Comparison of 1-year effectiveness between phaco-microhook ab-interno trabeculotomy and phaco-iStent trabecular micro-bypass stent in primary open-angle glaucoma with low-teen intraocular pressure.

PURPOSE: To investigate the surgical effectiveness of combined cataract surgery with microhook ab-interno trabeculotomy (phaco-µLOT) or iStent trabecular micro-bypass stent (phaco-iStent) in eyes with primary open-angle glaucoma (POAG) and preoperative intraocular pressure (IOP) controlled below 15 mmHg (low-teen IOP). METHODS: This retrospective cohort study included consecutive patients with POAG and low-teen IOP who underwent phaco-µLOT or phaco-iStent as their initial glaucoma surgery and were followed up for 1 year postoperatively. Surgical failure was defined as the inability to achieve the following criteria twice in a row: (A) IOP of 6-15 mmHg with over 20% IOP reduction; (B) IOP of 6-12 mmHg with over 20% IOP reduction. RESULTS: A total of 75 eyes from 75 subjects were included, with 48 in the phaco-µLOT group and 27 in the phaco-iStent group. The mean preoperative IOP and number of antiglaucoma medications were 13.1 ± 2.1 mmHg and 3.4 ± 0.9 in the phaco-µLOT group, and 12.6 ± 2.0 mmHg and 2.5 ± 1.2 in the phaco-iStent group, respectively. The number of antiglaucoma medications was significantly reduced to 2.5 ± 0.9 (phaco-µLOT) and 2.0 ± 1.1 (phaco-iStent) at 1-year postoperatively (all p < 0.05). For criteria A and B, the survival rates were significantly higher in the phaco-µLOT group than in the phaco-iStent group (all p < 0.01). CONCLUSION: Both phaco-µLOT and phaco-iStent hold promise in reducing the need for antiglaucoma medications in POAG eyes with low-teen IOP. Phaco-µLOT may be more effective than phaco-iStent in controlling IOP. KEY MESSAGES: What is known Minimally invasive glaucoma surgeries (MIGS) procedures target the pressure gradient pathways in patients with higher preoperative intraocular pressure (IOP) levels, however, evidence on their effectiveness in normotensive glaucoma patients remains limited. What is new Combined cataract surgery with microhook ab-interno trabeculotomy (phaco-µLOT) or iStent trabecular micro-bypass stent (phaco-iStent) significantly reduced the number of antiglaucoma medications in primary open-angle glaucoma (POAG) eyes with preoperative IOP controlled below 15 mmHg (low-teen IOP). Phaco-µLOT may be more effective than phaco-iStent in controlling IOP. These procedures should be limited to reducing the number of antiglaucoma medications used, as they did not significantly reduce the postoperative IOP in POAG eyes with low-teen IOP.

Outcomes of iStent inject combined with cataract surgery in Asian eyes: Australian data from the Fight Glaucoma Blindness international registry.

PURPOSE: To analyse real-world outcomes in Asian eyes of iStent inject, a second-generation trabecular micro-bypass stent, combined with phacoemulsification. METHODS: This is a multi-centre, observational study of glaucomatous Asian eyes that have undergone iStent inject implantation combined with cataract surgery. Patient data were extracted from the Fight Glaucoma Blindness! Registry. Outcome measures included those of IOP reduction, glaucoma medication reduction, and adverse events including the need for secondary surgery. RESULTS: 123 eyes of 86 patients with a mean age of 68.4 ± 9.3 years underwent iStent inject implantation with phacoemulsification. At baseline, the mean ± SD preoperative intraocular pressure (IOP) was 16.0 ± 4.4 mmHg, and the mean preoperative number of topical glaucoma medications was 1.9 ± 1.4. At 12 months 30.8% of eyes demonstrated a reduction in IOP greater than 20%, the mean IOP reduction was 12.5% with an additional reduction of 0.7 glaucoma medications. 40% of eyes were using no medications at 12 months compared to 16.3% preoperatively. 8.2% of eyes required a subsequent procedure within the 12-month follow-up window. CONCLUSION: iStent inject implantation combined with phacoemulsification in Asian eyes showed a reduction of IOP and glaucoma medication use in a real-world clinical setting. The safety profile of the device is good with minimal adverse outcomes, however, a subset of patients required secondary procedures within the 12 month follow up.

A case of two connected stents deployed during iStent inject W surgery.

