Aqueous Shunts with Extraocular Reservoir for Open-Angle Adult Glaucoma: A Report by the American Academy of Ophthalmology.

PURPOSE: To evaluate the recently published literature on the efficacy and safety of the use of aqueous shunts with extraocular reservoir for the management of adult open-angle glaucomas (OAGs). METHODS: A search of peer-reviewed literature was last conducted in April 2023 of the PubMed database and included only articles published since the last aqueous shunt Ophthalmic Technology Assessment, which assessed articles published before 2008. The abstracts of these 419 articles were examined, and 58 studies were selected for full-text analysis. After inclusion and exclusion criteria were applied, 28 articles were selected and assigned ratings by the panel methodologist according to the level of evidence. Twenty-five articles were rated level I and 3 articles were rated level II. There were no level III articles. RESULTS: Implantation of aqueous shunts with extraocular reservoir can lower intraocular pressure (IOP) by between one-third and one-half of baseline IOP, depending on whether it is undertaken as the primary or secondary glaucoma surgery. Success rates for aqueous shunts were found to be better than for trabeculectomies in eyes with prior incisional surgery. Conversely, in eyes without prior incisional surgery, implantation of aqueous shunts was found to have an overall lower success rate as the primary glaucoma procedure compared with trabeculectomy. Although both valved and nonvalved aqueous shunts with extraocular reservoir were effective, the nonvalved device generally achieved slightly lower long-term IOPs with fewer glaucoma medications and less need for additional glaucoma surgery. Both devices slow the rates of visual field progression with efficacy comparable with that of trabeculectomy. Early aqueous humor suppression after aqueous shunt implantation is recommended for the management of the postoperative hypertensive phase and long-term IOP control. No strong evidence supports the routine use of mitomycin C with aqueous shunt implantation for OAG. CONCLUSIONS: Implantation of aqueous shunts with extraocular reservoir, including valved or nonvalved devices, has been shown to be an effective strategy to lower IOP. Strong level I evidence supports the use of aqueous shunts with extraocular reservoir by clinicians for the management of adult OAG. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

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

PURPOSE: To compare the effectiveness and safety of the MicroShunt (Santen Inc) versus trabeculectomy in patients with primary open-angle glaucoma (POAG). DESIGN: Prospective, randomized, multicenter trial conducted in the United States and Europe. PARTICIPANTS: Adult 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. METHODS: Patients were randomized 3:1 to stand-alone MicroShunt implantation (n = 395) or trabeculectomy (n = 132), both augmented with mitomycin C (MMC) 0.2 mg/ml for 2 minutes. MAIN OUTCOME MEASURES: The primary effectiveness end point was surgical success, defined as ≥ 20% reduction in mean diurnal IOP from baseline with no increase in glaucoma medications. Secondary end points included changes in mean IOP and medication use from baseline and the need for postoperative interventions. RESULTS: At 2 years, the rate of surgical success was lower in the MicroShunt group than in the trabeculectomy group (50.6% vs. 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 2 groups, except that hypotony was more common in eyes undergoing trabeculectomy (51.1% vs. 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. CONCLUSION: At 2 years, both the MicroShunt and trabeculectomy provided significant reductions in IOP and medication use, with trabeculectomy continuing to have greater surgical success. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Hypotony Failure Criteria in Glaucoma Surgical Studies and Their Influence on Surgery Success.

PURPOSE: Review hypotony failure criteria used in glaucoma surgical outcome studies and evaluate their impact on success rates. DESIGN: Systematic literature review and application of hypotony failure criteria to 2 retrospective cohorts. PARTICIPANTS: A total of 934 eyes and 1765 eyes undergoing trabeculectomy and deep sclerectomy (DS) with a median follow-up of 41.4 and 45.4 months, respectively. METHODS: Literature-based hypotony failure criteria were applied to patient cohorts. Intraocular pressure (IOP)-related success was defined as follows: (A) IOP ≤ 21 mmHg with ≥ 20% IOP reduction; (B) IOP ≤ 18 mmHg with ≥ 20% reduction; (C) IOP ≤ 15 mmHg with ≥ 25% reduction; and (D) IOP ≤ 12 mmHg with ≥ 30% reduction. Failure was defined as IOP exceeding these criteria in 2 consecutive visits > 3 months after surgery, loss of light perception, additional IOP-lowering surgery, or hypotony. Cox regression estimated failure risk for different hypotony criteria, using no hypotony as a reference. Analyses were conducted for each criterion and hypotony type (i.e., numerical [IOP threshold], clinical [clinical manifestations], and mixed [combination of numerical or clinical criteria]). MAIN OUTCOME MEASURES: Hazard ratio (HR) for failure risk. RESULTS: Of 2503 studies found, 278 were eligible, with 99 studies (35.6%) lacking hypotony failure criteria. Numerical hypotony was predominant (157 studies [56.5%]). Few studies used clinical hypotony (3 isolated [1.1%]; 19 combined with low IOP [6.8%]). Forty-nine different criteria were found, with IOP < 6 mmHg, IOP < 6 mmHg on ≥ 2 consecutive visits after 3 months, and IOP < 5 mmHg being the most common (41 [14.7%], 38 [13.7%], and 13 [4.7%] studies, respectively). In both cohorts, numerical hypotony posed the highest risk of failure (HR, 1.51-1.21 for criteria A to D; P < 0.001), followed by mixed hypotony (HR, 1.41-1.20 for criteria A to D; P < 0.001), and clinical hypotony (HR, 1.12-1.04; P < 0.001). Failure risk varied greatly with various hypotony definitions, with the HR ranging from 1.02 to 10.79 for trabeculectomy and 1.00 to 8.36 for DS. CONCLUSIONS: Hypotony failure criteria are highly heterogenous in the glaucoma literature, with few studies focusing on clinical manifestations. Numerical hypotony yields higher failure rates than clinical hypotony and can underestimate glaucoma surgery success rates. Standardizing failure criteria with an emphasis on clinically relevant hypotony manifestations is needed. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Visual Field Outcomes in the Primary Tube Versus Trabeculectomy Study.

