Lower Mean Intraocular Pressure Research Articles

Long-term Visual Field Variability in Patients with Primary Open-angle Glaucoma

Purpose: To investigate factors associated with variability in the longitudinal visual field (VF) test in patients with primary open-angle glaucoma (POAG).Methods: This retrospective study enrolled POAG patients with VF ≥ 12 who were followed up for ≥ 6 years. First, 52 total deviation values of VF series for each eye were linearly regressed against time (years), and the root mean square error (RMSE) of the residuals was used to measure long-term pointwise VF variability. The mean deviation (MD) of the VF series for each eye was linearly regressed against time (years), and the RMSE of the residuals was used to measure long-term global VF variability. Using hierarchical clustering, variable clustering was performed to select variables and Spearman’s correlation was used as a similarity index. We fitted a mixed effect linear regression model and evaluated factors associated with the long-term VF variability in each regression model.Results: The study included 246 eyes of 157 patients with POAG. Worse baseline peripapillary retinal nerve fiber layer (RNFL) thickness, lower baseline intraocular pressure (IOP), lower mean IOP, greater IOP fluctuation, and a faster VF decay rate were associated with increased long-term pointwise VF variability in the RNFL thickness model (all <i>p</i> ≤ 0.037). Worse baseline MD, lower baseline IOP, lower mean IOP, and faster VF decay rate were associated with increased long-term global VF variability in the MD model (all <i>p</i> ≤ 0.035).Conclusions: Lower baseline and mean IOP, greater IOP fluctuation, worse glaucoma severity, and a faster VF decay rate were associated with greater long-term VF variability in patients with POAG. These factors should be considered when evaluating VF progression.

Increased incidence of acute primary angle closure during the COVID-19 outbreak in China: A retrospective analysis.

This study aimed to investigate the incidence and clinical characteristics of acute primary angle closure (APAC) during the Coronavirus Disease 2019 (COVID-19) pandemic in China. This was a retrospective study of patients diagnosed with APAC in a glaucoma clinic over a 5-year period. We compared the number of APAC cases during the COVID-19 outbreak (December 7, 2022 to January 7, 2023) with those during the same period in previous years and 2 months prior to the outbreak. We also collected data on the demographic and clinical features of APAC patients, such as age, sex, disease course, visual acuity, intraocular pressure (IOP), and lens opacity. We included 95 eyes of 88 patients with APAC were included. Of these, 65 were female and 23 were male. The mean age was 68.0 ± 8.1 years. The median disease course was 10.8 ± 9.5 days. There was a significant increase in the number of APAC cases during the COVID-19 outbreak compared with the same months over a 5-year period (44 vs 51, P < .001). A higher proportion of women developed APAC during the outbreak period than during the non-outbreak period (P < .001). Eyes with APAC in the outbreak period had a lower mean IOP than those in the preceding 6 months (40.5 ± 8.8 mm Hg vs 46.1 ± 10.1 mm Hg; P = .043). No significant differences were observed in disease duration, lens opacity, or bilateral or unilateral onset between the 2 groups. Our study suggests a potential correlation between APAC and COVID-19, marked by a significant surge in APAC cases concurrent with the COVID-19 outbreak. However, the underlying mechanisms and preventive strategies remain to be elucidated.

Exploring ethnic and racial differences in intraocular pressure and glaucoma: The Canadian Longitudinal Study on aging

PurposeTo determine whether self-reported race/ethnicity is associated with intraocular pressure (IOP) and glaucoma and to explore whether any associations are due to social, behavioral, genetic, or health differences. DesignCross-sectional analysis of population-based data. MethodsWe used the Canadian Longitudinal Study on Aging Comprehensive Cohort, which consists of 30,097 adults aged 45–85 years. Race/ethnicity was self-reported. Corneal-compensated intraocular pressure (IOP) was measured in mmHg using the Reichert Ocular Response Analyzer. Participants were asked to report if they have ever had a diagnosis of glaucoma and whether they used eye care in the past year. A glaucoma polygenic risk score (PRS) was calculated. Logistic and linear regression models were used. ResultsBlack individuals had higher mean IOP levels (beta coefficient (β) = 1.46; 95% confidence interval [CI], 0.62, 2.30) while Chinese, Japanese and Korean (β = −1.00; 95% CI, −1.63, −0.38) and Southeast Asian and Filipino individuals (β = −1.56; 95% CI, −2.68, −0.43) had lower mean IOP levels as compared to White individuals after adjustment for sociodemographic, behavioral, genetic, and health-related variables. Black people were more likely to report glaucoma as compared to White people after adjustment (odds ratio [OR] = 2.43; 95% CI, 1.27, 4.64). ConclusionRacial and ethnic differences in IOP and glaucoma were identified. Adjusting for sociodemographic, behavioral, genetic, and health-related variables did not fully explain these differences. Longitudinal research is needed to further explore the reasons for these differences and to understand their relevance to disease pathogenesis and progression.