BACKGROUND: We report a case with two connected stents ejected simultaneously during an iStent inject W surgery, a modified second-generation iStent Trabecular Micro-Bypass System. CASE PRESENTATION: A 57-year-old woman with primary open-angle glaucoma underwent a combined cataract and iStent inject W surgery in her left eye. After the trabecular meshwork/Schlemm's canal was pierced by the trocar of injector, the delivery button was pressed a first time, but the stent was not ejected. After the button was pressed a second time, connected two stents were ejected. After removing the dislocated stents from the anterior chamber, two stents were implanted into the desired places using another injector. Except for mild hyphema, no postoperative complication occurred. Stereomicroscopic observation showed that the two stents were connected by a broken trocar shaft. An X-ray showed that the trocar shaft was broken at the part referred to as the "sprayed trocar". Scanning electron microscopy showed that the surface features of the broken trocar and trocar tip represented tensile failure. CONCLUSIONS: Although rare, considering that the damage was seen at the structurally weak part (i.e., sprayed trocar), the same phenomenon can happen. For patient safety, surgeons are recommended to inspect the device when the deployment of either the first or second stent is unsuccessful during the iStent inject surgery.

Phacoemulsification with and without iStent: A Systematic Review and Meta-Analysis of Comparative Studies.

BACKGROUND: The iStent (Glaukos Corporation; Laguna Hills, CA, USA) is one of the minimally invasive glaucoma devices. It can be inserted at the time of phacoemulsification or as a stand-alone procedure to lower the intraocular pressure (IOP). OBJECTIVE: Our aim was to conduct a systematic review and meta-analysis comparing the effect of iStent insertion at the time of phacoemulsification with phacoemulsification alone in patients with ocular hypertension or open-angle glaucoma. METHODS: We searched EMBASE, MEDLINE (OVID and PubMed), CINAHL, and Cochrane Library for articles published between 2008 and June 2022 (PRISMA 2020 for the checklist). Studies comparing the IOP-lowering effect of iStent with phacoemulsification versus phacoemulsification alone were included. The endpoints were IOP reduction (IOPR) and the mean reduction in the number of glaucoma drops. A quality-effects model was used to compare both surgical groups. RESULTS: Ten studies were included, reporting on 1,453 eyes. Eight hundred fifty three eyes had the combined iStent and phacoemulsification, and 600 eyes underwent phacoemulsification alone. IOPR was higher in the combined surgery at of 4.7 ± 2 mm Hg compared to 2.8 ± 1.9 mm Hg in phacoemulsification alone. A greater decrease in postoperative eye drops was noted in the combined group having a decrease of 1.2 ± 0.3 eye drops versus of 0.6 ± 0.6 drops in isolated phacoemulsification. The quality effect model showed an IOPR weighted mean difference (WMD) of 1.22 mm Hg (confidence interval [CI]: [-0.43, 2.87]; Q = 315.64; p < 0.01; I2 = 97%) and decreased eye drops WMD 0.42 drops (CI: [0.22, 0.62]; Q = 42.6; p < 0.01; I2 = 84%) between both surgical groups. Subgroup analysis shows that the new generation iStent may be more effective in reducing IOP. CONCLUSION: iStent has a synergetic effect with phacoemulsification. The reduction of IOP and glaucoma eye drops was higher when iStent is combined with phacoemulsification compared with isolated phacoemulsification.

Posture-Induced Intraocular Pressure Changes after iStent Inject W Combined with Phacoemulsification in Open Angle Glaucoma Patients.

Background and Objectives: The purpose of this study was to evaluate the posture-induced intraocular pressure (IOP) changes after iStent inject W combined with phacoemulsification procedure in Japanese patients with open-angle glaucoma. Materials and Methods: We prospectively evaluated the posture-induced IOP changes after surgery. The primary outcome was the posture-induced IOP changes postoperatively. Secondary outcome measures included postoperative complications, visual acuity, visual field, and corneal endothelial cell density. Results: This study completed the prospective observation for 15 eyes (15 patients). The mean preoperative IOP with the Goldmann applanation tonometer was 16.0 ± 2.6 mm Hg with a mean glaucoma medication usage of 2.5 ± 1.2, which decreased to 14.4 ± 2.4 mm Hg (p = 0.14) and 0.5 ± 0.9 medications (p < 0.01), respectively, 12 months postoperatively. The mean baseline IOP with the ICare was 12.0 ± 2.7 mmHg in the sitting position, which significantly increased to 15.2 ± 3.8 mmHg in the lateral decubitus position (p < 0.01). This postural IOP difference was 3.2 ± 2.2 mmHg and 3.2 ± 2.4 mmHg at baseline and 12 months postoperatively, respectively, with no significant changes (p > 0.99). Conclusions: iStent inject W combined with cataract surgery reduced the IOP and the number of glaucoma medications during short-term follow-ups with high safety. However, iStent inject W did not affect the degree of posture-induced IOP changes.