PURPOSE: To describe visual field outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. DESIGN: Cohort analysis. PARTICIPANTS: A total of 155 eyes (155 subjects) randomly assigned to treatment with tube shunt surgery (n = 84) or trabeculectomy with mitomycin C (n = 71). METHODS: The PTVT Study was a multicenter randomized clinical trial comparing the safety and efficacy of trabeculectomy and tube shunt surgery in eyes without previous intraocular surgery. Subjects underwent standard automated perimetry (SAP) at baseline and annually for 5 years. Standard automated perimetry tests were deemed reliable if the false-positive rate was ≤ 15%. Tests were excluded if visual acuity was ≤ 20/400 or loss of ≥ 2 Snellen lines from baseline because of a nonglaucomatous etiology. Linear mixed-effects models were used to compare rates of change in SAP mean deviation (MD) between the 2 groups. Intraocular pressure (IOP) control was assessed by percentage of visits with IOP < 18 mmHg and mean IOP. MAIN OUTCOME MEASURES: Rate of change in SAP MD during follow-up. RESULTS: A total of 730 SAP tests were evaluated (average of 4.7 tests per eye). The average SAP MD at baseline was -12.8 ± 8.3 decibels (dB) in the tube group and -12.0 ± 8.4 dB in the trabeculectomy group (P = 0.57). The mean rate of change in SAP MD was -0.32 ± 0.39 dB/year in the trabeculectomy group and -0.47 ± 0.43 dB/year in the tube group (P = 0.23). Eyes with mean IOP 14 to 17.5 mmHg had significantly faster rates of SAP MD loss compared with eyes with mean IOP < 14 mmHg (-0.59 ± 0.13 vs. -0.27 ± 0.08 dB/year; P = 0.012), and eyes with only 50% to 75% of visits with IOP < 18 mmHg had faster rates than those with 100% of visits with IOP < 18 mmHg (-0.90 ± 0.16 vs. -0.29 ± 0.08 dB/year; P < 0.001). Multivariable analysis identified older age and worse IOP control as risk factors for faster progression in both treatment groups. CONCLUSIONS: No statistically significant difference in mean rates of visual field change was observed between trabeculectomy and tube shunt surgery in the PTVT Study. Worse IOP control was significantly associated with faster rates of SAP MD loss during follow-up. Older patients were also at risk for faster progression. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Cost-utility analysis of treating mild stage normal tension glaucoma by surgery in China: a decision-analytic Markov model.

BACKGROUND: Many individuals suffer from normal tension glaucoma (NTG) in China. This study utilized Markov models to evaluate the cost-utility of applying many medications and surgery for mild-stage NTG when disease progression occurred at a mild stage. METHODS: A 10-year decision-analytic Markov model was developed for the cost-utility analysis of treating mild-stage NTG with surgery and increased application of medication. We hypothesized that all 100,000 samples with a mean age of 64 were in mild stages of NTG. Transitional probabilities from the mild to moderate to severe stages and the basic parameters acquired from the CNTGS were calculated. Incremental cost-utility ratios (ICUR) were calculated for treating all patients with NTG by probabilistic sensitivity analysis (PSA) and Monte Carlo simulation. One-way sensitivity analysis were conducted by adjusting the progression rate, cost of medications or trabeculectomy, cost of follow-up, and surgical acceptance rate. RESULTS: The ICUR of treating mild stage NTG with medication over 10 years was $12743.93 per quality-adjusted life years (QALYs). The ICUR for treating mild stage NTG patients with a 25% and 50% surgery rate with medication were $8798.93 and $4851.93 per QALYs, respectively. In this model, the cost-utility of treating NTG was sensitive to disease progression rate, surgical treatment rate, and medication costs. CONCLUSIONS: According to the results of the cost-utility analysis, it was a reasonable and advantageous strategy to administer a lot of medication and surgery for NTG in the mild stages of the disease. In the model, the greater the probability of patients undergoing surgery, the strategy becomes more valuable.

Management of experimental trabeculectomy filtering blebs via crosslinking of the scleral flap inhibited vascularization.

