0.16,p<0.01).
Conclusion
Trabeculectomy demonstrates superior IOP control and higher complete success rates, but at the expense of a higher complication profile. XEN45 offers a relatively safer but less effective alternative. A patient-tailored approach is essential when selecting the optimal surgical intervention.
Presenting Author
George R. Reiss, IV, BSc
Co-Authors
Marco Robles (MD), Carolina Rodriguez Libreros (MD), Pablo Robles (MD), Kevin Waltz (OD, MD), John Vukich (MD)
Purpose
To evaluate the safety and efficacy of supraciliary microstent implantation for primary open-angle glaucoma in a real-world Honduran cohort, with emphasis on reducing financial and medication burden in a resource-limited setting.
Methods
This non-randomized, unmasked, retrospective analysis includes 42 patients (52 eyes), aged 25-86 years, with primary open angle glaucoma. Patients underwent microstent implantation at various dates between June and November of 2024 (8 standalone and 44 combined with phacoemulsification cataract surgery). Among the 8 standalone procedures, 4 eyes were pseudophakic. The primary outcome was change in mean number of IOP-lowering medications at 6 months post-op. Secondary endpoints included mean IOP at 6 months and exploratory outcomes at ?9 months including mean IOP, mean number of IOP-lowering medications, percentage of medication-free eyes, eyes with IOP ?21 mmHg, and safety/adverse events.
Results
Of 52 eyes at baseline, 19 and 15 were available at 6 and ?9-month follow-up, respectively. Mean IOP was 15.7 ± 6.5 mmHg at baseline and did not change at 6 months (15.5 ± 8.5; p=0.40) or ?9 months (13.4 ± 2.5; p=0.42). Medications decreased from 1.9 ± 1.7 to 0.84 ± 1.21 at 6 months (p=0.003) and 1.13 ± 1.51 at ?9 months (p=0.011). Post-op hypotony (?5 mmHg) occurred in 10 eyes (19%) at 1 week; by 1 month, 9 resolved spontaneously to 6-15 mmHg, while 1 remained at 5 mmHg but was since lost to follow-up (LTFU). Three eyes at 1 month (6.5%) had IOP of 26-34 mmHg that was resolved with medication, and one at 6 months (48 mmHg) was recommended for trabeculectomy (advanced POAG) but remains LTFU.
Conclusion
Data shows a significant reduction in glaucoma medication burden with minimal adverse event rates, which may have important implications for cost and adherence in low-resource settings globally. Findings reflect early trends; interpretation and comparison are limited by attrition, and efforts to improve sample size at ?9 months are ongoing.
Presenting Author
Arsham Sheybani, MD
Co-Authors
Vanessa Vera (MD), Eric Hillson (MSc, PhD), Yifan Yu (PhD, MSc), Yanan Dong (MSc), Iqbal Ike Ahmed (MD, FRCSC)
Purpose
Despite growing adoption of Xen45 Gel Stent procedures, there remains a significant knowledge gap regarding how the use of the stent and outcomes have evolved over time. This study aimed to explore procedures performed in 2018 and 2023, examining patient demographics, clinical characteristics, ophthalmologist subspecialty, experience, and volume.
Methods
Adult OAG patients received ? 1 Xen45 implant (CPT 0449T) in 2018 and 2023 were identified from the IRIS Registry data. Index date was earliest implantation; 12-month pre/post index were baseline/follow-up periods. All patients had ? 1 medical diagnosis of OAG (ICD-10) during the 24-60 months pre index year, and ? 12-month IRIS Registry activity. Patient and eye-level demographics, surgeon characteristics, surgical outcomes including mean IOP, combined phacoemulsification/XEN use rate, surgical success (defined as ? 20% IOP reduction or IOP ? 18 mmHg without additional glaucoma surgery) and adverse events (AEs) were described and compared between 2018 and 2023.
