Mean Change In Intraocular Pressure Research Articles

Outcomes of Micropulse Laser Trabeculoplasty Compared to Selective Laser Trabeculoplasty: A Systematic Review and Meta-Analysis.

To perform a meta-analysis and systematic review to compare the efficacy and complications of micropulse laser trabeculoplasty (MLT) and selective laser trabeculoplasty (SLT) in adult patients with open-angle glaucoma (OAG) and ocular hypertension (OHT). We performed a systematic review utilizing PubMed, Embase, and Scopus, on April 8, 2024. Meta-analyses were performed for the mean change in intraocular pressure (IOP) at one-month, six-month, and one-year follow-up visits, rate of IOP spikes (>5 mmHg increase from the pre-procedure baseline IOP), rate of treatment failure (<20% or <3 mmHg reduction in IOP or requiring additional medications or procedures), and mean change in number of medications. Six studies, with a total of 593 eyes, were included: 283 underwent MLT, while 310 underwent SLT. A statistically significant difference in the efficacy of MLT versus SLT at one-month and six-month follow-ups was present, with SLT reducing IOP by 0.83 mmHg (95% CI: 0.20, 1.47; P = 0.01) more and 0.55 mmHg (95% CI: 0.02, 1.08; P = 0.04) more than MLT, respectively. At the one-year follow-up, there was no significant disparity in IOP reduction between SLT and MLT (WMD = 0.16; 95% CI: -0.40, 0.71; P = 0.58). There was a significantly lower rate of IOP spikes in the MLT treatment group (RR = 0.37; 95% CI: 0.16, 0.89; P = 0.03). There was no statistically significant difference in the rate of treatment failures (RR = 1.05; 95% CI: 0.68, 1.62; P = 0.84) or number of topical medications reduced (WMD = 0.06; 95% CI: -0.13, 0.26; P = 0.53). While SLT may offer greater short-term reductions in IOP, it may be associated with more postoperative IOP spikes when compared to MLT. At one-year follow-up, there were no significant differences in IOP reduction or failure rates between the MLT and SLT groups.

Intermediate-Term Outcomes of Ahmed Glaucoma Valve Implantation for Uveitic Glaucoma: A Tertiary Centre Experience

ABSTRACT Purpose To present the outcomes of Ahmed glaucoma valve (AGV) implantation in uveitic glaucoma (UG) in a tertiary eye center in Riyadh, Saudi Arabia. Methods A retrospective review of all UG patients who underwent AGV implantation at a single, tertiary care eye center from January 2008 to December 2018. The main outcome measures were change in mean intraocular pressure (IOP), number of antiglaucoma medications, overall success rate in different follow-up periods, complete and qualified success from last follow up, and complications. The success of the treatment was defined as patients achieving intraocular pressure (IOP) levels between 6- and 21-mm Hg with or without additional antiglaucoma medications and/or a minimum of 20% reduction from baseline IOP. Results The study included 74 patients (86 eyes), with a mean follow-up of 4.9 ± 2.9 years. The mean IOP was 32.2 ± 8.5 mmHg at baseline and 16.3 ± 6.6 mmHg at the last follow-up (p < 0.001). The mean number of antiglaucoma medications decreased from 3.5 ± 0.7 preoperatively to 1.3 ± 1.4 at the last follow-up (p < 0.001). Overall survival rates at 1, 3, 5, and 10 years were 96.5%, 92.7%, 91%, and 56.9%, respectively. Complete and qualified success rates were 37.9% and 48.3% at the end of follow up, respectively. The rate of postoperative complications was 56%, of which 18 eyes (20%) required surgical revision. Bivariate Cox proportional hazards regression analysis did not reveal any factors significantly associated with failure. Conclusions AGV is safe and effective in providing intermediate-term IOP control in UG patients. Complications reported in our cohort were mostly transient and conservatively treated.

The effect of cycloplegia on intraocular pressure with and without adjusting for central corneal thickness in patients with diabetes mellitus

