Intraocular Pressure Reduction Research Articles

Efficacy of gonioscopy-assisted transluminal trabeculotomy and trabeculectomy in patients with primary open-angle glaucoma and pseudoexfoliative glaucoma: A single surgeon's experience.

To compare the intraocular pressure (IOP)-lowering efficiency of gonioscopy-assisted transluminal trabeculotomy (GATT) and trabeculectomy (TRAB) with mitomycin C in patients with primary open-angle glaucoma (POAG) and pseudoexfoliative glaucoma (PEXG). In this retrospective comparative study, consecutive patients with POAG or PEXG who underwent GATT or TRAB by a single surgeon and with a follow-up period of at least 1 year were included. Surgical success rates, change in best-corrected visual acuity, IOP, the need for antiglaucoma medication, surgical complications, and the need for additional glaucoma surgery were compared. Surgical success was defined as an IOP reduction of ≥30% or an IOP of ≤18 mmHg. Complete success was defined as without medication. Qualified success was defined as with or without topical medication. The mean baseline IOP was 27.4 ± 8.3 and 24.6 ± 7.6 mmHg (P = 0.13) with the mean number of medications being 3.7 ± 1.0 and 3.7 ± 1.1 (P = 0.98) in TRAB and GATT, respectively. At 12 months, the mean IOP was 15.3 ± 3.5 and 12.5 ± 4.6 mmHg (P = 0.24) with the mean number of medications being 0.9 ± 1.2 and 0.8 ± 1.4 (P = 0.76) after GATT and TRAB, respectively. IOP was lowered from baseline by 52.7% ± 17.5% after TRAB and 45.7% ±18.6% after GATT (P = 0.12). There was no decrease in best-corrected visual acuity in either group. The qualified surgical success rate was 94.4% in the GATT group and 94.9% in the TRAB group (P = 0.75). Percentage of complete success was 64.1% and 52.8% (P = 0.22) after TRAB and GATT, respectively. In patients with POAG and PEXG, GATT was as effective and safe as TRAB in lowering IOP and reducing the number of antiglaucomatous drugs.

Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension.

This study was conducted to analyze and compare the intraocular pressure (IOP) treatment effect of the slow-eluting (SE) travoprost intracameral implant to the IOP treatment effect of topical prostaglandin analog (PGA) monotherapy in a subgroup of subjects who were on pre-study PGA monotherapy prior to enrollment in the two pivotal phase 3 trials of the travoprost intracameral implant. A combined study population of 133 subjects from two phase 3 trials, who were on topical PGA monotherapy at screening, subsequently underwent a washout period from their topical PGA, and then were randomized and administered an SE travoprost intracameral implant. The subjects were analyzed for the IOP treatment effects of the pre-study topical PGA monotherapy and the in-study SE travoprost intracameral implant. Paired t-tests were used to compare the difference in screening minus post-washout baseline IOP versus month 3 minus post-washout baseline IOP. The IOP-lowering efficacy in eyes administered an SE travoprost intracameral implant was compared to the IOP lowering in the same eyes while on a topical PGA monotherapy prior to study entry. Pre-study topical PGA monotherapy and the SE travoprost intracameral implant demonstrated IOP treatment effects of -5.76mmHg and -7.07 mmHg, respectively. The IOP-lowering treatment effect was significantly greater by 1.31mmHg for the SE travoprost intracameral implant relative to pre-study PGA monotherapy (95% confidence interval: -2.01, -0.60; P = 0.0003). The SE travoprost intracameral implant demonstrated superior IOP-lowering treatment effect versus pre-study topical PGA monotherapy with a superiority margin that was both statistically significant and clinically meaningful. The greater IOP reduction from baseline while on the SE implant versus pre-study topical PGA monotherapy may be a reflection of the optimized adherence and continuous elution of PGA therapy into the anterior chamber achieved with the SE travoprost intracameral implant. ClinicalTrials.gov identifiers, NCT03519386 and NCT03868124.

Managing Normal Tension Glaucoma with Dietary Folate

Normal-Tension Glaucoma (NTG) is the most prevalent form of glaucoma among individuals in Asian countries. While lowering intraocular pressure (IOP) remains the standard of care, this approach is insufficient for most NTG patients. Recent evidence documents the role of ischemia and oxidative stress as critical factors affecting the optic nerve in NTG. Consequently, addressing these factors has been recommended as a neuroprotective strategy. While conventional treatment strategies primarily target the reduction of IOP, this yields limited efficacy and eventual blindness in many NTG cases. Recent studies document another crucial parameter: Retinal Venous Pressure (RVP). Elevated RVP impedes retinal perfusion, resulting in oxidative stress and localized ischemia, and exacerbating optic nerve damage in NTG. Elevated RVP also appears to be a contributing factor in small vessel ischemia associated with diabetic retinopathy and macular degeneration. The underlying cause of elevated RVP is small vessel endotheliopathy, which may result from alterations in methylation and B-vitamin metabolism, leading to changed microcirculation. This metabolic disruption can arise from dietary inadequacies, malabsorption, or genetic polymorphisms affecting the methylation pathways. Restoring plasma levels of folate and B-12 can be achieved through supplementation with natural forms of these vitamins, specifically L-methylfolate, and methylcobalamin. Unlike oxidized folate (folic acid), which must be enzymatically converted to methylfolate to penetrate the blood-retinal barrier, L-methylfolate can be directly utilized. Excess unmetabolized folic acid can impede methyl folate absorption into the retina, underscoring the necessity of using methyl folate for effective supplementation. We propose integrating RVP screening into NTG risk assessments and consider a targeted vitamin supplement, such as Ocufolin®, as a viable adjunct approach to manage elevated RVP and potentially mitigate NTG progression.

