Early Real-World Safety and Short-Term Outcomes of Combined iStent Infinite and Intracameral Travoprost Implant (iDose TR) with or without Cataract Surgery

Abstract

Purpose

To evaluate early real-world safety and short-term outcomes of combined trabecular bypass and intracameral travoprost implantation with or without cataract surgery in patients treated to optimize intraocular pressure control and/or reduce topical medication burden.

Methods

This retrospective case series included eyes with open-angle glaucoma undergoing combined trabecular bypass and intracameral travoprost implantation with or without cataract surgery at a single center, with a minimum of three months of follow-up. The primary endpoint was a composite of ≥1 medication reduction without clinically meaningful intraocular pressure (IOP) worsening (increase <2 mmHg) or ≥20% IOP reduction with stable medication use at postoperative month three. Secondary endpoints included changes in IOP, medication burden, and safety. Baseline and postoperative outcomes were compared using generalized estimating equation models to account for inter-eye correlation, with exploratory subgroup analyses using independent t-tests and Fisher’s exact tests.

Results

Thirty-three eyes from 24 patients were included, including 18 standalone procedures and 15 combined with cataract surgery. At postoperative month three (POM3), the composite primary endpoint was achieved in 26 of 33 eyes (78.8%). Mean intraocular pressure decreased from 19.64±7.32 mmHg to 14.97±4.62 mmHg (mean reduction 4.67 mmHg; p<0.001), and mean topical medication burden decreased from 1.97±1.05 to 0.82±0.92 medications (p<0.001). No intraoperative complications, postoperative adverse events, layered hyphema, intraocular pressure spikes, device malposition, or return to the operating room occurred.

Conclusion

Combined trabecular bypass and sustained intracameral prostaglandin delivery demonstrated favorable early safety and clinically meaningful short-term control of both medication burden and IOP in a real-world cohort. Longer-term follow-up is warranted to assess durability.

Plain Language Summary

Glaucoma can cause vision loss if eye pressure is not controlled. Many patients use daily eye drops, but some have difficulty using them or develop side effects. In this study, patients received two treatments together: a small drainage implant (iStent Infinite) and a long-acting medication implant (iDose TR), with or without cataract surgery. We reviewed 33 eyes and followed patients for about three months. Most eyes had lower eye pressure and needed fewer or no eye drops after surgery. No serious complications were observed. These early results suggest this combined approach may help reduce dependence on daily glaucoma medications, but longer follow-up is needed.

Introduction

Topical intraocular pressure–lowering medications remain the foundation of glaucoma management; however, long-term adherence is frequently limited by ocular surface toxicity, systemic intolerance, dosing complexity, and inconsistent compliance.¹ Many patients experience difficulty tolerating chronic topical therapy despite adequate pressure control, highlighting the need for strategies that reduce medication dependence while preserving physiologic intraocular pressure (IOP) stability.²

The iStent Infinite trabecular bypass system (Glaukos, Aliso Viejo, CA) was developed to address patients with inadequately controlled or refractory glaucoma, for whom traditional next steps have historically included incisional filtration surgery such as trabeculectomy or tube shunt implantation. Although highly effective, these procedures are associated with well-recognized risks and long-term management burdens, prompting interest in less invasive alternatives when appropriate. Prior clinical studies have demonstrated that trabecular bypass using multiple stents provides moderate IOP reduction with a favorable safety profile, supporting its role as a lower-risk interventional option that may delay or potentially avert the need for incisional glaucoma surgery in selected patients.^3–5

However, trabecular bypass procedures alone are not typically expected to eliminate topical medication dependence, particularly in eyes with higher baseline IOP or more advanced disease. In patients who also struggle with topical medication tolerance, adherence, or dexterity, additional strategies to reduce drop burden are desirable. Sustained-release intracameral drug delivery systems provide continuous prostaglandin exposure independent of daily drop administration. The intracameral travoprost implant (iDose TR; Glaukos, Aliso Viejo, CA) delivers consistent prostaglandin therapy while minimizing ocular surface exposure and adherence challenges and has demonstrated clinically meaningful IOP lowering in both controlled trials and real-world studies.^6–8

Singh et al⁷ reported early outcomes following combined cataract extraction and intracameral travoprost implantation, demonstrating substantial short-term IOP reduction with a favorable safety profile. In eyes undergoing glaucoma surgery, however, it is also clinically relevant to address trabecular outflow dysfunction—the primary site of resistance in open-angle glaucoma—supporting the rationale for combining sustained intracameral prostaglandin delivery with trabecular bypass rather than pharmacologic therapy alone.