PurposeTo assess and compare the effects of cycloplegia using 0.5% tropicamide and 1% tropicamide on intraocular pressure (IOP) in patients with diabetes mellitus, with and without considering adjustments for central corneal thickness (CCT). MethodsA total of 98 eyes of 98 patients with open angles were included. Patients were randomly assigned to receive either 0.5% tropicamide (49 eyes) or 1% tropicamide (49 eyes). IOP was measured by Goldmann applanation tonometry. Pupillary diameter and CCT were measured by a Pentacam HR (Oculus Optikgeräte GmbH, Wetzlar, Germany) before and 30 min after tropicamide administration. ResultsThe mean IOP change was 0.12 ± 1.71 mmHg in the 0.5% tropicamide group and 0.25 ± 1.70 mmHg in the 1% tropicamide group. These two values were not significantly different, even after adjusting IOP for CCT using all formulae (P > 0.05). Without adjustment, the mean post-dilation IOP was similar to the mean pre-dilation IOP in both groups (P > 0.5), and none of the patients experienced an IOP increase of 5 mmHg or more. With adjustment, the mean IOP increased significantly after administration of 0.5% tropicamide, as determined by the Ehlers formula (P = 0.02). Similarly, the mean IOP increased significantly after administration of 1% tropicamide, as determined by the Ehlers formula (P = 0.008), the Doughty formula (P = 0.03), and the Kohlhaas formula (P = 0.04). In each study group, a single patient encountered an increase in IOP ≥5 mmHg when IOP adjustment was performed using the Ehlers formula. ConclusionCycloplegia with 0.5% and 1% tropicamide leads to similar mean changes in IOP in patients with diabetes. However, the statistical significance of the change and the occurrence of the significant increases in IOP, as determined by a predefined cut-off point, are dependent upon the method used to adjust the IOP.

Long-term efficacy and safety of XEN-45 gel stent implantation in patients with normal-tension glaucoma

BackgroundMinimally invasive bleb surgery using the XEN-45 gel stent has not been established for the treatment of normal-tension glaucoma (NTG). The main objective of this study was to evaluate the long-term treatment efficacy and safety of XEN-45 in eyes with uncontrolled NTG.MethodsA retrospective analysis of patients with NTG who underwent XEN-45 gel stent implantation at university hospital Tuebingen between 2016 and 2021. The primary outcome measure was surgical success after three years defined as lowering of intraocular pressure (IOP) of ≥ 20%, with target IOP between 6 and 15 mmHg. Success was complete without and qualified irrespective of topical antiglaucoma medication use. The need for further glaucoma surgery, except for needling, was regarded as a failure. The secondary outcome measures included changes in mean IOP, number of antiglaucoma medications, and needling and complication rates.ResultsTwenty-eight eyes from 23 patients were included in the final analysis. Complete and qualified success rates were 56.5% and 75% after three years, respectively. Mean postoperative IOP ± standard deviation decreased significantly after three years from 19.3 ± 2.0 mmHg at baseline to 13.7 ± 4.2 mmHg (n = 22; p < 0.0001). The median number of antiglaucoma medications decreased from 2 (range 0–4) to 0 after three years (range 0–3; p < 0.0001). Sixteen eyes (57%) required a median of 1 (range 1–3) needling procedures. One eye required further glaucoma surgery. No sight-threatening complications were observed.ConclusionThe XEN-45 stent is effective and safe for the long-term treatment of NTG. However, needling was frequently required to improve outcomes.

One-year outcome of goniotomy with Kahook Dual Blade in primary open-angle glaucoma patients

Objectives: The objective is to describe a -year outcome of goniotomy using the Kahook Dual Blade (KDB, New World Medical Inc., Rancho Cucamonga, CA) in patients with primary open-angle glaucoma (POAG) either as a standalone or plus phacoemulsification (phaco). Material and Methods: We reviewed 12 eyes of 9 patients who had goniotomy with KDB either as a standalone or combined with cataract surgery by phaco from April 2017 to July 2018 at Eye Foundation Hospital, Ikeja, Lagos. The patients were followed for a minimum of 12 months. Results: The mean age of the patients was 66.4 ± 8.8 years. The mean pre-operative intraocular pressure (IOP) for all eyes was 18.58 ± 5.42 mmHg. After 12 months of follow-up, the mean IOP was 14.27 ± 5.22 mmHg, representing a drop of 4.31 mmHg (23.2%) from baseline. For the Phaco+KDB group, the mean IOP changed from 19.25 ± 4.56 mmHg to 15.0 ± 6.03 mmHg for the same period, representing a reduction of 4.25 mmHg (22.1%) from baseline, and for the KDB as a standalone, the mean IOP change was 4.25 mmHg (24.6%) from baseline (17.25 ± 7.45 to 13.0 ± 3.83 mmHg). For all eyes, the mean number of topical antiglaucoma medications dropped by 0.88 (36.4%) from 2.42 ± 0.90 to 1.54 ± 1.51, whereas for the Phaco+KDB group, the topical antiglaucoma medications were reduced by 1.17 (46.8%) from 2.50 ± 0.93 to 1.33 ± 1.50. However, there was no change in the number of topical antiglaucoma medications in the KDB group after 12 months of follow-up (2.25 ± 0.96 to 2.25 ± 1.50). Transient hyphema in one and posterior capsular opacity (PCO) were the only recorded post-operative complications. Conclusion: KDB, either as a standalone or with phaco, recorded at least a 20% reduction in IOP after one year of follow-up in these series.

Prospective randomized clinical trial evaluating efficacy and safety of a new ophthalmic viscosurgical device in patients undergoing cataract surgery.