PURPOSE: The aim of this study was to evaluate whether UVA-light-activated riboflavin-induced collagen crosslinking (UVA-CXL) can maintain the function of filtering blebs after trabeculectomy (TRAB) in rabbits. METHODS: Thirty-six healthy rabbits were randomized to one of the following groups with 12 rabbits in each group: Trabeculectomy group (TRAB group), trabeculectomy combined with CXL group (CXL group), and trabeculectomy combined with MMC group (MMC group). Six rabbits of each group were performed with intraocular pressure (IOP), optical coherence tomography (OCT), and OCT angiography (OCTA). Bleb structure was observed via hematoxylin & eosin (H&E) and Masson staining. Immunohistochemistry, proteomic study, western blot, and tensile test were performed between CXL group and the control. In vitro, cell viability was evaluated by CCK-8 and Calcein/PI staining. TRPV4 and VEGF-a expression levels were measured by Q-PCR. Ca2+ concentration was observed with Fluo-4 AM. RESULTS: The IOP and bleb median survival day were significantly modified in CXL (5.92 ± 0.32 mmHg and 15.5 days) than TRAB group (7.50 ± 0.43 mmHg and 9 days). The bleb area and height increased. CXL inhibited vascularization, and vascularization peaked at postoperative day (POD) 14 and then decreased gradually. In proteomic analyses, Z disc, actin filament binding, and sarcomere organization were significantly enriched. CXL inhibited scleral stress‒strain in tensile tests. Compared with TRAB group, TRPV4 expression was significantly increased, but VEGF-a and TGF-ß1 levels were reduced in the CXL group in western blot. Meanwhile, TRPV4 expression colocalized with CD31. In vitro, CXL inhibited HUVECs cell viability. After CXL, expression level of TRPV4 was increased and calcium influx was activated, but VEGF-a was decreased in HUVECs. CONCLUSIONS: This study demonstrates that intraoperative UV-RF CXL can significantly improve the success rate of TRAB via inhibiting filtering bleb vascularization. CXL increased sclera stiffness, in turn, induced TRPV4 activation, thus contributing to vascular endothelial cells suppression.

PreserFlo MicroShunt versus trabeculectomy: an updated meta-analysis and systematic review.

PURPOSE: This meta-analysis compares PreserFlo (PF) and trabeculectomy (TB) in moderate-to-advanced glaucoma (defined by visual fields with a mean deviation (MD) worse than -6 dB). Key outcomes include success rates (qualified success is defined as a target IOP of less than 21 mm Hg or a 20% reduction from baseline at the endpoint, with or without medications. Complete success is achieving these targets without any medications), intraocular pressure (IOP), complications, reinterventions, needling, glaucoma medication reduction, retinal nerve fibre layer (RNFL), and visual field progression. METHODS: We searched PubMed, Scopus, and Cochrane Central up to 13/01/24, including randomized and non-randomized studies with at least 2 months follow-up. Bias risk was assessed using ROB-2 for RCTs and ROBIN-I for non-RCTs. Publication bias was evaluated via funnel plots and Egger's regression. RESULTS: Ten studies (n = 1833 eyes; 57.4% PF) were analyzed. Preoperative IOP was 22.1 mmHg; 56.1% had moderate-to-severe glaucoma. No significant differences were found in qualified (QSR) and complete success rates (CSR) between PF and TB. Trabeculectomy achieved better IOP outcomes (mean difference, MD 1.59 mmHg; p = 0.0004) and greater IOP reduction (MD -2.52 mmHg; p = 0.0003), but PF showed less visual field progression (MD -1.21; p = 0.03) and lower hypotony maculopathy risk (OR 0.30; p = 0.03). PF had a higher reintervention rate, particularly in patients without prior glaucoma surgery (OR 1.74; p = 0.02) or with primary open-angle glaucoma (OR 1.84; p = 0.04). CONCLUSION: Trabeculectomy is more effective for uncontrolled glaucoma up to 2 years, while PF presents a lower risk of hypotony-related events and may benefit patients sensitive to visual field progression. Study strengths include detailed subgroup analyses and mid-term follow-up, with limitations noted in the number of RCTs. KEY MESSAGES: What is known PreserFlo MicroShunt has been shown to provide an efficient surgical solution for intraocular pressure (IOP) control with a favourable safety profile. Compared to trabeculectomy thereis still contentious regarding the best surgical approach. What is new Trabeculectomy is more effective in uncontrolled glaucoma patients up to 2 years, particularly if lower target IOPs are considered. PreserFlo had lower hypotony-related events risk and may be preferred for patients sensitive to visual field loss. PreserFlo showed a higher risk of reintervention, especially without prior glaucoma surgery or primary open-angle glaucoma diagnosis.

Comparison of clinical outcomes between gonioscopy-assisted transluminal trabeculotomy and trabeculectomy in advanced-stage pseudoexfoliation glaucoma.