Canaloplasty and trabeculotomy with the OMNI® surgical system in OAG with prior trabecular microbypass stenting.

PURPOSE: Evaluate effectiveness and safety outcomes for patients treated with canaloplasty and trabeculotomy previously treated with a trabecular microbypass stent (TBS). METHODS: Retrospective, multicenter, IRB approved study. Patients treated with TBS (iStent/iStent inject, Glaukos) and subsequently with OMNI surgical system (OSS) (Sight Sciences). From 5 practices in 5 US states. Open-angle glaucoma (OAG), minimum 3 months follow-up after OSS surgery, Pre-OSS IOP ≥ 17 mmHg on ≥ 1 medication. No glaucoma procedures between TBS and OSS. ENDPOINTS: proportion with ≥ 20% reduction in IOP, IOP between 6 and 18 mmHg, mean IOP, change in IOP, mean number of medications. Adverse events and secondary surgical interventions (SSI). Mann-Whitney rank sum test compared pre-OSS IOP and medications with follow-up. RESULTS: Twenty seven patients. Average age (SD) 72.2 (10.8), 22/27 primary OAG (82%), mean MD - 6.2 (7.0) dB. Mean IOP before OSS 22.3 (4.3) mmHg on 2.2 (1.3) medications. At last follow-up (mean 11 months) IOP was 17.2 mmHg on 1.8 medications, - 5.1 mmHg (- 23%, p < .001), - 0.4 meds (- 18%, p = .193); ≥ 20% IOP reduction (41%), IOP ≤ 18 (56%). Adverse events were non-serious. Hyphema > 1 mm (3, 11%), BCVA decrease (4, 15%), IOP spike (2, 7%). SSI (4, 15%) had higher pre-OSS IOP (23.4 mmHg) and worse MD (- 9.6 dB). CONCLUSION: Patients uncontrolled by medication and a prior TBS would once have been candidates for trabeculectomy and tube shunts. OSS offered a minimally invasive option that provided IOP control and avoidance of traditional surgery for the majority over follow-up averaging 11 months and up to 42 months.

[Micro-invasive glaucoma surgery]. / Mikroinvazivnaya khirurgiya glaukomy.

Glaucoma is a severe, rapidly progressing disease that in the absence of proper treatment leads to blindness in 20% of patients. According to the World Glaucoma Association, this disease is the most socially significant in modern ophthalmology and requires searching for new and effective methods of treatment. This article presents the results of research and reviews on this issue, considers both conservative therapy and surgical methods of treatment, analyzes in detail modern methods of micro-invasive eye surgery actively used in clinical practice. The article also describes indications for a various types of interventions, as well as the effect achieved by them and the possible complications, and presents the conclusions about the possibility of using these procedures in wide clinical practice.

Roles of Toric intraocular Lens implantation on visual acuity and astigmatism in glaucomatous eyes treated with iStent and cataract surgery.

BACKGROUND: To assess the efficacy of toric intraocular lenses (IOLs) in combined cataract and minimally invasive glaucoma surgery (MIGS), visual and refractive outcomes were compared between eyes implanted with non-toric and toric IOLs during iStent triple procedures. METHODS: In this retrospective study, open angle glaucoma eyes with preexisting corneal astigmatism of -1.5 diopter (D) or more and implanted with non-toric (n = 9) or toric (n = 9) IOLs were included. The main outcome measures were the intergroup difference in the uncorrected visual acuity (UCVA) and refractive astigmatism at 3 months postoperatively. RESULTS: Preoperatively, the logarithm of the minimum angle of resolution (logMAR) UCVAs and refractive astigmatism were equivalent between the groups. Postoperatively, the logMAR UCVA (non-toric, 0.45 ± 0.31; toric, 0.14 ± 0.15; P = 0.021) was significantly better and the refractive astigmatism (non-toric, -2.03 ± 0.63 D; toric, -0.67 ± 0.53 D; P = 0.0014) significantly less in the toric group. The toric group had postoperative improvements in the logMAR UCVA (-0.21, P = 0.020) and refractive astigmatism (+ 1.72 D, P = 0.0039). Vector analyses showed the postoperative centroid magnitude and confidence eclipses of refractive astigmatism was less in the toric group (0.47 D at 173°±0.73D) than the non-toric group (1.10 D at 2°±1.91D). Postoperatively, 78% of eyes in the toric group had 1.0 D or less refractive astigmatism compared with 11% in the non-toric group. Surgically induced astigmatism (non-toric, 0.18 D at 65°; toric, 0.29 D at 137°) did not differ between groups. CONCLUSION: Use of toric IOLs is a reasonable option for better visual outcomes when the combined cataract and iStent surgery is performed in glaucomatous eyes with corneal astigmatism.