To evaluate the efficacy and safety of Bio-Hyalur LVD compared with Viscoat ophthalmic viscosurgical device (OVD) in patients undergoing routine cataract surgery. 2 tertiary eyecare hospitals in Italy. Prospective randomized clinical trial. This study compared the outcomes of Bio-Hyalur LVD vs Viscoat OVD in patients undergoing standard cataract surgery with phacoemulsification and intraocular lens implantation from January 2021 to April 2022. The primary outcome was mean change in IOP at 6 hours. Secondary outcomes included 1-day, 7-day, 30-day, and 90-day mean intraocular pressure (IOP); 7-day, 30-day, and 90-day corrected distance visual acuity; endothelial cell density (ECD); change in central corneal thickness (CCT); and complications including intraocular inflammation. 84 eyes of 84 patients (n = 41 in the Bio-Hyalur LVD group and n = 43 in the Viscoat group) were screened, enrolled, randomized, and included in the analysis. Mean change in IOP was significantly higher in the Viscoat group than in the Bio-Hyalur LVD group 6 hours ( P = .034), 7 days ( P < .001), 30 days ( P < .001), and 90 days ( P = .003) postoperatively. Mean change in uncorrected distance visual acuity and corrected distance visual acuity was significantly higher in the Bio-Hyalur LVD group 30 and 90 days postoperatively. No significant differences in ECD, CCT, and complication rates were observed between groups at any timepoint. Bio-Hyalur LVD OVD was safe and effective in patients undergoing routine cataract surgery. Bio-Hyalur LVD OVD did not confer a higher risk of postoperative increase in IOP.

Results of XEN45 Gel Stent Implantation in the Treatment of Primary Open‐Angle Glaucoma Using 5, 10 or 20 μg Mitomycin C: A Pilot Study

Background: No consensus has been reached on the adequate dose of mitomycin C (MMC) in XEN45 gel stent implantation. Lower doses have the potential to reduce MMC‐linked side effects. This study aimed to evaluate treatment efficacy of ab interno XEN45 gel stent in primary open‐angle glaucoma (POAG) with three different MMC doses.Methods: This retrospective single‐centre nonrandomised trail included 54 patients (56 eyes) who underwent XEN45 gel stent implantation for POAG with above‐target intraocular pressure (IOP) under medical therapy. Eyes were grouped according to the received MMC dose: Group 1 (20 μg; n = 21), Group 2 (10 μg; n = 14) and Group 3 (5 μg; n = 21). The primary endpoint was the mean IOP change in the three MMC dose groups after 6, 12 and 24 months. Secondary endpoints included the success rate defined as lowering of baseline IOP ≥ 20% and below a cut‐off IOP set at three different levels: ≤ 18, ≤ 16 and ≤ 14 mmHg (Criteriums 1, 2 and 3), the mean number of ocular hypotensive medications and the frequency of needling procedures.Results: After 24 months, the overall mean (standard error) IOP was significantly reduced from 24.7 (0.9) mmHg to 15.2 (0.7) mmHg (p &lt; 0.0001). The average IOP change (standard error) in MMC dose groups 1, 2 and 3 was −8.6 (2) mmHg, −10.1 (2.1) mmHg and −10.4 (2.8) mmHg. Complete success (Criterium 1) was achieved in 50%, 62% and 43% of the eyes in groups 1, 2 and 3. No statistically significant difference was found within the first 24 months between the three MMC dose groups for IOP change, success rate, number of ocular hypotensive medications and the frequency of needling procedures.Conclusions: XE45 was effective in all three dose groups. As the success rate did not significantly differ between the MMC doses, these results may support the use of the lowest dose.Trial Registration: ClinicalTrials.gov identifier: 559/2016BO2

Short-Term Outcomes of XEN45 Standalone versus Combined with Phacoemulsification in Open-Angle Glaucoma Patients: A Retrospective Study.

The XEN45 is a minimally invasive glaucoma surgery device commonly used in clinical practice. This retrospective study included consecutive patients with open-angle glaucoma who underwent a XEN45 implant with mitomycin C, either alone or in combination with phacoemulsification, between June 2015 and March 2021. The primary end point was the mean change in intraocular pressure (IOP) from the baseline to month 6. A total of 677 eyes, 395 (58.3%) in the XEN alone group and 282 (41.7%) in the XEN+Phaco group, were included in this study. The preoperative IOP was significantly lowered from 28.7 ± 8.6 mmHg and 25.4 ± 6.9 mmHg to 13.5 ± 5.0 mmHg and 13.5 ± 4.1 mmHg at month 6 in the XEN solo and XEN+Phaco groups, respectively, with p < 0.0001 each. The mean (95% confidence interval) number of ocular hypotensive medications was significantly reduced from 3.3 (3.2-3.4) to 0.2 (0.1-0.2) and from 3.1 (2.9-3.2) to 0.2 (0.1-0.2) in the XEN solo and XEN+Phaco groups, respectively, with p < 0.0001 each. Needling was performed in 228 (33.7%) eyes. Conclusions: the XEN implant significantly reduces both IOP and the number of ocular hypotensive medications. IOP lowering was higher in the XEN solo group than in the XEN+Phaco one, although such a difference was only evident during the first month after surgery.