While intracameral travoprost implantation and trabecular bypass have each been evaluated independently, published data examining their combined use in the same surgical setting remain limited. Early real-world evaluation is therefore important to assess safety and short-term clinical performance before longer-term durability and comparative effectiveness can be determined. Importantly, some patients with glaucoma may remain above individualized target intraocular pressures despite IOP measurements below 21 mmHg, particularly when further escalation of topical therapy is limited by medication intolerance or adherence challenges. We hypothesized that combined trabecular bypass and sustained intracameral prostaglandin delivery would demonstrate favorable early safety while reducing medication burden and improving intraocular pressure control in appropriately selected eyes with open-angle glaucoma.

The purpose of this study was to evaluate early safety and short-term clinical outcomes of combined trabecular bypass using the iStent Infinite system and intracameral travoprost implantation, with or without cataract surgery, in a cohort primarily undergoing intervention to reduce topical medication burden or lower IOP without need for additional medicine.

Methods

This retrospective consecutive case series evaluated eyes undergoing combined trabecular bypass and intracameral travoprost implantation between August 2024 and October 2025 at a single private practice ambulatory surgery center in Atlanta, Georgia. All procedures were performed by a single glaucoma surgeon (AY).

Eligible eyes carried a diagnosis of open-angle glaucoma, underwent combined trabecular bypass using the iStent Infinite system and intracameral travoprost implantation with or without phacoemulsification cataract surgery, and had a minimum of three months of postoperative follow-up. Eyes with angle-closure glaucoma, neovascular glaucoma, uveitic glaucoma, traumatic glaucoma, or other secondary glaucomas were excluded. Eyes without a minimum of three months postoperative follow-up were also excluded. Baseline clinical data were obtained from visits occurring within three months prior to surgery. Postoperative month three was defined as visits occurring within ±1 month of the nominal three-month time point.

The clinical intent of surgery in this cohort was to achieve additional intraocular pressure reduction or improved pressure stability while also reducing topical medication burden in eyes with clinically suboptimal intraocular pressure relative to individualized target IOPs, where further escalation of medical therapy was limited by medication intolerance, ocular surface disease, adherence difficulty, dexterity limitations, or quality-of-life concerns.

Trabecular bypass was performed to enhance aqueous outflow and support pressure stability or additional intraocular pressure (IOP) reduction when topical medications were reduced.

Phacoemulsification cataract surgery was performed using a standard clear corneal sutureless technique through a temporal 2.2-mm incision with posterior chamber intraocular lens implantation In combined cataract surgery cases, phacoemulsification with intraocular lens implantation was performed first, followed by intracameral travoprost implantation and subsequent iStent Infinite implantation under gonioscopic visualization. In standalone cases, intracameral travoprost implantation was similarly performed prior to iStent Infinite implantation. The intracameral travoprost implant was delivered intraoperatively using the manufacturer-provided injector system, which secures the implant within Schlemm’s canal.

All eyes received intracameral moxifloxacin at the conclusion of surgery, and no postoperative topical antibiotics were prescribed. Eyes undergoing standalone trabecular bypass received topical nonsteroidal anti-inflammatory therapy for two weeks postoperatively, whereas eyes undergoing combined cataract surgery received a prednisolone acetate taper for approximately one month. Because this was a retrospective real-world study, postoperative medication management was individualized based on clinical judgment rather than a standardized protocol. In eyes with prior angle-based glaucoma surgery, intraoperative gonioscopy was used to identify segments of intact, untreated trabecular meshwork for placement of the iStent Infinite implants, and previously instrumented or scarred regions were avoided.

Baseline data collected included age, sex, race/ethnicity, glaucoma stage, baseline IOP, baseline number of topical glaucoma medications, retinal nerve fiber layer thickness, cup-to-disc ratio, central corneal thickness, prior selective laser trabeculoplasty, and lens status. Glaucoma severity staging was determined using Hodapp-Parrish-Anderson classification criteria based on visual field assessment. IOP and medication burden were recorded at postoperative day one, week one, month one, and month three. Baseline IOP was obtained from the routine preoperative clinical visit immediately preceding surgery. Since this was a retrospective real-world study, no medication washout protocol or standardized time-of-day IOP protocol was employed. Goldmann applanation tonometry measurements were preferentially used when available; otherwise, Icare tonometry measurements obtained during routine clinical care were recorded. Because some patients contributed both eyes, analyses were performed at the eye level.

