Effectiveness and safety of VISULAS® green selective laser trabeculoplasty: a prospective, interventional multicenter clinical investigation.

PURPOSE: To evaluate the effectiveness and safety of Selective Laser Trabeculoplasty (SLT) with the SLT mode of the VISULAS® green laser in patients with primary open-angle glaucoma (POAG). METHODS: This prospective, interventional multicenter clinical investigation included patients with POAG who either needed a treatment escalation because the individual intraocular pressure (IOP) target was not met or treatment initiation and had an IOP ≥ 17 mmHg at baseline in the study eye. The study was conducted in five research centers across Germany. Approximately 100 laser applications were delivered to 360° of the trabecular meshwork. Glaucoma medications were not modified during the 3-month follow-up to allow evaluation of the sole effect of VISULAS® green with SLT. Efficacy outcomes were postoperatively absolute and relative IOP changes at 1 and 3 months. Safety outcomes analyzed the rate of intra- and postoperative adverse events. RESULTS: Thirty-four eyes of 34 POAG patients were included. The overall mean number of preoperative glaucoma medications was 2.2 ± 1.4 in 29 treated eyes, 5 eyes were treatment naïve. Mean baseline IOP (mmHg) was 21.0 ± 2.69 and was reduced by - 3.53 ± 3.34 [95% CI - 4.61; - 2.45] and - 3.59 ± 3.41 [95% CI - 4.64; - 2.53] at the 1- and 3-month follow-up, respectively (p < 0.0001), with 48.5% of cases achieving a ≥ 20% IOP reduction at 3 months [95% CI = 30.8%; 66.5%]. The mean relative IOP reduction was - 16.4% and - 16.3% at 1 and 3 months, respectively (p < 0.0001). Potentially device- or procedure-related adverse events were mild to moderate and included 3 postoperative IOP-spikes and 6 reports regarding eye pain and discomfort. All were resolved without sequelae. CONCLUSIONS: SLT performed with the VISULAS® green laser achieved clinically significant additional IOP reductions in medically treated as well as in treatment naïve eyes with POAG and there were no relevant safety issues. The results are comparable to other reported SLT studies.

Cost-utility analysis of trabecular micro-bypass stents (TBS) in patients with mild-to-moderate open-angle Glaucoma in Italy.

BACKGROUND: Glaucoma is a disease characterized by progressive damage of the optic nerve. Several therapeutic options are available to lower intraocular pressure (IOP). In primary open-angle glaucoma (POAG) patients with inadequate IOP control (or controlled with multiple medical therapies or for whom medical therapy is contraindicated), the implantation of micro-invasive glaucoma surgery devices (MIGS) and concomitant cataract surgery has proved to be more effective in reducing intraocular pressure (IOP), as compared to cataract surgery alone. The objective of this study was to assess the cost-effectiveness of iStent inject® device with concurrent cataract surgery vs. cataract surgery alone, in patients with mild-to-moderate POAG, adopting the Italian National Health Service (NHS) perspective. METHODS: Simulation of outcomes and costs was undertaken using a Markov model with 4 health states and one-month cycles, that is used to simulate the prognosis of these patients. Efficacy data were obtained from the randomized clinical trial (RCT). A lifetime horizon was adopted in the analysis. A discount rate of 3.5% was applied to both costs and effects. The Italian National Healthcare Service (NHS) perspective was considered, therefore only healthcare direct costs (acquisition of main interventions and subsequent procedures; medications; monitoring and follow-up; adverse events). Model robustness was tested through sensitivity analyses. RESULTS: Results of the base-case analysis showed that the total lifetime costs were higher in the iStent inject® + concurrent cataract surgery, compared with the cataract surgery alone group (€8368.51 vs. €7134.71 respectively). iStent inject® + concurrent cataract surgery was cost-effective vs. cataract surgery alone, with an incremental cost-effectiveness ratio of €13,037.01 per quality-adjusted life year (QALY) gained. Both one-way deterministic and probabilistic sensitivity analyses confirmed robustness of base-case results. The cost-effectiveness accessibility curve (CEAC) showed that iStent inject® + cataract surgery would have a 98% probability of being cost-effective, compared to cataract surgery alone, when the willingness to pay (WTP) is equal to €50,000 per QALY gained. CONCLUSIONS: The results of the cost-utility analysis confirm that iStent inject® + cataract surgery is a cost-effective option for the treatment of patients affected by mild-to-moderate POAG, compared with cataract surgery alone, when evaluated from the Italian NHS perspective.

