Trabectome Surgery Research Articles

Comparison of surgical outcomes between Kahook Dual Blade goniotomy and Trabectome surgery in patients with open-angle glaucoma

Objective: To compare the medium-term therapeutic effects of Kahook Dual Blade (KDB) goniotomy and Trabectome surgery in the treatment of patients with primary open-angle glaucoma (POAG). Methods: This study was a non-randomized prospective interventional controlled clinical study. POAG patients who underwent KDB goniotomy or Trabectome surgery at Beijing Tongren Hospital from May 2017 to April 2022 were enrolled. The definition of successful surgery was postoperative average intraocular pressure (IOP)≤21 mmHg (1 mmHg=0.133 kPa) and IOP decrease≥20%. Follow-up visits were conducted on the 1st day, 1st week, 1st, 3rd and 6th month after surgery. The IOP value, the number of IOP-lowering medications, the proportion of surgical success (average IOP≤21 mmHg at 6 months), and complications were evaluated. Statistical methods included independent sample t-test, Mann-Whitney rank sum test, χ2 test, repeated measures two-factor analysis of variance, Bonferroni, Friedman M test, Wilcoxon, and Log-rank. The Kaplan-Meier method was used to calculate the cumulative success rate of each group. Results: Seventeen male patients (17 eyes) and 10 female patients (10 eyes) were included. The mean age was (39.9±17.7) years old. There were 11 patients in the KDB group and 16 patients in the Trabectome group. There was no significant difference in clinical baseline conditions between the two groups (P>0.05). The IOPs in the KDB and Trabectome groups at postoperative 1 week [(16.6±6.3) and (16.4±4.1) mmHg) and 6 months [(17.8±5.3) and (19.9±4.4) mmHg) were lower than those before surgery [(25.1±9.3) and (27.4±9.1) mmHg) (all P<0.05). There was no significant difference in the overall IOP between groups (P>0.05). The IOP reduction rates in the KDB and Trabectome groups were 23.4% and 19.0%, with no significant difference (P=0.674). The numbers of IOP-lowering medications used in the KDB and Trabectome groups at 3 months [2.0 (1.0, 4.0) and 2.0 (1.0, 2.3)] and 6 months [2.0 (0.0, 4.0) and 2.0 (1.0, 3.0)] after surgery were not significantly different from those before surgery [4.0 (2.0, 4.0) and 3.0 (2.0, 4.0)] (both P>0.05). There was no statistical significance in the overall number of IOP-lowering medications used between the two groups (P>0.05). There was also no statistically significant difference in the proportion of patients with an IOP decrease of≥20% and the proportion of patients whose mean postoperative IOP was≤21 mmHg (all P>0.05). The proportions of IOP≤21 mmHg in the KDB group and the Trabectome group at 6 months after surgery were 81.8% and 68.8% (P>0.05). Serious intraoperative or postoperative complications occurred in neither group. Conclusions: Both KDB trabeculotomy and Trabectome surgery can effectively reduce IOP and have a good safety profile in treating POAG, with the same number of IOP-lowering medications.

IOP-lowering and drug-sparing effects of trabectome surgery with or without cyclodialysis ab interno.

To compare the postoperative intraocular pressure (IOP) after ab interno trabeculectomy (AIT; trabectome surgery) alone or combined with cyclodialysis ab interno (AITC). Forty-three eyes with insufficiently controlled open-angle glaucoma were included in this consecutive case series. All eyes received AIT, combined with phacoemulsification and IOL-implantation in phakic instances, with or without additional cyclodialysis ab interno. Postoperative visual acuity, IOP, number of IOP-lowering medications and complications were registered over 12months. A total of 19 eyes (14 patients) received AIT and 24 (19 patients) received AITC. Both groups were comparable for baseline IOP (AIT: 19.7 ± 8.2mmHg; AITC: 19.4 ± 6.8mmHg; p = 0.96), there was a comparable IOP reduction after 6months (AIT: - 3.8 ± 12.3, median (interquartile range (IQR)): - 3.8 (- 7.8-4.8) mmHg; AITC: - 4.9 ± 8.3, median (IQR): - 2.0 (- 10.8-2.0) mmHg; p = 0.95) and 12months (AIT: - 4.3 ± 6.6, median (IQR): - 4.0 (- 8.0 to - 1.0) mmHg; AITC: - 3.7 ± 6.7, median (IQR): - 1.5 (- 5.5 to - 0.5) mmHg; p = 0.49). While final visual acuity was similar between the groups, they differed regarding topical IOP-lowering medications (baseline: AIT 2.9 ± 1.2 and AITC 2.9 ± 1.2; 1year after surgery: AIT 2.6 ± 1.5 (p = 0.16) and AITC 1.3 ± 1.3; p < 0.001)). Depending on the definition, a complete or qualified success of 33.4-45.8% was achieved in AITC compared to 15.8-21.1% in AIT. The additional suprachoroidal outflow when AIT is combined with cyclodialysis ab interno (AITC) seems to result in an additional drug sparing effect for at least 1year without critical safety signals. Thus, AITC might be further investigated prospectively prior to advocating its use in routine minimally invasive glaucoma surgery.