Real-World Analysis of the Efficacy of Bimatoprost Sustained-Release Glaucoma Implant Where American Indians Comprise the Largest Minority Population.

To assess the effectiveness and safety of bimatoprost sustained release (SR) glaucoma implant as a treatment for open-angle glaucoma and ocular hypertension in a real-world private practice setting with a significant American Indian population. This retrospective study included 156 eyes from adult patients who received a single injection of bimatoprost implant between June 2020 and May 2022 at the Oklahoma Eye Surgeons. Patients were stratified by baseline intraocular pressure (IOP) (≥21 mmHg versus IOP<21 mmHg). The co-primary endpoints were changes in the mean IOP and the number of topical IOP-lowering medications from baseline to Month 6. At 6 months, eyes with baseline IOP≥21 mmHg had a significantly lower mean IOP (19.85±8.01 versus 26.25±4.84 mmHg; p<0.0001) and the mean number of IOP-lowering medications (1.04±1.44 versus 1.38±1.50; p=0.048) compared with baseline. One year after implantation, 73.58% of eyes had a ≥20% reduction in IOP, 41.51% were medication-free and 30.19% were receiving at least one fewer medication. Among eyes with baseline IOP<21 mmHg, there was a significant reduction in the mean number of IOP-lowering medicines by Month 6 (0.61±1.03 versus 1.93±1.21 at baseline; p<0.0001), with no change in IOP. At 12 months, 24.27% of eyes had a ≥20% decrease in IOP, 43.69% of eyes did not require any medications and 63.11% had at least one fewer medication compared with baseline. An analysis using Welch's two-sample t-test showed no significant differences in the outcomes between the overall population and the American Indian population (number of eyes, 23). Bimatoprost SR glaucoma implant lowered IOP in eyes with high, uncontrolled baseline IOP, while it reduced the number of medications in eyes with a controlled baseline IOP. No clinically meaningful and statistically significant differences in the efficacy of bimatoprost were observed in patients of American Indian descent.

Factors Associated with Increased Intraocular Pressure in Type 2 Diabetes Patients

Background: Over one-third of patients living with diabetes will develop ocular disease during their lifetime. The present study analyzes the association between metabolic and anthropometric markers, associated comorbidities, and intraocular pressure (IOP) in patients with type 2 diabetes mellitus (DM). Methods: The retrospective study included 87 adult patients with type 2 DM who underwent routine eye examinations and blood/urine tests. Results: 67.9% of the patients had an IOP &gt; 14.5 mmHg and only 41.3% had an HbA1c &lt; 7%. In a multivariate regression analysis, the mean IOP was associated with diabetes duration in subjects with a disease duration &lt; 15 years and an HbA1c &lt; 7% (adjusted R2 = 0.29, p = 0.008). Also, patients with shorter diabetes duration and optimal glucose control had a lower mean IOP than patients with a higher HbA1c (mean IOP 15.1 mmHG vs. 18.9 mmHg, p = 0.04). The patient’s age, anthropometric or metabolic markers, associated comorbidities like hypertension (HTN) or retinal angiosclerosis, and diabetes therapies were not associated with IOP in this study. Conclusion: Diabetes progression is directly associated with increased IOP. Avoiding clinical inertia and optimizing glycemic control could prevent or delay the increase of IOP. Routine eye examination should include measuring IOP, not only diabetic retinopathy screening.