Does TRABECULECTOMY meet the 10-10-10 challenge in PACG, POAG, JOAG and Secondary glaucomas?

PURPOSE: Evaluation of the intraocular pressure (IOP) lowering efficacy of trabeculectomies over > 10 years and their ability to stabilize glaucomatous optic neuropathy. METHODS: In total, 181 eyes (136 patients), which underwent trabeculectomy (10 min surgery) at least 10 years prior and were on regular follow-up, were evaluated. Qualified/complete success was taken as criteria A: IOP ≤ 12 mmHg, B: IOP ≤ 15 mmHg and C: IOP ≤ 18 mmHg, with all > 5 mmHg, with/without medications. Target IOP in advanced glaucoma is about 10 mmHg, therefore trabeculectomy 10-10-10 challenge! RESULTS: The mean age of patients was 46.32 ± 11.50 years. Absolute success was 50.27%, 54.14% and 59.66% according to criteria A, B and C at last follow-up, while qualified success was 70.11%, 81.77% and 96.13%. An IOP of ≤ 12 mmHg was noted in 34, 64.15%, PACG eyes, 14, 73.68%, POAG, 15, 65.22%, JOAG and 64, 74.42%, secondary glaucoma eyes. The reduction in IOP overall was 64.83 ± 16.80% at last review and was 59.47 ± 16.07% in PACG, 62.40 ± 17.72% in POAG, 71.89 ± 8.50% in JOAG and 67.74 ± 18.10% in secondary glaucoma eyes. "Target" IOP was achieved in 97.29% of early glaucoma, 85.71% moderate glaucoma and 70% severe glaucoma eyes. 97.24% of patients were perimetrically stable. 2.21% of eyes post-trabeculectomy had a shallow anterior chamber needing surgical intervention. Visual acuity was maintained or better in 93.92% of patients, with a cataract surgery performed in 6.63% eyes. A repeat trabeculectomy was performed in 3.31% of eyes. CONCLUSION: Trabeculectomy 10-10-10 is achievable in the long term, with few complications or repeat surgical interventions in the majority of POAG, PACG, JOAG and secondary glaucomas. Therefore, trabeculectomy should not be relegated to a last resort, but should be undertaken as soon as possible, if medical therapy is inadequate, unaffordable or compliance is an issue.

Predictive factors for the IOP reduction in phacocanaloplasty with suprachoroidal drainage.

PURPOSE: Although the pressure-reducing effect of cataract surgery alone is not very high, it is often cited in the literature. Some authors describe predictive factors correlated with the IOP (intraocular pressure) reduction: in particular noteworthy are age, axial length, preoperative pressure level and the ratio of preoperative pressure/anterior chamber depth. The aim of this study was to determine the applicability of these predictive factors to phacocanaloplasty with suprachoroidal drainage. Setting Eye Clinic Sulzbach Germany. DESIGN: Retrospective study with a 12-month follow-up, including patients that underwent phacocanaloplasty with suprachoroidal drainage between 2012 and 2014. METHODS: Preoperatively, baseline information was collected (including age, diagnosis, medication), and the patients underwent a basic examination and optical biometry. To investigate the relationship between preoperative parameters and the IOP reduction, Pearson's correlation analysis and linear regression were used. Patients with missing data pre- or postoperatively were excluded from the analysis. RESULTS: The study comprised 89 patients. Mean preoperative IOP was 23.0 ± 5.3 mmHg with 4.0 different antiglaucomatous eye drops. After 12 months, IOP was reduced to 12.1 ± 1.4 mmHg with a median medication of 0.0. The preoperative IOP and the ratio of preoperative IOP/anterior chamber depth were identified as predictive factors. There was no influence of axial length and anterior chamber depth. CONCLUSION: Unlike in cataract surgery, anterior chamber depth and axial length have no influence on the pressure reduction caused by phacocanaloplasty. However, a strong predictive factor is the preoperative pressure level. The higher the preoperative IOP, the greater the postoperative pressure reduction.