Results
In 2018 vs 2023, gel stent was implanted by 83 vs 148 ophthalmologists in 303 vs 858 eyes. Glaucoma specialists performed 80.2% vs 63.1%, while comprehensive, cataract and anterior segment surgeons increased from 5.6% to 19.3%. Mean eyes per surgeon increased from 3.5 (SD=4.5) to 5.8 (8.1) (P<.01). At month 12, mean IOP was similar (14.4 mmHg (SD=4.7, Median=14.0) vs 14.3 mmHg (SD=5.5, Median=13.0), P= 0.77) and surgical success was reached in 75.2% vs 72.3% (P=0.36). Combined cases were performed in 21.1% vs 17.8% (P= 0.16). Postoperative AEs were similar (1.0% vs 0.8% for sight-threatening AEs, 2.0% vs 3.7% for serious AEs and 16.2% vs 20.3% for other AEs; all P values >0.05).
Conclusion
Xen implantation increased from 2018 to 2023, with increased surgeon participation and case volumes. The shift from predominantly glaucoma subspecialists to broader subspecialty involvement suggests growing acceptance across practices, and results indicate good outcomes and low rates of sight-threatening complications over time.
Presenting Author
Iqbal Ike K. Ahmed, MD, FRCSC
Co-Authors
Paul Harasymowycz (MD, FRCSC, MSc), Sebastien Gagne (MD, FRCSC)
Purpose
To evaluate the safety and efficacy of implant-free office-based subconjunctival glaucoma procedure in first in human.
Methods
This is a multicenter, open-label study, which enrolled adults ?40 with POAG uncontrolled on maximal tolerated medical therapy. The trial evaluated an ab-interno minimally invasive bleb-forming implant-free scleral punch system (n~25). Primary outcome: mean IOP reduction at 6 months. Secondary outcomes: medication burden, safety, bleb morphology, PROs.
Results
Preliminary results demonstrate clinically significant IOP reductions (?20% from baseline), decreased dependence on topical medications, and favorable bleb morphology with minimal complications. No serious device-related adverse events have been reported to date. This study remains ongoing, with 12-month follow-up and adaptive expansion planned
Conclusion
Early clinical data demonstrate that this office-based, implant-free ab-interno procedure effectively lowers intraocular pressure while creating a functioning bleb. This approach provides a safe and effective alternative to implant-based surgery, with the potential to broaden access to care.
Presenting Author
Mohammad Javad Ghanbarnia, MD
Co-Authors
Mayar Alkhawaja (BSc), Matthew Schlenker (MD, FRCSC), Iqbal Ike Ahmed (MD, FRCSC)
Purpose
To evaluate the association between pre-operative corneal biomechanics with the development of hypotony following SIBS Microshunt implantation.
Methods
This single-centre, retrospective study included all consecutive patients who underwent SIBS Microshunt implantation and had available pre-operative corneal biomechanics measurements. Corneal biomechanics were measured using Ocular Response Analyzer including Goldmann-correlated IOP (IOPg), corneal-compensated IOP (IOPcc), corneal hysteresis (CH), and corneal resistance factor (CRF). Numerical hypotony was defined as IOP<6mmHg at any post-operative visit during the early (?3months) or late post-operative periods. Clinical hypotony was defined as numerical hypotony with clinical signs. Risk factors for early numerical and clinical hypotony were analyzed using generalized estimating equation.
Results
In total, 72 eyes of 54 patients with a median(IQR) age of 64 (53–69) years were included. Early postoperative hypotony occurred in 40.3% (n=29), comprising 30.6% numerical and 9.7% clinical hypotony. No significant difference in mean CH (8.16 vs. 8.23mmHg, P=0.824) or CRF (9.87 vs. 10.36mmHg, P=0.310) was found between hypotony and non-hypotony groups. Mean axial length was 24.8 vs. 25.5 mm (P=0.124). No significant risk factors were identified on univariable analysis. A multivariable model including low CH (≤8.2mmHg; OR 1.35, 95% CI 0.50–3.60), low CRF (≤10mmHg; OR 1.97, 95% CI 0.80–4.81), and axial length ≥26mm (OR 0.35, 95% CI 0.11–1.13) showed no statistically significant associations.
Conclusion
Early postoperative hypotony was common, occurring predominantly within the first week. Preoperative ORA-derived corneal biomechanics and axial length did not reach statistical significance as risk factors for early postoperative hypotony in this cohort.