The primary endpoint was a composite outcome assessed at postoperative month three and defined as meeting either of the following criteria: (1) reduction of at least one topical glaucoma medication with no clinically meaningful IOP worsening (IOP increase <2 mmHg from baseline), or (2) maintenance of the same or fewer medications with a reduction in IOP of at least 20% from baseline.

Secondary endpoints included mean absolute and percent change in IOP, proportion of eyes achieving at least 20% IOP reduction, mean change in medication burden, proportion achieving at least one medication reduction, medication-free rate at postoperative month three, pathway-specific responder rates, and exploratory comparison between standalone and combined cataract surgery eyes.

Layered hyphema was defined as ≥1 mm of layered blood in the anterior chamber on postoperative day one; microhyphema without a layered component was not considered an adverse event. Intraocular pressure spike was defined as an increase greater than 10 mmHg compared with the immediately preceding visit.

Continuous variables were summarized as mean ± standard deviation and categorical variables as proportions. Paired t-tests were used to compare baseline and postoperative outcomes across timepoints. Exploratory subgroup comparisons between combined cataract surgery and standalone cases used independent t-tests for continuous variables and Fisher’s exact tests for categorical variables. To account for inter-eye correlation among patients contributing both eyes, generalized estimating equations (GEE) with an exchangeable working correlation structure and clustering by patient identifier were used for inferential analyses. Continuous outcomes were modeled using a Gaussian distribution, and binary outcomes were modeled using a binomial distribution with logit link. Statistical analyses were performed using standard statistical software, and p<0.05 was considered statistically significant for exploratory analyses.

This retrospective consecutive case series was reviewed by Salus IRB (Austin, Texas, USA; Salus Number: 26010), an independent institutional review board providing oversight for research conducted at Omni Eye Atlanta, and determined to be exempt from institutional review board oversight in accordance with 45 CFR 46.104(d)(4). A waiver of HIPAA authorization was approved under 45 CFR 164.512(i)(2). The requirement for informed consent was formally waived by Salus IRB because the study involved retrospective review of existing clinical data, posed minimal risk to participants, and did not involve any deviation from standard clinical care. The study was conducted in accordance with the principles of the Declaration of Helsinki.

Results

Baseline Characteristics

Thirty-three eyes from 24 patients met inclusion criteria, including 18 standalone procedures and 15 combined with cataract surgery. Baseline demographic and clinical characteristics are summarized in Table 1. The cohort included 72.7% Caucasian, 21.2% Black or African American, and 6.1% other racial backgrounds. Among the 33 treated eyes, 45.5% had mild glaucoma, 42.4% had moderate disease, and 12.1% had severe or advanced glaucoma, indicating that the majority of eyes (87.9%) had mild-to-moderate disease. Mean cup-to-disc ratio and visual field mean deviation values were influenced by a smaller subset of advanced glaucoma eyes included within the cohort.

Table 1.

Baseline Demographic and Clinical Characteristics

Eyes, n	33
Age (years), mean ± SD	74.3 ± 7.7
Female eyes, n (%)	11 (33.3%)
Male eyes, n (%)	22 (66.7%)
Race: Caucasian, n (%)	24 (72.7%)
Race: Black/AA, n (%)	7 (21.2%)
Race: Other, n (%)	2 (6.1%)
Glaucoma stage: Mild, n (%)	15 (45.5%)
Glaucoma stage: Moderate, n (%)	14 (42.4%)
Glaucoma stage: Severe/Advanced, n (%)	4 (12.1%)
Baseline IOP (mmHg), mean ± SD	19.6 ± 7.3
Baseline medications, mean ± SD	2.0 ± 1.0
Cup-to-disc ratio, mean ± SD	0.73 ± 0.16
Central corneal thickness (µm), mean ± SD	533.3 ± 48.9
RNFL average (µm), mean ± SD	66.6 ± 12.9
HVF Mean Deviation (dB), mean ± SD	−8.1±6.3
Prior SLT, n (%)	8 (24.2%)
Prior Glaucoma Surgery, n (%)	9 (27.3%)

Abbreviations: AA, African American; IOP, intraocular pressure; SD, standard deviation; RNFL, retinal nerve fiber layer; HVF, Humphrey visual field; SLT, selective laser trabeculoplasty.