Five-year Clinical Outcomes of Inferior Quadrant Trabectome Surgery for Open Angle Glaucoma.

This retrospective study of 264 eyes having inferior-quadrant trabectome surgery confirms its safety and relatively effectiveness. Most patients however still require IOP-lowering agents and a considerable proportion may need additional glaucoma surgery. To report outcomes from a large single-centre cohort of inferiorly-applied trabectome surgery. Retrospective review of patients undergoing trabectome surgery for chronic open angle glaucoma (COAG) at the University Eye Clinic Bonn, Germany, from 2012 to 2020. Twohundred-sixty-four eyes of 206 patients with COAG were included. Mean review period was 45.43 (range 12-101) months. 105 eyes (39.8%) underwent standalone surgery, of which 74 were pseudophakic and 31 phakic. Mean preoperative IOP was 17.58mmHg (range 12-50mmHg). 105 eyes (39.8%) developed a 'failure event' according to pre-defined criteria at a mean interval of 14.8 months post-op. In absolute terms, 211 patients (79.9%) had a long-term IOP >14mmHg at 7.6 months, 174 patients (65.9%) >16mmHg at 10.6 months, 127 patients (48.1%) >18mmHg at 10.9 months and 77 patients (29.2%) >21mmHg at 11.1 months. Over a five-year period, overall mean IOP remained stable at 13mmHg. The majority of patients were still on glaucoma drops (mean number reduced from 2.9 to 2.7 agents). Sub-group analyses showed that higher pre-operative IOP was a positive predictor for failure whereas combined surgery (with phaco) had better IOP outcomes (16.5mmHg vs. 19.3mmHg respectively). 41 patients (15.5%) developed minor complications: 22 had high postoperative IOP within 3 months, 11 developed a self-resorbing hyphema, 6 had fibrinous uveitis. Trabectome surgery is a safe and relatively effective procedure for lowering IOP but most patients still need IOP-lowering agents and a considerable proportion may need additional glaucoma surgery within a relatively short time. Inferior quadrant treatment may result in inferior IOP outcomes when compared to nasal quadrant surgery.

Long-Term Clinical Results of Trabectome Surgery in Turkish Patients with Primary Open Angle Glaucoma and Pseudoexfoliative Glaucoma.

The objectives of the study were to analyze the long-term results of trabectome surgery in Turkish patients with primary open angle glaucoma (POAG) and pseudoexfoliative glaucoma (PEXG) and to characterize the risk factors for failure. This single-center retrospective non-comparative study included 60 eyes of 51 patients diagnosed with POAG and PEXG, who underwent trabectome alone or phacotrabeculectomy (TP) surgery between 2012 and 2016. Surgical success was defined as a 20% decrease in intraocular pressure (IOP) or IOP≤21 mmHg and no further glaucoma surgery. Risk factors for further surgery were analyzed with the Cox proportional hazard ratio (HR) models. The cumulative success analysis was undertaken with the Kaplan-Meier method based on the time to further glaucoma surgery. The mean follow-up period was 59.4±14.3 months. During the follow-up period, 12 eyes required additional glaucoma surgery. The mean pre-operative IOP was 26.9±6.8 mmHg. The mean IOP at the last visit was 18.8±4.7 mmHg (p<0.01). IOP decreased 30.1% from the baseline to the last visit. The average number of antiglaucomatous drug molecules used was 3.4±0.7 (range 1-4) preoperatively and 2.5±1.3 (range 0-4) at the last visit (p<0.01). The risk factors for further surgery requirement were determined as a higher baseline IOP value (HR: 1.11, p=0.03] and the use of a higher number of preoperative antiglaucomatous drug molecules (HR: 2.54, p=0.09). The cumulative probability of success was calculated as 94.6%, 90.1%, 85.7%, 82.1%, and 78.6% at three, 12, 24, 36, and 60 months, respectively. The success rate of trabectome was 67.3% at 59 months. A higher baseline IOP value and the use of a higher number of antiglaucomatous drug molecules were associated with an increased risk of further glaucoma surgery requirement.