Presenting Author
Sharmila Rajendrababu, MBBS, MD
Purpose
To compare the efficacy and safety outcomes of MIGS-KDB Goniotomy Versus NPDS combined with phacoemulsification in eyes with advanced glaucoma
Methods
Retrospective, interventional study. We included 114 patients diagnosed to have advanced open angle glaucoma, of which 49 patients underwent MIGS-KDB goniotomy combined with phacoemulsification (in Group A) and 65 patients underwent NPDS combined with phacoemulsification (in Group B) with 12 months follow up period.
Results
: Mean (SD) baseline IOP in Group A & Group B was 15.47(4.78) and 17.43(5.92)mmhg respectively. There was no significant difference in mean IOP at all follow up visits between the groups (p=0.712). However, there was significant decrease in the number of glaucoma medications use in Group A than Group B at all follow up visits (p<0.001). We observed stabilization of visual fields, central visual acuity at 12 months follow-up. Uncontrolled high IOP was noted in 8.2% in Group A and 6.2% in Group B. About 6% in group A and 4.5% in Group B required additional surgical intervention for IOP control. Failure rate was 13% in Group A and 12% in Group B at 12 months follow up.
Conclusion
We observed non inferiority of MIGS-KDB goniotomy combined with phacoemulsification over NPDS with phacoemulsification in advanced glaucoma patients with better efficacy, decrease in number of glaucoma medications and stabilization of visual fields without any major vision threatening complications.
Presenting Author
Teresa Park, MD
Co-Authors
Christoph Kranemann (MD)
Purpose
To compare rates of hypotony following Preserflo implant with and without intraluminal stenting using 9-0 Nylon suture
Methods
Retrospective comparative chart review of patients who underwent Preserflo implant from Feb 2022-Jul 2025. Patients from Feb 2022-Feb 2024 underwent Preserflo implant without intraluminal stenting and patients from Feb 2024 onwards underwent Preserflo implant with intraluminal stenting. Hypotony was defined as IOP less than or equal to 6mmHg. Patients with minimum 1 month follow up data were included in the study.
Results
Among the 45 patients included in the "with stenting" group, there were 5 cases of hypotony and 0 cases of suprachoroidal hemorrhage. Among the 35 patients included in the "non-stenting" group, there were 26 cases of hypotony and 2 cases of suprachoroidal hemorrhage (p<0.05, CI 17.16%).
Conclusion
Intraluminal stenting of Preserflo Microshunt using 9-0 Nylon suture intraoperatively may prevent postoperative complications related to hypotony.
Presenting Author
Arsham Sheybani, MD
Purpose
To assess the endothelial health of eyes undergoing anterior chamber-clear homologous allogeneic bio-tissue reinforcement for ab-interno cyclodialysis combined with cataract surgery.
Methods
Eyes were analyzed from the interim results of the CREST real-world, multicenter, prospective evidence study. Specular microscopy was performed at baseline and 12M, and 24M postoperatively, and analysis was performed on the evaluable cohort of patients who underwent combined phaco cataract and bio-interventional cyclodialysis procedures with a baseline endothelial cell count (ECC) > 1,600.
Results
A total of n=41 eyes were available for analysis with baseline, 12M, and 24M specular microscopy data at the time of the interim data snapshot. The baseline mean ± SD ECC was 2413 ± 394, compared to 2283 ± 388 at 12M, and 2200 ± 401 at 24M (a paired reduction of 8.7%).
Conclusion
Concomitant cataract surgery plus bio-interventional cyclodialysis had a minimal effect, comparable to other FDA-approved MIGS procedures and cataract surgery alone.
Presenting Author
Robert L. Stamper, MD
Purpose
To evaluate the efficacy and safety of surgical cyclodialysis for glaucoma through a systematic review and meta-analysis, with emphasis on evolving techniques and clinical relevance for modern practice.
Methods
Databases searched (PubMed, Cochrane, Web of Science, EMBASE) for interventional studies of cyclodialysis in glaucoma. Outcomes included sustained IOP control, medication use, and adverse events. Analyses addressed variability in surgical approach and time era. Protocol registered with PROSPERO (CRD42025632759).
Results
Forty studies (4082 eyes, >100 years) were analyzed. Most were non-randomized; 75% ab-externo, 25% ab-interno. Success rates averaged 72.3% (range 33–97%) with follow-up of 6–132 months. Ab-interno techniques showed modestly higher efficacy and fewer complications. Durability was reduced in advanced disease. Hyphema, hypotony, and vision loss were infrequent. Modern ab-interno approaches demonstrated superior IOP lowering, safety, and long-term performance compared to historical methods.