Chitosan/carbomer nanoparticles- laden in situ gel for improved ocular delivery of timolol: in vitro, in vivo, and ex vivo study.

Due to the small capacity of the eye cavity and the rapid drainage of liquid into the nasolacrimal duct, patients must frequently administer the drops. Nanoparticles (NPs) and in situ gel systems have each proven their ability to achieve eye retention independently. In this study, timolol-loaded chitosan-carbomer NPs were prepared using the polyelectrolyte complexation method, and incorporated into a pH-responsive in situ gel system made of carbomer. The rheological behavior of NPs-laden in situ gel was examined at room and physiological conditions. Characteristics such as zeta potential, surface tension, refractive index, mucoadhesive properties, drug release, transcorneal permeability, and intra-ocular pressure (IOP) lowering activity were investigated on NPS and NPs-laden in situ gel formulations. The optimum gained NPs system had an encapsulation efficiency of about 69% with a particle size of 196nm. The zeta potential of the NP and NPs-laden in situ gel were - 16 and + 11 mV respectively. NPs-laden in situ gel presented enhanced viscosity at physiological pH. All physicochemical properties were acceptable for both formulations. NPs and NPs-laden in situ gel systems proved to sustain drug release. They showed mucoadhesive properties which were greater for NPs-laden in situ gel. IOP reduction by NPs-laden in situ gel was significantly higher and more long-lasting than the timolol solution and NPs. In conclusion, the developed NPs-laden in situ gel is a promising carrier for ocular drug delivery due to the slow release of drug from nanoparticles, its mucoadhesive properties, and high viscosity acquisition in contact with precorneal film, which lead to improved therapeutic efficacy.

1235 Challenges in Glaucoma Management: A Case Study on OMNI® Surgical System Interventions for Primary Open-Angle Glaucoma

Abstract Introduction This report explores the challenges faced in addressing early-stage primary open-angle glaucoma (POAG) in a 74-year-old male. Following a steroid-induced elevation in intraocular pressure (IOP) after endoscopic cyclophotocoagulation (ECP) in the right eye, the patient underwent minimally invasive canaloplasty and goniotomy using the OMNI® Surgical System (Sight Sciences) on his left eye. Case Description IOPs at diagnosis measured at 28 mmHg and 27 mmHg in the right and left eye, respectively, leading to the prescription of bilateral latanoprost. An adverse reaction to latanoprost resulted in eye swelling, hyperaemia, facial and jaw discomfort, and photophobia, prompting the cessation of the medication. In December 2022, bilateral selective laser trabeculoplasty (SLT) was performed, with minimal impact on IOP. Subsequently, in March 2023, right cataract surgery with ECP successfully reduced right eye IOP to 16 mmHg. Postoperatively, the use of dexamethasone 0.1% drops caused an intraocular steroid-response, increasing IOP (maximal IOP =25 mmHg), resolving upon medication completion. To mitigate prolonged steroid drop-associated complications, left eye phacoemulsification with OMNI canaloplasty and goniotomy was conducted in June 2023. Standard 4-week low-frequency steroid drops were administered postoperatively with no complications. Conclusions Pressure control was successfully achieved with IOP normalization to 15 mmHg bilaterally. Significant visual acuity improvements were noted post ECP (right eye=6/24 to 6/6) and OMNI (left eye=6/7.5 to 6/6). This case highlights the efficacy of OMNI combined with phacoemulsification in the safe reduction of IOP and sustained IOP control in POAG patients, alluding to its favourable safety profile.

Long-term results of Ahmed glaucoma valve implantation with/without intravitreal anti-VEGF injection in neovascular glaucoma patients

This study aimed to evaluate the efficacy of Ahmed glaucoma valve (AGV) implantation with or without anti-VEGF injections in neovascular glaucoma patients. This single-center retrospective study assessed NVG patients who underwent AGV implantation with or without anti-VEGF injections. Demographic and clinical data, including ocular findings, intraocular pressure (IOP), visual acuity, and glaucoma medication count, were recorded preoperatively and postoperatively at one day, one month, and one year. The study included 35 patients. Group 1 consisted of 23 patients who received anti-VEGF injections before AGV surgery. Group 2, with 12 patients, had no anti-VEGF injections prior to surgery. Successful surgery was defined as IOP values between 6 and 21mmHg. The primary outcome was a 30% or more reduction in IOP. The groups displayed no significant difference in their demographic or clinical profiles (P>0.05). The visual acuity before and one year after surgery did not differ significantly between the groups. However, IOP values significantly decreased by the end of the one-year follow-up for both groups. No significant differences were found between the groups regarding visual acuity, IOP, or the number of medications during the one-year follow-up (P>0.05). Success rates were 95.7% for Group 1 and 91.7% for Group 2. No significant difference in complications between the groups was observed (P>0.05). Anti-VEGF injections prior to AGV implantation did not significantly impact visual acuity, IOP values, or medication count during the one-year follow-up.

