Moderate Open-angle Glaucoma Research Articles

Two-Year Retrospective Study of Cataract Surgery and Schlemm Canal Hydrus Microstent in Black and Afro-Latino Patients.

The Hydrus Microstent has been shown to be efficacious in the treatment of Open-angle Glaucoma. We previously reported 1-year results of the Hydrus Microstent in Black and Afro-Latino patients. Here we report two-year results of the Hydrus Microstent in Black and Afro-Latino patients with mild to moderate open-angle glaucoma. This was a retrospective, nonrandomized study that was carried out at two private practices in Harlem, NY and Queens, NY. This study consisted of Black and Afro Latino patients who had a Hydrus Microstent implanted for the treatment of glaucoma. The evaluated parameters were intraocular pressure (IOP), reductions in the number of medications, mean deviation on visual field test and visual acuity. We excluded persons with advanced glaucoma and incomplete data. We included those with mild to moderate glaucoma and had complete two-year follow-up data. The study consisted of 86 patients and 86 eyes. The mean age was 69.The mean pre-op IOP was 14.1 on 2.17 medications. At two years the mean IOP was 14 (p = 0.651) on 0.42 medications (p = 0.000003); 88% of patients were medication free (p = 0.651), The MD on the visual field changed little from -5.73 preoperatively to -5.21 at two years. There were 3 intraocular pressure spikes and 1 case of hyphema that were treated and had complete resolution. No patients required secondary surgery. Our results show that at two years the Hydrus Microstent can maintain low intraocular pressures, reduce medication burden and, in aggregate, experienced little change in visual field Mean Deviation in Black and Afro Latino patients with mild to moderate glaucoma.

Ocular blood flow biomarkers may predict long-term glaucoma progression

Background/aimTo examine the relationship between baseline blood flow biomarkers and long-term open-angle glaucoma (OAG) progression.Methods112 patients with early to moderate OAG (mean age 64.9±11.0 years; 68 female) were evaluated at...

Corneal endothelial safety profile in minimally invasive glaucoma surgery.

To compare 5-year corneal endothelial safety of 3 minimally invasive glaucoma surgery (MIGS) devices (iStent inject , Hydrus Microstent, CyPass Micro-Stent). U.S. multicenter trials. Post hoc 5-year analysis from prospective randomized single-masked pivotal trials. Mild to moderate open-angle glaucoma subjects received a MIGS implant with phacoemulsification (implant + phaco) or phaco alone (control). In addition, 5-year end points comparing the implant and control groups included proportion of eyes with significant endothelial cell loss (ECL) (>30% or ≥30% vs baseline) and mean endothelial cell density (ECD). Comparable proportions of eyes in the iStent inject + phaco and control groups had significant 60-month ECL (9.4% vs 6.3%, respectively, diff: 3.2%, 95% CI, -5.0% to 11.3%, P = .77). Hydrus (20.8% vs 10.6%, diff: 10.2%, 95% CI, 3.2% to 17.2%, P = .01) and CyPass (27.2% vs 10.0%, diff: 17.2%, 95% CI, 5.6% to 28.7%, P = .02) had more eyes with ECL vs controls (iStent inject 1.49X, Hydrus 1.96X, CyPass 2.72X vs controls). Mean ECD over 60 months for iStent inject was indistinguishable vs control, whereas greater ECL was observed primarily 3 months postoperative (Hydrus) or accelerated after 2 years (CyPass). No iStent inject or Hydrus subjects developed persistent corneal edema, whereas 7 CyPass-implanted eyes developed ECL-related complications. Through 5 years postoperative, there were no differences in proportion of eyes with significant ECL or mean ECD between the iStent inject and control groups. There was greater 5-year ECL and lower ECD in the Hydrus and CyPass groups vs controls. The Hydrus ECL rate mirrored control after 3 months; the CyPass ECL rate accelerated vs control.

Trabecular Procedures Combined with Cataract Surgery for Open-Angle Glaucoma: A Report by the American Academy of Ophthalmology