Gel Stent Versus Trabeculectomy: The Randomized, Multicenter, Gold-Standard Pathway Study (GPS) of Effectiveness and Safety at 12 Months

To compare effectiveness and safety of the gel stent to trabeculectomy in open-angle glaucoma (OAG). Prospective, randomized, multicenter, noninferiority study. Patients with OAG and intraocular pressure (IOP) 15 to 44 mm Hg on topical IOP-lowering medication were randomized 2:1 to gel stent implantation or trabeculectomy. Primary end point (surgical success): percentage of patients at month 12 achieving ≥20% IOP reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or secondary surgical intervention (SSI) in a noninferiority test with 24% margins. Secondary end points (month 12) included mean IOP and medication count, postoperative intervention rate, visual recovery, and patient-reported outcomes (PROs). Safety end points included adverse events (AEs). At month 12, the gel stent was statistically noninferior to trabeculectomy (between-treatment difference [Δ], -6.1%; 95% CI, -22.9%, 10.8%); 62.1% and 68.2% achieved the primary end point, respectively (P=.487); mean IOP and medication count reductions from baseline were significant (P<.001); and the IOP change-related Δ (2.8 mm Hg) favored trabeculectomy (P=.024). The gel stent resulted in fewer eyes requiring in-office postoperative interventions (P=.024 after excluding laser suture lysis), faster visual recovery (P≤.048), and greater 6-month improvements in visual function problems (ie, PROs; P≤.022). The most common AEs were reduced visual acuity at any time (gel stent, 38.9%; trabeculectomy, 54.5%) and hypotony (IOP <6 mm Hg at any time) (gel stent, 23.2%; trabeculectomy, 50.0%). At month 12, the gel stent was statistically noninferior to trabeculectomy, per the percentage of patients achieving ≥20% IOP reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or SSI. Trabeculectomy achieved a statistically lower mean IOP, numerically lower failure rate, and numerically lower need for supplemental medications. The gel stent resulted in fewer postoperative interventions, better visual recovery, and fewer AEs.

Choroidal Effusions after Glaucoma Drainage Implant Surgery: Risk Factors and Surgical Management

To report the incidence of patients who developed choroidal effusions after glaucoma drainage implant (GDI) surgery and determine risk factors for and outcomes of surgical intervention. Retrospective case series. Medical records of 605 patients who underwent GDI surgery from January 1, 2017 to June 7, 2021 at New York University Langone Health and New York Eye and Ear Infirmary of Mount Sinai were reviewed. Preoperative, intraoperative, and postoperative clinical data were obtained. Multivariate logistic regression evaluated the factors associated with the need for surgical intervention. Patient records were analyzed for effusion resolution, intraocular pressure (IOP), visual acuity (VA), and complications across treatment modalities. Incidence of choroidal effusion development and need for surgical intervention. Choroidal effusions developed in 110 (18%) patients (110 eyes). Surgical intervention to drain the effusion or ligate the implant tube was performed in 19 (17%) patients. The average time to surgical intervention was 47.6 days. Among patients who developed postoperative effusions, risk factors for requiring surgical intervention included history of selective laser trabeculoplasty (SLT) (P=0.004; odds ratio [OR], 14.4), prior GDI surgery (P=0.04; OR 8.7), 350-mm2 Baerveldt glaucoma implant placement (P=0.05; OR, 4.8), and anterior chamber shallowing (AC; P<0.001; OR, 25.1) in the presence of effusions. The subgroup that required multiple surgeries for effusion resolution had a significantly lower mean IOP at the most recent follow-up compared with those who received medical management only (P<0.001). A higher percentage of patients who required surgical intervention lost VA at the most recent follow-up compared with patients whose effusions resolved with conservative management (i.e., medical management, AC viscoelastic injection). Choroidal effusions after GDI surgery resolved with conservative management in most patients. A history of SLT or GDI placement, implantation of a BGI-350, and the presence of a shallow chamber were risk factors for surgical intervention. Although interventions, such as surgical drainage are at times necessary, a better understanding of their impacts can help guide postoperative decisions. The risks and benefits of these procedures must be carefully considered in these high-risk eyes. Proprietary or commercial disclosure may be found after the references.

Lens extraction versus laser peripheral iridotomy for acute primary angle closure.

Lens extraction versus laser peripheral iridotomy for acute primary angle closure.

Size Matters: Ab Interno Canaloplasty Revision with Suture Trabeculotomy.