Sixteen eyes (48.5%) had undergone prior glaucoma laser or surgical intervention, including eight eyes (24.2%) with prior selective laser trabeculoplasty. Eight eyes (24.2%) had undergone prior minimally invasive glaucoma surgery, including phacoemulsification combined with a trabecular microbypass stent, canal-based device, or goniotomy, and one additional eye (3.0%) had previously undergone micropulse transscleral cyclophotocoagulation. In eyes with prior angle-based glaucoma surgery, untreated regions of viable trabecular meshwork remained available for implantation, and previously scarred or instrumented segments were intentionally avoided intraoperatively.

Eyes undergoing standalone procedures had a significantly higher baseline topical medication burden compared with eyes undergoing combined cataract surgery (2.50 ± 0.92 vs 1.33 ± 0.82 medications, p=0.0012), reflecting the real-world tendency for patients selected for standalone glaucoma surgery to have more advanced or difficult-to-control disease. All eyes were successfully implanted with the iStent Infinite system without intraoperative complications or device malposition. Early safety outcomes were comparable between eyes with and without prior glaucoma procedures.

Intraocular Pressure Outcomes

Mean intraocular pressure (IOP) decreased significantly from baseline at all postoperative timepoints through postoperative month three (Figure 1). All inferential p-values reported reflect generalized estimating equation models accounting for inter-eye correlation among patients contributing both eyes. Compared with baseline, mean IOP was significantly lower at postoperative day one (p<0.001), week one (p=0.002), month one (p<0.001), and month three (p<0.001). At postoperative month three, mean IOP decreased from 19.64 ± 7.32 mmHg to 14.97 ± 4.62 mmHg, representing a mean absolute reduction of 4.67 ± 5.61 mmHg (95% CI, 2.75–6.58 mmHg) and a mean percent reduction of 18.8% ± 23.3% (Table 2).

Figure 1.

Mean IOP Over Time. Mean IOP from baseline through postoperative day 1, week 1, month 1, and month 3. Error bars represent standard deviation. Asterisks indicate statistically significant differences compared with baseline (*p < 0.01). Statistical significance was determined using generalized estimating equation models accounting for inter-eye correlation.

Table 2.

Month 3 Clinical Endpoints and Success Outcomes

Endpoint	All Eyes (n=33)	Combined (n=15)	Standalone (n=18)	P value (GEE)
Primary composite success	26/33 (78.8%)	12/15 (80.0%)	14/18 (77.8%)	0.8081
≥1 medication reduction with IOP increase <2 mmHg	21/33 (63.6%)	9/15 (60.0%)	12/18 (66.7%)	0.8297
Same or fewer medications with ≥20% IOP reduction	16/33 (48.5%)	10/15 (66.7%)	6/18 (33.3%)	0.145
Baseline IOP (mmHg)	19.64±7.32	18.07±7.59	20.94±7.02	0.6408
POM3 IOP (mmHg)	14.97±4.62	12.53±4.82	17.00±3.38	0.0616
IOP change (mmHg)	−4.67±5.61	−5.53±4.58	−3.94±6.38	0.3825
IOP % reduction	18.8%±23.3%	26.3%±22.5%	12.6%±22.8%	0.117
Baseline medications	1.97±1.05	1.33±0.82	2.50±0.92	0.0012*
POM3 medications	0.82±0.92	0.40±0.74	1.17±0.92	0.0468*
Medication free at POM3	17/33 (51.5%)	11/15 (73.3%)	6/18 (33.3%)	0.1215

Note: *p < 0.05.

Abbreviations: GEE, generalized estimating equation; IOP, intraocular pressure; POM3, postoperative month 3.

Medication Outcomes

Topical medication burden decreased significantly from baseline at all recorded postoperative timepoints (Figure 2). Compared with baseline, mean medication burden was significantly reduced at week one (p<0.001), month one (p<0.001), and month three (p<0.001). At postoperative month three, mean medication burden decreased from 1.97 ± 1.05 to 0.82 ± 0.92 medications, representing a mean reduction of 1.15 ± 1.06 medications (95% CI, 0.79–1.51 medications) (Table 2). Twenty-seven eyes (81.8%) achieved at least one medication reduction, and seventeen eyes (51.5%) were medication-free at postoperative month three. Baseline and postoperative month three IOP and medication outcomes are illustrated in Figure 3.