Double-Arc Slow-Coagulation Transscleral Cyclophotocoagulation Laser Protocol: One-Year Effectiveness and Safety Outcomes

To report the short-term efficacy and safety results of a new continuous laser protocol, double-arc slow-coagulation transscleral cyclophotocoagulation (DA-TSCPC). Multicenter retrospective study. Refractory glaucoma patients that had undergone DA-TSCPC between April 2019 and July 2022, with at least 12 months of postoperative follow-up, were consecutively enrolled. The technique was standardized (energy: 1400mW; duration: 4s; 28 applications). The applications were divided into 2 rows (upper and lower arcs). For each arc, 7 spots were applied over the ciliary body shadow and 7 spots 1.5mm behind, sparing the 3 and 9 o'clock meridians. Success was defined as postoperative intraocular pressure (IOP) between 6 and 18 mmHg, and an IOP reduction of 30% (without oral acetazolamide). For eyes with no light perception (NLP), in which treatment goal was pain relief, success was defined as a 30% IOP reduction and no pain (without oral acetazolamide). Patients were divided according to visual acuity: ≥20/400 (group 1) and <20/400 (group 2). Ninety eyes of 90 patients (mean age: 61±15 years) were included. Glaucoma diagnosis frequency was: neovascular glaucoma (38%), open-angle glaucoma (28%), silicone oil secondary glaucoma (17%) and others (18%). Overall, the mean IOP was significantly reduced from 35±12 to 22±14 mmHg (p<0.01) at the last follow-up visit. The number of hypotensive eye drops (2.6±1 to 2.3±1; p=0.02) and the use of oral acetazolamide (61% to 11%; p<0.01) were also reduced. Kaplan-Meier survival analysis revealed a global success rate of 65.6% after 12 months. A higher success rate was found for group 1 (78.6%) compared to group 2 (59.6%; p=0.047; logrank test). The main complications observed were corneal ulcer (4.4%), macular edema (1.1%) and hyphema (1.1%). Among the 26 eyes with NLP, 65% achieved success criteria at 12 months and 2 (7.7%) developed phthisis. Based on these initial retrospective data, the DA-TSCPC protocol seems to be an alternative for refractory glaucoma management, presenting significant IOP reduction and a good safety profile after one year. Better outcomes were observed in eyes with less severe functional damage.

Three-year analysis of results, safety and progression in patients with open-angle glaucoma or ocular hypertension, undertaking trabecular microsurgery

AimTo evaluate the efficacy, safety, structural and functional progression following the insertion of iStent inject ® implants in patients with open-angle glaucoma or ocular hypertension at a tertiary-level hospital. Materials and methodsA retrospective study included 98 eyes (57 males and 41 females) with open-angle glaucoma or ocular hypertension, which underwent iStent inject W® implantation (Glaukos, Corporation, CA) between December 2018 and December 2022. Differences in intraocular pressure (IOP), the number of hypotensive eye drops used, and structural and functional tests were assessed between preoperative values and subsequent reviews during a follow-up period of one (n = 98), two (n = 55), and three years (n = 15) after surgery. ResultsAmong the 98 eyes studied, 85% were diagnosed with open-angle glaucoma (50% mild, 32% moderate, and 18% severe) and 15% with ocular hypertension. There was a statistically significant reduction in IOP compared to preoperative values for all visits except the 1-month (p = 0.36) and 3-year (p = 0.39) visits. Visual acuity increased from 0.39 ± 0.25 to 0.72 ± 0.24 (p < 0.01), considering that a significant portion of the interventions included cataract surgery. Before surgery, 66% of the sample used 2 or more hypotensive medications. Post-surgery, the number of hypotensive medications decreased (from 1.88 ± 0.84 to 0.21 ± 0.59 at 3 years) (p < 0.01), with an 88.9% reduction in the number of medications over three years. After surgery, 75% of cases did not require any medication.Regarding structural and functional tests, thickness of retinal nerve fiber layers (RNFL (p = 0.35), excavation / papilla ratio E/P (p = 0.31), visual function index(VFI (p = 0.06), and deviation mean (MD (p = 0.06) showed no statistically significant differences post-intervention. However, standard deviation of the pattern (DSM) did exhibit differences, decreasing from 5.46 ± 4.03 dB to 5.34 ± 3.48 dB (p = 0.02). ConclusionThe results of this study suggest that the iStent inject W® technique constitutes an effective and safe option for tension control and glaucoma treatment.