Comparative study of 2-year outcomes for Hydrus or iStent inject microinvasive glaucoma surgery implants with cataract surgery.

BACKGROUND: To compare real-world 24-month outcomes of phacoemulsification combined with either iStent inject or Hydrus Microstent. METHODS: Analysis of data from the Fight Glaucoma Blindness (FGB) international registry. Anonymized data from 344 eyes with mild-to-moderate open-angle glaucoma, normal-tension glaucoma or ocular hypertension that underwent phacoemulsification combined with either iStent inject (224) or Hydrus Microstent (120) were included. Data were adjusted for baseline characteristics using linear regression and propensity score matching. The primary endpoint was a comparison of mean intraocular pressure (IOP) at 24 months. RESULTS: At 24 months, there was no significant difference in IOP reduction between the two groups, consistent across all analyses. The matched cohort showed iStent inject achieved 3.1 mmHg reduction and Hydrus a 2.3 mmHg reduction (p = 0.530) and a mean medication reduction of 1.0 for iStent inject versus 0.5 for Hydrus (p = 0.081). 5.4% of eyes in the iStent inject group and 7.5% of eyes in the Hydrus group required subsequent procedures to improve IOP control within 24 months. Complications were rare with no significant differences between the groups. CONCLUSIONS: Twenty-four-month outcomes showed sustained IOP reduction with a good safety profile for both groups. There was no significant difference in IOP outcomes between the groups. There may be a small additional reduction in glaucoma medication usage following cataract surgery with iStent inject compared to Hydrus.

Refractive outcomes of toric intraocular lens in combined trabecular micro bypass stent implantation and cataract surgery in glaucomatous eyes.

PURPOSE: To evaluate the impact of trabecular micro bypass stents (iStent Inject) on refractive outcomes with toric intraocular lens (IOL) in glaucomatous eyes. METHODS: We identified glaucomatous eyes receiving a toric IOL between October 2017 and December 2020. Eyes with iStent implantation were included in the study group and eyes undergoing isolated phacoemulsification served as controls. Corrected and uncorrected visual acuity, manifest refraction, intraocular pressure (IOP), and number of hypotensive drugs three months after surgery were evaluated. RESULTS: 26 eyes comprised the study group and 41 eyes the control group. Mean postoperative refractive cylinder was 0.26D in the control and 0.11D in the iStent group, with 63% and 85% of eyes with a cylinder of 0 and 85% and 92% of eyes with a cylinder ≤ 0.5D respectively. The mean absolute difference between target and outcome spherical equivalent was 0.26D in the control and 0.22D in the iStent group, with all eyes within 0.75D of target. LogMar uncorrected postoperative vision in eyes targeted for emmetropia was 0.04 in the control and 0.03 in the iStent group. There was a statistically significant reduction in IOP and number of hypotensive drugs in both groups, with a mean decrease in IOP of 8.6% in the control and 15.7% in the iStent group. The number of hypotensive drugs dropped from 1.63 ± 0.80 to 1.34 ± 0.91 in the control group and from 2.12 ± 0.65 to 0.44 ± 0.71 in the iStent group. CONCLUSION: Toric IOLs provide predictable refractive outcomes in glaucomatous eyes undergoing combined phacoemulsification with iStent implantation, reducing postoperative spectacle dependence.

12-Month Outcomes of Combined Phacoemulsification and iStent Inject in Asian Eyes with Normal Tension Glaucoma: A Single-Centre Experience.