Noninferiority of Microhook to Trabectome: Trabectome versus Ab Interno Microhook Trabeculotomy Comparative Study (Tram Trac Study)

To elucidate the noninferiority of ab interno microhook trabeculotomy (μTLO) using a recently developed reusable stainless spatula-type microhook device to incise the trabecular meshwork to Trabectome (Neomeix, Inc) surgery in terms of the 1-year postoperative outcomes of Japanese patients with glaucoma by means of propensity score analyses. Multicenter, retrospective cohort study. We enrolled 553 and 392 patients who underwent Trabectome surgery and μTLO, respectively, between January 2014 and March 2020 at 10 facilities. Logistic regression analysis was conducted to calculate the propensity score, which indicates the likelihood of treatment assignment (Trabectome or μTLO). We set the following factors as outcome-related covariates: age, sex, facility, glaucoma disease types, preoperative intraocular pressure (IOP), glaucoma drug score, mean deviation of Humphrey visual field test results, antithrombotic drug use, the presence or absence of combined cataract surgery, and incision range of the trabecular meshwork (1 or 2 quadrants). We analyzed 4 different methods (matching, inverse probability of treatment weighting [IPTW], stratification, and regression adjustment) using the propensity score. We set 15% as the noninferiority margin based on previous Trabectome meta-analysis results. The primary outcome was surgical success at 1 year after surgery. We defined surgical success as satisfying all 3 criteria: (1) IOP within 5 to 21 mmHg, (2) IOP reduction of 20% or more from preoperative IOP, and (3) no additional glaucoma surgery. The 95% confidence interval of risk difference of surgical failure in μTLO in reference to Trabectome surgery was-12.1% to+9.5% in matching,-12.7% to+11.1% in IPTW,-12.2 to+7.0 in stratification, and-9.7% to+8.1% in regression adjustment, all of which fell within the predetermined noninferiority margin of 15%. Surgical success of μTLO at 1 year after was not inferior to that of Trabectome surgery.

Characteristics of glaucoma patients with intraocular pressure elevation early after trabectome surgery.

To analyze the rate and time of occurrence of intraocular pressure (IOP) elevation early after trabectome surgery (TOM) and the characteristics of glaucoma patients recovering from IOP elevation. Four hundred sixty eyes of 460 glaucoma (191 primary and 269 secondary open-angle glaucoma) patients who underwent TOM were evaluated. IOP elevation early after TOM was diagnosed when IOP increased by more than 5mmHg over baseline within 1week to 3months. If the IOP decreased with the administration of anti-glaucoma eye drops alone, patients were classified as recovered. If the IOP did not decrease despite additional anti-glaucoma eye drop use, patients were classified as non-recovered. The rate and time of occurrence of IOP elevation early after TOM were investigated. Demographic and ocular variables related to recovery and non-recovery were identified by multivariate logistic regression analysis. Of the 460 patients, IOP elevation early after TOM occurred in 102 (22.2%). IOP elevation occurred most frequently at postoperative week 1. Of the 102 patients with IOP elevation, 55 (53.9%) recovered and 47 (46.1%) did not. A large hyphema size the day after surgery was associated with increased likelihood of recovery from IOP elevation (odds ratio [OR], 6.6). A history of past selective laser trabeculoplasty (SLT; OR, 0.10) and high baseline IOP (OR, 0.86) were associated with reduced likelihood of recovery from IOP elevation. IOP elevation early after TOM occurred most frequently at postoperative week 1. Patients with a large hyphema size, no history of SLT, and a lower baseline IOP recovered from IOP elevation early after TOM. A large hyphema the day after surgery suggested an increased likelihood of recovery from IOP elevation.