Conclusion
Cyclodialysis is a proven surgical option to enhance uveoscleral outflow in glaucoma. While outcomes vary with patient severity and older techniques, contemporary ab-interno approaches provide improved efficacy, safety, and durability—making them especially valuable in mild-to-moderate cases.
Presenting Author
Leon W. Herndon, MD
Purpose
To assess the one-year safety and effectiveness of 2 scleral allograft spacer implants following ab interno cyclodialysis when combined with cataract surgery.
Methods
The interim subgroup analysis of patients enrolled in CREST – a prospective, multicenter, real-world evidence study. Eyes undergoing cataract surgery with bio-interventional uveoscleral outflow enhancement with 2 scleral spacers in the cyclodialysis cleft that completed 12-month follow-up were included. Intraocular pressure (IOP), medications (meds), and safety (adverse events) were analyzed.
Results
A total of n=101 eyes underwent combination cataract surgery with dual bio-interventional uveoscleral enhancement, with n=96 eyes available at 12M. Baseline medicated mean ± SD IOP was 19.0 ± 5.6 mmHg with on a mean ± SD meds of 1.8 ± 1.5. At 12M, the medicated IOP reduced to 12.8 ± 4.1 mmHg, a paired IOP reduction of -6.1 mmHg (32% , p<0.001), taking 1.0 ± 1.2 meds. There were no serious adverse events. There were 3 total high IOP adverse events within 30 days (2 within 30 days, and 1 beyond 90 days), and 3 cases of transient hypotony.
Conclusion
Dual allograft spacer implantation with cyclodialysis combined with cataract surgery demonstrates good IOP-lowering outcomes and excellent safety at 12M. Further studies are warranted to evaluate this promising approach.
Presenting Author
Davinder S. Grover, MD
Co-Authors
Antonio Fea (MD), Philippe Denis (MD, PhD), Iqbal Ike Ahmed (MD, FRCSC)
Purpose
Three-year safety and efficacy of a novel, minimally invasive glaucoma surgery (MIGS) device, MINIject® (iSTAR Medical, Wavre, Belgium) is described. The device was implanted ab interno into the supraciliary space in phakic and pseudophakic eyes with medically uncontrolled primary open-angle glaucoma.
Methods
MINIject was implanted in a standalone procedure in four prospective trials (STAR-I,II,III,IV) with two-year follow-up. The trials were completed in 83 subjects in 11 sites in Europe, Asia and Central America. Subjects were then invited to enroll into the STAR-GLOBAL study to continue follow-up annually from three to five years post implantation. Outcome measures were intraocular pressure (IOP), IOP-lowering medications (meds), adverse events (AEs) and measurements of corneal endothelial cell density (ECD). Seventy-three subjects were enrolled in STAR-GLOBAL, with 65 completing three-year post-implantation follow-up (89%). Interim, preliminary results are reported here.
Results
In STAR-GLOBAL, mean diurnal IOP prior to implantation was 23.9±3.5 mmHg with a mean of 2.5±1.2 meds (n=73). At two-years, mean diurnal IOP was 14.3±4.1mmHg (-9.7mmHg, -39.9%; p<0.0001) on 1.4±1.3 meds (n=72). At three-year post-implantation follow-up (n=65), mean diurnal IOP was 15.1±4.2mmHg (-8.7mmHg, -36.2%; p<0.0001) on 1.3±1.3 meds (p<0.0001). Further, 90.8% of subjects had an IOP reduction >=20% from baseline, 81.5% achieved IOP <=18 mmHg, and 36.9% were medication-free at three years. Since STAR-GLOBAL enrollment, AEs were one case of ECD loss and one cataract progression and secondary incisional glaucoma surgery included one deep sclerectomy.
Conclusion
Standalone MINIject implantation resulted in a clinically significant reduction in IOP and hypotensive medication use up to three-years post-implantation in an ethnically diverse cohort of subjects. This supraciliary MIGS device offers an effective bleb-free treatment option for patients with open angle glaucoma requiring low target IOPs.