In vivo optimization of 2,3-diaminopyrazine Rho Kinase inhibitors for the treatment of glaucoma.

A series of 2,3,6-pyrazine Rho Kinase inhibitors were optimized for in vivo activity for topical ocular dosing. Modifications of the 2-(piperazin-1-yl)pyrazine derivatives produced compounds with improved solubility and physicochemical properties. Modifications of the 6-pyrazine substituent led to improvements in in vitro potency. Compound 9 had the best in vitro and in vivo potency of EC50=260 nM with a 30% reduction of IOP in a non-human primate model at a dose of 0.33%.

Possible dose-dependent effect of eplerenone on intraocular pressure.

Purpose: Intraocular pressure (IOP) is the main modifiable risk factor for glaucoma. Current therapies target the anterior outflow of aqueous humor or its production. This study aims to demonstrate eplerenone could reduce IOP through a possible posterior outflow path via retinal pigment epithelium (RPE). Methods: In this retrospective study, IOP changes in patients undergoing eplerenone treatment were investigated. Inclusion criteria were IOP data immediately before and during treatment. Exclusion criteria included ophthalmic procedures, changes in topical glaucoma treatment, or taking systemic medications affecting IOP. After reviewing 162 charts, 41 subjects were eligible. Pearson correlation test was used to investigate the correlation between continuous IOP and eplerenone dosage. Results: The mean ± SD IOP before eplerenone treatment was 14.31 ± 3.73 mmHg and decreased to 13.50 ± 4.04 mmHg; however, this was not statistically significant (P = 0.39). In subset of patients with eplerenone dose of more than 25 mg/day and baseline IOP equal to or less than 15 mmHg, the mean IOP before eplerenone treatment was 12.33 ± 2.59 mmHg and decreased to 10.33 ± 2.99, which is a trend toward IOP reduction with a 16% reduction in IOP (P = 0.055). Conclusion: A possible dose-dependent decrease in IOP with eplerenone provides indirect evidence for the posterior flow model and suggests the mineralocorticoid receptors (MRs) in RPE play a role in the posterior flow of aqueous humor. It can be deduced that the RPE pumps responsible for the posterior flow of aqueous humor are MR-regulated and their function can be enhanced with MR antagonists.

Bimatoprost-loaded lipidic nanoformulation development using quality by design: liposomes versus solid lipid nanoparticles in intraocular pressure reduction.

Background: Bimatoprost is a drug used to lower intraocular pressure in the treatment of glaucoma. Conventional eye drops have the limitations of repeated dosing, drug loss due to tear outflow and hence poor availability for action. Materials & methods: Using a systematic quality by design approach, liposomes and solid lipid nanoparticles were formulated and further encapsulated in thermo-sensitive in situ hydrogel. Results & conclusion: Optimized liposomes had 87.04% encapsulation efficiency and 306.78 nm mean particle size, while solid lipid nanoparticles had 90.51% and 304.21 nm. Bimatoprost liposomes had controlled zero-order drug kinetics and no initial burst release, making them better than solid lipid nanoparticles. Bimatoprost-loaded liposomes in thermo-sensitive hydrogel decreased intraocular pressure for 18 h.

Nasal trabeculo-ciliary angle and relative lens vault as predictors for intraocular pressure reduction following phacoemulsification.