Figure 2.

Change in Glaucoma Medication Burden. Mean number of topical glaucoma medications at baseline and postoperative follow-up visits. Error bars represent standard deviation. Asterisks indicate statistically significant differences compared with baseline (*p < 0.01).

Figure 3.

Comparison of Baseline and Month 3 Intraocular Pressure and Medication Burden. Bar graph demonstrating mean IOP and number of glaucoma medications at baseline and postoperative month 3. Error bars represent standard deviation. Asterisks indicate statistically significant differences compared with baseline (*p < 0.001).

Primary Endpoint and Subgroup Outcomes

The composite primary endpoint at postoperative month three was achieved in 26 of 33 eyes (78.8%) (Table 2). Among treated eyes, 21 (63.6%) achieved a reduction of at least one topical medication without clinically meaningful IOP worsening (IOP increase <2 mmHg), and 16 eyes (48.5%) achieved at least 20% IOP reduction while maintaining the same or fewer medications (Table 2). Outcomes stratified by cataract surgery status are summarized in Table 2.

In unadjusted subgroup analyses, combined cataract surgery eyes demonstrated lower mean postoperative month 3 intraocular pressure (12.53 ± 4.82 mmHg vs 17.00 ± 3.38 mmHg; p = 0.006) and higher medication-free rates (73.3% vs 33.3%; p = 0.037) compared with standalone eyes. However, after adjustment for inter-eye correlation using generalized estimating equation models, these differences were no longer statistically significant (IOP: p = 0.0616; medication-free rate: p = 0.1215). Mean postoperative medication burden remained significantly lower in combined cataract surgery eyes after adjustment (0.40 ± 0.74 vs 1.17 ± 0.92 medications; p = 0.0468).

Individual eye-level intraocular pressure trajectories are illustrated in Figure 4, demonstrating the distribution of baseline versus postoperative month three outcomes across treated eyes and showing that most eyes experienced pressure stability or improvement.

Figure 4.

Individual Eye Outcomes - Relationship Between Baseline and Month 3 Intraocular Pressure Scatter plot showing baseline versus postoperative month 3 intraocular pressure (IOP) for individual treated eyes. Blue markers represent combined cataract surgery eyes, and Orange markers represent standalone glaucoma surgery eyes. The dashed line represents the line of identity; points below the line indicate postoperative IOP reduction.

Exploratory subgroup analyses were conducted to identify potential baseline predictors of failure to meet the composite endpoint. No significant associations were observed for glaucoma stage, baseline medication burden, retinal nerve fiber layer thickness, prior laser treatment, or prior glaucoma surgery. Higher baseline intraocular pressure demonstrated a trend toward association with failure, although this did not achieve statistical significance after adjustment and should be interpreted cautiously given limited sample size.

Safety

No intraoperative complications occurred. There were no cases of layered hyphema, postoperative inflammation beyond postoperative month one, intraocular pressure spikes, corneal complications, wound issues, device malposition, or return to the operating room. Microhyphema without layering was observed and resolved without intervention. Since this was a retrospective real-world review, transient postoperative microhyphema without layering was not consistently documented and therefore was not systematically analyzed.

Discussion

In this retrospective real-world series, combined trabecular bypass using the iStent Infinite system with intracameral travoprost implantation demonstrated favorable early safety and meaningful short-term reductions in both intraocular pressure and topical medication burden at three months. The majority of treated eyes achieved the composite clinical endpoint, and no intraoperative complications or clinically significant postoperative adverse events were observed. These findings support the feasibility of combining sustained prostaglandin delivery with enhanced trabecular outflow in appropriately selected glaucoma patients.

Topical therapy remains foundational in glaucoma management; however, long-term adherence is frequently limited by ocular surface toxicity, systemic intolerance, dosing complexity, and inconsistent compliance.^1,2 Sustained-release intracameral drug delivery provides continuous prostaglandin exposure while minimizing dependence on daily drop administration.⁶ Separately, trabecular bypass procedures enhance aqueous outflow through Schlemm’s canal and collector channels and may provide modest pressure reduction or pressure stabilization, particularly when topical therapy is reduced.^4,5 Combining these complementary mechanisms offers a rational strategy to address both medication burden and intraocular pressure control in real-world clinical practice.