To determine the intraocular pressure (IOP) reduction of various trabecular procedures (a form of minimally invasive glaucoma surgery [MIGS]) combined with cataract surgery compared with cataract surgery alone, to compare the safety of the various trabecular procedures, and to highlight patient characteristics that may favor one trabecular procedure over another. A search of English-language peer-reviewed literature in the PubMed database was initially conducted in February 2021 and updated in April 2023. This yielded 279 articles. Twenty studies met initial inclusion and exclusion criteria and were assessed for quality by the panel methodologist. Of these, 10 were rated level I, 3 were rated level II, and 7 were rated level III. Only the 10 level I randomized controlled trials (RCTs) were included in this assessment, and all were subject to potential industry-sponsorship bias. The current analysis focuses on the amount of IOP reduction (in studies that involved medication washout) and on IOP reduction with concurrent medication reduction (in studies that did not involve medication washout). Based on studies that performed a medication washout, adding a trabecular procedure to cataract surgery provided an additional 1.6 to 2.3 mmHg IOP reduction in subjects with hypertensive, mild to moderate open-angle glaucoma (OAG) at 2 years over cataract surgery alone, which itself provided approximately 5.4 to 7.6 mmHg IOP reduction. In other words, adding a trabecular procedure provided an additional 3.8% to 8.9% IOP reduction over cataract surgery alone, which itself provided 21% to 28% IOP reduction. There was no clear benefit of one trabecular procedure over another. Patient-specific considerations that can guide procedure selection include uveitis predisposition, bleeding risk, metal allergy, and narrowing of Schlemm's canal. There are no level I data on the efficacy of trabecular procedures in subjects with pretreatment IOP of 21 mmHg or less. Trabecular procedures combined with cataract surgery provide an additional mild IOP reduction over cataract surgery alone in hypertensive OAG subjects. Additional research should standardize outcome definitions, avoid industry sponsorship bias, and study the efficacy of these procedures in normotensive OAG. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Association of superficial macular vessel density with visual field progression in open-angle glaucoma with central visual field damage

Identifying the clinical relevance of superficial versus deep layer macular vessel density (mVD) in glaucoma is important for monitoring glaucoma patients. Our current retrospective longitudinal study investigated the association of superficial and deep layer mVD parameters with glaucomatous visual field (VF) progression in mild to moderate open-angle glaucoma (OAG) eyes with central visual field (CVF) damage. Serial optical coherence tomography (OCT) angiography-derived mVD measurements were obtained in 182 mild to moderate OAG eyes (mean deviation ≥ -10 decibels). Forty-eight eyes (26.4%) showed VF progression during a mean follow-up of 3.5 years. The parafoveal and perifoveal mVDs of both superficial and deep layers showed significantly faster reduction rates in the VF progressors than in the non-progressors according to linear mixed effects models (P < 0.05). Cox and linear regression analyses showed that greater reduction rates of both the superficial layer parafoveal and perifoveal mVDs, but not their deep layer counterparts, were significant predictors of VF progression and faster VF loss (P < 0.05). In conclusion, faster rates of change in superficial but not deep layer mVD parameters are significantly associated with subsequent VF progression and faster VF deterioration in mild to moderate OAG eyes with CVF damage.

Comparative outcomes of phacoemulsification combined with micro-invasive glaucoma surgery plus: Schlemm canal microstent versus Ab interno trabecular excision

To report the relative efficacy of combining phacoemulsification with a Schlemm's canal microstent (Phaco/Hydrus) or dual blade trabecular excision (Phaco/KDB). Retrospective study. One hundred and thirty-one eyes of 131 patients who underwent Phaco/Hydrus or Phaco/KDB procedures from January 2016 to July 2021 at a tertiary care center were included and assessed for up to 36months postoperatively. Primary outcomes were intraocular pressure (IOP) and number of glaucoma medications, evaluated by generalized estimating equations (GEE). Two Kaplan-Meier estimates (KM) assessed survival without additional intervention or pressure lowering medication while maintaining: (1) IOP≤21mmHg and≥20% IOP reduction or (2) IOP≤preoperatively designated goal. Mean preoperative IOP was 17.70±4.91 (SD) mmHg on 0.28±0.86 medications in the Phaco/Hydrus cohort (n=69) and 15.92±4.34mmHg on 0.19±0.70 medications in the Phaco/KDB cohort (n=62). At 12months, mean IOP was reduced to 14.98±2.77mmHg on 0.12±0.60 medications after Phaco/Hydrus and 13.52±4.13mmHg on 0.04±0.19 medications after Phaco/KDB. GEE models of IOP (P<0.001) and medication burden (P<0.05) showed significant patterns of reduction across all timepoints in both cohorts. There were no differences in IOP reduction (P=0.94), number of medications (P=0.95) or survival (P=0.72 by KM1, P=0.11 by KM2) between procedures. Both Phaco/Hydrus and Phaco/KDB resulted in significantly reduced IOP and medication burden for over 12months. Phaco/Hydrus and Phaco/KDB confer similar outcomes in terms of IOP, medication burden, survival, and procedural time in a population with predominantly mild and moderate open-angle glaucoma.