PURPOSE: To evaluate quantitative relationships between biometric measurements and expected intraocular pressure reduction following phacoemulsification. DESIGN: A prospective, comparative clinical study. METHODS: Forty nine candidates for phacoemulsification were included. Intraocular pressure was measured preoperatively and after 7 and 30 days. Ocular biometrics were measured using optical biometry and ultrasound biomicroscopy preoperatively and 1 month postoperatively. RESULTS: Patients were sub-grouped into open-angle glaucoma (12 eyes), angle-closure glaucoma (18 eyes), and cataract-only groups (19 eyes). The mean intraocular pressure reduction was -1.67 ± 2.73, -13.11 ± 7.98, and -7.50 ± 3.58 mmHg in the cataract-only, angle-closure glaucoma, and open-angle glaucoma groups (p = 0.001). The delta-intraocular pressure at day 7 showed positive correlations with lens vault and relative-lens vault (p = 0.005 and 0.001). It showed negative correlations with lens position, relative-lens position, anterior chamber depth, aqueous depth, and nasal and temporal angles in addition to lens thickness, anterior vault, nasal trabeculo-ciliary angle, and temporal-trabeculo-ciliary angle at the end of the follow-up period. Regression analysis revealed significant associations between preoperative intraocular pressure and both nasal-trabeculo-ciliary angle and anterior vault (p = 0.038 and 0.019) and delta-intraocular pressure and both nasal-trabeculo-ciliary angle and relative-lens vault (p = 0.001 and ≤0.001) with an area under the curve of 0.71 for relative-lens vault. For every degree decrease in nasal-trabeculo-ciliary angle, there was an expected 0.33 mmHg intraocular pressure reduction with no expected change if nasal-trabeculo-ciliary angle decreased to <22°. CONCLUSIONS: The relationship between anterior-segment-biometrics could determine intraocular pressure behavior after phacoemulsification. The preoperative nasal-trabeculo-ciliary angle and relative-lens vault could be significant predictors for postoperative intraocular pressure reduction.

Evaluation of Macular and Peripapillary Blood Flow in Response to Intraocular Pressure Reduction in Patients With Posner-Schlossman Syndrome.

Purpose: The study aimed to evaluate the effect of intraocular pressure (IOP) reduction on macular and peripapillary microcirculation in patients with Posner-Schlossman syndrome (PSS) by optical coherence tomography angiography (OCTA). Methods: A prospective comparative study was conducted. Patients diagnosed with PSS at the Eye Center of Xiangya Hospital, Central South University, from February 2020 to November 2021 were consecutively included. OCTA was used for the macular and peripapillary microcirculation measurements, and optical coherence tomography (OCT) was employed for the retinal nerve fiber layer (RNFL) and lamina cribrosa depth (LCD) measurements. The patients received OCT and OCTA examinations at baseline and 1 week post-treatment when the IOP was under control. Changes in macular and peripapillary microcirculation, RNFL, and LCD were calculated for all the analyzed areas. Results: Twenty-one eyes from 21 patients were included in the study. Pre-treatment and post-treatment IOP were 43.17 ± 10.36 mm Hg (range, 30-60 mm Hg) and 17.17 ± 2.85 mm Hg (range, 13-23 mm Hg), respectively. No statistically significant changes were detected in RNFL, LCD, or macular and peripapillary microcirculation after significant IOP reduction. Conclusion: The results suggested that a large IOP reduction may not result in a significant increase in peripapillary and macular capillary perfusion in patients with PSS.

PRESERFLO™ MicroShunt versus trabeculectomy: first results on efficacy and safety.

PURPOSE: To report efficacy and safety outcomes of the PRESERFLO™ MicroShunt compared with trabeculectomy, the current gold-standard treatment for advanced glaucoma, in the early and intermediate postoperative period. METHODS: Institutional prospective interventional cohort study of primary open-angle glaucoma (POAG) patients scheduled for the PRESERFLO™ MicroShunt. The comparison group were POAG patients who had had received trabeculectomy and were matched for age, known duration of disease, number and classes of intraocular pressure (IOP)-lowering medications to ensure a similar conjunctival condition. The study is part of the Dresden Glaucoma and Treatment Study (DGTS), was not randomized, but used a uniform study design, with the same inclusion and exclusion criteria as well as standardized definitions of success and failure. MAIN OUTCOME MEASURES: mean diurnal IOP (mdIOP, mean of 6 measurements), diurnal peak IOP, diurnal IOP fluctuations, glaucoma medical therapy, success rates, visual acuity, visual fields, surgical complications and interventions, and severe adverse events. RESULTS: Fifty-two eyes of 52 patients, 26 in each group, were analysed. At 6 months, median [Q25, Q75] mdIOP was 10.8 [9.5-12.2] mmHg in the microshunt and 10.3 [7.6-11.8] mmHg in the trabeculectomy group. Reduction in mdIOP (p = 0.458), peak diurnal IOP (p = 0.539), and median diurnal fluctuation (p = 0.693) was not statistically significantly different between groups. The rate of interventions was statistically significantly higher in the trabeculectomy compared with the microshunt group (p = 0.004). None of the patients experienced severe adverse events. CONCLUSION: Both procedures are equally effective and safe in lowering mdIOP in patients with POAG. Because the microshunt is less invasive with less follow-up and interventions needed postoperatively, it might be recommended earlier in the treatment of glaucoma.

