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Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract: Two-Year Results

Update on Microinvasive Glaucoma Surgery.

To estimate the effect of reducing intraocular pressure (IOP) on: (i) the incidence of primary open-angle glaucoma (POAG) in patients with ocular hypertension (OH), and (ii) the progression of glaucoma. A meta-analysis of relevant randomized controlled trials was conducted. A literature search was performed to identify trials with: a randomized comparison of IOP-lowering intervention versus placebo or no treatment; visual field loss or optic disc changes as outcome; and follow-up >6 months. A pooled relative risk (RR) was calculated by a random effects model. Risk reduction of glaucoma conversion per mmHg of IOP reduction was quantified in a meta-regression model. We identified nine OH and one POAG trials. A meta-analysis of OH trials gives a pooled RR of 0.61 [95% confidence interval (CI) 0.45-0.83]. A meta-regression shows a decrease of the RR of glaucoma conversion by 14% with each mmHg extra IOP reduction (P = 0.045). No meta-analysis of POAG trials was performed because only one study has been identified. There is sufficient evidence that OH therapy reduces the risk of conversion to glaucoma. This risk reduction increases with greater IOP reduction.

European Glaucoma Prevention Study

Central corneal thickness in children—does it help or hinder our evaluation of eyes at risk for glaucoma?

To identify predictors of intraocular pressure (IOP) reduction following selective laser trabeculoplasty (SLT) in patients with high- and low-pressure primary open-angle glaucoma, who are already taking maximally tolerated IOP-lowering medication and need further IOP reduction. In this prospective interventional case series, 157 eyes of 157 open-angle glaucoma patients who were assigned for SLT for further IOP reduction were included. Each patient had diurnal IOP measurements taken before and on average 6months following SLT. The mean of six IOP measurements was compared. The following parameters were analysed for their association with SLT success: age, gender, spherical equivalent, high-pressure or normal-pressure open-angle glaucoma, number and type of pressure-lowering medications, lens status, pre-SLT IOP, IOP at the time of diagnosis, duration of glaucoma, visual field stage and central corneal thickness. The only parameter that was predictive for absolute and relative mean diurnal IOP reduction after SLT was the preoperative mean diurnal IOP. One hundred per cent of the patients with a mean diurnal preoperative IOP of more than 18mmHg had an IOP reduction after SLT. With mean diurnal preoperative values of 14-18mmHg, 83.1% of the patients, and with values below 14mmHg only 64% of the patients, showed an IOP reduction. This difference was statistically significant (>18 compared to 14-18: p=0.002; >18 compared to <14: p=0.001; 14-18 compared to <14: p=0.030). The pressure-lowering effect of SLT can best be predicted by the individual IOP level before treatment. Patients with mean diurnal IOP levels below 14mmHg might not benefit from the procedure at all.

IntroductionThis study evaluated long-term reductions in intraocular pressure (IOP) and medication following implantation of 2 second-generation trabecular micro-bypass stents (iStent inject®) in eyes with open-angle glaucoma (OAG) not controlled on 1 preoperative medication.Material and MethodsIn this prospective interventional multi-surgeon study, standalone implantation of 2 iStent inject stents was performed in 57 eyes of 57 subjects with OAG, preoperative IOP of 18–30 mmHg on 1 medication, and preoperative post-washout IOP of 22–38 mmHg. The main outcome measures included the proportions of eyes achieving medication-free IOP ≤18 mmHg, IOP ≤15 mmHg, or ≥20% IOP reduction versus preoperative unmedicated IOP. Assessments included IOP, medications, visual acuity, visual field, pachymetry, complications, and interventions. Subjects were followed for 48 months with follow-up continuing in all eyes.ResultsAt Month 48 (n=57), 95% of eyes achieved an IOP reduction of ≥20% without medication versus preoperative washout IOP; and although they had eliminated medication, 81% of eyes still had an IOP reduction of ≥20% versus preoperative IOP on 1 medication. Mean 48-month unmedicated IOP decreased by 46% to 13.2±1.6 mmHg vs 24.4±1.3 mmHg preoperatively (p<0.0001), with 95% of medication-free eyes having IOP ≤18mmHg and 82% having IOP ≤15mmHg. Over the course of follow-up, 3 eyes had medication added and 1 eye underwent a secondary glaucoma surgery, and safety parameters were favorable.DiscussionStandalone iStent inject implantation in OAG patients on 1 preoperative medication resulted in average IOP reduction to ≤15 mmHg with the elimination of medication and favorable safety through 48 months.Trial RegistrationClinicalTrials.gov identifier, NCT02868190.