PURPOSE: To compare clinical outcomes between gonioscopy-assisted transluminal trabeculotomy (GATT) and trabeculectomy (TRAB) in patients with advanced-stage pseudoexfoliation glaucoma (PEXG). METHODS: This comparative study comprised 62 patients who underwent GATT (N = 31) or TRAB (N = 31) for advanced-stage PEXG. Primary outcome was cumulative probability of surgical success at the end of 12-month follow-up. Success was determined as intraocular pressure (IOP) reduction ≥ 30% from baseline, IOP between 6 and 18 mmHg and IOP upper limits for IOP < 15 mmHg and < 12 mmHg, separately. Secondary outcomes were IOP reduction, antiglaucoma medication (AGM) use, and complications in the study. RESULTS: Age, sex, cup/disc ratio, mean deviation, pattern standard deviation, and retinal nerve fiber layer thickness did not significantly differ between the groups (p > 0.05 for all). The probability of cumulative surgical success at the end of 12 months was similar between the two groups for IOP < 15 mmHg and < 18 mmHg but significantly higher after TRAB (92.0%) than GATT (82.5%) for IOP < 12 mmHg (log-rank test p = 0.035). Percentage of IOP reduction from baseline was similar between the groups (53.1 ± 18.6% in GATT group and 53.0 ± 16.6% in TRAB group, p = 0.98) at the end of 12 months. No significant difference in the mean number of AGM was present at the 12-month visit (1.3 ± 1.4 in GATT and 1.1 ± 1.4 in TRAB, p = 0.65). CONCLUSION: At the end of 12 months, IOP reduction rate was similar between GATT and TRAB. Cumulative surgical success was higher after TRAB than GATT for IOP < 12 mmHg.

Failed Ahmed glaucoma valves: trabeculectomy versus repeat shunt surgery.

INTRODUCTION: To investigate the outcomes of trabeculectomy (TRAB) versus repeat Ahmed glaucoma valve (re-AGV) implantation in eyes with Ahmed glaucoma valve (AGV) failure. METHODS: This quasi-experimental study includes patients with failed AGV implants requiring additional surgical intervention between 2018 and 2022. Patients in the TRAB group underwent a fornix-based procedure with mitomycin C 0.01% injection (0.1 mL). Eyes in the re-AGV group underwent repeat shunt surgery. The choice of the procedure was based on conjunctival condition. The primary outcome measure was surgical success rate based on various intraocular pressure (IOP) targets and percentages of IOP reduction from baseline: IOP ≤ 21 mmHg and 20% reduction (conventional criteria), IOP ≤ 18 and > 20% reduction (criterion A), IOP ≤ 15 and > 25% reduction (criterion B), and IOP ≤ 12 and > 30% reduction (criterion C). RESULTS: Forty-eight eyes of 48 patients were operated and reported herein, consisting of 22 eyes of 22 patients undergoing TRAB and 26 eyes of 26 subjects undergoing re-AGV. No significant difference was observed between the study groups in terms of initial diagnoses, baseline IOP or the number of prior surgeries. The cumulative probability of survival at one year was significantly higher in the trabeculectomy group using the three stricter success definitions. In both study groups, IOP was significantly reduced from baseline at all postoperative visits, and was significantly lower in the TRAB group at all time points beyond one month. At 12 months, 5% of TRAB versus 48% of re-AGV eyes required glaucoma medications (P < 0.001). The rate of complications was comparable between the study groups (P = 0.76) but there was a trend toward a greater need for repeat surgery in the re-AGV group (4 eyes versus nil, P = 0.07). CONCLUSIONS: Trabeculectomy can be considered a safe and effective surgical option in eyes with failed AGV leading to significantly lower IOP levels and more favorable success rates than re-AGV in selected patients.

Non-penetrating filtration surgery versus trabeculectomy in postoperative astigmatism: a meta-analysis.

OBJECTIVE: Trabeculectomy and non-penetrating trabecular surgery are common operations for glaucoma. This meta-analysis aims to compare the effect of trabeculectomy and non-penetrating trabecular surgery in postoperative astigmatism of patients with glaucoma. METHODS: A systematic literature search was performed for studies comparing trabeculectomy and non-penetrating trabecular surgery in patients with glaucoma. The time frame for the search was from the time of construction to April 2024. There were no restrictions regarding study type or type of glaucoma. The endpoint was the surgically induced astigmatism assessed 6 months after operation. We conducted this meta-analysis following the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis). RESULTS: Five eligible studies were included in this meta-analysis and presented data for 359 eyes with various types of glaucoma at different stages. The results revealed an increase in astigmatism in patients with glaucoma after trabeculectomy and non-penetrating trabecular surgery. Trabeculectomy had a higher incidence of astigmatism than in the non-penetrating trabecular surgery group at or around 6 months postoperatively, and the difference was statistically significant. (SMD = 0.40, 95% CI = 0.19 to 0.61, P = 0.02). CONCLUSION: Our results demonstrated that both trabeculectomy and non-penetrating trabecular surgery could increase astigmatism until 6 months after operation. Moreover, non-penetrating trabecular surgery group seems to have less influence on astigmatism. TRIAL REGISTRATION NUMBER: CRD42024517708.