To report the efficacy of the revision of failed ab interno canaloplasty with micro-invasive suture trabeculotomy (MIST) over a follow-up period of 24 months. A retrospective analysis was performed on 23 eyes with open-angle glaucoma (OAG), on whom an ab interno canaloplasty revision with MIST was performed for glaucoma progression. The primary outcome was the proportion of eyes with a significant intraocular pressure (IOP) reduction at 12 months post trabeculotomy, defined as an IOP ≤ 18 mm Hg or ≥20% reduction in IOP without any secondary intervention (SI), and with the same or fewer number of glaucoma medications (NGM). All parameters, including best corrected visual acuity (BCVA), IOP, NGM, and SI, were evaluated at 1, 6, 12, 18, and 24 months. At 12 months, eight out of 23 eyes (36.4%) achieved complete success, maintained in six eyes (27.3%) at 24 months. A significantly lower mean IOP was recorded at all visits [14.3 ± 4.0 mm Hg at 24 months vs 23.1 ± 6.8 mm Hg at baseline (BL)] with a percent IOP change of up to 27.3% at 24 months postoperatively. NGM and BCVA did not significantly decrease from BL. A total of 11 eyes (47.8%) needed an SI throughout the follow-up period. Ab interno trabeculotomy in patients with failed canaloplasty was not shown to be effective in providing a satisfactory control of IOP in OAG patients, possibly due to the small suture gauge used in the initial canaloplasty. Further research is needed to optimize the surgical outcome. Seif R, Jalbout NDE, Sadaka A, et al. Size Matters: Ab Interno Canaloplasty Revision with Suture Trabeculotomy. J Curr Glaucoma Pract 2022;16(3):152-157.

Single versus Double PreserFlo MicroShunt Implantation in Glaucoma Patients: A Retrospective Cohort Study

Introduction: The aim of this study was to describe and evaluate double PreserFlo MicroShunt implantation as a modified micro-invasive glaucoma surgery technique and to retrospectively compare the outcomes in a cohort of glaucoma patients with single or double implantation. Materials and Methods: A retrospective data analysis of 57 glaucoma patients who consecutively underwent PreserFlo implantation was performed. Medical records were examined for patients’ demographics, glaucoma type, intraocular pressure (IOP), medication, complications, and re-interventions. Two groups with single (n = 29) or double (n = 28) implantation were formed, and the outcomes were compared. In cases of two-stage double implantation (n = 17), the courses of the initial and the second implantations were compared. Results: Mean preoperative IOP was significantly higher in the double compared to the single implantation group (29.4 ± 10.0 mm Hg; 21.7 ± 8.2 mm Hg; p = 0.003). Postoperatively, IOP was significantly lower in the double implantation group at various time-points (day 1, week 1, months 3 and 6; all p < 0.021). In the subgroup with two-stage procedures, mean preoperative IOP was 24.5 ± 8.5 mm Hg and 29.8 ± 10.1 mm Hg, respectively (p = 0.128). While immediately postoperatively, mean IOP lowering was clinically significant and similar following both procedures, the longer sustainable effect was observed after the second procedure (month 12: 25.5 ± 7.5 mm Hg; 12.4 ± 4.8 mm Hg; p = 0.001). No serious complications were observed. Discussion/Conclusion: Double PreserFlo implantation appears safe and efficient for lowering IOP in glaucoma patients. Our preliminary findings suggest that double is superior to single implantation in terms of IOP lowering and the need for additional topical medication. Patients with insufficient IOP lowering following single implantation may benefit from a second implantation. Further research is warranted to evaluate double implantation as a first-line, one-stage procedure.

Long-term surgical outcomes of Aurolab aqueous drainage implant in pediatric eyes with primary congenital glaucoma versus aphakic glaucoma

PurposeTo compare the outcomes of the Aurolab aqueous drainage implant (AADI) placed in eyes with refractory primary congenital glaucoma (PCG) versus aphakic glaucoma (APG).DesignRetrospective comparative interventional case series.MethodsCase files of...