Importantly, the present cohort was not composed of eyes with fully optimized glaucoma control. Although mean baseline IOP was not very high, these pressures were considered clinically above individualized target IOPs by the treating surgeon, particularly in eyes with moderate disease and limited ability to further escalate topical therapy due to medication intolerance, ocular surface disease, adherence limitations, or dexterity challenges. Prior studies such as AGIS have demonstrated improved visual field stability among eyes maintaining consistently lower IOPs, supporting interventional approaches in appropriately selected patients even when baseline IOP is not markedly elevated.

Prior studies have evaluated intracameral travoprost implantation and trabecular bypass independently, providing useful benchmarks for interpreting the present findings. In a real-world series of standalone intracameral travoprost implantation, Teymoorian and Kaur⁷ reported substantial short-term intraocular pressure reduction and elimination of topical medications at three months; however, their cohort had relatively low baseline treatment intensity, with a mean baseline intraocular pressure similar to the present study but an average of only 0.28 topical medications at baseline. In contrast, the present cohort had a substantially higher baseline medication burden and included patients with medication intolerance or adherence challenges, which likely influenced both treatment goals and the magnitude of observed pressure reduction while emphasizing clinically meaningful medication sparing.

Vest et al³ evaluated iStent infinite implantation exclusively in combination with cataract surgery and demonstrated meaningful reductions in intraocular pressure and medication burden with favorable safety at 12 months. Because all eyes in that cohort underwent phacoemulsification, the observed outcomes reflect the additive intraocular pressure–lowering effect of cataract surgery, consistent with the enhanced outcomes observed in the combined cataract surgery subgroup of the present study. While early outcomes appear comparable in magnitude, direct assessment of the incremental contribution of intracameral travoprost will require longer-term follow-up beyond the three-month horizon of the current study to provide meaningful comparisons.

Singh et al⁷ conducted a prospective trial evaluating intracameral travoprost implantation in combination with cataract surgery using a medication washout design, allowing for clear assessment of pharmacologic intraocular pressure–lowering efficacy and demonstrating meaningful and durable intraocular pressure reduction through one year of follow-up. That study represents a higher level of evidence and confirms the sustained pressure-lowering capability of intracameral prostaglandin delivery. However, eyes in that cohort did not incorporate a trabecular outflow–modifying procedure at the time of surgery, thereby not leveraging the opportunity to enhance conventional aqueous outflow in conjunction with sustained pharmacologic therapy. In contrast, the present study incorporates both sustained prostaglandin delivery and trabecular bypass, offering a complementary mechanistic strategy that may support pressure stability when topical therapy is reduced, although longer-term follow-up will be necessary to assess durability.

In the present cohort, more than half of treated eyes achieved complete freedom from topical glaucoma medications at short-term follow-up, which is particularly meaningful given that many patients underwent intervention due to medication intolerance, ocular surface disease, adherence limitations, or difficulty with chronic drop administration. Achieving medication independence in this population represents a clinically important outcome beyond numerical pressure reduction alone. Notably, a subset of treated eyes had refractory moderate-to-advanced glaucoma, in which meaningful medication reduction or elimination is often difficult to achieve without escalation to more invasive filtering surgery. The ability to reduce or eliminate topical therapy while maintaining pressure stability and favorable safety in this context highlights the potential value of combining trabecular bypass with sustained intracameral prostaglandin delivery as an early interventional strategy.

Eyes undergoing combined cataract surgery demonstrated numerically lower intraocular pressure and higher rates of medication independence compared with standalone procedures. Although unadjusted analyses suggested statistically significant differences, these findings were not significant after adjustment for inter-eye correlation using generalized estimating equation models. Given the modest sample size, these analyses may have been underpowered to detect subgroup differences, raising the possibility of type II error. Mean postoperative medication burden, however, remained significantly lower in combined cataract surgery eyes. These findings are consistent with the known additive intraocular pressure–lowering effect of phacoemulsification and support the potential benefit of combined surgery in patients seeking maximal medication reduction. Notably, eyes undergoing standalone procedures had a significantly higher baseline medication burden, consistent with more advanced or refractory disease in patients typically selected for standalone glaucoma intervention.