Endoscopic cyclophotocoagulation and Kahook Dual Blade trabeculotomy in combination with phacoemulsification

IntroductionMinimally invasive glaucoma surgery (MIGS) has become more widespread in open-angle glaucoma (OAG) management. Broad evidence has shown a greater decrease in mean intraocular pressure (IOP) when cataract surgery is combined with MIGS, compared with cataract surgery alone. In this study, we evaluated the effectiveness and safety of second-generation trabecular micro-bypass implantation (iStent inject®) either in combination with cataract surgery (Combined subgroup) or as a standalone procedure (Standalone subgroup) in eyes with OAG. Our hypothesis was that implementing interventional glaucoma management would provide meaningful reductions in IOP and topical medication burden.MethodsThis long-term retrospective consecutive case series included patients with mild to moderate OAG who received the iStent inject® Trabecular Micro-bypass stent with or without phacoemulsification between 2018 and 2024. Eligible patients were ≥ 18 years of age with mild or moderate OAG, cataract requiring surgery (for the Combined subgroup), and the need for IOP and/or medication reduction. Study outcomes included mean and proportional analyses of IOP and medications over time. Analyses were completed for the overall population and for the Combined/Standalone and Mild/Moderate subgroups.ResultsThe study included 271 eyes with mean age 69 years and a mean of 40 months of follow-up (range 10–79 months). In the overall population, mean IOP decreased from 16.4 mmHg at baseline to 13.7 mmHg at last follow-up (p = 0.001), while the mean number of medications decreased from 2.24 at baseline to 0.62 at last follow-up (p = 0.001). IOP reductions were also significant in the Combined/Standalone subgroups and in the Mild/Moderate subgroups (p = 0.001 for all), and all subgroups experienced increased proportions of eyes on no topical medications at last follow-up versus preoperative (p = 0.001 for all).ConclusionThis 5-year real-world study showed significant and sustained reductions in IOP and topical medication burden following iStent inject trabecular micro-bypass with or without cataract surgery in eyes with mild and moderate open-angle glaucoma.

The times they are a‐changin’: time to change glaucoma management

Is Corneal Thickness an Independent Risk Factor for Glaucoma?

To compare the effect of time on therapy, efficacy, tolerability and resource utilization of latanoprost or non-prostaglandin analogues (non-PGs) in patients who required a change in intraocular pressure (IOP)-lowering monotherapy. This open-label, multicentre study (Sweden, 19 sites; Finland, seven sites) included adults with glaucoma or ocular hypertension with mean diurnal IOP > or = 21 mmHg on ocular hypotensive monotherapy. Patients were randomized to latanoprost monotherapy or non-PG therapy (commercially available therapy other than a PG) and followed for 36 months. End-points included: time to treatment failure (baseline to visit with a change in/addition to treatment); diurnal IOP (mean of 08.00, 12.00 and 16:00 hr measurements) at months 6, 12, 24 and 36; tolerability; and resource utilization, where analyses used Swedish and Finnish 2006 unit costs. Three hundred and twenty-six patients received >or = 1 dose of latanoprost (n = 162) or non-PGs (n = 164). Median time to treatment failure was longer for latanoprost (36 months) than for non-PGs (12 months; p < 0.001); 51% and 24% of patients remained on randomized therapy after 36 months, respectively (p < 0.001). Decreases in mean diurnal IOP from baseline were significantly greater for latanoprost than for non-PGs at months 6 and 12 (p < 0.01). No serious adverse events were judged to be treatment-related. Mean total 36-month direct costs were similar in patients initiated with latanoprost and non-PGs. Patients who failed previous monotherapy remained on therapy longer when switched to latanoprost. Latanoprost's IOP-reducing effect and tolerability were sustained over the long term. Resource utilization and costs were generally similar in those initiating latanoprost or non-PG therapy.