Microinvasive glaucoma surgery: A review of 3476 eyes.

Microinvasive glaucoma surgery (MIGS) is a potentially safer and more efficacious method studied in patients with mild-to-moderate open-angle glaucoma requiring less invasive treatment goals; however, the literature on MIGS must be thoroughly evaluated. We conducted a review of MIGS by searching MEDLINE, EMBASE, and Cochrane CENTRAL. Primary efficacy indicators were reductions in intraocular pressure and topical medication use postoperatively. While all comparative randomized controlled trials assessing MIGS in English peer-reviewed journals were included, only observational studies with a target follow-up of at least one year and a high priority score were analyzed, resulting in a total of 3476 eyes across 20 trials. The mean age was 69.5 ± 2.9 years, 53.7% were female, and 77.4% were Caucasian. One study had last follow-up at less than one year, fifteen studies had follow-up extending 1-2 years, and four had longer than two years of follow-up. A pattern of more significant intraocular pressure and medication reduction was observed in patients who underwent MIGS (n = 2170) relative to control (n = 1306) interventions. iStent had the most literature supporting its efficacy, followed by Hydrus. The most common adverse events after MIGS implantation included stent obstruction, inflammation, and subsequent surgical intervention. Surgical complication rates and efficacy are favorable after MIGS. This review helps to consolidate the high-quality evidence that exists for various MIGS procedures and to identify gaps where further research is needed.

Minimally Invasive Surgery in Mild-to-Moderate Glaucoma Patients in Italy: Is It Time to Change?

Medical therapy is the first treatment choice for most patients with glaucoma; however, in a relevant proportion of patients, intraocular pressure (IOP) reduction is achieved with multi-therapy and/or high therapeutic doses. Conventional surgery is the standard alternative to medical therapy when this is not effective or not tolerated. Recently, selective laser trabeculoplasty (SLT) has been advocated as first-line therapy, and "minimally invasive glaucoma surgery" (MIGS) has been developed as safer and less traumatic surgical intervention for patients with glaucoma. Schlemm's canal surgery has emerged as one of the approaches with the most favorable risk-benefit profile for glaucoma patients in need of cataract surgery. However, despite the promising results, use of MIGS in Italy has been extremely low. We aimed to investigate the reasons of the lower-than-expected use of Schlemm's canal-based MIGS devices in Italy, share our perspective on their potential place in therapy, and give practical suggestions to improve the management of glaucoma patients.

Comparison of clinical effects of two latanoprost 0.005% solutions (Xalatan® and Arulatan®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial.

Purpose: To evaluate the therapeutic non-inferiority between two ophthalmic latanoprost 0.005% solutions (Arulatan® [ALT] versus the reference drug Xalatan® [XLT]) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH). Patients and methods: This was a 12-week Phase IV, experimental, randomized, parallel-group, double-masked clinical trial. Consecutive patients with POAG or OH from the Glaucoma Service of Instituto Paulista de Estudos e Pesquisas em Oftalmologia (São Paulo, Brazil) were enrolled between July and December 2017. The primary outcome of the study was an analysis of therapeutic non-inferiority between ALT versus XLT at 12 weeks, while secondary outcomes were mean intraocular pressure (IOP) change from baseline at 2, 6 and 12 weeks, mean IOP at 2, 6 and 12 weeks, and topical and systemic side effects. Statistical significance was set at P<0.05. Computerized analysis was performed using the R software, version 3.4.4. Results: A total of 45 patients were randomized to the two treatment groups: ALT (22) and XLT (23). A statistically significant reduction in IOP from baseline was observed in both treatment groups at all timepoints, while no statistically significant difference between groups was detected. By week 12, observed IOP reduction was -7.95 and -7.89 mmHg in the ALT and in the XLT groups, respectively (P=0.60). Treatment difference between the ALT and the XLT groups was -0.06 mm Hg (95% CI: -0.97, 0.85) and fell within the interval set for therapeutic non-inferiority. There was no statistically significant difference between the two groups in terms of safety profiles. The most commonly reported side effect was mild conjunctival/palpebral hyperemia. Conclusion: ALT was considered non-inferior to XLT in achieving a statistically significant reduction in IOP at 12 weeks in POAG and OH patients. No significant difference in the occurrence of side effects was found between both groups.