Comparison of retinal nerve fiber layer thickness and Bruch’s membrane opening minimum rim width thinning rate in open-angle glaucoma

This study aimed to compare the rate of thinning between retinal nerve fiber layer thickness (RNFLT) and Bruch’s membrane opening minimum rim width (BMO-MRW) in open-angle glaucoma (OAG) according to glaucoma severity. We retrospectively reviewed subjects with a total of 111 eyes with OAG that had undergone optical coherence tomography more than four times during more than 3 years of follow-up. The subjects were divided into three groups based on the mean deviation (MD) of the baseline visual field test: high MD (MD > − 2 dB), medium MD (− 2 dB ≥ MD > − 6 dB), and low MD (− 6 dB ≥ MD > − 12 dB) groups. A linear mixed model was employed to compare the rate of thinning between RNFLT and BMO-MRW among the three groups. The rate of RNFLT thinning was fastest in the inferotemporal sector in all three groups. The rate of BMO-MRW thinning was fastest in the inferotemporal sector of the high MD group and the superotemporal sector of the other two groups. Among the three groups, the rate of RNFLT thinning was not significantly different in the global sector and all sectors except the nasal sector. The rate of BMO-MRW thinning in the inferotemporal sector showed no significant difference, but that in the superotemporal sector was faster in the medium MD and low MD groups than in the high MD group. The fastest rate of RNFLT thinning was consistently observed in the inferotemporal sector, but BMO-MRW showed a change in the fastest thinning sector from inferotemporal to superotemporal, with increasing severity in early to moderate OAG. The difference in the changes in the two parameters may help understand the pathogenesis of glaucoma and predict its progression.

IStent Trabecular Micro-bypass Stent Implantation Combined with Phacoemulsification for Open-Angle Glaucoma: A 2-Year Post-marketing Surveillance Study in Japan.

IntroductionWe report 2-year outcomes after implantation of iStent trabecular micro-bypass stent with phacoemulsification, in Japanese patients with mild–moderate open-angle glaucoma (OAG).MethodsThis was a 24-month, prospective, longitudinal, observational, post-marketing study conducted between July 2017 and September 2020. Patients consisted of adults with OAG on antiglaucoma medications who had cataract surgery combined with one iStent implantation. Outcome measures included intraocular pressure (IOP), antiglaucoma medications, treatment success rates (defined as eyes having lower IOP with same or reduced number of medications from baseline, or same IOP with reduced number of medications from baseline, and not requiring secondary glaucoma surgeries postoperatively), and safety. Outcomes were analyzed in the overall cohort and in glaucoma subtypes: primary OAG, normal-tension glaucoma, and exfoliative glaucoma.ResultsOverall, 232 eyes were enrolled. At 24 months, mean ± standard deviation IOP decreased from 17.6 ± 4.0 mmHg preoperatively to 14.3 ± 3.0 mmHg (p < 0.05), and mean number of medications reduced from 2.2 ± 1.2 preoperatively to 0.7 ± 1.2 (p < 0.05). Similar trends were observed across glaucoma subtypes. In the overall cohort, 96.7%, 95.3%, and 93.7% of patients achieved treatment success at 6, 12, and 24 months, respectively. There were 67.6% medication-free eyes at 24 months compared to 3.2% medication-free eyes preoperatively (p < 0.0001). Safety profile was favorable over the 2-year period.ConclusionsFollowing iStent implantation with phacoemulsification, clinically relevant and statistically significant reductions in IOP and number of medications were observed in Japanese eyes with OAG over 2 years, with favorable safety profile. These reductions were observed across all glaucoma subtypes.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02207-0.

360° Ab-Interno Schlemm's Canal Viscodilation with OMNI Viscosurgical Systems for Open-Angle Glaucoma-Midterm Results.

Purpose: To evaluate the effectiveness of ab-interno microcatheterization and 360° viscodilation of Schlemm’s canal (SC) performed with OMNI viscosurgical system in open angle glaucoma (OAG) together or not with phacoemulsification. Setting: Two surgical sites. Design: Retrospective, observational. Methods: Eighty eyes from 73 patients with mild to moderate OAG underwent ab- interno SC viscodilation performed with OMNI system. Fifty eyes (Group 1) underwent only SC viscodilation, while 30 eyes (Group 2) underwent glaucoma surgery + cataract extraction. Primary success endpoint at 12 months was an intraocular pressure (IOP) reduction higher than 25% from baseline with an absolute value of 18 mmHg or lower, either on the same number or fewer ocular hypotensive medications, without further interventions. Secondary effectiveness endpoints included mean IOP, number of medications and comparison of outcomes between groups. Safety endpoints consisted of best-corrected visual acuity (BCVA), adverse events (AEs), and subsequent surgical procedures. Results: Primary success was achieved in 40.0% and 67.9% in Groups 1 and 2, respectively. Mean IOP at 12-month follow-up showed a significant reduction in both groups (from 23.0 to 15.6 mmHg, p < 0.001, and from 21.5 to 14.1, p < 0.001, in Groups 1 and 2, respectively). Mean medication number decreased in both groups (from 3.0 to 2.0, p < 0.001 and from 3.4 to 1.9, p < 0.001, in Groups 1 and 2, respectively). AEs included hyphema (2 eyes), mild hypotony (4 eyes), IOP spikes one month after surgery (1 eye). Twelve eyes (15.0%) required subsequent surgical procedures. No BCVA reduction was observed. Conclusions: Viscodilation of SC using OMNI viscosurgical systems is safe and relatively effective in reducing IOP in adult patients with OAG.