Comparison of bleb morphologies between phacoemulsification combined with Ex-PRESS mini shunt implantation, phacotrabeculectomy and trabeculectomy alone: a two-year retrospective in vivo confocal microscopy study.

BACKGROUND: To compare the bleb morphologies of phacoemulsification combined with Ex-PRESS implantation (Phaco-ExPRESS), phaco trabeculectomy (Phaco-Trab), and trabeculectomy (Trab) in postoperative two years. METHODS: Patients with primary open-angle glaucoma (POAG) with or without cataracts were included in this study. All patients underwent surgeries of either Phaco-ExPRESS, Phaco-Trab, or Trab. The morphologic structures of the filtering bleb, including microcysts area, hyperreflective dot density, and stromal connective tissue under in vivo confocal microscope (IVCM), were compared between the three groups. The data were collected preoperatively and postoperatively at 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months. RESULTS: Eighty-nine eyes from 89 patients were enrolled, including 32 in the Phaco-ExPRESS group, 25 in the Phaco-Trab group, and 32 in the Trab group. In a 24-month follow-up, bleb morphologies in Phaco-ExPRESS were similar to the Trab group. The area of epithelial microcysts was significantly increased in Phaco-ExPRESS and Trab groups while significantly decreased in Phaco-Trab. At postoperative 24 months, the complete success rate was 65.1% in Phaco-ExPRESS, 32.0% in Phaco-Trab, and 59.4% in the Trab group (P = 0.03). The phaco-Trab group had more postoperative anti-glaucoma medications than the other two groups (P < 0.05). CONCLUSIONS: Phaco-ExPRESS group and Trab group had similar blebs morphologies in IVCM, with larger microcyst area, looser connective tissue, and less inflammation than Phaco-Trab, indicating that the function of blebs in the Phaco-ExPRESS and Trab group, was more potent than that of Phaco-Trab. All these surgical methods provided adequate IOP control, but Phaco-Trab required more anti-glaucoma medications.

Evaluation of Macular Thickness in Glaucoma Patients Using Prostaglandin Analog Eye Drops Undergoing Trabeculectomy with Mitomycin C: Prospective, Comparative, Randomized, Masked Examiner Study.

INTRODUCTION: The aim of the study was to evaluate the macular thickness of glaucomatous patients undergoing trabeculectomy (TREC) with mitomycin C (MMC) with or without the use of prostaglandin analog (PA) eye drops. METHODS: In this prospective, comparative clinical trial, patients with glaucoma and indications for TREC with MMC using PA and without previous macular changes were randomized into 2 groups: the study group (SG) and the control group (CG). In the CG, PA was suspended between 30 and 60 days after the preoperative exams. The subjects were evaluated, including optical coherence tomography (OCT) with the Cirrus 4000 macular protocol preoperatively and in the postoperative period on 3 occasions: 1-3 days ("PO1"), 6-9 days ("PO7"), and 27-30 days ("PO30") after surgery. The results were compared between groups. RESULTS: Thirty-five eyes of 35 patients were included (17 in the CG and 18 in the SG). There was no statistically significant difference in age (p = 0.2), the preoperative visual field mean deviation (p = 0.08), or the preoperative intraocular pressure (SG: 24.8 ± 7.8 mm Hg vs. CG: 22.8 ± 6.0 mm Hg, p = 0.4). The preoperative macular OCT parameters were equivalent between the groups (p > 0.05). When comparing the variation of parameters between the groups between preop and PO30 there was equivalence in all of the comparisons evaluated. The presence (or absence) of the lens did not affect the results. CONCLUSION: PA eye drops did not affect macular thickness after TREC with MMC in glaucomatous patients.

Matched case-control comparison of surgical success after XEN45 Gel Stent and PRESERFLO MicroShunt implantation in a Caucasian population.

BACKGROUND: The aim of this study was to compare the outcome of implantation of a XEN45 Gel Stent with the outcome of implantation of a Preserflo MicroShunt in a matched-pair analysis in eyes being naïve to filtering surgery. METHODS: In this comparative, retrospective study, 50 eyes that had undergone XEN45 Gel Stent implantation were compared with 50 eyes after Preserflo implantation. Follow-up was at least 6 months, and surgical success was measured by criteria A (IOP < 21 mmHg, IOP reduction >20%, no repeat surgery); criteria B (IOP < 18 mmHg, IOP reduction >20%, no repeat surgery); and criteria C (IOP ≤15 mmHg, IOP reduction ≥40%, no repeat surgery). RESULTS: After a follow-up period of 12 months, mean IOP had decreased from preoperative 25.2 ± 4.8 mmHg in the XEN group to 14.5 ± 4.0 (n = 35) and from 25.3 ± 6.8 mmHg to 11.9 ± 2.9 (n = 41) in the Preserflo group, respectively. The IOP at the last follow-up of the two groups differed significantly (p < 0.01). The probability of surgical success did not differ concerning Criteria A and B, but surgical success was significantly higher in the Preserflo group for Criteria C (60%, p < 0.01). CONCLUSION: Both the Preserflo and XEN45 Gel Stent provide an effective and safe treatment option for advanced glaucoma and have a high potential to reduce intraocular pressure. Absolute IOP levels of <16 mmHg after 12 months were significantly more frequent in the Preserflo group.