A systematic review and meta-analysis of randomised controlled trials in the management of neovascular glaucoma: absence of consensus and variability in practice

PurposeNeovascular glaucoma (NVG) is characterised by neovascularisation of the angle and therefore elevated intraocular pressure (IOP). This results in progressive optic neuropathy and loss of visual acuity. Treatment aims to reduce IOP in order to prevent optic nerve damage. A systematic review was completed synthesising results from randomised control trials (RCTs) comparing interventions for the management of NVG and their efficacy and safety.MethodsData was sourced from Web of Science, Embase and Medline after 1st January 2000. The primary outcome measures were mean IOP at follow-up and success rate. The secondary outcomes included mean IOP lowering medications and total complications. A meta-analysis was completed on comparative studies using Revman (version 5.4).ResultsFor the two studies comparing Ahmed glaucoma valve (AGV) + pan-retinal photocoagulation (PRP) vs AGV + PRP + intra-vitreal bevacizumab (IVB), there was no difference in mean IOP or odds of success from the meta-analysis. From the 4 studies examining the utilisation of anti-vascular endothelial growth factor (anti-VEGF), one study showed lower mean IOP at 1 (p = 0.002) and 3 months (p = 0.033) for IVB vs sham injection. In the 2 studies studying transcleral diode laser (TDL), there were no significant findings. From the 4 studies looking at trabeculectomy (trab), lower mean IOP at 6 (p = 0.001), 9 (p = 0.01), 12 (p = 0.02) and 18 months (p = 0.004) was shown for intra-vitreal ranibizumab (IVR) + PRP + visco-trabeculectomy vs IVR + PRP + trab, and a significantly lower mean IOP was present in the Baerveldt group vs trab at 6 months (p = 0.03). In the 2 studies investigating the AGV, there was a lower mean IOP at 1 month (p = 0.01) in the AGV + triamcinolone (TCA) group. The risk of bias was low for 4 studies, high for 4 studies and 6 studies had some concerns.ConclusionThis is the first meta-analysis of RCTs in the management of neovascular glaucoma. The lack of high-quality evidence contributes to the lack of consensus in managing NVG. Our results highlight modern treatment strategies and the need for better powered RCTs with long-term follow-up in order to establish optimal treatment modalities and true patient outcomes.

Bleb Analysis Using Anterior Segment Optical Coherence Tomography and Surgical Predictors of XEN Gel Stent.

PurposeTo determine the early predictors of surgical success 6 months after XEN surgery among clinical parameters, including anterior segment optical coherence tomography (AS-OCT).MethodsA total of 31 eyes with medically uncontrolled primary open-angle glaucoma or pseudoexfoliation glaucoma was enrolled retrospectively. Using AS-OCT, XEN tip location was categorized into intraconjunctival, intratenon, or uviform at day 1 and blebs were classified into no or low, high sparse, high thick, cystic, or mixed walls at month 6. Using slit-lamp photography, blebs were classified into no or low, localized avascular, diffuse avascular, localized vascular, or diffuse vascular blebs at month 6. Surgical success was defined as an intraocular pressure (IOP) of less than 14 mm Hg.ResultsIntraconjunctival and intratenon locations of the tip mostly created a high sparse wall, whereas the uviform type mostly created no or low wall and no or low bleb. The uviform type was linked to pseudoexfoliation glaucoma. A high sparse wall and diffuse avascular bleb showed a lower mean IOP than a high thick wall and localized vascular bleb. In the multivariate analysis, female sex and IOP at week 1 were early predictors of surgical success (8.45 times and 33.1% per 1 mm Hg-decrease, respectively).ConclusionsBleb evaluation using AS-OCT is valuable to correlate tip location and bleb morphology with clinical profiles, considering that a lower early postoperative IOP is linked to surgical success.Translational RelevanceBleb analysis using AS-OCT on day 1 could help to predict bleb morphology after 6 months, which is important to maintain the functioning bleb in the longer term.

The Quality of Life of Medically Versus Surgically Treated Primary Open-angle Glaucoma Patients at a Nigerian Hospital.