The long-term clinical outcomes of latanoprostene bunod 0.024% in glaucoma treatment at a tertiary glaucoma center

ABSTRACT Purpose To evaluate the clinical outcomes of latanoprostene bunod 0.024% (LB) in intraocular pressure (IOP) control in patients with glaucoma. Methods This retrospective cohort study analyzed eyes treated with LB between 01/2018 and 01/2020. Demographic and clinical data were collected at baseline and up to 24-months (mo). Primary outcomes were mean change in IOP (∆IOP) from baseline in eyes switched from a prostaglandin analogue (PGA) to LB (Group 1) vs. eyes in which LB was added as a first PGA to a glaucoma regimen (Group 2). Results 262 eyes of 162 patients were included. Overall, baseline IOP was 18.67 ± 5.65 mmHg. Group 1 (n = 168 [64%]) and Group 2 (n = 66 [25%]) each individually had significant ∆IOP at 1, 3, 6, 12, and 18 mo compared to baseline (p = 0.005). ∆IOP and duration of IOP control (9.5 ± 11.4 vs. 9.7 ± 9.9 months) on LB was similar between Group 1 and 2 at all time points. Additional pharmacologic or surgical intervention was required in 71 (27%) and 66 (25%) eyes, respectively, and LB was stopped in 24 (9.1%) eyes due to side effects. Discussion LB successfully reduced IOP and was well-tolerated in our cohort. PGA naivete does not seem to influence the LB efficacy or its duration of effect.

Retrospective Analysis of the Efficacy and Safety of Omidenepag Isopropyl 0.002% Ophthalmic Solution in Korean Patients

Purpose: This study aimed to analyze the clinical efficacy and safety of omidenepag isopropyl (OMDI) 0.002% in Korean patients.Methods: A retrospective study was conducted involving 306 patients diagnosed with glaucoma or ocular hypertension, who were administered OMDI 0.002% from May 2021 to June 2022. The primary outcomes were the change in intraocular pressure (IOP) at months 1, 3, and 6 compared to the baseline IOP, and the reactions to the OMDI drug.Results: Out of 235 patients who met the study inclusion criteria, the mean IOP was 16.5 ± 3.4 mmHg at baseline, 14.5 ± 3.0 mmHg at month 1, 14.3 ± 2.7 mmHg at month 3, and 14.7 ± 3.1 mmHg at month 6. The mean IOP reduction at month 6 was -1.6 ± 2.8 mmHg (p &lt; 0.001). On analyzing the IOP by types of glaucoma, the mean IOP change at the 6-month point showed statistically significant results in all types, including normal tension glaucoma, primary open-angle glaucoma, and ocular hypertension (p &lt; 0.05). The frequency of side effects in all patients was 29.8%, with the most commonly reported adverse drug reaction being hyperemia in 18.7% of the total patients. There was one case (0.4%) of uveitis after OMDI administration, but no other systemic adverse drug reactions were reported.Conclusions: Omidenepag isopropyl demonstrated a statistically significant IOP-lowering effect in Korean patients with various types of glaucoma. This suggests that OMDI could potentially serve as a first-line treatment for glaucoma.

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

PurposeTo compare the effectiveness and safety of the MicroShunt (Santen Inc., Emeryville, CA, USA) versus trabeculectomy in patients with primary open-angle glaucoma (POAG). DesignProspective, randomized, multicenter trial conducted in the United States and Europe. ParticipantsAdult patients (aged 40-85 years) with mild to severe POAG inadequately controlled on maximum tolerated medical therapy and intraocular pressure (IOP) ≥15 mmHg and ≤40 mmHg. MethodsPatients were randomized 3:1 to standalone MicroShunt implantation (n=395) or trabeculectomy (n=132), both augmented with mitomycin C (MMC) 0.2 mg/mL for 2 minutes. Main Outcome MeasuresThe primary effectiveness endpoint was surgical success, defined as ≥20% reduction in mean diurnal IOP from baseline with no increase in glaucoma medications. Secondary endpoints included changes in mean IOP and medication use from baseline and the need for postoperative interventions. ResultsAt 2 years, the rate of surgical success was lower in the MicroShunt than in the trabeculectomy group (50.6% versus 64.4%, p=0.005). Mean diurnal IOP was reduced from 21.1 ± 4.9 mmHg at baseline to 13.9 ± 3.9 mmHg at 24 months in the MicroShunt group and from 21.1 ± 5.0 mmHg at baseline to 10.7 ± 3.7 mmHg at 24 months in the trabeculectomy group (p<0.001 compared with baseline in both groups). Mean medication use decreased from 3.1 to 0.9 in the MicroShunt group and from 2.9 to 0.4 in the trabeculectomy group (p<0.001 compared with baseline in both groups). Adverse events at 2 years were generally similar in the two groups, except that hypotony was more common in eyes undergoing trabeculectomy (51.1% versus 30.9%, p<0.001). Repositioning or explantation of the implant occurred in 6.8% of MicroShunt patients. The majority of these patients had device removal at the time of subsequent glaucoma surgery. Vision-threatening complications were uncommon in both groups. ConclusionAt 2 years, both the MicroShunt and trabeculectomy provided significant reductions in IOP and medication use, with trabeculectomy continuing to have greater surgical success.