Safety and Efficacy of Mitomycin C: Augmented Trabeculectomy: Subtenon's Injection versus Sponge Application.

The objective of the study was to study the safety and efficacy of subtenon injection of mitomycin C (MMC) versus sponge application of MMC during trabeculectomy. Thirty-seven patients having primary glaucoma warranting trabeculectomy were enrolled in the study and their forty eyes were alternately allocated into either of the two groups: subtenon injection (ST) of 0.1 mL of 0.01% of MMC or sponge application (SP) of 0.02% of MMC and were operated by a single surgeon and followed for 3 months. The outcome was analyzed primarily based on reduction in intraocular pressure (IOP) and bleb morphology. Similar outcome in terms of complete success (ST - 90% and SP - 85%), qualified success (ST - 5% and SP - 5%), and failure rate (ST - 5% and SP - 10%) was seen at the end of 3 months. The absolute reduction in IOP from the baseline was -10.00 ± 3.67 mmHg (-41.2% ± 12.30) in ST versus -8.90 ± 5.56 mmHg (-35.9% ± 16.1) in the SP group at the end of 3 months. At the end of 3 months, blebs in the ST group had low-to-medium height and in the SP group had low height. Blebs in both the groups were diffuse with mild vascularity. Antiglaucoma medications required postoperatively were 0.20 ± 0.62 versus 0.40 ± 1.10 in the ST and SP group, respectively. The duration of surgery was 19.85 ± 0.75 min in the ST group versus 22.50 ± 0.51 min in the SP group. Subtenon injection of MMC is as efficacious and safe as the conventional sponge application technique.

Subconjunctival Administration of an Adeno-Associated Virus Expressing Stanniocalcin-1 Provides Sustained Intraocular Pressure Reduction in Mice

PurposeTo investigate subconjunctival administration of a single-stranded, adeno-associated virus, serotype 2, engineered to express Stanniocalcin-1 with a FLAG tag (ssAAV2-STC-1-FLAG) as a novel sustained intraocular pressure (IOP) lowering agent with a reduced ocular surface side effect profile. DesignIn vivo pre-clinical investigation in mice SubjectsC57BL/6J, DBA/2J, FP receptor knockout mice MethodsNormotensive C57BL/6J mice were treated with a subconjunctival injection of ssAAV2-STC-1-FLAG (2 μL; 6 x 109 viral genomes [VGs]) in one eye and the same volume and concentration of ssAAV2-GFP or the same volume of PBS in the fellow eye. Ocular hypertensive DBA/2J mice were subconjunctivally injected with 6 x 109 VGs of ssAAV2-STC-1-FLAG or ssAAV2-GFP. Steroid-mediated ocular hypertension was induced in C57BL/6J mice with weekly injections of dexamethasone into the conjunctival fornix, and mice were then injected subconjunctivally with 6 x 109 VGs of ssAAV2-STC-1-FLAG or ssAAV2-GFP. FP receptor knockout mice were injected subconjunctivally with 6 x 109 VGs of ssAAV2-STC-1-FLAG or PBS. An identical vector was constructed without the FLAG tag (ssAAV2-STC-1) and evaluated in normotensive C57BL/6J mice. IOP was assessed using the Tonolab tonometer for all experiments. Tumor necrosis factor alpha (TNFα), a marker of ocular surface inflammation, was compared between subconjunctivally delivered ssAAV2-STC-1 and other treatments including daily topical latanoprost. Main outcome measuresIOP assessment ResultsSubconjunctival delivery of ssAAV2-STC-1-FLAG significantly reduced IOP for 10 weeks post injection in normotensive mice. Maximal IOP reduction was seen at week 2 post injection (17.4%; 17.1 ± 0.8 vs 14.1 ± 0.8 mmHg, P<0.001). After the IOP-lowering effect had waned, a second injection restored the ocular hypotensive effect. Subconjunctivally delivered ssAAV2-STC-1-FLAG lowered IOP in DBA/2J mice (16.9%; 17.8 ± 2.0 vs 14.8 ± 0.9 mmHg, P<0.001) and steroid-mediated ocular hypertensive mice (19.4%; 18.7 ±0.9 vs 15.1 ± 0.5 mmHg, P<0.001) over the experimental period. This construct also reduced IOP to a similar extent in wild type (15.9%) and FP receptor knockout (15.7%) mice compared to the fellow eye. A related construct also lowered IOP without the FLAG tag in a similar manner. Reduction in conjunctival TNFα was seen when comparing subconjunctivally delivered ssAAV2-STC-1-FLAG to daily topical latanoprost. ConclusionsSubconjunctival delivery of the STC-1 transgene with a vector system may represent a novel treatment strategy for sustained IOP reduction and improved ocular tolerability that also avoids the daily dosing requirements of currently available medications.