Factors associated with achieving intraocular pressure lower than 15\xa0mmHg by Trabectome surgery in primary open-angle glaucoma

To assess good prognostic factors of Trabectome surgery in primary open-angle glaucoma (POAG), clinical records of patients with POAG who underwent Trabectome surgery with/without cataract surgery as the first additive therapy to eye drops between January 2015 and March 2018 were retrospectively reviewed. Overall, data of 79 eyes (79 patients; 50 men; mean age, 68.0 years) up to postoperative 24 months were analyzed. Their mean intraocular pressure (IOP) was 20.4 ± 6.0 mmHg at baseline. Forty-two eyes (53.2%) achieved an IOP < 15 mmHg and ≥ 20% reduction from baseline without additional treatments. Phakic eyes had a better survival probability than pseudophakic eyes after adjusting for age, sex, baseline IOP, best-corrected visual acuity, and eye drop score (hazard ratio 3.096; 95% confidence interval [95% CI] 1.367–7.013; P = 0.007). Phakic eyes treated with combined Trabectome and cataract surgeries (mean survival time, 22.250 months; 95% CI 17.606–26.894) had a better survival probability than pseudophakic eyes treated with Trabectome surgery only (mean survival time, 12.111 months; 95% CI 8.716–15.506; P = 0.009) after the adjustment. Among the eyes treated with Trabectome surgery only, phakic eyes required significantly less additional treatments than pseudophakic eyes (P = 0.04). Trabectome surgery may be indicated for phakic eyes with POAG in addition to eye-drop therapy.

Effect of Preoperative Intraocular Pressure in Patients with and without Intolerance to Their IOP-Lowering Medication on the Outcome of Trabectome Surgery

PurposeThis study aimed to compare the effect of trabectome surgery in patients with and without intolerance to their medication and with preoperatively sufficiently controlled, insufficiently controlled, and uncontrolled intraocular pressure (IOP) on the surgical outcome.Patients and MethodsA total of 155 eyes (133 patients) with different forms of open angle glaucoma with or without intolerance to their glaucoma medication undergoing trabectome surgery alone (AIT) or combined with phacoemulsification (phaco-AIT) were included in this retrospective monocentric study. Patients were corresponding to IOP ≤ 18 mmHg (controlled but glaucoma progression or intolerance, group 1), 19–26 mmHg (insufficiently controlled, group 2), and ≥ 26 mmHg (not controlled, group 3), respectively. Pre- and postoperative IOP and the number of IOP-lowering medications were registered over 12 months. Surgical success was defined as a postoperative IOP of ≤18mmHg and/or reduction of the topical treatment demand after 1 year.ResultsOf the 155 included eyes, 79 received AIT and 76 received phaco-AIT. Sixty-nine eyes had a preoperatively sufficiently controlled IOP, 63 had an insufficiently controlled IOP, and 23 had an uncontrolled IOP. In all groups, the IOP significantly dropped by 6 and 12 months after surgery (p < 0.001). Surgical success war similar in all groups [47.8% (group 1), 38.1 (group 2) and 34.8% (group 3); p= 0.47]. The effect of AIT on IOP and glaucoma medication independent of intolerance to the anti-glaucoma medication and type of surgery (AIT/phaco-AIT).ConclusionIndependently of the preoperative IOP, a satisfying surgical success was achieved using AIT. In instances that do not qualify for filtrating surgery, trabectome surgery alone or in combination with phacoemulsification thus represents a safe and effective minimally invasive glaucoma surgery technique regardless of an intolerance to the topical medication.

Predictability of ab-interno trabeculectomy success in the subsequent eye: A contralateral eye comparison study.

To determine whether the outcome of the first eye may serve as a predictor for intraocular pressure (IOP)-lowering effectiveness in the second eye following bilateral ab interno trabeculectomy. This retrospective single-centre study included 168 eyes from 84 participants, who underwent combined Trabectome surgery with phacoemulsification cataract surgery in a hospital setting. The clinical endpoint was defined as either 'success' or 'failure' based on four separate scores at the longest follow-up time point: IOP at follow-up <21 mm Hg (Score A) or IOP < 18 mm Hg (Score B), without re-surgery and IOP reduction >20%; IOP ≤15 mm Hg without re-surgery and IOP reduction ≥40% (Score C); and the sole absence of re-surgery according to the discretion of the surgeon (Score D). No significant difference was observed between the outcomes of first and second eyes. The frequency of success in the second eye after effective surgery in the first eye significantly exceeded that after prior failure. Within our analysis, the probability calculations determined a 75% chance of success following prior success for Score A. If surgery in the first eye failed, the chance of success in the subsequent eye was 37%. The corresponding probabilities were 79% and 32% for Score B, 56% and 9% for Score C, and 99% and 50% for Score D. The results of our study offer a useful tool to assess the success of subsequent eye surgeries based on the outcome in the initial eye, owing to the high predictive potential.

The Outcomes of Trabectome Surgery in Patients with Low, Middle, and High Preoperative Intraocular Pressure.