Plasma rich in growth factors (PRGF) technology as adjuvant to Ab Externo trabeculectomy.

PURPOSE: Plasma rich in growth factors (PRGF) technology creates blood-derived products with growth factors that promote wound healing and regeneration. The goal of this study was to assess the potential role of PRGF products as wound modulators in trabeculectomy. Our premise is that due to PRGF's regenerative and antifibrotic properties, its use in trabeculectomy may produce a more physiological bleb, without altering IOP reduction. METHODS: A retrospective, longitudinal study was conducted in a Hospital in Portugal. Patients with eyes with open angle glaucoma were included. Trabeculectomy was performed on all patients using PRGF membrane (mPRGF) under the conjunctiva, as adjuvant. Data regarding patients' demographics and number of medications used, was collected. Intraocular pressure (IOP) before surgery, 8 days, 1 month, 3 month, 6 month, 9 month and 1 year after surgery was recorded. Bleb morphology was classified according to Moorfields Bleb Grading System 6 months after surgery. RESULTS: Nine eyes of 9 patients were enrolled. Mean age was 71 ± 5.1 years old. Six were male. Mean IOP decreased from 24.0 ± 8.8 mmHg pre-surgery to 12.9 ± 2.6 mmHg at one year follow-up. The number of hypotensive drugs (mean ± SD) was 4.3 ± 0.9 preoperatively and 0.8 ± 1.1 at 1-year. Complete success was defined as IOP equal to or less than 21 mm Hg without ocular hypotensive medications and qualified success as IOP equal to or less than 21 mm Hg with medications. Complete success was 66.7% and qualified success was 100% at 1 year follow-up. CONCLUSION: In our study, trabeculectomy with mPRGF demonstrated both safety and efficacy. Low values of bleb height (1.6 ± 0.8) were recorded. mPRGF could improve wound healing and produce a more well-tolerated, favourable bleb, avoiding antimetabolite complications.

Efficacy and safety of intraoperative injection of mitomycin C during trabeculectomy: a systematic review and meta-analysis.

PURPOSE: Trabeculectomy, a primary surgical treatment for glaucoma, often employs mitomycin C (MMC) to reduce scar formation and improve surgical outcomes. However, the optimal application method of MMC, whether by injection or sponge, remains a subject of debate. This meta-analysis aims to compare injectable and sponge-based MMC application in terms of efficacy and safety, focusing on various clinical outcomes in glaucoma patients. METHODS: A comprehensive literature search of Scopus, MEDLINE, EMBASE, Ovid, Chinese biomedical literature database, China National Knowledge Infrastructure, and Cochrane Library was done for eligible studies that report data of glaucoma patients who were administered MMC by injection or sponge application during trabeculectomy. Outcomes of interest included intraocular pressure (IOP) reduction, bleb appearance grading (height, extent, vascularity), use of anti-glaucoma medications, and rates of complete success, qualified success, and failure. Data were reported as weighted mean differences (WMD) or odds ratios (OR) with confidence intervals (CI). The random-effects inverse-variance model with DerSimonian-Laird estimate of tau2 was employed, with continuity correction applied where necessary. RESULTS: A total of 15 studies with 1276 participants were included. The meta-analysis revealed no significant difference in IOP reduction between patients treated by MMC injection and sponge application (WMD = - 0.434). Significant differences were observed in bleb appearance grading scores for height (WMD = - 0.170) and extent (WMD = 0.174), with substantial heterogeneity. The use of anti-glaucoma medications was significantly lower in the injection group (WMD = - 0.274). However, there were no significant differences in the rates of complete success, qualified success, and failure. The study demonstrated moderate to high heterogeneity across various outcomes. CONCLUSION: This meta-analysis indicated that while both injection and sponge methods of MMC application during trabeculectomy were equally effective for IOP reduction, they differ in their impact on bleb morphology and postoperative medication requirement. The findings highlight the need for individualized treatment approaches in glaucoma surgery, taking into account the specific needs and characteristics of each patient.

A comparative study of cystoid macula edema following glaucoma drainage device surgery versus trabeculectomy.