XEN 45 Gel Stent Implantation In Open Angle Glaucoma: 5-Year Results Of A Prospective Study.

XEN 45 Gel Stent is safe and effective for 3 years. The study results provide useful insight into the outcome of XEN 45 Gel Stent surgery over 5 years in daily clinical practice. To evaluate 5-year outcomes of XEN 45 gel stent implantation (XEN) in patients with open-angle glaucoma. This is a prospective, single-center, interventional study. XEN implantation either alone (XEN) or combined with phacoemulsification (Phaco + XEN) was performed on 170 consecutive eyes (126 patients) with uncontrolled intraocular pressure (IOP) or disease progression despite medical treatment. 'Complete' surgical success at 60 months was defined as unmedicated IOP ≤15mmHg and a relative IOP reduction ≥ 20% from medicated baseline, while 'qualified' success allowed fewer ocular hypotensive medications (OHM) than at baseline. Other definitions of success with various IOP targets were also analyzed. Secondary outcomes included mean IOP and IOP lowering medication changes, and rates of re-operations. Mean age was 78.1±9.2 years and 70.3% were female. Mean medicated IOP decreased from 19.8±7.7mmHg (19.6±7.1 [XEN] vs. 19.8±7.0mmHg [Phaco+XEN]) at baseline to 12.6±3.1mmHg (12.5± 3.1 [XEN] vs. 12.6±3.1 [Phaco+XEN]) at 5 years (-37.0%; P < 0.001). Medications decreased from 2.0±1.3 (2.0±1.3 [XEN] vs. 2.0±1.3 [Phaco+XEN]) to 0.8±1.1 (0.8±1.1 [XEN] vs. 0.8±1.1 [Phaco + XEN]) (-60%; P<0.001). Needling was performed in 84 eyes (49%), and 19.4% underwent a secondary surgical intervention. Complete success at 3 years was a strong predictor of success at 5 years (OR:3.06, P<0.01), while needling was associated with higher rates of failure (OR:3.6, P<0.01). At 5 years, XEN gel stent implantation was a safe procedure and achieved clinically meaningful IOP and medication reduction. Success at 3 years is a predictor of success at 5 years. Needling correlates with higher failure rates.

Contributing factors for intraocular pressure control in patients with mostly normal-tension glaucoma after initial Ex-PRESS drainage device implantation.

To investigate the postoperative intraocular pressure (IOP) control and identify the factors associated with failure of initial Ex-PRESS surgery in patients with open-angle glaucoma for 3years. A total of 79 patients with medically uncontrolled open-angle glaucoma (55 normal-tension glaucoma and 24 primary open-angle glaucoma) were enrolled. All patients underwent Ex-PRESS implantation (including combined cataract surgery). The outcome measure was the survival rate using life table analysis, thefailure wasdefined as IOP of > 18mmHg (criterion A), > 15mmHg (criterion B) or > 12mmHg (criterion C) and/or IOP reduction of < 20% from baseline (each criterion) without any glaucoma medications. The Cox proportional hazards model was used to identify risk factors for IOP management defined as the above criterion. RESULTS: The mean preoperative IOP was 19.3 ± 5.8mmHg. At 36months, the mean IOP was 11.8 ± 3.6mmHg with a mean IOP change of 7.5mmHg (reduction rate 39.0%). The cumulative probability of success was 58% (95%CI: 42-64%) (criterion A), 48% (95%CI: 37-59%) (criterion B) and 30% (95%CI: 20-40%) (criterion C). In multivariate analyses, factors that predicted poor IOP control included the intervention of bleb needling after 6months after the surgery (HR: 2.43; 95%CI: 1.35-4.37; P = 0.032). Transient hypotony was observed in 4 patients. The implementation of bleb needling after Ex-PRESS surgery in the late postoperative period was suggested to be the main risk factor for achieving lower IOP.