BackgroundWe compared the efficiency of trabectome surgery for patients with differing preoperative intraocular pressure (IOP) values in a single-facility retrospective study. We evaluated surgical outcomes based on three grades of preoperative IOP: high (hi-IOP, >26 mmHg), middle (mid-IOP, 18–26 mmHg), and low (lo-IOP, <18 mmHg).Patients and MethodsWe analyzed the cases of 204 eyes that underwent trabectome surgery and were followed >2 years. We defined failure as a reduction of IOP <20% or requiring additional glaucoma surgery. We used 4 cutoff values >21, >18, >15, and >12 mmHg. Other factors that may affect surgical outcomes were also investigated: age, central corneal thickness (CCT), history of selective laser trabeculotrabculoplasty (SLT), preoperative visual field, and simultaneous cataract surgery.ResultsTrabectome surgeries significantly decreased the IOP values from 23.0 ± 7.2 mmHg to 13.6 ± 3.6 mmHg at 2 years post-surgery. The mid-IOP group achieved significantly better surgical outcomes than the lo-IOP and hi-IOP groups with cutoff values 21, 18, and 15 mmHg. A thin CCT and simultaneous cataract surgery were significantly related to better surgical outcomes with cutoff value 21.18 and 15 mmHg.ConclusionFor the patients with preoperative IOP <18 mmHg, it was difficult to decrease their IOP >20% with trabectome surgery. Patients with preoperative IOP values >26 mmHg often required additional glaucoma surgery.

Evaluation of Blood-filling Patterns in Schlemm Canal for Trabectome Surgery.

The purpose of this study was to evaluate the association between trabectome surgery outcomes and the blood filling patterns in SC before TM ablation. This retrospective cohort study included 105 eyes of 84 Japanese primary open-angle glaucoma patients who had undergone trabectome surgery in combination with cataract surgery. Provocative gonioscopy was performed before TM ablation to classify the blood filling patterns in SC into 3 groups: no filling (group 1); patchy/irregular filling (group 2); and complete filling (group 3). The subjects were divided into 3 groups according to the blood filling patterns and the trabectome surgery outcomes were compared, including intraocular pressure (IOP), the percentage reduction in IOP, surgical success rate, and the number of glaucoma medications. Success was defined by IOP ≤15 mm Hg and a >20% reduction in IOP with/without glaucoma medication, and without additional glaucoma surgery after trabectome surgery combined with cataract surgery. Twenty-four eyes were assigned to group 1, 48 to group 2, and 33 to group 3. Between-group analyses showed no significant intergroup differences in age (P=0.213), preoperative mean deviation (P=0.505), preoperative and postoperative IOP (P=0.941 and 0.458, respectively), preoperative and postoperative number of glaucoma medications (P=0.805 and 0.077, respectively), percentage IOP reduction (P=0.256), and success rates (P=0.540). Trabectome surgery is effective for mild to moderate primary open-angle glaucoma patients, independent of the blood-filling patterns in SC before the TM ablation.

Long-term clinical results of trabectome surgery in patients with open-angle glaucoma.

To evaluate the 72-month clinical results of trabectome surgery (TOM) in patients with primary open-angle glaucoma (POAG), secondary OAG and childhood glaucoma. A total of 305 eyes from 249 glaucoma patients were analyzed in the current retrospective single-center study. Kaplan-Meier analysis was performed using three criteria: criterion A (postoperative intraocular pressure [IOP] ≤ 21mmHg and ≥ 20% reduction from baseline IOP); criterion B (postoperative IOP ≤ 18mmHg and ≥ 20% reduction from baseline IOP); and criterion C (postoperative IOP ≤ 16mmHg and ≥ 20% reduction from baseline IOP). The changes in IOP, medication score, success probability, results of the multivariate analysis for success and failure risk factors, and complications were analyzed. The baseline IOP in all glaucoma patients decreased from 29.2 ± 9.8mmHg with a 5.3 ± 1.7 medication score to 16.4 ± 5.8mmHg (- 43.8%) with a 4.2 ± 1.5 medication score at 72months (p < 0.01). The success probabilities in all cases for 72months based on criterion A, B, and C were 44%, 35%, and 17%, respectively. For criterion A, no significant differences were found in the success probability according to the glaucoma subtype for 72months. The combined surgical procedure significantly decreased the failure risk (hazard ratio [HR]: 0.59). On the other hand, the presence of POAG (HR: 1.6) and a history of past selective laser trabeculoplasty (HR: 2.2) significantly increased failure risk. One patient (0.3%) demonstrated endophthalmitis after TOM but recovered through appropriate treatment. At the 72-month time point, approximately half of the glaucoma patients maintained an IOP ≤ 21mmHg with ≥ 20% IOP reduction. TOM is a safe surgery but may not yield sufficient IOP reduction in patients who have received SLT or have POAG.