PURPOSE: To evaluate efficacy and safety of the iStent inject combined with phacoemulsification in Asian eyes with normal-tension glaucoma (NTG) up to 12 months after surgery. STUDY DESIGN: Retrospective case series. METHODS: Retrospective case series of eyes undergoing surgery from April 2017 to August 2019. Outcome measures included intraocular pressure (IOP), number of topical glaucoma medications and adverse outcomes. Data were retrieved from the post-operative day 1 (POD1), week 1 (POW1), month 1 (POM1), month 3 (POM3), month 6 (POM6) and month 12 (POM12) timepoints. Data were analysed at each timepoint for eyes with available clinical data at that visit. Subgroup analysis was performed for a consistent cohort which included only eyes with data at all six follow-up timepoints. RESULTS: Data from 91 eyes in the collective subject group was analysed. Majority of subjects were male (53, 58.2%) and Chinese (79, 86.8%). Mean age was 73.2 ± 7.2 years. Pre-operatively, mean IOP was 14.3 ± 3.0 mmHg and mean number of medications was 1.5 ± 0.8. Significant IOP reduction was observed at all timepoints except POW1 and POM12. The number of medications was reduced at all timepoints (p < 0.001). By POM12, there was reduction of 1.2 ± 1.0 medications (p < 0.001). Both the collective and consistent cohorts demonstrated a trend towards decreasing surgical efficacy with time, in IOP reduction and decrease in medications. None of the eyes experienced sight-threatening complications. CONCLUSIONS: Asian eyes with NTG undergoing combined phacoemulsification and iStent inject surgery demonstrated significant and sustained reduction in number of glaucoma medications up to 12 months post-operatively.

Comparison of 1-year surgical outcomes of combined cataract surgery and gonioscopy-assisted transluminal trabeculotomy (GATT) versus cataract surgery and iStent Inject.

PURPOSE: Evaluate the efficacy, safety, and complication rates of phacoemulsification cataract surgery when combined with either gonioscopy-assisted transluminal trabeculotomy (GATT) or iStent Inject. METHODS: This is a retrospective case-control study to compare the surgical outcomes of combined phacoemulsification cataract surgery with either GATT (phaco-GATT) or iStent Inject (phaco-iStent). Both groups had at least 1-year follow-up. The primary outcome measures were IOP and number of glaucoma medications (NGMs) at 1 year. Secondary outcomes measures were best corrected visual acuity (BCVA) and intra- or postoperative complications within the first year of follow-up. Success was defined as intraocular pressure (IOP) < 21 mmHg and ≥ 20% reduction in IOP at 1 year regardless of the NGM. RESULTS: Each group included 37 patients. The median baseline IOP (24 vs 17) and NGM (3 vs 2) were higher in the phaco-GATT group (p < 0.001). Phaco-GATT achieved a 38% (p < 0.0001) reduction in IOP compared to 13.2% (p < 0.001) in the phaco-iStent group at 1-year follow-up. The reduction in IOP and NGM was significantly higher in the phaco-GATT group (p < 0.01). After adjusting for baseline IOP, the reduction in IOP at 12 months was still significantly higher in the phaco-GATT group (p = 0.042). At 1 year, 86.4% of patients in the phaco-GATT group met the success criteria compared to 35.1% in the phaco-iStent group. Safety outcomes were slightly favourable in the phaco-iStent group. CONCLUSION: Phaco-GATT and phaco-iStent showed a significant reduction in IOP and NGM, with phaco-GATT having a significantly higher reduction. Phaco-iStent appears to have a higher safety profile and is probably preferable in monocular patients and those with a high risk of bleeding.

Effectiveness of iStent Trabecular Microbypass System Combined with Phacoemulsification versus Phacoemulsification Alone in Patients with Glaucoma and Cataract Depending on the Initial Intraocular Pressure.