Combined Micro-Invasive Glaucoma Surgery (MIGS) with Phacoemulsification in Open Angle Glaucoma: A Systematic Review and Meta-Analysis

The purpose of this study is to compare efficacies and safeties of combined phacoemulsification-Micro-Invasive Glaucoma Surgeries (MIGS) to phacoemulsification only in eyes with open angle glaucoma. Systematic Review and Meta-Analysis. A multi-database literature search was conducted to caputre MIGS articles published prior to April 19th, 2024. Key exclusion criteria were inadequate follow-up, significant loss to follow-up, standalone MIGS surgery, or primary outcomes unreported. MIGS were grouped according to mechanisms of action: 1) Trabecular Meshwork (TM) bypass which improve aqueous drainage into Schlemm's canal (SC), 2) non-GATT Goniotomies which remove TM with varying devices, and 3) GATT which remove TM with a catheter or suture placed into SC. Efficacy was measured by reductions in IOP and medications while safety was compared using incidence of sight-threatening and other adverse events. A total of 95 studies were included, accounting for 9733 eyes followed up at 1-year. The control group had a baseline IOP of 16.9(95%CI 15.9-17.9) mmHg on 1.43(1.19-1.68) medications and a postoperative IOP of 15.2(14.4-15.9) mmHg on 0.80(0.54-1.00) medications. The TM bypass baseline IOP was 18.2(17.6-18.7) mmHg on 1.89(1.78-2.01) medications which lowered to an IOP of 14.8(14.5-15.1) mmHg on 0.80(0.65-0.95) medications at 1-year-postoperation. The non-GATT goniotomy baseline IOP was 20.0(19.2-20.8) mmHg on 2.30(2.09-2.53) medications, and at 1-year followup the IOP was 14.6(14.3-15.0) mmHg on 1.41(1.22-1.62) medications. Lastly, the GATT baseline IOP of 21.8(19.5-24.1) mmHg on 2.90(2.36-3.44) medications was reduced to an IOP of 12.5(10.0-15.0) mmHg on 0.73(0.37-1.09) medications at 1-year-postoperation. All MIGS groups had equal or lower rates of sight-threatening events and secondary glaucoma surgery when compared to control. GATT had the highest hyphema rate at 27.7(13.5-44.5) % followed by non-GATT goniotomy with 15.5(7.8-25.0) %. These were both significantly higher than TM bypass and control groups, with hyphema rates of 3.5(1.6-5.9) % and 4% (only 1 study reporting hyphema rate), respectively. Based on current peer-reviewed articles, there is strong evidence that when compared to phacoemulsification alone, combined phaco-MIGS is beneficial for patients with open angle glaucoma and does not increase the incidence of vision-threatening events. Key limitations of our review stem from heterogeneities in protocol design or outcome reporting, and a limited number of high-quality studies with long-term follow-up.

The Impact of Baseline Intraocular Pressure on Initial Treatment Response in the LiGHT Trial: Selective Laser Trabeculoplasty versus Medication

The Laser in Glaucoma and Ocular Hypertension Trial demonstrated the efficacy and safety of selective laser trabeculoplasty (SLT) compared with topical hypotensive medication as first-line therapy for ocular hypertension and open-angle glaucoma. This substudy explored the impact of pretreatment (baseline) intraocular pressure (IOP) on treatment response. Post hoc analysis of randomized control trial data. A total of 1146 eyes from 662 patients were included in this analysis: 559 eyes in the SLT group and 587 in the medication group. Intraocular pressure reduction at 8 weeks after treatment with either SLT or prostaglandin analog (PGA) eye drops was assessed at different levels of baseline IOP, and the groups were compared. Differences in absolute and percentage IOP lowering between SLT and PGA groups were tested with a linear mixed-effects model. Differences in the probability of achieving ≥ 20% IOP lowering between SLT and PGA groups, at different levels of baseline IOP, were estimated using a logistic mixed-effects model. Intraocular pressure-lowering response to SLT versus PGA eye drops. Mean IOP was not significantly different between the groups at baseline or 8 weeks after treatment initiation. Both treatments showed greater IOP lowering at higher baseline IOP and less IOP lowering at lower baseline IOP. Selective laser trabeculoplasty tended to achieve more IOP lowering than PGA drops at higher baseline IOP. Prostaglandin analog drops performed better at lower baseline IOP, and the difference compared with SLT, in terms of percentage IOP reduction, was significant at baseline IOP of ≤ 17 mmHg. A significant difference was found in the relationship between baseline IOP and probability of ≥ 20% IOP lowering between the two treatments (P= 0.01), with SLT being more successful than PGA at baseline IOP of more than 22.5 mmHg. We confirm previous reports of greater IOP lowering with higher baseline IOP for both SLT and PGA drops. In treatment-naïve eyes, at higher baseline IOP, SLT was more successful at achieving ≥ 20% IOP lowering than PGA drops. At lower baseline IOP, a statistically greater percentage, but not absolute, IOP lowering was seen with PGA drops compared with SLT, although the clinical significance of this is uncertain. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Outcomes and Baseline Predictors of Failure in Primary Standalone Xen45 Gel Stent versus Trabeculectomy for Glaucoma