Comparison of trabectome and microhook surgical outcomes

Several methods can be applied for a trabeculotomy, including the uses of thread, a blade, cauterization, and a hook. We compared the outcomes of trabectome surgery and microhook surgery. We analyzed the cases of 133 eyes that underwent trabectome (72 eyes) or microhook (61 eyes) surgery and were followed for > 1year. We defined failure as a < 20% reduction in the postoperative intraocular pressure (IOP) value or requiring additional glaucoma surgery. We used three surgical success definitions: ≤ 21, ≤ 18, and ≤ 15mmHg IOP reduction. A Kaplan-Meier survival analysis was performed for the surgical outcomes. We compared the trabectome and microhook groups' postoperative IOP values, number of glaucoma medications, and postoperative complications. At 1year postsurgery, the trabectome surgeries decreased the IOP significantly from 24.6 ± 7.3 to 13.3 ± 3.7mmHg, and the microhook surgeries significantly decreased the IOP from 24.1 ± 9.2 to 12.5 ± 3.9mmHg. The two groups' 1-year postoperative IOP values were not significantly different (p = 0.310). The surgical outcomes of the trabectome surgeries were significantly better than those of the microhook surgeries (≤ 21mmHg: p = 0.0049, ≤ 18mmHg: p = 0.0029, and ≤ 15mmHg: p = 0.0393). There were three patients with ciliary detachment in the microhook surgery group. Trabectome surgery provided significantly better surgical outcomes than microhook surgery. The risk of postoperative ciliary detachment should be considered in microhook surgery cases.

Can a contact lens sensor predict the success of trabectome surgery?

We examined whether a contact lens sensor (CLS) is useful for the postoperative evaluation of trabectome surgery. We investigated the correlations between the outcomes of trabectome surgery and the output of a CLS. We examined 24 consecutive eyes of patients with pseudo-exfoliation glaucoma. In each eye, the intraocular pressure (IOP) fluctuations over 24h were measured with the SENSIMED Triggerfish CLS before and at 3months after the trabectome surgery. We divided the patients into success (n = 12 eyes) and failure (n = 12 eyes) groups; success was defined as a postoperative IOP level ≤ 21mmHg plus an IOP reduction ≥ 20% relative to the preoperative IOP value with or without anti-glaucoma medications. We investigated CLS parameters that correlate with surgical outcomes by performing a Cox hazard regression analysis. We determined the maximum value, minimum value, and range of IOP fluctuation as CLS parameters. The mean follow-up period was 38.0 ± 3.0months. The success rate was 50%. The postoperative range of IOP fluctuation during the nocturnal period with the CLS was significantly correlated with the surgical results (p = 0.024). A smaller range of IOP fluctuation was significantly correlated with better surgical outcomes. We were able to predict the surgical success after trabectome surgery at 3months using the CLS. Thus, CLS results could be a new surgical evaluation parameter.

The Influence of Trabectome Surgery on Corneal Endothelial Cells.

The purpose of this study was to evaluate the influence of trabectome surgery on corneal endothelial cells by site. Retrospective observational study. Trabectome surgeries were performed on 159 eyes of 132 adult Japanese patients. Corneal endothelial cells were measured at the center (C), inferior (I), nasal inferior (NI), nasal superior (NS), superior (S), temporal superior (TS), and temporal inferior (TI) sectors at <1 month preoperatively and 3, 6, 12, 24, and 36 months postoperatively, for changes in corneal endothelial cell density (ECD), coefficient of variation (CV), and incidence of hexagonal cells (6A). Mean preoperative ECD in all groups were 2401±451 (SD) cells/mm (C), 2366±450 cells/mm (I), 2397±479 cells/mm (NI), 2476±554 cells/mm (NS), 2493±596 cells/mm (S), 2464±558 cells/mm (TS), and 2329±510 cells/mm (TI). The 12-month postoperative mean ECDs were 2344±480 cells/mm (C), 2312±469 cells/mm (I), 2325±536 cells/mm (NI), 2473±517 cells/mm (NS), 2438±607 cells/mm (S), 2227±578 cells/mm (TS), and 2193±523 cells/mm (TI). There was no change in ECD in all sectors before and after surgery. ECD decreased at the TS and TI in combination with cataract surgery (2620±430 and 2445±384 cells/mm) preoperatively to 2264±501 and 2216±477 cells/mm at 12 months postoperatively. CV and 6A did not change at all sites in all surgical procedures before and after surgery. Trabectome surgery involves minimal effects to corneal endothelial cells, although long-term prospective studies with greater sample sizes are necessary to confirm this conclusion.