Efficacy and safety of tafluprost 0.0015% - retrospective analysis of real-world data from the Philippines.

PURPOSE: To investigate the IOP lowering effect and safety of tafluprost 0.0015% in a routine clinical setting in the Philippines. PATIENTS AND METHODS: A retrospective review of glaucoma patients receiving tafluprost 0.0015% (BAK 0.001% preserved) with a minimum follow-up of 3 months was conducted. Main outcome measure was the mean IOP change at month 3. Secondary outcome measures included longitudinal IOP assessments and occurrence of any adverse events. RESULTS: Three-hundred twenty-nine eyes of 177 patients with mean age 64.8 years were included and followed for mean 8.8 months. Most common diagnosis was primary open-angle glaucoma (POAG) (34.9%), followed by primary angle-closure (PAC) glaucoma post-laser iridotomy (24.0%), PAC post-laser iridotomy (15.5%), ocular hypertension (OHT)(14.6%), secondary glaucoma (6.7%), and normal-tension glaucoma (4.3%). Mean IOP change at month 3 was -6.18 mmHg (SD 4.06), a -26.37% reduction (p<0.001) and IOP reduction was sustained throughout the study period (p<0.001). Sub-group analysis of treatment naïve (n=203); add-on (n=53) and replacement therapy (n=73) showed a 3-month mean IOP reduction of -8.34 mmHg (SD 2.57, p<0.001) or -31.24%, -5.08 mmHg (SD 2.86, p<0.001) or -23.68%, and -1.00 mmHg (SD 3.08; p=0.007) or -6.31%, respectively. There was significant IOP reduction from baseline in both POAG/OHT sub-group and the PAC/PACG post-laser iridotomy with ≥90° open-angle sub-group (p<0.001), sustained up to month 12 post-treatment. However, there was no significant difference in the average absolute (mmHg) or proportional IOP change from baseline between the two sub-groups. Conjunctival hyperemia was the most common adverse reaction occurring in 15% of patients. CONCLUSION: Tafluprost was a safe and effective IOP-lowering treatment in this routine clinical setting.

Midterm outcome of single scleral suture technique in trabeculectomy and phacotrabeculectomy: a simplified approach.

PURPOSE: To report outcome of trabeculectomy performed by single scleral suture in Indian eyes. METHODS: Non-randomized, non-masked, retrospective cohort analysis. Medical records of all consecutive patients who underwent trabeculectomy between 1 January 2011 and 31 December 2016 at CL Gupta Eye Institute, Moradabad (India), were reviewed and analyzed. Trabeculectomy was performed using single scleral suture for flap closure. The suture knot was buried inside sclera. The laser lysis of scleral suture was not done. Success was defined as complete success if an intraocular pressure (IOP) was >5 and ⩽21 mmHg without any glaucoma medications or re-surgery. Qualified success was defined as IOP ⩽21 mmHg with or without antiglaucoma medications. RESULTS: Data of 98 patients was analyzed. A total of 61 (62.2%) of them underwent trabeculectomy, and 37 (37.7%) underwent phacotrabeculectomy. The probability of complete success in patient underwent phacotrabeculectomy was 86% at 3 years, and in-patient underwent only trabeculectomy was 95% at 3 years. The probability of qualified success in patient undergone phacotrabeculectomy was 91% at 3 years, and in patient undergone only trabeculectomy was 97% at 3 years. CONCLUSION: The mean postoperative IOP was significantly less then mean preoperative IOP, at all follow-up visits. This simplified technique also resulted in high midterm success probabilities with low complication rates.

The effect of the extent of the incision in the Schlemm canal on the surgical outcomes of suture trabeculotomy for open-angle glaucoma.