PurposeTo compare safety, effectiveness and baseline predictors of failure in standalone primary Xen45 gel stent (Xen) vs trabeculectomy (Trab) in glaucoma. DesignRetrospective study SubjectsSubjects that underwent primary Xen or Trab augmented by mitomycin-C with at least 12 months follow-up. MethodsMultinational observational study of eyes in the Fight Glaucoma Blindness international registry Main outcome measuresThe primary outcome was success at 12 months defined by IOP reduction ≥ 20% from baseline and ≤ threshold IOPs of 15mmHg, 18mmHg and 21mmHg with (qualified) or without (complete) medications and without secondary glaucoma surgery. Multivariable mixed effects cox regression models were used to identify risk factors for failure in each cohort. Results701 eyes (Xen, 308; Trab, 393) of 596 subjects were included with baseline IOP being significantly higher (22.4 vs 19.9 mmHg, p < 0.001) and baseline medications significantly lower in the Xen vs the Trab group (2.9 vs 3.4, p <0.001). Baseline visual field (VF) mean deviation (MD) was less severe in the Xen group (-9.47 vs -13.04 dB, p < 0.001). The proportion of complete surgical success was significantly lower in the Xen vs Trab group across the three upper IOP limits at 12 months; 32% vs 52% at 15mmHg, 37% vs 54% at 18mmHg, and 39% vs 55% at 21mmHg (p < 0.001). The incidence of post-operative numerical and symptomatic hypotony was lower in the Xen vs Trab group. In the Xen cohort, a higher failure rate was associated with Asian ethnicity (HR, 1.97; 95% CI, 1.03-3.79) and use of oral acetazolamide at baseline (HR, 1.74; 1.13-2.70), while a lower failure rate was associated with diagnosis of ocular hypertension/open angle glaucoma suspect (HR, 0.52; 0.28-0.94) and secondary open angle glaucoma (HR, 0.45; 0.25-0.8). Exposure to prostaglandin analogue was associated with greater failure in the Trab group (HR, 2.66; 1.18-6.01). ConclusionsThere was significantly greater complete success at 12 months across all complete success definitions for Trab compared to Xen, while the rate of post-operative hypotony was significantly lower in Xen group. Asian ethnicity and use of oral acetazolamide at baseline were associated with greater failure in Xen, while exposure to prostaglandin analogue was associated with greater failure in Trab patients. Such baseline predictors of success and failure may help guide patient selection for subconjunctival minimally invasive glaucoma surgery in patients undergoing surgical intervention.

Effectiveness of pars plana Ahmed® valve implantation in patients with refractory glaucoma

PurposeTo evaluate the success rate and complications of the Ahmed FP7 valve implanted via Pars Plana in a group of vitrectomized patients with refractory glaucoma and anterior segment abnormalities from January 2018 to June 2023. MethodsQuasi-experimental, prospective study. Eleven eyes with refractory glaucoma were included. Participants underwent a comprehensive ophthalmic examination, including assessment of intraocular pressure (IOP) reduction, visual acuity, characterization of glaucoma type, and number of antiglaucoma medications. ResultsThe mean baseline IOP was 37.3 ± 11 mmHg, which decreased to 13.5 ± 3.0 mmHg after one year. The qualified success rate was 63.7%, while the complete success rate was 36.3%. The most common diagnosis was neovascular glaucoma in 36.4% of cases. The most frequent postoperative complications were choroidal detachment and hypotony. ConclusionsOur data suggest that implantation of the Ahmed FP7 valve via pars plana is an effective and safe option for patients with refractory secondary glaucoma.

The Effects of the STREAMLINE™ Surgical System versus Endoscopic Cyclophotocoagulation in Primary and Secondary Glaucoma

Introduction: Glaucoma is an optic neuropathy that is the second most common cause of blindness worldwide and affects over three million Americans. Currently, the only known modifiable risk factor to prevent glaucomatous damage is to decrease the intraocular pressure (IOP). The STREAMLINE™ Surgical System (SSS) is a microinvasive glaucoma (MIGs) device that can create a goniotomy and dilates the drainage system of the eye to reduce IOP. Question &amp; Significance: This study aims to compare the effects on intraocular pressure of patients that had cataract surgery combined the SSS, endoscopic cyclophotocoagulation (ECP), or ECP with SSS in patients with primary and secondary glaucoma’s for 6 months post operatively. Methods: This is a retrospective chart review of patients that had cataract surgery with either ECP, SSS, or SSS + ECP from April 1st, 2022 through April 1st, 2023. Primary endpoints were mean IOP reductions and medication reliance at 6 months compared to baseline. Secondary outcomes were best corrected visual acuity (BCVA), number of patients with  20% decrease in IOP, number of patients with a decrease in IOP lower medications, and significant complications after treatment. Results: Comparing 6-month post-operative mean IOPs in these treatment groups, a significant reduction was noted only in the ECP group at the 6-month visit (p&lt;0.003). No statistically significant reduction was found in either the SSS (p=0.333) or SSS+ECP (p=0.134) groups. The percent of patients having a  20% decrease in IOP from baseline were 52%, 10%, and 38% for ECP, SSS, and SSS+ECP groups, respectively. Conclusions: In the SSS only group, we found a significantly smaller proportion of patients able to achieve the  20% IOP reduction at only 10% of patients compared to other previous studies. This difference is likely due no medication washout in our study. This study did find similar decrease in IOP lowering medications.