INTRODUCTION: To assess the effect of iStent trabecular microbypass implantation combined with phacoemulsification on intraocular pressure (IOP) and glaucoma medications and to compare this to outcomes of phacoemulsification alone in patients with mild to moderate primary open-angle glaucoma (POAG) depending on initial IOP. MATERIALS AND METHODS: Eighty subjects with cataract and POAG were randomized 1:1 into either iStent implantation and cataract surgery (iStent group) (n = 44) or cataract surgery alone (control group) (n = 36). Groups were divided according to initial IOP (after washout period) into IOP <26 mm Hg and IOP ≥26 mm Hg. Patients were assessed preoperatively and at postoperative day 1, week 1, and months 1, 3, 6, 12, and 24. Outcome measures included best-corrected visual acuity, IOP, and glaucoma medications. RESULTS: Postoperatively at 24 months, mean IOP decreased from 20.93 ± 1.28 to 17.79 ± 2.50 mm Hg in the IOP subgroup <26 mm Hg and from 26.00 ± 0.00 to 19.86 ± 2.19 in the subgroup ≥26 mm Hg in the control group. In the iStent group <26 mm Hg, IOP decreased from 22.04 ± 1.64 to 15.57 ± 2.13 mm Hg and from 26.6 ± 1.09 to 17.06 ± 2.43 mm Hg in the iStent group ≥26 mm Hg. CONCLUSION: In patients with open-angle glaucoma and cataract, iStent implantation combined with cataract surgery reduced IOP significantly through 2 years, with greater reductions achieved versus phacoemulsification alone. In patients with baseline IOP <26 mm Hg, surgery reduced IOP and medication use significantly declined through 2 years, with greater reductions achieved versus patients with baseline IOP ≥26 mm Hg. The study was registered at ClinicalTrials.gov under the number NCT03807869.

Influence of oral anticoagulation on success rates and risk of bleeding events after iStent inject implantation combined with phacoemulsification.

PURPOSE: We conducted a retrospective study to evaluate the intraocular pressure (IOP) lowering effect, the success rates, and the risk of bleeding events of patients receiving an iStent inject combined with phacoemulsification under anticoagulation therapy compared with a matched control group. METHODS: In this retrospective study, sixty-four eyes underwent an iStent inject implantation combined with phacoemulsification at two centers. Thirty-two eyes received surgery while under anticoagulation therapy, and another thirty-two eyes served as a control group matched for visual acuity, IOP, and medication score. Success was defined as criteria A and B (IOP < 18/21 mmHg, > 20% IOP reduction, no resurgery) and criteria C (IOP ≤ 15 mmHg, IOP reduction ≥ 40%, no resurgery). The clinical goal of the study was to determine the difference between the study and control groups with respect to IOP, medication score, and the frequency of intraoperative and postoperative bleeding events. RESULTS: After a mean follow-up time of 1 year, the IOP lowered 28% from 20.1 ± 4.8 to 14.5 ± 3.7 mmHg in the group of 64 eyes. The medication score lowered 38% from 2.1 ± 1.1 to 1.3 ± 1.2. The two groups with and without anticoagulant agents did not significantly differ in postoperative IOP, medication score, success rates, or number of bleeding events. CONCLUSION: We conclude that in cataract surgery combined with the iStent inject a discontinuation of anticoagulant agents might not be necessary. It might be a good option in glaucoma surgery when anticoagulation treatment should not be interrupted and the target pressure is not very low.

Comparison of a second-generation trabecular bypass (iStent inject) to ab interno trabeculectomy (Trabectome) by exact matching.

PURPOSE: To achieve a highly balanced comparison of trabecular bypass stenting (IS2, iStent inject) with ab interno trabeculectomy (T, Trabectome) by exact matching. METHODS: Fifty-three IS2 eyes were matched to 3446 T eyes. Patients were matched using exact matching by baseline intraocular pressure (IOP), the number of glaucoma medications, and glaucoma type, and using nearest neighbor matching by age. Individuals without a close match were excluded. All surgeries were combined with phacoemulsification. RESULTS: A total of 78 eyes (39 in each group) could be matched as exact pairs with a baseline IOP of 18.3 ± 5.1 mmHg and glaucoma medications of 2.7 ± 1.2 in each. IOP in IS2 was reduced to 14.6 ± 4.2 mmHg at 3 months and in T to a minimum of 13.1 ± 3.2 mmHg at 1 month. In IS2, IOP began to rise again at 6 months, eventually exceeding baseline. At 24 months, IOP in IS2 was 18.8 ± 9.0 mmHg and in T 14.2 ± 3.5 mmHg. IS2 had a higher average IOP than T at all postoperative visits (p < 0.05 at 1, 12, 18 months). Glaucoma medications decreased to 2.0 ± 1.5 in IS2 and to 1.5 ± 1.4 in T. CONCLUSION: T resulted in a larger and sustained IOP reduction compared with IS2 where a rebound occurred after 6 months to slightly above preoperative values.