The purpose of this study is to compare the quality of life (QoL) of medically treated versus surgically treated primary open-angle glaucoma (POAG) patients attending Lagos University Teaching Hospital, Lagos, Nigeria. The study was a hospital-based, comparative cross-sectional study. Consecutive consenting POAG participants who met the inclusion criteria were recruited until the sample size was achieved. QoL of all participants was assessed using the glaucoma QoL-15 and National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) questionnaires. Analysis was done using the IBM statistical package for the social sciences version 25.0. The study involved 81 participants who were only on medical treatment for POAG and 81 age- and sex-matched POAG participants who had trabeculectomy surgery. Surgically treated participants had a lower mean intraocular pressure 11.68 mmHg when compared to the medically treated participants 14.82 mmHg. Medically treated participants however had a better overall mean glaucoma QoL using the glaucoma QoL-15 (medical 34.36 ± 10.4, surgical 39.11 ± 13.9 P = 0.015) and NEI-VFQ-25 questionnaires (medical 68.32 ± 15.0, surgical 62.44 ± 18.8 P = 0.029). Controlling for the severity of glaucoma using the glaucoma QoL-15 questionnaire, medically treated participants had a better QoL only among participants with severe POAG (medical 49.13 ± 5.9, surgical 54.06 ± 4.6 P = 0.003). While using the NEI-VFQ-25 questionnaire, medically treated participants had a significantly better QoL only among participants with moderate (medical 74.70 ± 6.6, surgical 67.07 ± 15.6 P = 0.012) and severe POAG (medical 54.52 ± 6.3, surgical 45.51 ± 10.0 P = 0.004). The study demonstrated that although participants that had trabeculectomy had a lower mean intraocular pressure, their overall mean QoL was reduced compared to the medically treated participants.

Ultrasound Cyclo Plasty for Treatment of Surgery-Naïve Open-Angle Glaucoma Patients: A Prospective, Multicenter, 2-Year Follow-Up Trial.

Background: The purpose of this prospective study was to evaluate the efficacy and safety of the Ultrasound Cyclo Plasty (UCP) procedure using high-intensity focused ultrasound in surgery-naïve open-angle glaucoma patients. Methods: prospective, non-randomized, single-arm, multicenter clinical trial. Sixty-six eyes with primary open-angle glaucoma, intraocular pressure (IOP) ≥21 mmHg and with no history of filtering surgery were enrolled. Patients were treated by UCP with a therapy probe comprising six piezoelectric transducers, consecutively activated for 8 s each. Complete ophthalmic examination was performed before the procedure, 1 day after the procedure, and 1, 3, 6, 12, 18 and 24 months after the procedure. Primary outcomes were complete success (defined as IOP lowering from baseline ≥20% without additional glaucoma medications) and vision-threatening complications. Secondary outcomes were the presence of complications and the reduction of the number of medications used. Results: IOP was significantly reduced after one procedure (p < 0.05), from a mean pre-operative value of 24.3 ± 2.9 mmHg (n = 2.3 hypotensive medications) to a mean value of 15.9 ± 3.6 mmHg (n = 2.2 hypotensive medications) at 2 years (mean IOP lowering of 33%). Surgical success was achieved in 74% of eyes. Notwithstanding side effects such as transient anterior chamber inflammation, refractive error changes, transient hypotony and macular edema, no major intra or post-operative complications such as phthisis, induced cataract, neovascularization or significant vision loss were observed. Conclusions: Ultrasound Cyclo Plasty is a valuable, effective and well-tolerated procedure to lower IOP in patients with open-angle glaucoma without previous filtering surgery.

Efficacy of Trabeculectomy Combined With Limited Deep Sclerectomy Versus Trabeculectomy Alone: A Randomized-controlled Trial.

The addition of limited deep sclerectomy (LDS) to conventional trabeculectomy increases the success rate, especially in pseudophakic eyes. This study aimed to evaluate the efficacy of LDS in enhancing the intraocular pressure (IOP)-lowering outcomes of trabeculectomy. This was a parallel-arm, single-masked, randomized-controlled trial. A total of 68 patients (68 eyes) with moderate to advanced primary open-angle glaucoma or primary angle-closure glaucoma with pseudophakia were recruited at a tertiary eye care center in Northern India and randomized into 2 groups. Thirty-five eyes in group 1 were subjected to trabeculectomy alone and 33 eyes in group 2 were subjected to trabeculectomy with LDS. All cases were supplemented with low-dose subconjunctival mitomycin-C (0.1 mg/mL for 1 min) in both groups. The primary outcome measure was IOP, and success rates were calculated for IOP ≤18/15/12 and ≥5 mm Hg. The secondary outcome measures included evaluation of bleb morphology, presence of an intrascleral aqueous lake, and supraciliary flow on ultrasound biomicroscopy. The mean postoperative IOP at 12 months was 13.4±1.83 mm Hg in group 1 and 12.5±1.67 mm Hg in group 2 (P=0.04). For IOP cutoff ≤15 mm Hg, absolute success was noted in 11 (31.4%) and 22 eyes (66.6%) in groups 1 and 2, respectively (P=0.004). At 12 months, the intrascleral lake was detected in 2 (6%) eyes in group 1 and in 9 (29%) eyes in group 2 (P=0.02). Supraciliary flow was detected in 2 eyes (6.2%) in group 2 and none in group 1 at 12 months (P=0.02). In the Cox proportional hazard model, trabeculectomy with LDS was associated with a lower rate of failure (hazard ratio: 0.32, 95% confidence interval: 0.13-0.75, P=0.009). The addition of LDS to trabeculectomy led to lower mean IOP and higher success rates at 12 months, compared with trabeculectomy alone.

Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study

To compare the effectiveness and safety of the MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG). One-year results from a 2-year, prospective, randomized, multicenter, noninferiority study (NCT01881425) conducted in the United States and Europe. Eligible patients were aged 40-85 years with intraocular pressure (IOP) ≥15 and ≤40 mmHg and mild-to-severe POAG inadequately controlled on maximum tolerated medical therapy. Patients were randomized 3:1 to undergo stand-alone MicroShunt implantation or trabeculectomy, both performed with adjunctive mitomycin C (0.2 mg/ml for 2 minutes). The primary effectiveness end point was surgical success, defined as ≥20% reduction in mean diurnal IOP from baseline (no medication washout) at year 1 without increasing the number of glaucoma medications. Secondary effectiveness end points at year 1 were the mean IOP change from baseline and requirement for postoperative intervention. Additional end points included glaucoma medication use and adverse events. Overall, 395 (MicroShunt) and 132 (trabeculectomy) patients were randomized (mean Humphrey visual field mean deviation,-12.34 decibels [dB]). At year 1, probability of success was lower in the MicroShunt group compared with the trabeculectomy group (53.9% vs. 72.7%, respectively; P < 0.01). In the MicroShunt group, mean IOP ± standard deviation decreased from 21.1 ± 4.9 mmHg at baseline to 14.3 ± 4.3 mmHg (-29.1%; P < 0.01) at year 1, with a mean of 0.6 ± 1.1 glaucoma medications (baseline 3.1 ± 1.0; P < 0.01). In the trabeculectomy group, mean IOP decreased from 21.1 ± 5.0 mmHg to 11.1 ± 4.3 mmHg (-45.4%; P < 0.01), with a mean of 0.3 ± 0.9 glaucoma medications (baseline 3.0 ± 0.9; P < 0.01). Postoperative interventions, including laser suture lysis, were reported in 40.8% (MicroShunt) versus 67.4% (trabeculectomy) of patients (P<0.01). Reported incidence of transient hypotony was higher in the trabeculectomy group versus the MicroShunt group (49.6% vs. 28.9%; P < 0.01). Vision-threatening complications were uncommon and reported in 1.0% of MicroShunt versus 0.8% of trabeculectomy patients. Probability of success was lower with MicroShunt compared with trabeculectomy. Although reductions in IOP and glaucoma medications over 1 year were observed in both groups, the trabeculectomy group had a lower mean IOP on fewer medications.

Early Experience with the New XEN63 Implant in Primary Open-Angle Glaucoma Patients: Clinical Outcomes

The new XEN63 implant is a minimally invasive glaucoma surgery device with limited experience in real life. This retrospective study included open-angle glaucoma patients who underwent XEN63 implant, either alone or in combination with cataract surgery. Primary endpoints were the intraocular pressure (IOP) at month 3 and the incidence of serious adverse events. Twenty-three eyes of 23 patients were included. Mean age was 67.8 ± 15.3 years and 15 (65.2%) were women. Mean IOP was significantly lowered from 27.0 ± 7.8 mmHg at baseline to 12.2 ± 3.4 mmHg at month 3 (p < 0.0001). Mean IOP lowering was 40.8 ± 23.5%, with 14 (60.9%) and 16 (69.6%) eyes achieving an IOP lowering ≥30% and ≥20% without hypotensive medication, respectively. The number of hypotensive medications (NHM) was significantly reduced from 2.27 ± 0.94 drugs at baseline to 0.09 ± 0.42 drugs at month 3, p < 0.0001. Four (17.4%) eyes had hypotony (IOP ≤ 6 mmHg) at postoperative day one, which was successfully resolved without sequelae. Four (17.4%) eyes had choroidal detachment (3 at day 7 and 1 at day 15), which was successfully resolved with medical treatment, at the month 1 visit. Three (13.0%) eyes required needling (mean time for needling 35.6 ± 9.7 days). XEN63 significantly lowered IOP and reduced the NHM, with a good short-term safety profile.