Phacotrabeculectomy Meta-analysis

IntroductionThis retrospective consecutive case series assessed 12-month effectiveness and safety of iStent® or iStent inject® trabecular micro-bypass implants with cataract surgery in patients with open-angle glaucoma (OAG) in a real-world clinical setting.MethodsEffectiveness outcomes consisted of intraocular pressure (IOP) reduction; glaucoma medication reduction; proportions of eyes achieving IOP < 18, < 15, or < 12 mmHg; and proportional analysis of medication usage. Safety outcomes included adverse events, secondary surgeries, and best-corrected visual acuity (BCVA).ResultsThis evaluation included 58 eyes with OAG (35 iStent, 23 iStent inject), with 96.6% of eyes having mild or moderate glaucoma. Diagnoses included primary open-angle glaucoma (the majority; 72.4%), pseudoexfoliative glaucoma, and pigmentary glaucoma. Baseline mean IOP and medications were statistically comparable between groups: 16.1 ± 3.6 mmHg on a mean of 1.8 ± 0.8 medications in the iStent group, and 16.2 ± 3.1 mmHg on a mean of 1.7 ± 0.8 medications in the iStent inject group. Twelve months after stent-cataract surgery, mean IOP was significantly lower in the iStent inject group than in the iStent group (13.1 mmHg vs. 15.4 mmHg, respectively; p < 0.001), and the percent reduction in IOP from baseline was significantly greater in iStent inject eyes than in iStent eyes (19.1% vs. 4.3% reduction, respectively; p < 0.001). At 12 months postoperative, significantly greater proportions of iStent inject eyes than iStent eyes achieved IOP < 18 mmHg (100% vs. 80.0% of eyes, respectively; p = 0.035), IOP < 15 mmHg (73.9% vs. 34.3% of eyes, respectively; p = 0.003), and IOP < 12 mmHg (26.1% vs. 0% of eyes, respectively; p = 0.002). Meanwhile, both groups achieved significant medication reductions at 12 months vs. baseline (94.1% reduction in iStent inject eyes, p < 0.0001; and 72.2% reduction in iStent eyes, p < 0.0001), with the percent reduction being significantly greater in iStent inject eyes than in iStent eyes (p = 0.023). At 12 months, mean number of medications was significantly lower in iStent inject eyes than iStent eyes (0.1 vs. 0.5 medications, respectively; p = 0.021), and significantly more iStent inject eyes (95.7%) than iStent eyes (71.4%) were off medications entirely (p = 0.021). A similarly high safety profile was observed in both groups.ConclusioniStent or iStent inject implantation with cataract surgery resulted in substantial and safe reductions in IOP and medications through 12 months postoperative. Consistent with prior observations, greater efficacy was observed with iStent inject than with iStent.FundingThe Rapid Service Fees were funded by Glaukos Corporation.

IntroductionTo investigate the 24-month efficacy and safety of iStent inject trabecular microbypass system implantation combined with phacoemulsification in subjects with primary open-angle glaucoma (POAG) and concomitant cataract.MethodsThis prospective, uncontrolled, interventional case series included 36 eyes (29 subjects) with POAG of mild to moderate severity and coexisting cataract that underwent combined phacoemulsification and implantation of a second-generation trabecular microbypass stent (iStent inject®). Main outcome measures involved mean intraocular pressure (IOP), number of antiglaucoma medications, and proportional analysis of eyes with IOP ≤ 18 mmHg or ≤ 15 mmHg, or with 0 or ≥ 2 glaucoma medications. Secondary outcome measures involved the cup-to-disc ratio, corrected distance visual acuity (CDVA), and adverse issues.ResultsIn 36 eyes, the mean IOP at baseline was 18.28 ± 2.87 mmHg, which decreased to 14.24 ± 1.36 (22.1%) and 14.46 ± 1.56 mmHg (20.9%) at 18 and 24 months, respectively (p < 0.001). At the last follow-up, 100% of eyes had an IOP ≤ 18 mmHg (vs. 50% preoperatively), and 75.7% of eyes had an IOP ≤ 15 mmHg (vs. 16.7% preoperatively); 58.3% of eyes achieved ≥ 20% IOP reduction from preoperative status. At baseline, eyes were treated with a mean of 2.35 ± 1.18 medications, which was reduced to 0.80 ± 1.04 (66% reduction) and 0.69 ± 0.95 medications (70.6% reduction) at 18 and 24 months, respectively (p < 0.001). At the last follow-up, 54.1% of eyes were medication-free (vs. 0% preoperatively) and 24.3% of eyes were treated with ≥ 2 medications (vs. 64.9% preoperatively). This combined procedure demonstrated an excellent safety profile with no reported intraoperative complications or adverse events; CDVA was maintained throughout the entire follow-up period.ConclusionsThis real-world series demonstrated that iStent inject device implantation at the time of phacoemulsification is a safe and effective method to decrease IOP and the necessity for antiglaucoma medications in patients with mild-to-moderate POAG and cataract; no associated vision-threatening complications were noted.