Mean Iop Change In Non-Glaucomatous Patients With Macular Edema Subsequently Intravitreal Injection Avastin.

The accumulation of fluid between the retinal layers is called retinal or macular oedema, while intraretinal oedema, or macular oedema, refers to fluid accumulation directly within the retina. The purpose of the study was to evaluate the effects of intravitreal injections of bevacizumab on intraocular pressure (IOP) in Non-Glaucomatous patients with Macular Oedema. A pre-and post-interventional study was conducted. 220 patients were studied utilizing a non-probability, consecutive sampling method. Open Epi software was used to determine the sample size. The Department of Ophthalmology at Islamabad's Tertiary Care Hospital hosted the study, which lasted six months. The study's participants ranged in age from 30 to 60, with a mean age of 50.38±6.53 years. Male to female ratio of these 220 patients was 1:1.6, with 86 (39.09%) men and 134 (60.91%) women. The mean IOP at baseline was 11.57±1.42 mmHg, and the mean IOP one month after the injection was 12.81±1.18 mmHg, with a mean change in IOP of 1.24±0.87 mmHg. This study found that non-glaucomatous patients with macular oedema experienced a high mean change in intraocular pressure (IOP) after intravitreal Avastin.

A randomized clinical trial comparing three fixed combinations of bimatoprost with timolol in patients with open-angle glaucoma or ocular hypertension

Objective: To compare the efficacy and safety of two fixed combination, preservative-free eye drops (bimatoprost 0.01% in combination with either timolol 0.1% or 0.5%) in a gel formulation, with bimatoprost 0.03%/timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods: Phase II, randomized, investigator-masked, multicenter, 3-arm parallel group (Eudract No. 2017-002823-46). Eighty-six patients aged ≥18 years with OAG or OHT, with intraocular pressure (IOP) initially controlled for at least 6 months by a combination therapy of a dual prostaglandin and timolol or insufficiently controlled by first-line monotherapy were included. Patients were randomized to receive T4030a (bimatoprost 0.01%/timolol 0.1%; N = 29), T4030c (bimatoprost 0.01%/timolol 0.5%; N = 29) or bimatoprost 0.03%/timolol 0.5% (N = 28), administered once daily in the evening for 12 weeks. Primary endpoint was defined as change in IOP from day 1 to week 12 measured at 08:00 (±1 hour). Further efficacy, safety and pharmacokinetic endpoints were assessed as secondary outcomes. Results: The mean change in IOP from baseline to week 12 was -9.8 ± 2.1 mmHg for T4030a, ­10.1 ± 2.5 mmHg for T4030c and -10.0 ± 2.8 mmHg for bimatoprost 0.03%/timolol 0.5%. All treatments were well tolerated with no safety issues identified in any group. In patients treated with T4030a, the systemic concentration of timolol was significantly lower after 12 weeks than in patients treated with T4030c or bimatoprost 0.03%/timolol0.5%. Conclusions: These study results suggest that the preservative-free ophthalmic formulation of T4030a (bimatoprost 0.01%/timolol 0.1%) can be regarded as a useful tool in the therapeutic management of OAG and OHT.

Long-Term Effectiveness of XEN 45 Gel-Stent in Open-Angle Glaucoma Patients.

To assess the effectiveness of XEN45, either alone or in combination with phacoemulsification, in open-angle glaucoma (OAG) patients in clinical practice. Retrospective and single-center study conducted on OAG patients who underwent XEN45 implant, either alone or in combination with cataract surgery. We compared the clinical outcomes of the eyes of thosewho underwent XEN-solo versus those who underwent XEN+Phacoemulsification. The primary endpoint was the mean change in intraocular pressure (IOP) from baseline to the last follow-up visit. A total of 154 eyes, 37 (24.0%) eyes that underwent XEN-solo and 117 (76.0%) eyes that underwent XEN+Phacoemulsification, were included. The mean preoperative IOP was significantly lowered from 19.1±5.0 mmHg to 14.9±3.8 mmHg at month-36, p<0.0001. Preoperative IOP was significantly lowered from 21.2±6.2 mmHg and 18.4±4.3 mmHg to 14.3±4.0 mm Hg and 15.2±3.7 mmHg at month-36 in the XEN-solo and XEN+Phacoemulsification groups, p<0.0004 and p=0.0009; with no significant differences between them. In the overall study population, the mean number of antiglaucoma medications was significantly reduced from 2.1±0.8 to 0.2±0.6, p<0.0001. There were no significant differences in the proportion of eyes with a final IOP ≤14 mmHg and ≤16 mmHg between XEN-solo and XEN+Phaco groups (p=0.8406 and 0.04970, respectively). Thirty-six (23.4%) eyes required a needling procedure. XEN implant significantly lowered IOP and reduced the need of ocular hypotensive medication, while maintaining a good safety profile. Beyond week-1, there were no significant differences in IOP lowering between XEN-solo and XEN+Phacoemulsification groups.