Five-year clinical outcomes of combined phacoemulsification and trabectome surgery at a single glaucoma center.

To analyze the 5-year results of trabectome ab interno trabeculectomy of a single glaucoma center. In this retrospective interventional single-center case series, data of 93 patients undergoing ab interno trabeculotomy between September 2010, and December 2012 were included. Kaplan-Meier analysis was performed using success criteria defined as postoperative intraocular pressure (IOP) ≤ 21mmHg, and > 20% reduction from preoperative IOP, and no need for further glaucoma surgery. Risk factors for failure were identified using Cox proportional hazards ratio (HR). The retention rate for 5-year follow-up was 66%. The cumulative probability of success at 1, 2, 3, 4, and 5years was 82.6%, 76.7%, 73.9%, 72.3%, and 67.5%. Risk factors for failure were lower baseline IOP (HR = 0.27, P = 0.001), younger age (HR = 0.25, P = 0.02), and higher central corneal thickness (HR = 0.18, P = 0.01). Exfoliative glaucoma was associated with a higher success rate (HR = 0.39, P = 0.02). IOP was decreased significantly from 20.0 ± 5.6mmHg at baseline to 15.6 ± 4.6mmHg at 5-year follow-up (P = 0.001). The baseline number of glaucoma medications was 1.8 ± 1.2, which decreased to 1.0 ± 1.2 medications at 5years. Trabectome surgery was associated with a good long-term efficacy and safety profile in this single-center case series with a high retention rate.

Reduction in Ocular Hypotensive Eyedrops by Ab Interno Trabeculotomy Improves Not Only Ocular Surface Condition But Also Quality of Vision.

Purpose To investigate the effect of ab interno trabeculotomy using the Trabectome surgical system on tear film stability and functional visual acuity (FVA). Patients and Methods Adult glaucoma patients who underwent Trabectome surgery alone or Trabectome surgery combined with phacoemulsification with intraocular lens insertion were included in this study. Corneal epithelial defects, tear film breakup time (TBUT), tear meniscus height, tear film spreading grade, tear interferometry grade, and FVA were assessed before and after surgery in addition to routine ophthalmic examinations. Changes in ocular surface conditions and visual acuity as a result of the Trabectome surgery were investigated. Results Thirty eyes of 22 patients with a mean age of 72.2 ± 7.9 years, including 8 males and 14 females, were enrolled. The Trabectome surgery significantly reduced the intraocular pressure (IOP) from 20.3 ± 5.2 to 15.0 ± 3.3 mmHg (P < 0.001) and the number of different types of ocular hypotensive eyedrops used from 3.2 ± 0.7 to 1.1 ± 0.7 types (P < 0.001). The surgery significantly improved corneal epithelial defects, the tear spreading grade, the tear interferometry grade, and FVA. The surgery also improved the visual maintenance ratio among all enrolled patients, including those who underwent Trabectome surgery only. Conclusion Trabectome surgery may be beneficial not only for IOP reduction but also for improving ocular surface conditions and FVA.

Two-year outcomes of ab interno trabeculectomy with the Trabectome for Chinese primary open angle glaucoma: a retrospective multicenter study.

To evaluate the 2-year efficacy and safety of ab interno trabeculectomy with the Trabectome in Chinese primary open angle glaucoma (POAG) patients. This was a multicenter, retrospective, observational study and included POAG patients with or without visually-significant cataracts. The Chinese patients were enrolled from three glaucoma centers and a group of comparable Japanese POAG patients was analyzed from our international Trabectome database. The patients received Trabectome or a combined surgery with phacoemulsification and intraocular lens implantation. The primary outcome was intraocular pressure (IOP) reduction. Secondary outcomes included reduction of glaucoma medications, surgical complications, and success at 2y. Success was defined as: 1) IOP≤21 mm Hg and at least 20% IOP reduction from baseline after 3mo at any two consecutive visits; 2) no additional glaucoma surgery required. A total of 42 Chinese POAG patients from three glaucoma centers were enrolled. Twelve patients underwent Trabectome surgery combined with phacoemulsification and intraocular lens implantation while the remainder underwent Trabectome surgery alone. Thirteen patients had a history of failed glaucoma surgery and were considered as complicated cases. In China data, the mean preoperative IOP was 21.4±1.23 mm Hg. The Trabectome lowered IOP to 17.9±1.8 mm Hg at 2y (P=0.05). The number of glaucoma medications also decreased significantly from a baseline of 2.0±0.9 to 1.1±0.8 at 2y post-surgery (P=0.04). The overall 2-year success rate was 78%, with patients undergoing combined surgery having a higher success rate compared with those undergoing Trabectome surgery alone (100% vs 76%). In Japan data, the mean preoperative IOP was 20.8±7.7 mm Hg. The Trabectome lowered IOP to 12.20±2.0 mm Hg at 2y. The number of glaucoma medications also decreased significantly from a baseline of 2.1±0.9 to 3.4±0.6 at 2y post-surgery. In all patients, no major complications were seen. Surgery with the Trabectome appears to be an efficient and safe procedure in Chinese POAG patients in the long-term.