Combined excimer laser trabeculostomy and phacoemulsification: One year follow-up real world data of a laser-based MIGS.

To evaluate the efficacy and complication profile of excimer laser trabeculostomy (ELT), an emerging laser-based trabecular minimally invasive glaucoma surgery (MIGS), combined with cataract surgery in routine clinical practice. Single-site, retrospective, interventional study. Preoperative and postoperative clinical data of patients with cataract and open-angle glaucoma (OAG) who underwent combined phacoemulsification and ELT were collected and analyzed at preoperative day, one week postoperatively, and after one, two, three, six, nine and 12 months. Main outcome measure was intraocular pressure (IOP). Qualified and complete success were defined as an IOP less than 21mmHg and an IOP reduction ≥20% from preoperative medicated IOP with or without adjuvant medical treatment, respectively. Thirty-four eyes of 29 patients were included; 29 eyes completed 1-year follow-up. The mean preoperative IOP under medications was 20.9±2.6mmHg (±standard deviation, SD) and decreased significantly at one year (16.3±1.9; p<0.0001). The mean number of IOP-lowering medications decreased from 1.7±0.7 to 0.3±0.8 (p<0.0001) at the 12-month follow-up. At one year, 81% of eyes were medication free. Qualified and complete success was obtained in 62% and 58% of eyes, respectively. Two eyes had postoperative hyphema, three eyes had transient IOP spikes and one patient underwent a subsequent filtering surgery at three months. Combining ELT with phacoemulsification in eyes with cataract and mild to moderate OAG significantly reduced IOP and medication use without meaningful complications after one-year follow-up in a real world clinical practice setting.

Retinal Nerve Fibre Layer Assessment in Glaucoma and Glaucoma Suspect by Optical Coherence Tomography (OCT)

Abstract Background Glaucoma is a progressive optic neuropathy characterized by structural changes in the optic nerve head, retinal nerve fiber layer (RNFL) defect, and accompanying visual field damage (VFD). In glaucoma management, detecting progression is essential in both early and late stages of the disease. In patients with an established diagnosis of glaucoma, evidence of progression will influence a clinician’s decision whether to modify glaucoma therapy. In patients who are suspected of having the disease, progression detection can confirm the diagnosis, and help decide how to manage the patient. Although standard automated perimetry has been the most commonly used test to monitor glaucomatous progression, evidence suggests that in some eyes substantial structural damage can be detected before the development of clinically detectable VFD. Objective To compare retinal nerve fibre layer thickness between glaucoma and glaucoma suspects. Methods We conducted our cross sectional comparative study on Forty eight eyes from patients recruited from Ain Shams University Hospitals, Ophthalmology Department during the period from February 2019 to December 2019. The Forty eight eyes were recruited in this study and divided into 2 groups. Group A- (Twenty-four eyes with moderate open angle glaucoma) and Group B- (Twenty four eyes with criteria of glaucoma suspects). Results There was highly Significant difference as regards OCT parameters of the patients (p &amp;lt; 0.001 for all). As the mean value of Cup/disc ratio was lower in Glaucoma Suspected cases, while Total RNFL, RNFL Superior and RNFL Inferior was higher in Glaucoma Suspected cases than patients with Moderate glaucoma. This study showed that; by using ROC-curve analysis, cup to disc ratio (CDR) at a cutoff point (&amp;gt;0.59) detected patients with glaucoma, with excellent accuracy, sensitivity= 95% and specificity= 100%. Also, by using ROC-curve analysis, superior RNFL at a cutoff point (≤116) detected patients with glaucoma, with fair accuracy, sensitivity= 66% and specificity= 91%. While inferior RNFL at a cutoff point (≤113) detected patients with glaucoma, with good accuracy, sensitivity= 70% and specificity= 95%. Conclusion In conclusion, structural progression measured using SD OCT was associated with functional progression shown in VF loss in glaucoma suspect or preperimetric glaucoma eyes and in glaucomatous eyes. Average, inferior and superior RNFL attenuations were the most important risk factors for visual field progression.