Importantly, overall composite success rates were similar between groups (80.0% vs 77.8%; p=1.0), suggesting that the combined trabecular bypass and intracameral prostaglandin strategy may be applicable across both surgical cohorts. Although limited by sample size and non-randomized design, these subgroup differences provide clinically relevant signals that warrant further evaluation in larger studies.

The favorable safety profile observed in this cohort is consistent with prior reports evaluating trabecular bypass and intracameral prostaglandin delivery independently. The absence of clinically significant postoperative complications supports the tolerability of combining these technologies in a real-world surgical setting and reinforces their suitability for patients seeking alternatives to more invasive filtering procedures. Importantly, maintaining a strong safety margin is particularly relevant when treating patients with medication intolerance or moderate-to-advanced disease who may otherwise face escalation to higher-risk surgical interventions.

Although favorable early outcomes were observed at 3 months, the durability of combined intracameral travoprost implantation and trabecular bypass beyond the short-term postoperative period remains an important area for future investigation. Longer follow-up will be necessary to better characterize sustained medication reduction, long-term IOP stability, and durability of combined therapy in real-world glaucoma populations.

This study has several limitations. The retrospective design, modest sample size, and short follow-up duration limit conclusions regarding long-term durability, late complications, and comparative effectiveness. Outcomes were analyzed at the eye level, and some patients contributed both eyes, which may introduce inter-eye correlation. Medication adjustments were guided by clinical judgment rather than a standardized protocol. The absence of a control group precludes direct comparison with trabecular bypass alone, intracameral prostaglandin therapy alone, or cataract surgery alone. A subset of eyes had undergone prior angle-based glaucoma procedures, which may introduce heterogeneity in outflow physiology and limit direct interpretation of the isolated contribution of trabecular bypass implantation. However, untreated viable trabecular meshwork remained available for implantation in these eyes, reflecting real-world glaucoma surgical practice.

Despite these limitations, the present analysis provides valuable early real-world evidence supporting the safety and short-term clinical performance of combining trabecular bypass with sustained intracameral prostaglandin delivery. This approach may represent a practical option for patients seeking to optimize intraocular pressure control while reducing reliance on topical medications, particularly in those wishing to avoid or delay more invasive glaucoma surgery. Larger studies with longer follow-up will be important to further define durability, patient selection, and comparative effectiveness.

Conclusions

In this real-world retrospective series, combined trabecular bypass using the iStent Infinite system with intracameral travoprost implantation demonstrated favorable early safety and clinically meaningful short-term reductions in topical medication burden while maintaining intraocular pressure control. These outcomes were achieved in a population that included patients with medication intolerance and refractory glaucoma, highlighting the potential value of this combined approach as an early interventional strategy prior to escalation to more invasive glaucoma surgery.

Although longer-term follow-up and larger prospective studies are needed to define durability and comparative effectiveness, the present findings support the feasibility of integrating sustained pharmacologic therapy with trabecular outflow enhancement in routine clinical practice.

Funding Statement

This study was self-funded. Glaukos provided no financial support, devices, data support, or editorial assistance.

Data Sharing Statement

De-identified data supporting the findings of this study are available from the corresponding author upon request.

Ethics Approval and Informed Consent

This retrospective consecutive case series was reviewed by Salus IRB (Austin, Texas, USA; Salus Number: 26010) an independent institutional review board providing oversight for research conducted at Omni Eye Atlanta, and determined to be exempt from institutional review board oversight in accordance with 45 CFR 46.104(d)(4). A waiver of HIPAA authorization was approved under 45 CFR 164.512(i)(2). The requirement for informed consent was formally waived by Salus IRB because the study involved retrospective review of existing clinical data, posed minimal risk to participants, and did not involve any deviation from standard clinical care. The study was conducted in accordance with the principles of the Declaration of Helsinki.

Author Contributions

The author made a significant contribution to the work reported, including conception, study design, execution, acquisition of data, analysis and interpretation; took part in drafting, revising, and critically reviewing the article; gave final approval of the version to be published; agreed on the journal to which the article has been submitted; and agrees to be accountable for all aspects of the work.

Disclosure

Dr. Yadgarov is a consultant for Glaukos. The author reports no other conflicts of interest in this work.