Trabectome outcomes across the spectrum of glaucoma disease severity.

To compare the efficacy of ab-interno trabeculotomy with Trabectome® in mild glaucoma versus moderate/severe glaucoma along the spectrum of glaucoma disease severity. Subjects with at least 12months follow-up were separated into two groups based on glaucoma severity. Severity was determined based on optic nerve cup-to-disc ratio and/or automated visual field data, with cup-to-disc ratio < 0.7 and/or visual field mean deviation ≤ 6.0dB used to define the mild group (n = 1127), and cup-to-disc ratio > 0.7 and/or visual field mean deviation > 6.0dB used to define the moderate/severe group (n = 1071). These groups were further subdivided into patients undergoing Trabectome with cataract surgery or Trabectome alone. Mean IOP reduction, medication usage, and success rates were compared between the two groups. Success was defined as IOP reduction of 20% or more from pre-operative IOP and IOP less than 21mmHg with no secondary surgery throughout the follow-up period. The mean post-operative IOP and success rates were similar between the groups. IOP reduction for the mild group was 26% (from pre-op IOP of 24 to 16.1mmHg) and for the moderate/severe group was 24% (from pre-op IOP of 22.6 to 15.7mmHg) at 12Months. The overall rate of success at 12months for the mild group was 86% and for the moderate/severe group was 83%. Trabectome surgery maintains efficacy across the spectrum of glaucoma disease severity. This particular minimally invasive glaucoma surgery procedure can be an excellent choice for subjects with moderate/advanced glaucoma as well as for early glaucoma with or without cataract surgery and is applicable to a broad patient population.

Impact of same-session trabectome surgery on Ahmed glaucoma valve outcomes.

To evaluate the efficacy and survival rates of same session ab interno trabeculectomy with the trabectome and Ahmed glaucoma valve implant (AT) in comparison to the Ahmed glaucoma valve alone (A). A total of 107 eyes undergoing primary glaucoma surgery were enrolled in this retrospective comparative case series, including 48 eyes which underwent AT and 59 eyes which received A alone. Participants were identified using the procedural terminology codes, and their medical records were reviewed. The primary outcome measure was success defined as IOP > 5mmHg, ≤ 21mmHg and ≥ 20% reduction of IOP from baseline at two consecutive visits after 3months, and no need for glaucoma reoperation. Secondary outcome measures were IOP, the number of glaucoma medications, incidence of a hypertensive phase, and best corrected visual acuity (BCVA). The cumulative probability of success at 1year was 70% in AT, and 65% in A (p = 0.85). IOP decreased significantly from 26.6 ± 10.1mmHg at baseline to 14.7 ± 3.3mmHg at the final follow-up in AT (p = 0.001). The corresponding numbers for A were 27.8 ± 10.2 and 16.7 ± 4.9, respectively (p = 0.001). The final IOP was significantly lower in AT (p = 0.022). The number of medications at baseline was comparable in both groups (2.6 ± 1.2 in AT and 2.5 ± 1.3 in A, p = 0.851). Corresponding number at 1year visit was 1.2 ± 2 in AT and 2.8 ± 1.8 in A (p = 0.001). The incidence of a hypertensive phase was 18.7% in AT and 35.5% in A (p = 0.05). HP resolved in only 30% of eyes. The criteria for HP resolution were fulfilled in 9 eyes (30%). There was no difference in the rate of resolution of the hypertensive phase between AT and A (33.3 and 28.5%, respectively, p = 0.67). Ahmed glaucoma valve implant with same session trabectome surgery significantly decreased the rate of the hypertensive phase and postoperative IOP as well as the number of glaucoma medications.