Comparative analysis of intraocular pressure dynamics after phacoemulsification with intraocular lens implantation in eyes with primary glaucoma

PURPOSE. To conduct a comparative analysis of changes in intraocular pressure (IOP) after cataract phacoemulsification with implantation of intraocular lens (IOL) in comorbidity with primary open-angle (POAG) and primary closed-angle glaucoma (PACG).METHODS. The study analyzed the dynamics of IOP changes after cataract phacoemulsification in 65 patients (89 eyes) with comorbid PACG and 46 patients (58 eyes) with comorbid POAG, aged 50 to 92 years. Thirty-five (53.85%) patients with POAG had history of glaucoma surgery, and 12 (20.69%) patients with PACG had been treated with laser iridectomy. The disease was in the initial stage in 14.6% of POAG patients and 5.15% of PACG patients; moderate stage — in 55.05% and 47.19%, respectively; advanced stage — in 30.34% and 24.14%. Intraocular pressure in POAG was compensated in 84.5% and subcompensated in 15.5% of patients; in PACG it was compensated in 77.6%, subcompensated in 12.6%, and uncompensated in 10.4% of patients. Compensation of IOP was achieved either by previous surgeries, or application of local antihypertensive medications. Patients with subcompensated and elevated IOP received the maximum possible amount of hypotensive medications. The follow-up period ranged from 1 month to 2 years.RESULTS. Patients were divided into three groups according to postoperative IOP levels: the first group with IOP equal to preoperative level, the second group — with IOP below the initial level, and the third group with IOP above the initial level. The IOP levels were consistent with preoperative values at all follow-up periods in most of study patients, and after 2 years their portion exceeded 70%, while in POAG it was somewhat higher than in PACG (77.42% against 71.43%). The IOP below the preoperative level was observed in eyes with initial and moderate open-angle and closed-angle glaucoma, with the amount decreasing with longer follow-up (from 63.16% at 3 months to 16.13% after 2 years in POAG, and from 62.74% to 19.04% in PACG). In the early postoperative period, number of POAG and PACG patients in this group was comparable, but after 8 months it included more PACG patients. Elevation of IOP in both forms of glaucoma was most often observed in faradvanced stage in the early post-op period after phacoemulsification, subsequently their number decreased and by two years it decreased by almost twice (6.45% vs. 11.84% in POAG and 9.53% vs. 15.69% in PACG). During the entire follow-up period, the number of patients with ophthalmic hypertension in PACG was 30% higher than in POAG.CONCLUSION. The study showed that in most cases phacoemulsification has a stabilizing effect in patients with cataracts in combination with glaucoma. The hypotensive effect of the operation was observed in initial and advanced stages of glaucoma, when the drainage system of the eye was still preserved, and in the long term it was observed in a larger percentage of cases in angle-closure glaucoma compared to open-angle glaucoma. An increase in intraocular pressure relative to the preoperative level was observed in advanced glaucoma throughout the entire follow-up period, and the number of patients with angleclosure glaucoma was one-third higher than the number of patients with open-angle glaucoma. The obtained ambiguous results of intraocular pressure measurements after phacoemulsification of cataract with implantation of IOL in combination with various forms of glaucoma dictate the need for further study of this problem.

Suppression of Diurnal (9AM-4PM) IOP Fluctuations with Minimally Invasive Glaucoma Surgery: An Analysis of Data from the Prospective, Multicenter, Single-Arm GEMINI Study.

PurposeThis study analyzes diurnal IOP data (9AM, 12PM, 4PM) from a prospective 12-month trial of the OMNI Surgical System in open-angle glaucoma (OAG) patients with the aim of evaluating effect of MIGS surgery on the amplitude of the diurnal IOP profile pre- and postoperatively.SettingFifteen ophthalmology practices and surgery centers located in 14 states in the United States.DesignProspective, multicenter, IRB approved study. Patients treated with canaloplasty (360°) and trabeculotomy (180°). Patients had cataract and mild–moderate OAG with intraocular pressure (IOP) ≤33 mmHg on zero to four hypotensive medications.MethodsPost-hoc analysis of diurnal IOP data from the multicenter GEMINI study. Analysis includes comparison of IOP preoperatively and at month 12 for each of the diurnal time points, 9AM, 12PM, 4PM, change in magnitude of spread between the maximum IOP and minimum IOP for each patient and the proportions of patients preoperatively and at month 12 with IOPs at or below 25, 21, 18, and 15 mmHg, average variability (standard deviation of the 9AM, 12PM, and 4PM IOP) preoperatively and at month 12.ResultsA total of 128 patients included in this analysis. IOP at each diurnal timepoint was significantly lower postoperatively (p<0.0001). The difference between highest and lowest IOP measurement for each patient averaged 2.8 mmHg preoperatively (SD 2.4, MAX 14, MIN 0) and 1.8 mmHg (SD 1.7, MAX 10, MIN 0) month 12 (P<0.00001). The proportion with IOP ≤ to 25, 21, 18, and 15 mmHg increased; 75%–97%, 27%–88%, 1%–79%, and <1%–56%, respectively. The average variability was greater at all time points preoperatively (P<0.0001).ConclusionThis study demonstrates that eyes with OAG can benefit from an overall decreased IOP and degree of IOP fluctuations for as long as 12 months after surgical treatment with canaloplasty and trabeculotomy.