Intraocular pressure control after combined phacotrabeculectomy versus trabeculectomy alone.

We compared the efficacy and safety of trabeculectomy and phacotrabeculectomy in patients with glaucoma. We retrospectively analyzed consecutive patients who underwent trabeculectomy or phacotrabeculectomy. Patients in the trabeculectomy group were pseudophakic. We established three different intraocular pressure (IOP) thresholds (A: <21 mmHg, B: <18 mmHg, and C: <15 mmHg) to measure complete (without medication) and qualified (with medication) success. Success criteria were analyzed through Kaplan-Meier survival curves. Sixty-seven eyes were included (40 trabeculectomy, 27 phacotrabeculectomy). The mean follow-up period was 25.70 ± 14.439 months. The baseline characteristics were similar between the groups. The complete and qualified success rates according to criterion C were significantly higher in the trabeculectomy group (p = 0.033, p = 0.021, respectively); however, there was a trend toward a higher success rate for all criteria in favor of trabeculectomy. Bleb needling was more frequent in the phacotrabeculectomy group. The mean IOP significantly decreased from 26.46 ± 7.07 to 12.27 ± 4.06 at 12 months (p < 0.001). The final mean IOP was significantly lower in the trabeculectomy than in the phacotrabeculectomy group (10.95 ± 3.08 vs 13.00 ± 4.56, p = 0.0003). In pseudophakic eyes, trabeculectomy alone achieves a higher success rate, lower mean IOP, and less frequent bleb needlings. More frequent follow-up and prolonged postoperative use of high-dose topical steroids should be considered in patients undergoing phacotrabeculectomy.

Clinical Study on the Ocular Manifestations in Patients with Obstructive Sleep Apnea Syndrome—Preliminary Results

Obstructive sleep apnea syndrome is a multisystemic disorder associated with a series of side effects. Obstructive sleep apnea syndrome (OSAS) includes hypoxemia and is correlated with an increased incidence for various neuronal conditions, including glaucoma, strokes, reduced mental ability, depressive disorders, peripheral neuropathy, and non-arteritic ischemic optic neuropathy. This study’s aims are the evaluation of the degree of ocular surface damage in obstructive sleep apnea patients (in the absence of the continuous positive airway pressure treatment) and the structural changes in the optic nerve, and to establish correlation between the degree of damage to the ocular surface (eye dryness by Schirmer test) and corneal biomechanics by ocular response analyzer. The subjects included in the study will be grouped as follows: a group of patients with glaucoma and obstructive sleep apnea syndrome that will be compared to patients with glaucoma only as well as identifying the evolution of structural changes in patients with glaucoma and sleep apnea syndrome. A prospective study included 65 eyes from 65 subjects diagnosed with obstructive sleep apnea (45 eyes of 45 subjects with glaucoma and OSAS as well as 20 subjects, 20 eyes with dry-eye syndrome and OSAS) who did not follow the continuous positive airway pressure treatment. The control group consisted of 45 subjects (45 eyes) with (mild or moderate) primary open-angle treated glaucoma without obstructive sleep apnea. All patients had ophthalmologic evaluations according to a standardized protocol. Moreover, respiratory functional parameters (apnea–hypopnea index—AHI) and the body mass index were recorded. Within the studied group, patients with mild or moderate primary open-angle glaucoma, with moderate or severe dry-eye syndrome, patients with floppy-eyelid syndrome, with optical non-arteritis ischemic neuropathy, and a patient with retinal central vein occlusion were identified. The increased rate of the apnea syndrome during sleep produces a severe disorder of the ocular surface and a retinal neuro-degenerative disorder. The eyes of patients with sleep apnea syndrome (SAS) and glaucoma have lower mean intraocular pressure than eyes with glaucoma without SAS. However, the mean C/D ratio in eyes with glaucoma correlates with the severity of SAS. There is a positive correlation between the severity of the apnea and the ocular disorder’s degree similar to the studies in the literature review. The joint cooperation between the sleep specialists and ophthalmologists can lead to the improvement of the vascular and ocular status for the obstructive sleep apnea patients.