The PAUL® glaucoma implant: 1-year results of a novel glaucoma drainage device in a paediatric cohort.

The PAUL® glaucoma implant (PGI) is a novel glaucoma drainage device, which has not been previously reported in paediatric glaucoma management. This study aims to evaluate the safety and effectiveness of the PGI in a paediatric cohort. A retrospective evaluation of 25 cases of paediatric PGI surgery (age 8months to 16years) wasperformed at Manchester Royal Eye Hospital between September 2019 and July 2020. Primary outcome measures included failure (intraocular pressure (IOP) > 21mmHg or < 20% reduction of IOP, removal of the implant, further glaucoma intervention or visual loss. Secondary outcomes included mean IOP, mean number of medications, logMAR visual acuity and complications. Eleven eyes (48%) had a complete success and achieved an unmedicated IOP < 21mmHg, and 21 eyes (84%) had a qualified success (with or without medications). Four failures were observed, 2 due to hypotony and 2 underwent further surgery (gonioscopy-assisted transluminal trabeculotomy). The mean preop IOP was 30.9 ± 5.9mmHg (n = 25), falling to 13.5 ± 6.8mmHg at 1month, 17.9 ± 7.2mmHg at 3months, 13.4 ± 5.1mmHg at 6months, 13.2 ± 4.9mmHg at 12months and 11.8 ± 4.6mmHg at 24months. The mean change in IOP from the preoperative visit to the last visit was a reduction of 19.1 ± 7.7mmHg. A significant reduction in the number of medications and IOP was demonstrated after PGI (p < 0.0001). Nine patients required removal of the intraluminal Prolene stent from the PGI for further pressure lowering. The one- to two-year results demonstrate paediatric PGI has high qualified success rates and effectively reduces IOP and the need for glaucoma medical therapy.

Device-modified trabeculectomy for glaucoma.

Glaucoma is an optic neuropathy that leads to visual field defects and vision loss. It is the second leading cause of irreversible blindness in the world. Treatment for glaucoma aims to reduce intraocular pressure (IOP) to slow or prevent further vision loss. IOP can be lowered with medications, laser, or incisional surgery. Trabeculectomy is a surgical approach which lowers IOP by shunting aqueous humor to a subconjunctival bleb. Device-modified trabeculectomy techniques are intended to improve the durability and safety of this bleb-forming surgery. Trabeculectomy-modifying devices include the Ex-PRESS, the XEN Gel Stent, the PreserFlo MicroShunt, as well as antifibrotic materials such as Ologen, amniotic membrane, expanded polytetrafluoroethylene (ePTFE) membrane, Gelfilm and others. However, the comparative effectiveness and safety of these devices are uncertain. To evaluate the benefits and harms of different devices as adjuncts to trabeculectomy on IOP control in eyes with glaucoma compared to standard trabeculectomy. We used standard, extensive Cochrane search methods. The latest search was August 2021. We included randomized controlled trials in participants with glaucoma comparing device-modified trabeculectomy techniques with standard trabeculectomy. We included studies that used antimetabolites in either or both treatment groups. We used standard Cochrane methods. Our primary outcomes were 1. change in IOP and 2. mean postoperative IOP at one year. Our secondary outcomes were 3. mean change in IOP from baseline, 4. mean postoperative IOP at any time point, 5. mean best-corrected visual acuity (BCVA), 6. visual field change, 7. quality of life, 8. proportion of participants who are drop-free at one year, 9. mean number of IOP lowering medications at one year, and 10. proportion of participants with complications. Eight studies met our inclusion criteria, of which seven were full-length journal articles and one was a conference abstract. The eight studies included 961 participants with glaucoma, and compared two types of devices implanted during trabeculectomy versus standard trabeculectomy. Seven studies (462 eyes, 434 participants) used the Ex-PRESS, and one study (527 eyes, 527 participants) used the PreserFlo MicroShunt. No studies using the XEN Gel Stent implantation met our criteria. The studies were conducted in North America, Europe, and Africa. Planned follow-up periods ranged from six months to five years. The studies were reported poorly, which limited our ability to judge risk of bias for many domains. None of the studies explicitly masked outcome assessment. We rated seven studies at high risk of detection bias. Low-certainty of evidence from five studies showed that using the Ex-PRESS plus trabeculectomy compared with standard trabeculectomy may be associated with a slightly lower IOP at one year (mean difference (MD) -1.76 mmHg, 95% confidence interval (CI) -2.81 to -0.70; 213 eyes). Moderate-certainty of evidence from one study showed that using the PreserFlo MicroShunt may be associated with a slightly higher IOP than standard trabeculectomy at one year (MD 3.20 mmHg, 95% CI 2.29 to 4.11). Participants who received standard trabeculectomy may have a higher risk of hypotony compared with those who received device-modified trabeculectomy, but the evidence is uncertain (RR 0.73, 95% CI 0.46 to 1.17; I² = 38%; P = 0.14). In the subgroup of participants who received the PreserFlo MicroShunt, there was a lower risk of developing hypotony or shallow anterior chamber compared with those receiving standard trabeculectomy (RR 0.44, 95% CI 0.25 to 0.79; 526 eyes). Device-modified trabeculectomy may lead to less subsequent cataract surgery within one year (RR 0.46, 95% CI 0.27 to 0.80; I² = 0%). Use of an Ex-PRESS plus trabeculectomy may produce greater IOP reduction at one-year follow-up than standard trabeculectomy; however, due to potential biases and imprecision in effect estimates, the certainty of evidence is low. PreserFlo MicroShunt may be inferior to standard trabeculectomy in lowering IOP. However, PreserFlo MicroShunt may prevent postoperative hypotony and bleb leakage. Overall, device-modified trabeculectomy appears associated with a lower risk of cataract surgery within five years compared with standard trabeculectomy. Due to various limitations in the design and conduct of the included studies, the applicability of this evidence synthesis to other populations or settings is uncertain. Further research is needed to determine the effectiveness and safety of other devices in subgroup populations, such as people with different types of glaucoma, of various races and ethnicity, and with different lens types (e.g. phakic, pseudophakic).