PURPOSE: To assess and compare the risk for development of cystoid macula edema (CME) after glaucoma drainage device (GDD) implantation versus conventional trabeculectomy with mitomycin (trab) for glaucoma. METHODS: Retrospective review of consecutive patients receiving trab or GDD implantation between 2016 and 2018. Inclusion criteria were availability of pre- and postoperative spectral domain optical coherence tomography (SD-OCT) of the macula. SD-OCT images were evaluated for presence of CME qualitatively, central subfield thickness (CST) and macular volume (MV). RESULTS: 73 eyes could be included, 42 received trab and 31 GDD surgery. Eyes receiving trab on average had 0.8 ± 0.8 previous intraocular operations, while eyes with GDD implantation had 3.1 ± 1.9 (p < 0.001). Occurrence of postoperative CME was significantly more frequent after GDD implantation (6 out of 31 (19.4%)) than after trab (2 out of 42 eyes = 4.8%), (p = 0.049). Mean preoperative CST as well as MV was comparable in both groups (CST before trab: 282.7 ± 23.0 µm, CST before GDD 284.2 ± 27.3 µm, p = 0.287; MV before trab: 7.8 ± 1.1 mm3, MV before GDD: 8.0 ± 0.8mm3, p = 0.305). Mean postoperative CST and MV were significantly higher after GDD (CST 338.5 ± 129.3 µm, MV 8.8 ± 2.6 mm3) than after trabeculectomy (CST 290.6 ± 60.2 µm, p = 0.038; MV 7.8 ± 1.2mm3, p = 0.039). CONCLUSIONS: In real-life conditions, GDD surgery seems to be associated with a higher risk to develop CME when compared to conventional trabeculectomy. This information may be helpful for glaucoma surgeons to advise the patients on postoperative risks of surgery.

Comparison of lacrimal gland dimensions and volume in unilateral Ahmed glaucoma valve versus trabeculectomy.

PURPOSE: To evaluate radiographic lacrimal gland (LG) volume and dimensions in Ahmed glaucoma valve (AGV)- versus trabeculectomy-treated eyes and contralateral non-treated eyes. METHODS: In this retrospective cohort study, 1616 medical records acquired between 2010 and 2020 were examined. In AGV-treated (group 1) eyes, there were 19 patients with records sufficient for radiological LG evaluation, and in trabeculectomy-treated (group 2) eyes, there were 18. The hospital workstation software was used to assess high-resolution computed tomography (HRCT) scans conducted under standard protocol using a 128 SL Optima CT 660 scanner. The software (Vitrea™) was used to perform semi-quantitative volumetric measurements. LG dimensions were obtained in the axial and reformatted coronal planes on each side, and four measures were generated using the widest LG tip-to-tip diameters in two planes: coronal length, coronal width (CW), axial length (AL), and axial width. RESULTS: The time interval between surgery and HRCT imaging was 50.97 ± 26.25 months. Group 1 had significantly lower LG volume than group 2 (594.11 ± 259.45 vs. 933.67 ± 294.09 mm3, P = 0.001). When compared to non-treated eyes, AGV-treated eyes had lower LG volume (P = 0.065) while trabeculectomy-treated eyes had higher LG volume (P = 0.031). Further, group 1 had decreased length and width in both the axial and coronal planes as compared to group 2, with AL and CW being significantly different (P < 0.05). CONCLUSIONS: AGV and trabeculectomy had varied impacts on LG volume and dimensions despite being conducted in the same quadrant. HRCT appears to be effective in analysing AGV position, which may be related to LG volumetric and dimensional issues.

[Efficacy of drainage implants in combined cataract and glaucoma surgery]. / Effektivnost' primeneniya drenazhei v kombinirovannoi khirurgii katarakty i glaukomy.

The combination of glaucoma and cataract occurs in 14.6-76% of cases, according to various sources. The goal of surgical treatment for these patients is to improve visual function while simultaneously reducing intraocular pressure. Due to the wide variety of proposed surgical methods, there is no consensus on the optimal management strategy for such patients. PURPOSE: This study evaluates the hypotensive effect and visual function outcomes of combined surgery for complicated cataract and glaucoma using the mesh drain made of digeland the xenocollagen drain. MATERIAL AND METHODS: Patients in Group 1 (n=43; 48.3%) underwent combined cataract and glaucoma surgery with implantation of the digel drainage implant, while patients in Group 2 (n=46; 51.7%) underwent an identical operation with the xenocollagen implant. Preoperative tonometric pressure was 27.2±1.7 and 27.3±1.9 mm Hg; best corrected visual acuity was 0.35±0.21 and 0.33±0.18, respectively. The following surgical technique was employed. At 3.0-4.0 mm from the limbus, an intrascleral tunnel was created using a 2.2 mm sclerotome through the conjunctiva in the anteroposterior direction, exiting into the anterior chamber. Capsulorhexis and phacoaspiration were performed. The scleral tunnel was widened to 3 mm, and the intraocular lens was implanted. Penetrating basal coloboma of the iris was formed. The deep flap of the scleral tunnel was dissected from the flat part of the ciliary body and removed. The digel implant was shaped into a T-configuration, while the xenocollagen implant was used without modification. Each drainage was implanted into the intrascleral tunnel (one end directed into the anterior chamber, the other exiting the scleral tunnel). The conjunctiva was sutured with 10/0 stitches, and the paracenteses were hydrated. RESULTS: Over a 24-month follow-up period, the tonometric intraocular pressure in Groups 1 and 2 was 18.8 and 18.5 mm Hg, respectively, and the best corrected visual acuity was 0.51 and 0.58. CONCLUSION: The use of both drainages in the proposed combined surgery for complicated cataract and glaucoma results in similarly stable hypotensive outcomes and high visual function.