Cost-effectiveness analysis of iStent Inject® implantation during cataract surgery compared to cataract surgery alone for mild to moderate open-angle glaucoma patients in Spain

ABSTRACT Objective To estimate the cost-effectiveness of two trabecular micro-bypass stent implants (iStent inject®) during cataract surgery, compared to cataract surgery alone, in patients with cataracts and mild-to-moderate primary Open Angle Glaucoma (OAG) in the Spanish National Health System (SNHS). Methods A Markov model was used to simulate the progression of OAG patients, undergoing either cataract-iStent Inject® surgery or cataract surgery alone, over a lifetime horizon. Health states of glaucoma were based on the Hodapp-Parrish-Anderson criteria. Efficacy and resource use were obtained from published literature and validated by experts. Costs (€, 2020) were obtained from the Spanish database eSalud. The incremental cost-effectiveness ratio (ICER) expressed as cost per quality-adjusted life-year (QALY) gained was calculated. A societal perspective was also explored. Sensitivity analysis tested the robustness of results. Results Cataract-iStent Inject® surgery was more effective and costly than cataract surgery alone, with an ICER of 12,676.48/QALY. The probability of iStent Inject being cost-effective was 90.9% and 78.4%, at a willingness-to-pay of €30,000/QALY and €21,000/QALY, respectively. From a societal perspective, Cataract-iStent Inject® surgery was cost-saving compared to cataract surgery alone. Conclusion Cataract-iStent Inject® surgery was cost-effective (SNHS perspective) or cost-saving (societal perspective) compared to cataract surgery alone in patients with mild-to-moderate OAG.

Cirugía combinada de trabeculostomía láser excímer y facoelmusificación: datos a un año en el mundo real de una MIGS de tipo láser

PurposeTo evaluate the efficacy and complication profile of excimer laser trabeculostomy (ELT), an emerging laser-based trabecular minimally invasive glaucoma surgery (MIGS), combined with cataract surgery in routine clinical practice. Patients and methodsSingle-site, retrospective, interventional study. Preoperative and postoperative clinical data of patients with cataract and open-angle glaucoma (OAG) who underwent combined phacoemulsification and ELT were collected and analyzed at preoperative day, one week postoperatively, and after one, two, three, six, nine and 12 months. Main outcome measure was intraocular pressure (IOP). Qualified and complete success were defined as an IOP less than 21 mmHg and an IOP reduction ≥ 20% from preoperative medicated IOP with or without adjuvant medical treatment, respectively. ResultsThirty-four eyes of 29 patients were included; 29 eyes completed 1-year follow-up. The mean preoperative IOP under medications was 20.9 ± 2.6 mmHg (± standard deviation, SD) and decreased significantly at one year (16.3 ± 1.9; p < 0.0001). The mean number of IOP-lowering medications decreased from 1.7 ± 0.7 to 0.3 ± 0.8 (p < 0.0001) at the 12-month follow-up. At one year, 81% of eyes were medication free. Qualified and complete success was obtained in 62% and 58% of eyes, respectively. Two eyes had postoperative hyphema, three eyes had transient IOP spikes and one patient underwent a subsequent filtering surgery at three months. ConclusionCombining ELT with phacoemulsification in eyes with cataract and mild to moderate OAG significantly reduced IOP and medication use without meaningful complications after one-year follow-up in a real world clinical practice setting.

12-month interim results of a prospective study of patients with mild to moderate open-angle glaucoma undergoing combined viscodilation of Schlemm's canal and collector channels and 360° trabeculotomy as a standalone procedure or combined with cataract surgery.