XEN Gel Stent Versus Non-penetrating Deep Sclerectomy in Ocular-hypertension and Open-angle Glaucoma Patients.

XEN gel-stent and non-penetrating deep sclerectomy, either alone or in combination with cataract surgery, significantly lowered the intraocular pressure and reduced the number of antiglaucoma medications in open-angle-glaucoma patients; with no significant differences between them. To compare the surgical outcomes of XEN45-implant and non-penetrating deep sclerectomy (NPDS), either alone or in combination with cataract surgery, in patients with ocular-hypertension (OHT) and open-angle glaucoma (OAG). Retrospective and single center cohort study conducted on consecutive patients who underwent a XEN45 implant or a NPDS, either alone or in combination with phacoemulsification. The primary endpoint was the mean change in intraocular pressure (IOP) from baseline to the last follow-up visit. One hundred twenty-eight eyes, 65 (50.8%) eyes in the NPDS-group and 63 (49.2%) eyes in the XEN-group, were included in the study. The mean preoperative IOP was significantly lowered from 17.6±5.3mmHg and 17.8±6.2mmHg to 12.6±2.6mmHg and 13.8±2.8mmHg at month-12, in the XEN and NPDS groups, respectively; P<0.0001 each. At month-12, 70(54.7%) eyes were classified as success, with no significant differences between XEN (57.1%; 36/63 eyes) and NPDS (52.3%; 34/65 eyes) (mean difference: 4.8%; 95% CI: -30.5% to 20.8%; P=0.7115). The number of ocular hypotensive medications was significantly reduced in the XEN (from 2.1±0.7 to 0.2±0.5, P<0.0001) and in the NPDS (from 2.0±0.8 to 0.3±0.6, P<0.0001) groups, with no significant differences between them (P=0.2629). The incidence of postoperative adverse events in the overall study population was 12.5%, with no significant differences between groups (P=0.1275). Seven (11.1%) eyes underwent needling (XEN-group) and 10 (15.4%) goniopuncture (NPDS-group); P=0.4753. XEN45-implant and the NPDS, either alone or in combination with cataract surgery, significantly lowered IOP and reduced the number of ocular hypotensive medications in OHT and OAG patients.

Ultrasound cycloplasty for refractory glaucoma treatment: The EyeTechCare Experience

In the 1980s, HIFU was successfully tested for treating refractory glaucoma (Lizzi et al.). A more recent device from EyeTechCare, made of six cylindrical transducers operating at 21MHz, can perform a conformal, partial, and fast thermal ablation of the ciliary bodies, a technique known as ultrasound cycloplasty (UCP). For the last 10 years, we investigated the safety and efficacy of UCP for reducing the production of aqueous humor and intraocular pressure (IOP). The primary outcomes that were validated (more than 55%) were therapeutic success (IOP reduction from baseline ≥20% and IOP &amp;gt;5 mm Hg without other surgical procedures) and vision-threatening complications. Secondary outcomes included mean IOP change from baseline at each follow-up visit, medication use, complications, and subsequent UCP and/or other postsurgical interventions. This technique was associated with a low complication rate and no cases of phthisis. In this presentation, we also highlight the remaining challenges in increasing the efficacy and reliability of UCP and its future developments. [Disclosure: Dietrich Wolf is CEO at EyeTechCare.]