Assessment of the correction of neuroretinal changes using 2-ethyl-6-methyl-3-hydroxypyridinium N-acetyltaurinate in the modeling of POAG

Introduction: Elevated intraocular pressure (IOP) has been identified as a major risk factor for the progression of primary open-angle glaucoma (POAG). However, the continued progression of POAG in some patients, despite the successful IOP reduction, indicates that IOP-independent mechanisms contribute to the development of optical neuropathy. Thus, it is relevant to further determine the molecular mechanisms of retinal ganglion cells (RGCs) death in order to develop therapeutic approaches independent of IOP in order to stop the progression of the disease. The aim: to research the correction possibility of experimental POAG induced by intracameral (i.c.)administration of hyaluronic acid using 2-ethyl-6-methyl-3-hydroxypyridinium N-acetyltaurinate. Materials and Methods: The study of the correction of neuroretinal changes on a model of POAG was carried out on Wistar rats. In order to correct POAG, 2-ethyl-6-methyl-3-hydroxypyridinium N-acetyltaurinate (EHMP-NAT) was used at doses of 27.5 mg/kg intramuscularly (i.m.) and 0.5 mg/kg instillationally. Further, the effectiveness of the combination of timolol eye drops with i.m. EHMP-NAT was studied. The effectiveness of the studied agents was evaluated on the 67th day of the experiment using ophthalmoscopic semi-quantitative assessment of the fundus condition, ocular tonometry, estimation of oxidative stress markers and markers involved in retinal apoptosis pathway using enzyme-linked immunosorbent assay (ELISA). Results: On the model of POAG, it was shown that 2-ethyl-6-methyl-3-hydroxypyridinium N-acetyltaurinate with the laboratory code EHMP-NAT has a pronounced neuro-, retinoprotectiveaction based on the data of ophthalmoscopy, semi-quantitative assessment of the fundus condition, ocular tonometry, estimation of oxidative stress markers (GSH, CAT, SOD) and markers involved in retinal apoptosis (BAX, BCL-2, Caspase-3). On the 67th day of the experiment, the results of a comprehensive analysis revealed that the combination of EHMP-NAT 27.5 mg/kg i.m. + timolol 0.04 mg/kg instillationally has a more pronounced protective effect than EHMP-NAT 27.5 mg/kg i.m. in monotherapy in the POAG model. Conclusion: The data obtained indicate the need for the combined use of drugs with a hypotensive effect to normalize IOP with neuroretinoprotective agents in the correction of POAG.

Assessing the Impact of PRESERFLO MicroShunt on Intraocular Pressure in Porcine Eyes Ex Vivo Using Infusion Pump System.

To evaluate the effectiveness of the PRESERFLO MicroShunt (PFM) in reducing intraocular pressure (IOP) ex vivo in porcine eyes using an infusion pump system and to simulate various IOP conditions, In this study, porcine eyes received increasing flows between 2 and 20 μL/min. IOP measurements were taken under conditions with and without the PFM [PFM (+) and PFM (-), respectively]. In the PFM (-) group, IOP increased from 7.4 mmHg to 46.3 mmHg as the flow rate increased from 2 μL/min to 20 μL/min. The rate of IOP reduction (%ΔIOP) rose with increasing flow rates, although the absolute IOP values achieved with the PFM insertion also increased. The correlation between IOPs in the PFM (-) conditions and the %ΔIOP was modeled as %ΔIOP = 22.4 Ln [PFM(-) IOP] - 41.7. According to this equation, IOP reduction by PFM insertion is 0% at IOPs of 6.4 mmHg or lower. IOP reductions of 10%, 20%, 30%, and 40% were observed when the pre-insertion IOPs were 10.1, 15.7, 24.6, and 38.4 mmHg, respectively. Achievable post-insertion IOP levels of ≤21 mmHg, ≤18 mmHg, ≤15 mmHg, and ≤12 mmHg corresponded to the initial IOPs of 33 mmHg, 26 mmHg, 20 mmHg, and 14.8 mmHg, respectively. In conclusion, the PFM effectively reduced IOP within a specific range of IOP values in an ex vivo experimental system. In clinical situations, the PFM is unlikely to be effective at low IOP levels. At higher levels, the PFM reduces IOP, but it may be insufficient to achieve the target IOP.