PURPOSE: To examine the relationship between the extent of the incision in the Schlemm canal during suture trabeculotomy (S-LOT) for open-angle glaucoma and the associated reduction in intraocular pressure (IOP). METHODS: Forty-eight consecutive eyes (primary open-angle glaucoma: 28; exfoliation glaucoma: 20) scheduled to undergo S-LOT were studied. A 320-degree opening in the Schlemm canal was planned when total circumferential cannulation had been achieved, and the remaining 40-degree region under the scleral flap was not incised. When the cannulation was incomplete, the canal was incised up to the point reached by the cannula, and the extent of the incision was measured. Logistic regression analysis was performed to identify potential predictors of surgical success (IOP ≤ 15 mmHg). RESULTS: A 320-degree incision was achieved in 23 eyes, and the mean extent of the incision was 275 ± 52.3°. The mean IOP fell from 34.0 ± 8.8 mmHg at baseline to 14.5 ± 4.0 mmHg at 1 year postoperatively (P < 0.0001). An IOP reduction of ≥30% was achieved in 46 eyes. Simple correlation analysis indicated that the extent of the incision in degrees did not correlate with IOP or with the reduction in IOP at 1 year postoperatively (P = 0.7665 and 0.693, respectively). Lower preoperative IOP values and concomitant cataract extraction were found to be associated with surgical success. CONCLUSIONS: The extent of the incision in the Schlemm canal during S-LOT does not correlate with postoperative reduction in IOP.

A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma.

PURPOSE: To evaluate 3-year safety and intraocular pressure (IOP) following two trabecular microbypass stents in phakic and pseudophakic subjects with open-angle glaucoma (OAG) not controlled on preoperative medication. PATIENTS AND METHODS: In this prospective pilot study, phakic or pseudophakic subjects with OAG and IOP between 18 mmHg and 30 mmHg on one preoperative topical ocular hypotensive medication underwent medication washout. Thirty-nine qualified subjects with preoperative unmedicated IOP ≥22 mmHg and ≤38 mmHg received two stents. Postoperative examinations were scheduled at Day 1, Week 1, Months 1, 3, 6, and 12, and semiannually through Month 60. Ocular hypotensive medication was considered if postoperative IOP exceeded 21 mmHg. IOP, medication use, and safety were assessed at each visit. Subject follow-up through Month 36 was completed. RESULTS: Thirty-six eyes (92.3%; 95% confidence interval [CI] 79.1%, 98.4%) achieved the primary efficacy end point of Month 12 reduction in IOP ≥20% from baseline (unmedicated IOP) without ocular hypotensive medication. Four subjects required medication during the Month 36 follow-up period. Mean IOP at 36 months for subjects not taking medication was 15.2 mmHg. At 36 months, subjects sustained mean IOP decrease of 9.1±2.7 mmHg (95% CI 8.0 mmHg, 10.14 mmHg), or 37% IOP reduction, from unmedicated baseline IOP. Compared to preoperative medicated IOP, subjects had mean reduction at Month 36 of 5.5±2.7 mmHg (95% CI 4.5 mmHg, 6.6 mmHg), or 26% reduction. Both measures of IOP reduction were highly significant (P<0.001). Other than one case of early postoperative hyphema that resolved at 1 week, no postoperative adverse events were attributed to stent implantation. CONCLUSION: In a pilot study, two trabecular microbypass stents to treat OAG subjects on one preoperative medication provided statistically significant, sustained, and safe reduction of IOP to ≤15 mmHg without medication through 36 months.

Prospective, randomized study of one, two, or three trabecular bypass stents in open-angle glaucoma subjects on topical hypotensive medication.