Surgical Results of Trabeculectomy among Groups Stratified by Prostaglandin-Associated Periorbitopathy Severity.

PURPOSE: To report the role of prostaglandin-associated periorbitopathy (PAP) severity in the surgical effectiveness of trabeculectomy (LEC). DESIGN: Retrospective observational case series. PARTICIPANTS: A total of 139 consecutive eyes of 139 Japanese subjects (74 men, 65 women; mean age ± standard deviation, 65.7 ± 10.6 years) who underwent LEC were included. All had primary open-angle glaucoma (POAG), no history of conjunctival incisional surgery, completed all postoperative visits for 12 months, and information on the PAP severity using the Shimane University PAP Grading System (SU-PAP). METHODS: Data were collected from a medical chart review at 2 hospitals. MAIN OUTCOME MEASURES: Comparison of surgical success rates among groups stratified by SU-PAP grades 0 to 3 by survival curve analysis using the definitions of failure based on surgical intervention other than laser suture lysis (LSL), intraocular pressure (IOP) reduction below 20%, postoperative IOP exceeding 15 mmHg (definition A) or 12 mmHg (definition B), and a postoperative IOP below 6 mmHg. RESULTS: Twelve months postoperatively, the success rates of grades 0, 1, 2, and 3 were 86%, 68%, 40%, and 0%, respectively, for definition A (P < 0.0001, log-rank test) and 86%, 61%, 36%, and 0%, respectively, for definition B (P < 0.0001). Interventions other than LSL (P < 0.0001, Cochran-Armitage trend test), IOP reduction less than 20% (P = 0.010), and IOP exceeding 15 mmHg (P = 0.016) or 12 mmHg (P < 0.0001) were associated with surgical failure; IOP under 6 mmHg was not (P = 0.31). The proportional hazard model for definition A showed that compared with grade 0, grade 2 (risk ratio [RR], 5.82, P = 0.0043) and grade 3 (RR, 12.2, P = 0.0003) were associated with surgical failure. For definition B, grade 1 (RR, 3.53, P = 0.040), grade 2 (RR, 6.65, P = 0.0021), and grade 3 (RR, 12.0, P = 0.0003) were associated with surgical failure. Differences in age, gender, preoperative IOP and medications, refractive error, and simultaneous cataract surgery were not associated with surgical failure in both models. CONCLUSIONS: The preoperative presence of severe PAP worsens the 1-year success rate of LEC in patients with POAG. To retain the surgical effectiveness, treating physicians should prevent patients from progressing to severe PAP, an avoidable side effect, by switching or stopping the causative medications. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Long-term Outcomes in Patients Undergoing Surgery for Primary Congenital Glaucoma between 1991 and 2000: A Single-Center Database Study.

PURPOSE: To estimate the long-term surgical and visual outcomes in patients with primary congenital glaucoma (PCG) who completed at least 20 years of follow-up. DESIGN: Retrospective study. PARTICIPANTS: Two hundred twenty eyes of 121 patients undergoing surgery for PCG between January 1991 and December 2000 and who returned for a follow-up visit from January 2021 through January 2022. METHODS: Retrospective review of medical records of patients who underwent primary combined trabeculotomy-trabeculectomy (CTT) without mitomycin C as an initial procedure. Success was defined as complete when intraocular pressure (IOP) was ≥ 6 mmHg and ≤ 21 mmHg without glaucoma medication and as qualified when up to 2 glaucoma medications were required. Failure was defined as uncontrolled IOP with more than 2 glaucoma medications, need for a second IOP-lowering procedure, chronic hypotony (IOP < 6 mmHg on 2 consecutive visits), or any sight-threatening complication. A mixed-effects model using maximum likelihood estimation was used in estimation of eye-based variables and to make comparisons between different visits. Kaplan-Meier survival analysis was used to estimate the probabilities of surgical and functional successes. Cox proportional hazards regression using sandwich clustered estimation was used to evaluate risk factors for failure and poor visual outcome. MAIN OUTCOME MEASURES: Primary outcome measure was the proportion of patients who demonstrated complete success over the 20-year follow-up. Secondary outcome measures included rate of surgical failure and need for reoperation for glaucoma, visual acuity, refractive errors, risk factors for poor outcome, and complications. RESULTS: Kaplan-Meier survival analysis revealed 1-year, 10-year, and 20-year complete success rates of 90.7%, 78.9%, and 44.5%, respectively. In univariate analysis, surgical failure was higher among patients with any additional non-glaucoma intraocular surgery. None of the clinical parameters were associated significantly with failure in multivariable analysis. Overall, the proportion of eyes with good, fair, and poor visual outcomes was 33.2%, 16.4%, and 50.4%, respectively. Myopia was seen in 68.9% eyes. Twenty-eight eyes of those who underwent primary CTT (14.4%) required second surgery for IOP control. No significant intraoperative complications occurred. Six eyes required enucleation because of painful blind eye. CONCLUSIONS: In this large cohort of patients with PCG, CTT is a useful procedure. It provides good IOP control and moderate visual recovery that remained over a 20-year follow-up after surgery. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.