Evaluation of the Effectiveness of Using a Fixed Combination of Dorzolamide 2.0 % and Timolol 0.5 % in Primary Open-­Angle Glaucoma

The purpose of the work was to evaluate the effectiveness of the drug Domizia Duo® (OTCPharm JSC), which is a fixed combination (dorzolamide 20 mg/ml and timolol 5 mg/ml) in the treatment of patients diagnosed with primary open­angle glaucoma. The multicenter study involved 156 patients (280 eyes) with primary open­angle glaucoma (POAG) (136 patients — 243 eyes), primary angle­closure glaucoma (PACG) (8 patients — 15 eyes), ocular hypertension (12 patients — 22 eyes). 37 doctors from 22 medical institutions took part in the study. Patients aged 55–75 years with first­time POAG stages I–III, PAOG, ocular hypertension, as well as with abnormal intraocular pressure, patients with pseudophakia, if the diagnosis of glaucoma was made before cataract extraction and at least 6 months before the study, were included. According to the study results, intraocular pressure decreased significantly in all groups of patients and at all stages of treatment: primary open­angle glaucoma, primary angle­closure glaucoma, ocular hypertension. In 136 patients (243 eyes) with POAG, a 28 % reduction in IOP was achieved at an initial level of 25 (22–28) mm Hg. In the group of patients with PCOG (8 patients, 15 eyes), a decrease in IOP by 19 % was shown with an initial intraocular pressure of 20.1 (19.1–23.0) mm Hg. The high effectiveness of the drug Domizia Duo® (OTCPharm JSC) was established at all stages of POAG, so at stage I of newly diagnosed POAG, the reduction in IOP was 35.5 % within a month after the start of therapy, at stage II of newly diagnosed POAG by 28 %, at stage III by 44.4 %, in the group of patients with ocular hypertension, the degree of reduction in intraocular pressure was 27 % at an initial level of 26 (23–27) mm Hg. The data obtained from the study prove the high effectiveness of the fixed combination (FC) Domizia Duo® (OTCPharm JSC) against the background of good tolerability in patients with primary open­angle glaucoma (POAG) at stages I–III. The drug was also highly effective not only when prescribed as monotherapy, but also when switching from another drug or adding Domizia Duo® to treatment.

Anterior Chamber Angle and Intraocular Pressure Control After Phacoemulsification in Primary Angle Closure With Different Mechanisms.

Different mechanisms of angle closure represented distinct aspects of intraocular pressure (IOP) control after phacoemulsification. Classification of angle closure mechanisms is necessary for postoperative IOP management and glaucoma progression in primary angle closure eyes. To investigate the relationship between the anterior chamber angle (ACA) characteristics, measured by swept-source anterior segment optical coherence tomography (SS AS-OCT), and intraocular pressure (IOP) control after phacoemulsification in eyes with primary angle closure disease (PACD) with different angle closure mechanisms. PACD eyes were classified into 3 groups according to angle closure mechanisms using preoperative SS AS-OCT images; pupillary block (PB), plateau iris configuration (PIC), exaggerated lens vault (ELV). This retrospective, clinical cohort study included eighty-five eyes of 85 PACD patients: 34 with PB, 23 with PIC, and 28 with ELV. ACA parameters were measured preoperatively and 1 month postoperatively using SS AS-OCT. IOP measurements were performed preoperatively and during 6 months postoperatively. Postoperative IOP reduction and fluctuation were calculated, and their correlations with SS AS-OCT parameters were analyzed. PIC group showed the lowest postoperative IOP reduction compared with the other groups ( P =0.023). Preoperative ACA measurements were significantly associated with postoperative IOP reduction in ELV and PB groups, while postoperative measurements were in PIC group. Preoperative and postoperative change of iridotrabecular contact (ITC) index and area were correlated with postoperative IOP reduction in PB and ELV groups but not in PIC group. Postoperative ITC index ( P =0.031) and area ( P =0.003) showed significant correlations with postoperative IOP fluctuation only in PIC group. SS AS-OCT parameters including ITC index and area showed different associations with postoperative IOP control, which should be considered in determination of lens extraction and treatment of PACD eyes.

Efficacy and safety of the paul glaucoma implant in the treatment of refractory primary congenital glaucoma

PurposeTo evaluate the safety and efficacy of the PAUL Glaucoma Implant (PGI) for managing refractory primary congenital glaucoma (PCG) over a one-year period.Study DesignRetrospective.MethodsA study was conducted using the medical records of thirty eyes of 17 patients who underwent PGI surgery for the treatment of refractory PCG. Primary outcome measures included failure criteria such as intraocular pressure (IOP) > 21 mm Hg, < 20% IOP reduction, necessity for further glaucoma intervention, implant removal, or loss of vision. Secondary outcomes focused on mean IOP, average number of glaucoma medications, best corrected visual acuity (logMAR), and incidence of complications.ResultsThe mean preoperative IOP of 38.8 ± 9.2 mmHg significantly decreased to 16.1 ± 3.3 mmHg at 12 months postoperatively (p < 0.001). The average number of glaucoma medications reduced from 3.6 ± 0.5 preoperatively to 0.9 ± 1.2 at 12 months post-op. Visual acuity remained stable in 24 eyes, decreased in 4, and increased in 2. Early postoperative complications occurred in 13.3% of patients, but no late complications were reported. The cumulative success rate was 86.6%.ConclusionThe PGI appears to be a safe and effective option for managing refractory primary congenital glaucoma, demonstrating significant IOP reduction and decreased dependence on glaucoma medications over a one-year period, with a high success rate and manageable complication profile.