PURPOSE: To assess the safety and efficacy of one, two, or three trabecular microbypass stents in eyes with primary open-angle glaucoma (OAG) not controlled on ocular hypotensive medication. A total of 119 subjects were followed for 18 months postoperatively. MATERIALS AND METHODS: Subjects with medicated intraocular pressure (IOP) 18-30 mmHg and postmedication-washout baseline IOP 22-38 mmHg were randomized to implantation of one, two, or three stents. Ocular hypotensive medication was to be used if postoperative IOP exceeded 18 mmHg. RESULTS: A total of 38 subjects were implanted with one stent, 41 subjects with two stents, and 40 subjects with three stents. Both month 12 IOP reduction ≥20% without ocular hypotensive medication vs baseline unmedicated IOP and month 12 unmedicated IOP ≤18 mmHg were achieved by 89.2%, 90.2%, and 92.1% of one-, two-, and three-stent eyes, respectively. Furthermore, 64.9%, 85.4%, and 92.1% of the three respective groups achieved unmedicated IOP ≤15 mmHg. Over the 18-month follow-up period, medication was required in seven one-stent subjects, four two-stent subjects, and three three-stent subjects. At 18 months, mean unmedicated IOP was 15.9±0.9 mmHg in one-stent subjects, 14.1±1.0 mmHg in two-stent subjects, and 12.2±1.1 mmHg in three-stent subjects. Month 18 IOP reduction was significantly greater (P<0.001) with implantation of each additional stent, with mean differences in reduction of 1.84 mmHg (95% confidence interval 0.96-2.73) for three-stent vs two-stent groups and 1.73 mmHg (95% confidence interval 0.83-2.64) for two-stent vs one-stent groups. Adverse events through 18 months were limited to cataract progression with best-corrected visual acuity loss and subsequent cataract surgery. CONCLUSION: In this series, implantation of each additional stent resulted in significantly greater IOP reduction with reduced medication use. Titratability of stents as a sole procedure was shown to be effective and safe, with sustained effect through 18 months postoperatively in OAG not controlled with medication.

Benefits of anterior chamber paracentesis in the management of glaucomatous emergencies.

UNLABELLED: Anterior chamber paracentesis (ACP) is an alternative technique to reduce intraocular pressure (IOP) in patients with acute closed-angle glaucoma (ACAG) and requires controlled drainage of aqueous humor from the anterior chamber using a needle or an incision paracentesis with a knife. PURPOSE: Evaluation of efficacy and safety of AC paracentesis in acute increases of intraocular pressure. METHOD: This was an observational study done on a group of 24 patients with acute, unilateral increases of IOP> 50mmHg. IOP was measured before, 10 minutes, 1 day, 7 days and 30 days after ACP using applanation tonometry. RESULTS: Intraocular pressure decreased from an average of 52.5 mmHg to 25.5 mmHg to 17.5 mmHg at 10 minutes and 7 days from the ACP. Anterior chamber paracentesis combined with glaucoma medication led to the cessation of symptoms in all patients included in the lot and the resolution of corneal edema in 20 cases. CONCLUSION: ACP is safe and effective in acute increases of IOP in the acute form of the primary angle closure glaucoma but remains an adjunct to conventional therapy drug.

Prospective unmasked randomized evaluation of the iStent inject (®) versus two ocular hypotensive agents in patients with primary open-angle glaucoma.

PURPOSE: The purpose of this study was to compare outcomes of subjects with open-angle glaucoma (OAG) not controlled on one medication who underwent either implantation of two iStent inject (®) trabecular micro-bypass devices or received medical therapy consisting of a fixed combination of latanoprost/timolol. PATIENTS AND METHODS: Of 192 subjects who qualified for the study and were enrolled, 94 were randomized to surgery with implantation of two iStent inject(®) devices in the treated eye and 98 to receive medical therapy. RESULTS: At the month 12 visit, 94.7% of eyes (89/94) in the stent group reported an unmedicated intraocular pressure (IOP) reduction of ≥20% versus baseline unmedicated IOP, and 91.8% of eyes (88/98) in the medical therapy group reported an IOP reduction ≥20% versus baseline unmedicated IOP. A 17.5% between-group treatment difference in favor of the iStent inject group was statistically significant (P=0.02) at the ≥50% level of IOP reduction. An IOP ≤18 mmHg was reported in 92.6% of eyes (87/94) in the iStent inject group and 89.8% of eyes (88/98) in the medical therapy group. Mean (standard deviation) IOP decreases from screening of 8.1 (2.6) mmHg and 7.3 (2.2) mmHg were reported in the iStent inject and medical therapy groups, respectively. A high safety profile was also noted in this study in both the iStent inject and medical therapy groups, as measured by stable best corrected visual acuity, cup-to-disc ratio, and adverse events. CONCLUSION: These data show that the use of iStent inject is at least as effective as two medications, with the clinical benefit of reducing medication burden and assuring continuous treatment with full compliance to implant therapy as well as having a highly favorable safety profile.