Influence of Selective Laser Trabeculoplasty (SLT) on the iStent inject® outcomes.

BACKGROUND: To evaluate the influence of Selective Laser Trabeculoplasty (SLT) on iStent inject® outcomes in open-angle glaucoma (OAG). METHODS: In this retrospective comparative cohort outcome study, 66 patients who were treated with two iStent inject® devices were included. Patients were divided into two subgroups consisting of patients without SLT treatment prior to surgery and patients who had been treated previously with 360° SLT but without sufficient response. Outcome measures included intraocular pressure (IOP) and number of antiglaucoma medications after 6 weeks with three, six, 12, and 24 month follow-ups. RESULTS: Mean preoperative IOP decreased from 20.4 ± 5.3 mmHg to 14.8 ± 3.0 mmHg for patients without SLT treatment prior to surgery (p = 0.001) and from 19.2 ± 4.5 mmHg to 14.0 ± 1.6 mmHg for patients with insufficient response to 360° SLT treatment (p = 0.027) at 12 months after iStent inject® implantation. No significant difference was found between the two groups (p >  0.05). The number of antiglaucoma medications did not change in both groups (p >  0.05) and showed no significant difference between the two groups (p >  0.05). CONCLUSION: Prior SLT treatment seems to have no negative influence on the IOP lowering-effect of iStent inject® implantation in patients with OAG. It is therefore an appropriate incremental procedure with no exclusion criterion for an iStent inject® implantation.

iStent inject trabecular micro-bypass stents with topical prostaglandin as standalone treatment for open-angle glaucoma: 4-year outcomes.

IMPORTANCE: Long-term data are needed regarding effective and safe glaucoma treatment modalities. BACKGROUND: This study evaluated 4-year outcomes of second-generation trabecular micro-bypass stent implantation (iStent inject) combined with topical travoprost in open-angle glaucoma (OAG). DESIGN: Prospective, non-randomized, multi-surgeon study at a tertiary care ophthalmology centre. PARTICIPANTS: OAG subjects with preoperative intraocular pressure (IOP) 18 to 30 mmHg on two medications and 22 to 38 mmHg post-washout. METHODS: Subjects (n = 53) underwent standalone iStent inject implantation and started travoprost on postoperative Day 1. Measures included IOP, medications, comprehensive ophthalmic examinations and testing, and adverse events (AEs). Annual medication washouts were performed. MAIN OUTCOME MEASURES: Mean medicated and unmedicated IOP; and proportions of eyes with IOP ≤18mmHg, ≤15 mmHg, or ≥20% reduced while on travoprost vs screening IOP on two medications. RESULTS: At 48 months postoperative, 85% of eyes reduced IOP ≥20% on travoprost vs screening IOP on 2 medications; 92% of eyes had IOP ≤18 mmHg on travoprost; and 83% had IOP ≤15 mmHg on travoprost. At Month 49 (post-washout), 90% of eyes reduced IOP ≥20% vs preoperative washout IOP. Throughout follow-up, mean IOP on travoprost was 11.9 to 13.0 mmHg (34%-40% reduced vs 19.7 mmHg on 2 medications preoperatively; P < .0001 throughout), and post-washout IOP was 16.5 to 17.7 mmHg (28%-34% reduced vs 24.9 mmHg preoperatively; P < .0001 throughout). Favourable safety included minimal AEs; stable visual acuity, cup-to-disc ratio and visual fields; and no secondary surgeries. CONCLUSIONS AND RELEVANCE: Combining iStent inject implantation with topical prostaglandin produced significant and safe 4-year IOP and medication reductions in OAG.

Trabecular micro-bypass stent implantation with cataract extraction in pigmentary glaucoma.