Purpose:To characterize clinical outcomes of combined viscodilation of Schlemm’s canal and collector channels and 360° trabeculotomy as a standalone procedure or combined with cataract surgery in eyes with mild to moderate open-angle glaucoma (OAG).Methods:In this prospective case series, the OMNI glaucoma surgical platform (Sight Sciences, Menlo Park, CA) was utilized to perform the procedure either combined with phacoemulsification or as a standalone procedure. Changes from baseline in intraocular pressure (IOP) and IOP-lowering medications were evaluated through the first 12 months of a planned 24-month follow-up period.Results:Among 17 eyes of 15 subjects, mean IOP was reduced from 20.4 mmHg to 12.7–13.7 mmHg through 12 months of follow-up (p < 0.001 at every time point) and mean medications reduced from 2.5 to 0.1–0.6 (p < 0.001 at every time point). IOP reductions in eyes undergoing standalone surgery were approximately 2–4 mmHg greater at each time point compared to eyes undergoing surgery combined with phacoemulsification; this may be related to a higher baseline IOP in the former eyes (22.1 vs 18.5 mmHg). Six eyes developed hyphema, of which three required washout for elevated IOP on the first postoperative day; six additional eyes had IOP elevations that resolved with medical management.Conclusion:Viscodilation of Schlemm’s canal and collector channels paired with ab interno trabeculotomy performed with a single integrated instrument (OMNI), whether as standalone or combined with phacoemulsification, effectively lowers both IOP and the need for IOP-lowering medications through 12 months of follow-up.

Superficial macular vessel density in eyes with mild, moderate, and severe primary open-angle glaucoma.

The aim of this study is to report changes in and associations of macular vessel density (VD) and perfusion density (PD) using optical coherence tomography angiography (OCTA) in mild, moderate, and severe open-angle glaucoma. One hundred thirty-three patients with open-angle glaucoma (133 eyes: 47 mild, 33 moderate, and 53 severe glaucoma) and 73 normal subjects (right eyes) were included in this cross-sectional study. All subjects underwent Cirrus OCTA measurements. One-way analysis of variance (ANOVA) was used to compare macular VD and PD between the controls and mild, moderate, and severe glaucoma groups. Multiple linear regression was performed with OCTA parameters as the predicted variable and age, gender, spherical equivalent (SE), intraocular pressure (IOP), mean deviation (MD), signal strength (SS), and mean macular ganglion cell-inner plexiform layer (mGCIPL) thickness as the predictor variables. The total area of VD showed significant differences between the controls vs. mild (p < 0.001) and moderate vs. severe glaucoma (p = 0.003); no significant difference was found between mild and moderate glaucoma (p = 1.000). Macular VD was associated with age (β = -0.02, p = 0.003), MD (β = 0.04, p = 0.001), SS (β = 1.43, p < 0.001), and mGCIPL thickness (β = 0.04, p = 0.002) but not with gender, SE, and IOP (all p > 0.05). Macular microcirculation declined significantly in mild and severe glaucoma. No significant difference was found between mild and moderate glaucoma. Decrease macular VD was independently associated with age, severe MD, lower SS, and thinner mGCIPL thickness.

Mid-term evaluation of the safety and efficacy of the iStent trabecular micro-bypass system combined with phacoemulsification.

Micro-invasive glaucoma surgery (MIGS) and MIGS devices have been gaining increasing attention in recent years. One such device is the trabecular micro-bypass stent, or iStent® (Glaukos Corporation, Laguna Hills, USA). To evaluate the safety and efficacy of the minimally invasive ab interno surgical implantation of a trabecular bypass during cataract surgery in reducing intraocular pressure (IOP) in patients with mild and moderate open-angle glaucoma and cataracts. The study was a prospective, uncontrolled, interventional case series (a prospective study of a case series), including 54 patients with a mean age of 72 years. All subjects underwent ab interno implantation of a single iStent together with cataract surgery. The corrected distance visual acuity (CDVA), IOP, anti-glaucoma medications, visual field, and number and type of complications were investigated after surgery. The patients were followed up at 1, 7, and 30 days, and 3, 6, 12, 24 and 36 months after the operation. The mean observation time was 20 months. At baseline, CDVA was 0.5 or better in 65% of the eyes; this improved to 0.5 or better in all eyes (0.8 or better in 79%) at the end of the observation. The mean baseline IOP was 17.1 mm Hg, which fell to a mean of 15.1 mm Hg. The mean number of medicinal eye drops prescribed preoperatively was 1.7, which decreased to 0.26 at the end of the observation. Cataract surgery combined with iStent implantation seems to be an effective procedure in patients with mild to moderate open-angle glaucoma and cataracts. The insertion of 1 stent resulted in a significant decrease in IOP and a reduction in the number of topical anti-glaucoma medications needed. Based on the characteristics of the observed complications, iStent implantation can be considered a safe method.

Canaloplasty and Trabeculotomy with the OMNI System in Pseudophakic Patients with Open-Angle Glaucoma: The ROMEO Study

Provide outcomes up to 12 months postsurgically for sequential canaloplasty and trabeculotomy with the OMNI surgical system (Sight Sciences, Inc) in pseudophakic patients with mild to moderate open-angle glaucoma. Retrospective, multicenter, single-arm study conducted at 10 multi-subspecialty ophthalmology practices and surgery centers located in 7 states (Arkansas, California, Kansas, Louisiana, Missouri, New York, and Texas). Eligible patients were pseudophakic, with mild/moderate open-angle glaucoma, 12-month follow-up, and medicated intraocular pressure (IOP) ≤36 mmHg on ≤4 medications preoperatively. One eye per patient was enrolled. Institutional Review Board approved. All available cases meeting eligibility criteria were enrolled. Analysis of secondary end points was stratified by baseline (BL) IOP (>18 mmHg in group 1 and ≤18 mmHg in group 2) recognizing that treatment goals differed depending on BL IOP. Primary success was defined as the proportion of patients with ≥20% reduction in IOP from BL or IOP between 6 and 18 mmHg (inclusive) and on the same or fewer medications without secondary surgical intervention (SSI). Other effectiveness end points included mean IOP and number of medications at 12 months. Safety end points were best-corrected visual acuity (BCVA), adverse events (AEs), and SSIs. Forty-eight patients were enrolled, 24 in each group. Primary success was met by 73%. Mean IOP was reduced in group 1 (21.8 to 15.6 mmHg, P < 0.0001) and remained controlled in group 2 (15.4 to 13.9 mmHg, P= 0.24). Medications went from 1.7 ± 1.3 to 1.2 ± 1.3 (P= 0.024) in group 1 and from 2.0 ± 1.3 to 1.3 ± 1.3 (P=0.003) in group 2. Adverse events were typical for the patient population undergoing angle surgery. Those reasonably related to the procedure were mild inflammation (13%), IOP spikes (6%), hyphema, corneal edema, and BCVA loss (all 4%). Five patients (10%) required an SSI. The sequential combination of canaloplasty followed by trabeculotomy performed as stand-alone procedures using the OMNI system in pseudophakic patients with open-angle glaucoma provides effective IOP reduction or sustained IOP control and meaningful medication reduction for up to 12 months postoperatively.

Gender-related Influences on Superficial Papillary Microcirculation Measured with Optical Coherence Tomography Angiography in Patients with Glaucoma

ABSTRACT Purpose: To evaluate the optic nerve head (ONH), macular vessel density, and retinal nerve fiber layer (RNFL) thickness differences between the genders. Material and methods: In this prospective case-control cross-sectional study 111 healthy subjects and 130 primary open-angle glaucoma (OAG) patients were examined with optical coherence tomography angiography (OCT-A (RS-3000 Advance (Nidek, Gamagori, Japan))). The vessel density in the peripapillary and macular area as well as the RNFL thickness was evaluated. Results: Men appeared to have less RNFL thickness compared with women in early glaucomatous group, being significant at the whole circumpapillary retinal nerve fiber layer (cpRNFL) thickness and inferior and nasal quadrants: (cpRNFL) (71.01 ± 9.32 vs 77.64 ± 9.95 μm; P = .001), superior quadrant (89.10 ± 16.63 vs 92.97 ± 17.53 μm; P = .284), inferior quadrant (83.03 ± 19.17 vs 95.07 ± 21.70 μm; P = .006), temporal quadrant (57.11 ± 10.36 vs 61.78 ± 11.37 μm; P = .043), nasal quadrant (54.81 ± 11.42 vs 60.73 ± 11.62 μm; P = .016). Circumpapillary (wcpVD) and macular (wmVD) vessel density values were lower in men than women in the early stage OAG group, being wmVD significantly lower: wcpVD (15.53 ± 2.45% vs 16.81 ± 3.17%, P = .032) and wmVD values (12.51 ± 2.21 vs 13.63 ± 2.28%, P = .019), but not in the moderate OAG group (wcpVD 14.46 ± 2.20% vs 16.61 ± 3.10%, P = .056 and wmVD 12.61 ± 2.40% vs 12.74 ± 2.54%, P = .870). There were no significant differences between men and women for RNFL thickness and the vessel density parameters in normal group. Conclusion: Both, the thickness of the nerve fiber layer and peripapillary and macular vessel density are lower in men than in women with glaucoma, more markedly in early stage glaucomatous patients.