IMPORTANCE: Use of the trabecular micro-bypass stent with cataract surgery is well established to be safe and effective in primary open-angle glaucoma. This is the first study to exclusively evaluate use of the device in pigmentary glaucoma. BACKGROUND: This study aimed to investigate the safety and efficacy of a trabecular micro-bypass stent in combination with cataract surgery in pigmentary glaucoma. DESIGN: Retrospective, consecutive case series. PARTICIPANTS: Twenty-four eyes of 12 patients with pigmentary glaucoma implanted with one trabecular micro-bypass stent with concomitant cataract surgery. METHODS: Baseline data was collected and compared to the following postoperative time points: 1 day, 1 week, 1 month out to 36 months (M36) after the procedure. MAIN OUTCOME MEASURES: These included intraocular pressure (IOP), number of glaucoma medications and need for additional surgery. RESULTS: At M36 there was a 25% reduction in IOP to 14.68 ± 3.0 (P < .01) from 19.50 ± 6.7 mmHg at baseline. The mean number of glaucoma medications was 0.75 ± 1.0 prior to the surgery and 0.59 ± 0.6 (P > .05) at 36 M. At the 36 M time-point, 95% of eyes had IOP ≤ 18 mmHg and 68% of eyes were ≤ 15 mmHg. No eyes underwent a secondary glaucoma procedure. CONCLUSIONS AND RELEVANCE: The insertion of a single trabecular micro-bypass stent in combination with cataract surgery effectively provides a sustained reduction in IOP up to 3 years after surgery in patients with pigmentary glaucoma. The safety profile is favourable with low rate of IOP spikes and no patients requiring additional surgery.

Minimally invasive glaucoma surgery: Comparison of iStent with iStent inject in primary open angle glaucoma.

IMPORTANCE: Minimally invasive glaucoma surgery has gained significant traction in recent years. This study evaluates the first- and second-generation trabecular micro-bypass stents "iStent" and "iStent inject". BACKGROUND: To evaluate and compare the effect of a single iStent and double iStent inject in primary open angle glaucoma. DESIGN: Prospective comparative case series. PARTICIPANTS: Primary open angle glaucoma patients undergoing trabecular micro-bypass stent insertion combined with cataract surgery. METHODS: Baseline demographic information, preoperative, intraoperative and postoperative outcomes including intraocular pressure (IOP), visual acuity, reliance on glaucoma medication and complications were collected and analysed. MAIN OUTCOME MEASURES: Primary, secondary and tertiary outcome measures were consecutively defined as an IOP of ≤18 mmHg with zero medications, an IOP of ≤18 mmHg with reduced medications or a 20% reduction in IOP with or without medication. RESULTS: The study comprised 145 eyes in the iStent and 100 eyes in the iStent inject group. At 12 months, 56.0% of the iStent and 51.3% of the iStent inject eyes had achieved primary success and 63.1% and 57.7% secondary success. The mean postoperative IOP was 16.6 mmHg in iStent and 16.9 mmHg in iStent inject. Survival analysis demonstrated a greater incidence of failure in the iStent inject beyond 5 months. CONCLUSIONS AND RELEVANCE: Both trabecular micro-bypass stents in this study were effective in reducing IOP and the burden of medication when combined with cataract surgery. There was no statistically significant difference between the two groups across our outcome measures although the iStent inject required earlier recommencement of medications for optimal IOP control.

A cost minimisation analysis comparing iStent accompanying cataract surgery and selective laser trabeculoplasty versus topical glaucoma medications in a public healthcare setting in New Zealand.

PURPOSE: To produce an economic comparison of the iStent ab interno trabecular microbypass implant accompanying cataract surgery and selective laser trabeculoplasty (SLT) as first-line treatment versus topical medications for open-angle glaucoma in New Zealand in 2016. METHODS: The current annual costs of 19 available fully subsidised topical glaucoma medications by Pharmaceutical Management Agency (Pharmac) in 2016 were identified. Adjustments for pharmacist prescribing charges and previously described wastage levels were applied. The costs to perform iStent implantation and the cost to perform SLT were obtained from the local distributors, with the latter taking into account staff and consumable cost. Procedure costs divided by eye drops' cost produced a break-even level in equivalent years of eye drops use. RESULTS: The range of annual eye drop cost was NZD$42.25 to NZD$485.11, with an average of NZD$144.81. Comparison of annual eye drop cost with iStent cost revealed 3 of 19 (15.8%) drops breaking even within 5 years, 9 of 19 (47.3%) within 10 years, and 12 of 19 (63.2%) within 15 years. The cost of bilateral SLT performed by a consultant was NZD$102.30 (breaking even in 0.71 years). The equivalent cost for a registrar was NZD$97.59 (breaking even in 0.67 years). CONCLUSION: Economically, the iStent would appear to be a reasonably cost-effective treatment for glaucoma patients undergoing cataract surgery in a public healthcare setting in New Zealand, particularly for those using more expensive topical glaucoma medications, whilst SLT appears to be a worthwhile consideration as a first-line treatment for glaucoma in New Zealand.